Slide 1

How To Run
OnSite Chlamydia Ag Rapid Test
(Catalog: R0080C)

C. trachomatis and Chlamydia
• Chlamydia trachomatis (C. trachomatis)
o The most common sexually transmitted
bacterial pathogen
o Major
cause of cervicitis, urethritis,
endometritis, and pelvic inflammatory
disease in women
o urethritis and epididymitis in men
• Chlamydia infection
o 80 million worldwide annually
o At least 3 million new cases in U.S.

Chlamydia Trachomatis

Current Diagnosis Methods
•
•
•
•
•

Cell culture
Direct fluorescence assay (DFA)
Enzyme immunoassays (EIA)
PCR
Immunological antigen test
Method

Rapid Test

DFA

EIA

PCR
> 4 hours

Culture

Time to result

15 minutes

2-3 hours

1-4 hours

>3 days

Facility

General Lab

Special Lab

General Lab Special Lab

Special Lab

Equipment

No

Expensive

PCR machine
Pipette

Incubator,
microscopy

Skill

Minimal

Well trained

Reader,
incubator,
pipette
Moderate

Well trained

Specialist

Comments

Cost effective

Costly

Costly

Costly

Costly

OnSite Chlamydia Ag Rapid Test

Intended Use
• Lateral flow chromatographic immunoassay

• Qualitative detection of C. trachomatis antigen in endocervical or
encourethral swab specimens
• Used as a screening test for diagnosis of infection with C.
trachomatis

Test Principle
• Double antibody-sandwich immunoassay

• A unique pair of Abs to selectively identify C. trachomatis Ag in the
specimen
• Test kit key components:
Test Band

Control Band

Pre-coated with another mouse
monoclonal anti-C. trachomatis Ab

Pe-coated with goat
anti-mouse IgG Ab

Kit Components
• 25 test devices (individually sealed
pouches containing with 1 cassette
device & 1 desiccant)
• 1 Extraction Buffer A (6 mL/vial)
• 1 Extraction Buffer B (6 mL/vial)
• 25 sample extraction tubes
• 1 package insert

Materials Required and Not Provided
• Swab for collecting specimen

• Clock or timer
• Disposable gloves
• Rack to hold extraction tube
• Biohazard container
• Marker pen

Precautions
Precautions

Explanation

Package insert MUST be read completely Pay attention to updated information
before testing
Do NOT open the pouch unless ready to Test device become moisture when
test
expose to humidity air, affect flow

Do NOT use components in any other Component in each kit is unique
type of test kit
Do NOT use expired devices

Expired product gives error result

Bring all reagents to room temperature Cold reagent has different viscosity,
(15-30°C) before use
affect flow migration and results
The testing results should be read within Extend reading time may lead to false
10 minutes after a specimen is applied to positive result.
the sample pad of the device
Do NOT perform the test in a room with Strong air flow causes specimen
strong air flow as the specimens might evaporation during assay, leads to
evaporate before reach
error result

Specimen Collection and Handling
• Consider any materials of human origin as infectious and handle them
using standard biosafety procedures
• Swab specimen should be collected by standard male or female
specimen collection methods
• Swabs should be processed as soon as possible after collection. If
swabs are not processed immediately, they should be placed into a
dry, sterile, tightly capped tube or bottle, and stored at 2-8°C for up to
5 days, preferably in a transportation tube

• Do NOT use bloody swabs
• Do NOT freeze swabs

Preparation for Assay
• Wear protective clothing and
disposable gloves

Preparation for Assay
• Set up work area

• Bring all kit components to room
temperature (15-30°C) prior to
testing

Preparation for Assay
• Double check product’s name
and expiration date
Product Name
Expiration Date

Do not use expired test device

Perform Assay
• Label an extraction tube for each
patient and place in a tube holder
or rack

Perform Assay
• Place specimen swab into the
extraction tube
• Add 4 drops (200 mL) of
Extraction Buffer A while holding
the bottle vertically

All drops must be free falling
with the reagent bottles held
vertically. Do not allow the tips
of the bottles to come in contact
with the extraction cups

Perform Assay
• Twirl briefly to mix the reagent

Perform Assay
• Incubate at room temperature
(15-30°C) for 5 minutes, but no
longer than 10 minutes

Perform Assay
• Add 4 drops (200 mL) of
Extraction Buffer B while holding
the bottle vertically

All drops must be free falling
with the reagent bottles held
vertically. Do not allow the tips
of the bottles to come in contact
with the extraction cups

Perform Assay
• Twirl the swab vigorously for 10 seconds and incubate for 1 minute,
but no longer than 10 minutes

Perform Assay
• Expunge as much liquid as
possible from swab by pressing
and rotating the fiber portion
against the wall of the tube

Perform Assay
• Discard used swab into biohazard
container

Perform Assay
• Cap the tube and mix contents by gentle swirling

• The swab extract can be tested immediately or remain at room
temperature for up to 3 hours without affecting test results

Perform Assay
• Remove a test device from its
protective pouch
• Place the test device on a clean,
flat surface
• Label the device with specimen’s
ID number

Do not open pouch unless ready
to run the test

Perform Assay
• Hold extraction tube vertically

• Dispense 2 drops (100 mL) of
extract to the sample pad

Do not over load samples

Perform Assay
• Set up timer

• Read test result within 15
minutes. Some positive results
may be visible as soon as 1
minute
• Complete reaction time of 15
minutes is required to confirm
negative results

Do not read result after 15 minutes

Read Assay Result
• Negative or non-reactive result
Only C band is developed
• Positive or reactive result
Both C and T bands are developed
• In valid result
No C band is developed

• Samples with positive results should be confirmed with alternative
testing method(s) such as antibody test, PCR and clinical findings
before to make diagnostic decision
• If C band isn’t developed, review whole procedure and repeat the
assay with a new device

Perform Assay
• Discard the used cassette device
and the protection sheet into
biohazard
container
after
interpreting the result

Quality Control
Internal Control

• Built-in control feature, the C band
o Developed C band indicates the procedure is correct
External Control
• Run 1 Positive Control and 1 Negative Control to assure proper
performance of the assay, when:
o a new operator uses the kit
o a new lot of test kit is used
o a new shipment of kits is used
o temperature used during storage of the kit falls outside of 2-30°C
o the temperature of the test area falls outside of 15-30°C
o to verify a higher than expected frequency of positive or negative
result
o to investigate the cause of repeated invalid results

Limitation of Test
• For optimal test performance, proper sample collection and storage
procedures are critical. Failure to follow the procedure may give
inaccurate results
• Limited to the qualitative detection of C. trachomatis antigen in swab
specimens. The intensity of the test band does not correlate with
antigen titer of the specimen
• Do not specifically differentiate between C. Trachomatis, C.
Pneumonia or C. Psittasi
• A negative or non-reactive test result:
o does not preclude the possibility of exposure to C. trachomatis
o It can occur if the concentration of the C. trachomatis antigen
present in the specimen is below the level detectable by the assay,
or the antigen is not present in the specimen or improper sample
treatment procedure
• If the symptom persists, while the result is negative or non-reactive
result, it is recommended to re-sample the patient few days later or
test with an alternative test device or method
• The results should only be interpreted in conjunction with other
diagnostic procedures and clinical findings

Technical Support
Contact Info.:
10110 Mesa Rim Rd. San Diego, CA 92121 USA
Email Address: [email protected]
Telephone: 1 (858) 457-8698
Fax: 1 (858) 535-1739

QUALITY . INNOVATION . SIMPLICITY


Slide 2

How To Run
OnSite Chlamydia Ag Rapid Test
(Catalog: R0080C)

C. trachomatis and Chlamydia
• Chlamydia trachomatis (C. trachomatis)
o The most common sexually transmitted
bacterial pathogen
o Major
cause of cervicitis, urethritis,
endometritis, and pelvic inflammatory
disease in women
o urethritis and epididymitis in men
• Chlamydia infection
o 80 million worldwide annually
o At least 3 million new cases in U.S.

Chlamydia Trachomatis

Current Diagnosis Methods
•
•
•
•
•

Cell culture
Direct fluorescence assay (DFA)
Enzyme immunoassays (EIA)
PCR
Immunological antigen test
Method

Rapid Test

DFA

EIA

PCR
> 4 hours

Culture

Time to result

15 minutes

2-3 hours

1-4 hours

>3 days

Facility

General Lab

Special Lab

General Lab Special Lab

Special Lab

Equipment

No

Expensive

PCR machine
Pipette

Incubator,
microscopy

Skill

Minimal

Well trained

Reader,
incubator,
pipette
Moderate

Well trained

Specialist

Comments

Cost effective

Costly

Costly

Costly

Costly

OnSite Chlamydia Ag Rapid Test

Intended Use
• Lateral flow chromatographic immunoassay

• Qualitative detection of C. trachomatis antigen in endocervical or
encourethral swab specimens
• Used as a screening test for diagnosis of infection with C.
trachomatis

Test Principle
• Double antibody-sandwich immunoassay

• A unique pair of Abs to selectively identify C. trachomatis Ag in the
specimen
• Test kit key components:
Test Band

Control Band

Pre-coated with another mouse
monoclonal anti-C. trachomatis Ab

Pe-coated with goat
anti-mouse IgG Ab

Kit Components
• 25 test devices (individually sealed
pouches containing with 1 cassette
device & 1 desiccant)
• 1 Extraction Buffer A (6 mL/vial)
• 1 Extraction Buffer B (6 mL/vial)
• 25 sample extraction tubes
• 1 package insert

Materials Required and Not Provided
• Swab for collecting specimen

• Clock or timer
• Disposable gloves
• Rack to hold extraction tube
• Biohazard container
• Marker pen

Precautions
Precautions

Explanation

Package insert MUST be read completely Pay attention to updated information
before testing
Do NOT open the pouch unless ready to Test device become moisture when
test
expose to humidity air, affect flow

Do NOT use components in any other Component in each kit is unique
type of test kit
Do NOT use expired devices

Expired product gives error result

Bring all reagents to room temperature Cold reagent has different viscosity,
(15-30°C) before use
affect flow migration and results
The testing results should be read within Extend reading time may lead to false
10 minutes after a specimen is applied to positive result.
the sample pad of the device
Do NOT perform the test in a room with Strong air flow causes specimen
strong air flow as the specimens might evaporation during assay, leads to
evaporate before reach
error result

Specimen Collection and Handling
• Consider any materials of human origin as infectious and handle them
using standard biosafety procedures
• Swab specimen should be collected by standard male or female
specimen collection methods
• Swabs should be processed as soon as possible after collection. If
swabs are not processed immediately, they should be placed into a
dry, sterile, tightly capped tube or bottle, and stored at 2-8°C for up to
5 days, preferably in a transportation tube

• Do NOT use bloody swabs
• Do NOT freeze swabs

Preparation for Assay
• Wear protective clothing and
disposable gloves

Preparation for Assay
• Set up work area

• Bring all kit components to room
temperature (15-30°C) prior to
testing

Preparation for Assay
• Double check product’s name
and expiration date
Product Name
Expiration Date

Do not use expired test device

Perform Assay
• Label an extraction tube for each
patient and place in a tube holder
or rack

Perform Assay
• Place specimen swab into the
extraction tube
• Add 4 drops (200 mL) of
Extraction Buffer A while holding
the bottle vertically

All drops must be free falling
with the reagent bottles held
vertically. Do not allow the tips
of the bottles to come in contact
with the extraction cups

Perform Assay
• Twirl briefly to mix the reagent

Perform Assay
• Incubate at room temperature
(15-30°C) for 5 minutes, but no
longer than 10 minutes

Perform Assay
• Add 4 drops (200 mL) of
Extraction Buffer B while holding
the bottle vertically

All drops must be free falling
with the reagent bottles held
vertically. Do not allow the tips
of the bottles to come in contact
with the extraction cups

Perform Assay
• Twirl the swab vigorously for 10 seconds and incubate for 1 minute,
but no longer than 10 minutes

Perform Assay
• Expunge as much liquid as
possible from swab by pressing
and rotating the fiber portion
against the wall of the tube

Perform Assay
• Discard used swab into biohazard
container

Perform Assay
• Cap the tube and mix contents by gentle swirling

• The swab extract can be tested immediately or remain at room
temperature for up to 3 hours without affecting test results

Perform Assay
• Remove a test device from its
protective pouch
• Place the test device on a clean,
flat surface
• Label the device with specimen’s
ID number

Do not open pouch unless ready
to run the test

Perform Assay
• Hold extraction tube vertically

• Dispense 2 drops (100 mL) of
extract to the sample pad

Do not over load samples

Perform Assay
• Set up timer

• Read test result within 15
minutes. Some positive results
may be visible as soon as 1
minute
• Complete reaction time of 15
minutes is required to confirm
negative results

Do not read result after 15 minutes

Read Assay Result
• Negative or non-reactive result
Only C band is developed
• Positive or reactive result
Both C and T bands are developed
• In valid result
No C band is developed

• Samples with positive results should be confirmed with alternative
testing method(s) such as antibody test, PCR and clinical findings
before to make diagnostic decision
• If C band isn’t developed, review whole procedure and repeat the
assay with a new device

Perform Assay
• Discard the used cassette device
and the protection sheet into
biohazard
container
after
interpreting the result

Quality Control
Internal Control

• Built-in control feature, the C band
o Developed C band indicates the procedure is correct
External Control
• Run 1 Positive Control and 1 Negative Control to assure proper
performance of the assay, when:
o a new operator uses the kit
o a new lot of test kit is used
o a new shipment of kits is used
o temperature used during storage of the kit falls outside of 2-30°C
o the temperature of the test area falls outside of 15-30°C
o to verify a higher than expected frequency of positive or negative
result
o to investigate the cause of repeated invalid results

Limitation of Test
• For optimal test performance, proper sample collection and storage
procedures are critical. Failure to follow the procedure may give
inaccurate results
• Limited to the qualitative detection of C. trachomatis antigen in swab
specimens. The intensity of the test band does not correlate with
antigen titer of the specimen
• Do not specifically differentiate between C. Trachomatis, C.
Pneumonia or C. Psittasi
• A negative or non-reactive test result:
o does not preclude the possibility of exposure to C. trachomatis
o It can occur if the concentration of the C. trachomatis antigen
present in the specimen is below the level detectable by the assay,
or the antigen is not present in the specimen or improper sample
treatment procedure
• If the symptom persists, while the result is negative or non-reactive
result, it is recommended to re-sample the patient few days later or
test with an alternative test device or method
• The results should only be interpreted in conjunction with other
diagnostic procedures and clinical findings

Technical Support
Contact Info.:
10110 Mesa Rim Rd. San Diego, CA 92121 USA
Email Address: [email protected]
Telephone: 1 (858) 457-8698
Fax: 1 (858) 535-1739

QUALITY . INNOVATION . SIMPLICITY


Slide 3

How To Run
OnSite Chlamydia Ag Rapid Test
(Catalog: R0080C)

C. trachomatis and Chlamydia
• Chlamydia trachomatis (C. trachomatis)
o The most common sexually transmitted
bacterial pathogen
o Major
cause of cervicitis, urethritis,
endometritis, and pelvic inflammatory
disease in women
o urethritis and epididymitis in men
• Chlamydia infection
o 80 million worldwide annually
o At least 3 million new cases in U.S.

Chlamydia Trachomatis

Current Diagnosis Methods
•
•
•
•
•

Cell culture
Direct fluorescence assay (DFA)
Enzyme immunoassays (EIA)
PCR
Immunological antigen test
Method

Rapid Test

DFA

EIA

PCR
> 4 hours

Culture

Time to result

15 minutes

2-3 hours

1-4 hours

>3 days

Facility

General Lab

Special Lab

General Lab Special Lab

Special Lab

Equipment

No

Expensive

PCR machine
Pipette

Incubator,
microscopy

Skill

Minimal

Well trained

Reader,
incubator,
pipette
Moderate

Well trained

Specialist

Comments

Cost effective

Costly

Costly

Costly

Costly

OnSite Chlamydia Ag Rapid Test

Intended Use
• Lateral flow chromatographic immunoassay

• Qualitative detection of C. trachomatis antigen in endocervical or
encourethral swab specimens
• Used as a screening test for diagnosis of infection with C.
trachomatis

Test Principle
• Double antibody-sandwich immunoassay

• A unique pair of Abs to selectively identify C. trachomatis Ag in the
specimen
• Test kit key components:
Test Band

Control Band

Pre-coated with another mouse
monoclonal anti-C. trachomatis Ab

Pe-coated with goat
anti-mouse IgG Ab

Kit Components
• 25 test devices (individually sealed
pouches containing with 1 cassette
device & 1 desiccant)
• 1 Extraction Buffer A (6 mL/vial)
• 1 Extraction Buffer B (6 mL/vial)
• 25 sample extraction tubes
• 1 package insert

Materials Required and Not Provided
• Swab for collecting specimen

• Clock or timer
• Disposable gloves
• Rack to hold extraction tube
• Biohazard container
• Marker pen

Precautions
Precautions

Explanation

Package insert MUST be read completely Pay attention to updated information
before testing
Do NOT open the pouch unless ready to Test device become moisture when
test
expose to humidity air, affect flow

Do NOT use components in any other Component in each kit is unique
type of test kit
Do NOT use expired devices

Expired product gives error result

Bring all reagents to room temperature Cold reagent has different viscosity,
(15-30°C) before use
affect flow migration and results
The testing results should be read within Extend reading time may lead to false
10 minutes after a specimen is applied to positive result.
the sample pad of the device
Do NOT perform the test in a room with Strong air flow causes specimen
strong air flow as the specimens might evaporation during assay, leads to
evaporate before reach
error result

Specimen Collection and Handling
• Consider any materials of human origin as infectious and handle them
using standard biosafety procedures
• Swab specimen should be collected by standard male or female
specimen collection methods
• Swabs should be processed as soon as possible after collection. If
swabs are not processed immediately, they should be placed into a
dry, sterile, tightly capped tube or bottle, and stored at 2-8°C for up to
5 days, preferably in a transportation tube

• Do NOT use bloody swabs
• Do NOT freeze swabs

Preparation for Assay
• Wear protective clothing and
disposable gloves

Preparation for Assay
• Set up work area

• Bring all kit components to room
temperature (15-30°C) prior to
testing

Preparation for Assay
• Double check product’s name
and expiration date
Product Name
Expiration Date

Do not use expired test device

Perform Assay
• Label an extraction tube for each
patient and place in a tube holder
or rack

Perform Assay
• Place specimen swab into the
extraction tube
• Add 4 drops (200 mL) of
Extraction Buffer A while holding
the bottle vertically

All drops must be free falling
with the reagent bottles held
vertically. Do not allow the tips
of the bottles to come in contact
with the extraction cups

Perform Assay
• Twirl briefly to mix the reagent

Perform Assay
• Incubate at room temperature
(15-30°C) for 5 minutes, but no
longer than 10 minutes

Perform Assay
• Add 4 drops (200 mL) of
Extraction Buffer B while holding
the bottle vertically

All drops must be free falling
with the reagent bottles held
vertically. Do not allow the tips
of the bottles to come in contact
with the extraction cups

Perform Assay
• Twirl the swab vigorously for 10 seconds and incubate for 1 minute,
but no longer than 10 minutes

Perform Assay
• Expunge as much liquid as
possible from swab by pressing
and rotating the fiber portion
against the wall of the tube

Perform Assay
• Discard used swab into biohazard
container

Perform Assay
• Cap the tube and mix contents by gentle swirling

• The swab extract can be tested immediately or remain at room
temperature for up to 3 hours without affecting test results

Perform Assay
• Remove a test device from its
protective pouch
• Place the test device on a clean,
flat surface
• Label the device with specimen’s
ID number

Do not open pouch unless ready
to run the test

Perform Assay
• Hold extraction tube vertically

• Dispense 2 drops (100 mL) of
extract to the sample pad

Do not over load samples

Perform Assay
• Set up timer

• Read test result within 15
minutes. Some positive results
may be visible as soon as 1
minute
• Complete reaction time of 15
minutes is required to confirm
negative results

Do not read result after 15 minutes

Read Assay Result
• Negative or non-reactive result
Only C band is developed
• Positive or reactive result
Both C and T bands are developed
• In valid result
No C band is developed

• Samples with positive results should be confirmed with alternative
testing method(s) such as antibody test, PCR and clinical findings
before to make diagnostic decision
• If C band isn’t developed, review whole procedure and repeat the
assay with a new device

Perform Assay
• Discard the used cassette device
and the protection sheet into
biohazard
container
after
interpreting the result

Quality Control
Internal Control

• Built-in control feature, the C band
o Developed C band indicates the procedure is correct
External Control
• Run 1 Positive Control and 1 Negative Control to assure proper
performance of the assay, when:
o a new operator uses the kit
o a new lot of test kit is used
o a new shipment of kits is used
o temperature used during storage of the kit falls outside of 2-30°C
o the temperature of the test area falls outside of 15-30°C
o to verify a higher than expected frequency of positive or negative
result
o to investigate the cause of repeated invalid results

Limitation of Test
• For optimal test performance, proper sample collection and storage
procedures are critical. Failure to follow the procedure may give
inaccurate results
• Limited to the qualitative detection of C. trachomatis antigen in swab
specimens. The intensity of the test band does not correlate with
antigen titer of the specimen
• Do not specifically differentiate between C. Trachomatis, C.
Pneumonia or C. Psittasi
• A negative or non-reactive test result:
o does not preclude the possibility of exposure to C. trachomatis
o It can occur if the concentration of the C. trachomatis antigen
present in the specimen is below the level detectable by the assay,
or the antigen is not present in the specimen or improper sample
treatment procedure
• If the symptom persists, while the result is negative or non-reactive
result, it is recommended to re-sample the patient few days later or
test with an alternative test device or method
• The results should only be interpreted in conjunction with other
diagnostic procedures and clinical findings

Technical Support
Contact Info.:
10110 Mesa Rim Rd. San Diego, CA 92121 USA
Email Address: [email protected]
Telephone: 1 (858) 457-8698
Fax: 1 (858) 535-1739

QUALITY . INNOVATION . SIMPLICITY


Slide 4

How To Run
OnSite Chlamydia Ag Rapid Test
(Catalog: R0080C)

C. trachomatis and Chlamydia
• Chlamydia trachomatis (C. trachomatis)
o The most common sexually transmitted
bacterial pathogen
o Major
cause of cervicitis, urethritis,
endometritis, and pelvic inflammatory
disease in women
o urethritis and epididymitis in men
• Chlamydia infection
o 80 million worldwide annually
o At least 3 million new cases in U.S.

Chlamydia Trachomatis

Current Diagnosis Methods
•
•
•
•
•

Cell culture
Direct fluorescence assay (DFA)
Enzyme immunoassays (EIA)
PCR
Immunological antigen test
Method

Rapid Test

DFA

EIA

PCR
> 4 hours

Culture

Time to result

15 minutes

2-3 hours

1-4 hours

>3 days

Facility

General Lab

Special Lab

General Lab Special Lab

Special Lab

Equipment

No

Expensive

PCR machine
Pipette

Incubator,
microscopy

Skill

Minimal

Well trained

Reader,
incubator,
pipette
Moderate

Well trained

Specialist

Comments

Cost effective

Costly

Costly

Costly

Costly

OnSite Chlamydia Ag Rapid Test

Intended Use
• Lateral flow chromatographic immunoassay

• Qualitative detection of C. trachomatis antigen in endocervical or
encourethral swab specimens
• Used as a screening test for diagnosis of infection with C.
trachomatis

Test Principle
• Double antibody-sandwich immunoassay

• A unique pair of Abs to selectively identify C. trachomatis Ag in the
specimen
• Test kit key components:
Test Band

Control Band

Pre-coated with another mouse
monoclonal anti-C. trachomatis Ab

Pe-coated with goat
anti-mouse IgG Ab

Kit Components
• 25 test devices (individually sealed
pouches containing with 1 cassette
device & 1 desiccant)
• 1 Extraction Buffer A (6 mL/vial)
• 1 Extraction Buffer B (6 mL/vial)
• 25 sample extraction tubes
• 1 package insert

Materials Required and Not Provided
• Swab for collecting specimen

• Clock or timer
• Disposable gloves
• Rack to hold extraction tube
• Biohazard container
• Marker pen

Precautions
Precautions

Explanation

Package insert MUST be read completely Pay attention to updated information
before testing
Do NOT open the pouch unless ready to Test device become moisture when
test
expose to humidity air, affect flow

Do NOT use components in any other Component in each kit is unique
type of test kit
Do NOT use expired devices

Expired product gives error result

Bring all reagents to room temperature Cold reagent has different viscosity,
(15-30°C) before use
affect flow migration and results
The testing results should be read within Extend reading time may lead to false
10 minutes after a specimen is applied to positive result.
the sample pad of the device
Do NOT perform the test in a room with Strong air flow causes specimen
strong air flow as the specimens might evaporation during assay, leads to
evaporate before reach
error result

Specimen Collection and Handling
• Consider any materials of human origin as infectious and handle them
using standard biosafety procedures
• Swab specimen should be collected by standard male or female
specimen collection methods
• Swabs should be processed as soon as possible after collection. If
swabs are not processed immediately, they should be placed into a
dry, sterile, tightly capped tube or bottle, and stored at 2-8°C for up to
5 days, preferably in a transportation tube

• Do NOT use bloody swabs
• Do NOT freeze swabs

Preparation for Assay
• Wear protective clothing and
disposable gloves

Preparation for Assay
• Set up work area

• Bring all kit components to room
temperature (15-30°C) prior to
testing

Preparation for Assay
• Double check product’s name
and expiration date
Product Name
Expiration Date

Do not use expired test device

Perform Assay
• Label an extraction tube for each
patient and place in a tube holder
or rack

Perform Assay
• Place specimen swab into the
extraction tube
• Add 4 drops (200 mL) of
Extraction Buffer A while holding
the bottle vertically

All drops must be free falling
with the reagent bottles held
vertically. Do not allow the tips
of the bottles to come in contact
with the extraction cups

Perform Assay
• Twirl briefly to mix the reagent

Perform Assay
• Incubate at room temperature
(15-30°C) for 5 minutes, but no
longer than 10 minutes

Perform Assay
• Add 4 drops (200 mL) of
Extraction Buffer B while holding
the bottle vertically

All drops must be free falling
with the reagent bottles held
vertically. Do not allow the tips
of the bottles to come in contact
with the extraction cups

Perform Assay
• Twirl the swab vigorously for 10 seconds and incubate for 1 minute,
but no longer than 10 minutes

Perform Assay
• Expunge as much liquid as
possible from swab by pressing
and rotating the fiber portion
against the wall of the tube

Perform Assay
• Discard used swab into biohazard
container

Perform Assay
• Cap the tube and mix contents by gentle swirling

• The swab extract can be tested immediately or remain at room
temperature for up to 3 hours without affecting test results

Perform Assay
• Remove a test device from its
protective pouch
• Place the test device on a clean,
flat surface
• Label the device with specimen’s
ID number

Do not open pouch unless ready
to run the test

Perform Assay
• Hold extraction tube vertically

• Dispense 2 drops (100 mL) of
extract to the sample pad

Do not over load samples

Perform Assay
• Set up timer

• Read test result within 15
minutes. Some positive results
may be visible as soon as 1
minute
• Complete reaction time of 15
minutes is required to confirm
negative results

Do not read result after 15 minutes

Read Assay Result
• Negative or non-reactive result
Only C band is developed
• Positive or reactive result
Both C and T bands are developed
• In valid result
No C band is developed

• Samples with positive results should be confirmed with alternative
testing method(s) such as antibody test, PCR and clinical findings
before to make diagnostic decision
• If C band isn’t developed, review whole procedure and repeat the
assay with a new device

Perform Assay
• Discard the used cassette device
and the protection sheet into
biohazard
container
after
interpreting the result

Quality Control
Internal Control

• Built-in control feature, the C band
o Developed C band indicates the procedure is correct
External Control
• Run 1 Positive Control and 1 Negative Control to assure proper
performance of the assay, when:
o a new operator uses the kit
o a new lot of test kit is used
o a new shipment of kits is used
o temperature used during storage of the kit falls outside of 2-30°C
o the temperature of the test area falls outside of 15-30°C
o to verify a higher than expected frequency of positive or negative
result
o to investigate the cause of repeated invalid results

Limitation of Test
• For optimal test performance, proper sample collection and storage
procedures are critical. Failure to follow the procedure may give
inaccurate results
• Limited to the qualitative detection of C. trachomatis antigen in swab
specimens. The intensity of the test band does not correlate with
antigen titer of the specimen
• Do not specifically differentiate between C. Trachomatis, C.
Pneumonia or C. Psittasi
• A negative or non-reactive test result:
o does not preclude the possibility of exposure to C. trachomatis
o It can occur if the concentration of the C. trachomatis antigen
present in the specimen is below the level detectable by the assay,
or the antigen is not present in the specimen or improper sample
treatment procedure
• If the symptom persists, while the result is negative or non-reactive
result, it is recommended to re-sample the patient few days later or
test with an alternative test device or method
• The results should only be interpreted in conjunction with other
diagnostic procedures and clinical findings

Technical Support
Contact Info.:
10110 Mesa Rim Rd. San Diego, CA 92121 USA
Email Address: [email protected]
Telephone: 1 (858) 457-8698
Fax: 1 (858) 535-1739

QUALITY . INNOVATION . SIMPLICITY


Slide 5

How To Run
OnSite Chlamydia Ag Rapid Test
(Catalog: R0080C)

C. trachomatis and Chlamydia
• Chlamydia trachomatis (C. trachomatis)
o The most common sexually transmitted
bacterial pathogen
o Major
cause of cervicitis, urethritis,
endometritis, and pelvic inflammatory
disease in women
o urethritis and epididymitis in men
• Chlamydia infection
o 80 million worldwide annually
o At least 3 million new cases in U.S.

Chlamydia Trachomatis

Current Diagnosis Methods
•
•
•
•
•

Cell culture
Direct fluorescence assay (DFA)
Enzyme immunoassays (EIA)
PCR
Immunological antigen test
Method

Rapid Test

DFA

EIA

PCR
> 4 hours

Culture

Time to result

15 minutes

2-3 hours

1-4 hours

>3 days

Facility

General Lab

Special Lab

General Lab Special Lab

Special Lab

Equipment

No

Expensive

PCR machine
Pipette

Incubator,
microscopy

Skill

Minimal

Well trained

Reader,
incubator,
pipette
Moderate

Well trained

Specialist

Comments

Cost effective

Costly

Costly

Costly

Costly

OnSite Chlamydia Ag Rapid Test

Intended Use
• Lateral flow chromatographic immunoassay

• Qualitative detection of C. trachomatis antigen in endocervical or
encourethral swab specimens
• Used as a screening test for diagnosis of infection with C.
trachomatis

Test Principle
• Double antibody-sandwich immunoassay

• A unique pair of Abs to selectively identify C. trachomatis Ag in the
specimen
• Test kit key components:
Test Band

Control Band

Pre-coated with another mouse
monoclonal anti-C. trachomatis Ab

Pe-coated with goat
anti-mouse IgG Ab

Kit Components
• 25 test devices (individually sealed
pouches containing with 1 cassette
device & 1 desiccant)
• 1 Extraction Buffer A (6 mL/vial)
• 1 Extraction Buffer B (6 mL/vial)
• 25 sample extraction tubes
• 1 package insert

Materials Required and Not Provided
• Swab for collecting specimen

• Clock or timer
• Disposable gloves
• Rack to hold extraction tube
• Biohazard container
• Marker pen

Precautions
Precautions

Explanation

Package insert MUST be read completely Pay attention to updated information
before testing
Do NOT open the pouch unless ready to Test device become moisture when
test
expose to humidity air, affect flow

Do NOT use components in any other Component in each kit is unique
type of test kit
Do NOT use expired devices

Expired product gives error result

Bring all reagents to room temperature Cold reagent has different viscosity,
(15-30°C) before use
affect flow migration and results
The testing results should be read within Extend reading time may lead to false
10 minutes after a specimen is applied to positive result.
the sample pad of the device
Do NOT perform the test in a room with Strong air flow causes specimen
strong air flow as the specimens might evaporation during assay, leads to
evaporate before reach
error result

Specimen Collection and Handling
• Consider any materials of human origin as infectious and handle them
using standard biosafety procedures
• Swab specimen should be collected by standard male or female
specimen collection methods
• Swabs should be processed as soon as possible after collection. If
swabs are not processed immediately, they should be placed into a
dry, sterile, tightly capped tube or bottle, and stored at 2-8°C for up to
5 days, preferably in a transportation tube

• Do NOT use bloody swabs
• Do NOT freeze swabs

Preparation for Assay
• Wear protective clothing and
disposable gloves

Preparation for Assay
• Set up work area

• Bring all kit components to room
temperature (15-30°C) prior to
testing

Preparation for Assay
• Double check product’s name
and expiration date
Product Name
Expiration Date

Do not use expired test device

Perform Assay
• Label an extraction tube for each
patient and place in a tube holder
or rack

Perform Assay
• Place specimen swab into the
extraction tube
• Add 4 drops (200 mL) of
Extraction Buffer A while holding
the bottle vertically

All drops must be free falling
with the reagent bottles held
vertically. Do not allow the tips
of the bottles to come in contact
with the extraction cups

Perform Assay
• Twirl briefly to mix the reagent

Perform Assay
• Incubate at room temperature
(15-30°C) for 5 minutes, but no
longer than 10 minutes

Perform Assay
• Add 4 drops (200 mL) of
Extraction Buffer B while holding
the bottle vertically

All drops must be free falling
with the reagent bottles held
vertically. Do not allow the tips
of the bottles to come in contact
with the extraction cups

Perform Assay
• Twirl the swab vigorously for 10 seconds and incubate for 1 minute,
but no longer than 10 minutes

Perform Assay
• Expunge as much liquid as
possible from swab by pressing
and rotating the fiber portion
against the wall of the tube

Perform Assay
• Discard used swab into biohazard
container

Perform Assay
• Cap the tube and mix contents by gentle swirling

• The swab extract can be tested immediately or remain at room
temperature for up to 3 hours without affecting test results

Perform Assay
• Remove a test device from its
protective pouch
• Place the test device on a clean,
flat surface
• Label the device with specimen’s
ID number

Do not open pouch unless ready
to run the test

Perform Assay
• Hold extraction tube vertically

• Dispense 2 drops (100 mL) of
extract to the sample pad

Do not over load samples

Perform Assay
• Set up timer

• Read test result within 15
minutes. Some positive results
may be visible as soon as 1
minute
• Complete reaction time of 15
minutes is required to confirm
negative results

Do not read result after 15 minutes

Read Assay Result
• Negative or non-reactive result
Only C band is developed
• Positive or reactive result
Both C and T bands are developed
• In valid result
No C band is developed

• Samples with positive results should be confirmed with alternative
testing method(s) such as antibody test, PCR and clinical findings
before to make diagnostic decision
• If C band isn’t developed, review whole procedure and repeat the
assay with a new device

Perform Assay
• Discard the used cassette device
and the protection sheet into
biohazard
container
after
interpreting the result

Quality Control
Internal Control

• Built-in control feature, the C band
o Developed C band indicates the procedure is correct
External Control
• Run 1 Positive Control and 1 Negative Control to assure proper
performance of the assay, when:
o a new operator uses the kit
o a new lot of test kit is used
o a new shipment of kits is used
o temperature used during storage of the kit falls outside of 2-30°C
o the temperature of the test area falls outside of 15-30°C
o to verify a higher than expected frequency of positive or negative
result
o to investigate the cause of repeated invalid results

Limitation of Test
• For optimal test performance, proper sample collection and storage
procedures are critical. Failure to follow the procedure may give
inaccurate results
• Limited to the qualitative detection of C. trachomatis antigen in swab
specimens. The intensity of the test band does not correlate with
antigen titer of the specimen
• Do not specifically differentiate between C. Trachomatis, C.
Pneumonia or C. Psittasi
• A negative or non-reactive test result:
o does not preclude the possibility of exposure to C. trachomatis
o It can occur if the concentration of the C. trachomatis antigen
present in the specimen is below the level detectable by the assay,
or the antigen is not present in the specimen or improper sample
treatment procedure
• If the symptom persists, while the result is negative or non-reactive
result, it is recommended to re-sample the patient few days later or
test with an alternative test device or method
• The results should only be interpreted in conjunction with other
diagnostic procedures and clinical findings

Technical Support
Contact Info.:
10110 Mesa Rim Rd. San Diego, CA 92121 USA
Email Address: [email protected]
Telephone: 1 (858) 457-8698
Fax: 1 (858) 535-1739

QUALITY . INNOVATION . SIMPLICITY


Slide 6

How To Run
OnSite Chlamydia Ag Rapid Test
(Catalog: R0080C)

C. trachomatis and Chlamydia
• Chlamydia trachomatis (C. trachomatis)
o The most common sexually transmitted
bacterial pathogen
o Major
cause of cervicitis, urethritis,
endometritis, and pelvic inflammatory
disease in women
o urethritis and epididymitis in men
• Chlamydia infection
o 80 million worldwide annually
o At least 3 million new cases in U.S.

Chlamydia Trachomatis

Current Diagnosis Methods
•
•
•
•
•

Cell culture
Direct fluorescence assay (DFA)
Enzyme immunoassays (EIA)
PCR
Immunological antigen test
Method

Rapid Test

DFA

EIA

PCR
> 4 hours

Culture

Time to result

15 minutes

2-3 hours

1-4 hours

>3 days

Facility

General Lab

Special Lab

General Lab Special Lab

Special Lab

Equipment

No

Expensive

PCR machine
Pipette

Incubator,
microscopy

Skill

Minimal

Well trained

Reader,
incubator,
pipette
Moderate

Well trained

Specialist

Comments

Cost effective

Costly

Costly

Costly

Costly

OnSite Chlamydia Ag Rapid Test

Intended Use
• Lateral flow chromatographic immunoassay

• Qualitative detection of C. trachomatis antigen in endocervical or
encourethral swab specimens
• Used as a screening test for diagnosis of infection with C.
trachomatis

Test Principle
• Double antibody-sandwich immunoassay

• A unique pair of Abs to selectively identify C. trachomatis Ag in the
specimen
• Test kit key components:
Test Band

Control Band

Pre-coated with another mouse
monoclonal anti-C. trachomatis Ab

Pe-coated with goat
anti-mouse IgG Ab

Kit Components
• 25 test devices (individually sealed
pouches containing with 1 cassette
device & 1 desiccant)
• 1 Extraction Buffer A (6 mL/vial)
• 1 Extraction Buffer B (6 mL/vial)
• 25 sample extraction tubes
• 1 package insert

Materials Required and Not Provided
• Swab for collecting specimen

• Clock or timer
• Disposable gloves
• Rack to hold extraction tube
• Biohazard container
• Marker pen

Precautions
Precautions

Explanation

Package insert MUST be read completely Pay attention to updated information
before testing
Do NOT open the pouch unless ready to Test device become moisture when
test
expose to humidity air, affect flow

Do NOT use components in any other Component in each kit is unique
type of test kit
Do NOT use expired devices

Expired product gives error result

Bring all reagents to room temperature Cold reagent has different viscosity,
(15-30°C) before use
affect flow migration and results
The testing results should be read within Extend reading time may lead to false
10 minutes after a specimen is applied to positive result.
the sample pad of the device
Do NOT perform the test in a room with Strong air flow causes specimen
strong air flow as the specimens might evaporation during assay, leads to
evaporate before reach
error result

Specimen Collection and Handling
• Consider any materials of human origin as infectious and handle them
using standard biosafety procedures
• Swab specimen should be collected by standard male or female
specimen collection methods
• Swabs should be processed as soon as possible after collection. If
swabs are not processed immediately, they should be placed into a
dry, sterile, tightly capped tube or bottle, and stored at 2-8°C for up to
5 days, preferably in a transportation tube

• Do NOT use bloody swabs
• Do NOT freeze swabs

Preparation for Assay
• Wear protective clothing and
disposable gloves

Preparation for Assay
• Set up work area

• Bring all kit components to room
temperature (15-30°C) prior to
testing

Preparation for Assay
• Double check product’s name
and expiration date
Product Name
Expiration Date

Do not use expired test device

Perform Assay
• Label an extraction tube for each
patient and place in a tube holder
or rack

Perform Assay
• Place specimen swab into the
extraction tube
• Add 4 drops (200 mL) of
Extraction Buffer A while holding
the bottle vertically

All drops must be free falling
with the reagent bottles held
vertically. Do not allow the tips
of the bottles to come in contact
with the extraction cups

Perform Assay
• Twirl briefly to mix the reagent

Perform Assay
• Incubate at room temperature
(15-30°C) for 5 minutes, but no
longer than 10 minutes

Perform Assay
• Add 4 drops (200 mL) of
Extraction Buffer B while holding
the bottle vertically

All drops must be free falling
with the reagent bottles held
vertically. Do not allow the tips
of the bottles to come in contact
with the extraction cups

Perform Assay
• Twirl the swab vigorously for 10 seconds and incubate for 1 minute,
but no longer than 10 minutes

Perform Assay
• Expunge as much liquid as
possible from swab by pressing
and rotating the fiber portion
against the wall of the tube

Perform Assay
• Discard used swab into biohazard
container

Perform Assay
• Cap the tube and mix contents by gentle swirling

• The swab extract can be tested immediately or remain at room
temperature for up to 3 hours without affecting test results

Perform Assay
• Remove a test device from its
protective pouch
• Place the test device on a clean,
flat surface
• Label the device with specimen’s
ID number

Do not open pouch unless ready
to run the test

Perform Assay
• Hold extraction tube vertically

• Dispense 2 drops (100 mL) of
extract to the sample pad

Do not over load samples

Perform Assay
• Set up timer

• Read test result within 15
minutes. Some positive results
may be visible as soon as 1
minute
• Complete reaction time of 15
minutes is required to confirm
negative results

Do not read result after 15 minutes

Read Assay Result
• Negative or non-reactive result
Only C band is developed
• Positive or reactive result
Both C and T bands are developed
• In valid result
No C band is developed

• Samples with positive results should be confirmed with alternative
testing method(s) such as antibody test, PCR and clinical findings
before to make diagnostic decision
• If C band isn’t developed, review whole procedure and repeat the
assay with a new device

Perform Assay
• Discard the used cassette device
and the protection sheet into
biohazard
container
after
interpreting the result

Quality Control
Internal Control

• Built-in control feature, the C band
o Developed C band indicates the procedure is correct
External Control
• Run 1 Positive Control and 1 Negative Control to assure proper
performance of the assay, when:
o a new operator uses the kit
o a new lot of test kit is used
o a new shipment of kits is used
o temperature used during storage of the kit falls outside of 2-30°C
o the temperature of the test area falls outside of 15-30°C
o to verify a higher than expected frequency of positive or negative
result
o to investigate the cause of repeated invalid results

Limitation of Test
• For optimal test performance, proper sample collection and storage
procedures are critical. Failure to follow the procedure may give
inaccurate results
• Limited to the qualitative detection of C. trachomatis antigen in swab
specimens. The intensity of the test band does not correlate with
antigen titer of the specimen
• Do not specifically differentiate between C. Trachomatis, C.
Pneumonia or C. Psittasi
• A negative or non-reactive test result:
o does not preclude the possibility of exposure to C. trachomatis
o It can occur if the concentration of the C. trachomatis antigen
present in the specimen is below the level detectable by the assay,
or the antigen is not present in the specimen or improper sample
treatment procedure
• If the symptom persists, while the result is negative or non-reactive
result, it is recommended to re-sample the patient few days later or
test with an alternative test device or method
• The results should only be interpreted in conjunction with other
diagnostic procedures and clinical findings

Technical Support
Contact Info.:
10110 Mesa Rim Rd. San Diego, CA 92121 USA
Email Address: [email protected]
Telephone: 1 (858) 457-8698
Fax: 1 (858) 535-1739

QUALITY . INNOVATION . SIMPLICITY


Slide 7

How To Run
OnSite Chlamydia Ag Rapid Test
(Catalog: R0080C)

C. trachomatis and Chlamydia
• Chlamydia trachomatis (C. trachomatis)
o The most common sexually transmitted
bacterial pathogen
o Major
cause of cervicitis, urethritis,
endometritis, and pelvic inflammatory
disease in women
o urethritis and epididymitis in men
• Chlamydia infection
o 80 million worldwide annually
o At least 3 million new cases in U.S.

Chlamydia Trachomatis

Current Diagnosis Methods
•
•
•
•
•

Cell culture
Direct fluorescence assay (DFA)
Enzyme immunoassays (EIA)
PCR
Immunological antigen test
Method

Rapid Test

DFA

EIA

PCR
> 4 hours

Culture

Time to result

15 minutes

2-3 hours

1-4 hours

>3 days

Facility

General Lab

Special Lab

General Lab Special Lab

Special Lab

Equipment

No

Expensive

PCR machine
Pipette

Incubator,
microscopy

Skill

Minimal

Well trained

Reader,
incubator,
pipette
Moderate

Well trained

Specialist

Comments

Cost effective

Costly

Costly

Costly

Costly

OnSite Chlamydia Ag Rapid Test

Intended Use
• Lateral flow chromatographic immunoassay

• Qualitative detection of C. trachomatis antigen in endocervical or
encourethral swab specimens
• Used as a screening test for diagnosis of infection with C.
trachomatis

Test Principle
• Double antibody-sandwich immunoassay

• A unique pair of Abs to selectively identify C. trachomatis Ag in the
specimen
• Test kit key components:
Test Band

Control Band

Pre-coated with another mouse
monoclonal anti-C. trachomatis Ab

Pe-coated with goat
anti-mouse IgG Ab

Kit Components
• 25 test devices (individually sealed
pouches containing with 1 cassette
device & 1 desiccant)
• 1 Extraction Buffer A (6 mL/vial)
• 1 Extraction Buffer B (6 mL/vial)
• 25 sample extraction tubes
• 1 package insert

Materials Required and Not Provided
• Swab for collecting specimen

• Clock or timer
• Disposable gloves
• Rack to hold extraction tube
• Biohazard container
• Marker pen

Precautions
Precautions

Explanation

Package insert MUST be read completely Pay attention to updated information
before testing
Do NOT open the pouch unless ready to Test device become moisture when
test
expose to humidity air, affect flow

Do NOT use components in any other Component in each kit is unique
type of test kit
Do NOT use expired devices

Expired product gives error result

Bring all reagents to room temperature Cold reagent has different viscosity,
(15-30°C) before use
affect flow migration and results
The testing results should be read within Extend reading time may lead to false
10 minutes after a specimen is applied to positive result.
the sample pad of the device
Do NOT perform the test in a room with Strong air flow causes specimen
strong air flow as the specimens might evaporation during assay, leads to
evaporate before reach
error result

Specimen Collection and Handling
• Consider any materials of human origin as infectious and handle them
using standard biosafety procedures
• Swab specimen should be collected by standard male or female
specimen collection methods
• Swabs should be processed as soon as possible after collection. If
swabs are not processed immediately, they should be placed into a
dry, sterile, tightly capped tube or bottle, and stored at 2-8°C for up to
5 days, preferably in a transportation tube

• Do NOT use bloody swabs
• Do NOT freeze swabs

Preparation for Assay
• Wear protective clothing and
disposable gloves

Preparation for Assay
• Set up work area

• Bring all kit components to room
temperature (15-30°C) prior to
testing

Preparation for Assay
• Double check product’s name
and expiration date
Product Name
Expiration Date

Do not use expired test device

Perform Assay
• Label an extraction tube for each
patient and place in a tube holder
or rack

Perform Assay
• Place specimen swab into the
extraction tube
• Add 4 drops (200 mL) of
Extraction Buffer A while holding
the bottle vertically

All drops must be free falling
with the reagent bottles held
vertically. Do not allow the tips
of the bottles to come in contact
with the extraction cups

Perform Assay
• Twirl briefly to mix the reagent

Perform Assay
• Incubate at room temperature
(15-30°C) for 5 minutes, but no
longer than 10 minutes

Perform Assay
• Add 4 drops (200 mL) of
Extraction Buffer B while holding
the bottle vertically

All drops must be free falling
with the reagent bottles held
vertically. Do not allow the tips
of the bottles to come in contact
with the extraction cups

Perform Assay
• Twirl the swab vigorously for 10 seconds and incubate for 1 minute,
but no longer than 10 minutes

Perform Assay
• Expunge as much liquid as
possible from swab by pressing
and rotating the fiber portion
against the wall of the tube

Perform Assay
• Discard used swab into biohazard
container

Perform Assay
• Cap the tube and mix contents by gentle swirling

• The swab extract can be tested immediately or remain at room
temperature for up to 3 hours without affecting test results

Perform Assay
• Remove a test device from its
protective pouch
• Place the test device on a clean,
flat surface
• Label the device with specimen’s
ID number

Do not open pouch unless ready
to run the test

Perform Assay
• Hold extraction tube vertically

• Dispense 2 drops (100 mL) of
extract to the sample pad

Do not over load samples

Perform Assay
• Set up timer

• Read test result within 15
minutes. Some positive results
may be visible as soon as 1
minute
• Complete reaction time of 15
minutes is required to confirm
negative results

Do not read result after 15 minutes

Read Assay Result
• Negative or non-reactive result
Only C band is developed
• Positive or reactive result
Both C and T bands are developed
• In valid result
No C band is developed

• Samples with positive results should be confirmed with alternative
testing method(s) such as antibody test, PCR and clinical findings
before to make diagnostic decision
• If C band isn’t developed, review whole procedure and repeat the
assay with a new device

Perform Assay
• Discard the used cassette device
and the protection sheet into
biohazard
container
after
interpreting the result

Quality Control
Internal Control

• Built-in control feature, the C band
o Developed C band indicates the procedure is correct
External Control
• Run 1 Positive Control and 1 Negative Control to assure proper
performance of the assay, when:
o a new operator uses the kit
o a new lot of test kit is used
o a new shipment of kits is used
o temperature used during storage of the kit falls outside of 2-30°C
o the temperature of the test area falls outside of 15-30°C
o to verify a higher than expected frequency of positive or negative
result
o to investigate the cause of repeated invalid results

Limitation of Test
• For optimal test performance, proper sample collection and storage
procedures are critical. Failure to follow the procedure may give
inaccurate results
• Limited to the qualitative detection of C. trachomatis antigen in swab
specimens. The intensity of the test band does not correlate with
antigen titer of the specimen
• Do not specifically differentiate between C. Trachomatis, C.
Pneumonia or C. Psittasi
• A negative or non-reactive test result:
o does not preclude the possibility of exposure to C. trachomatis
o It can occur if the concentration of the C. trachomatis antigen
present in the specimen is below the level detectable by the assay,
or the antigen is not present in the specimen or improper sample
treatment procedure
• If the symptom persists, while the result is negative or non-reactive
result, it is recommended to re-sample the patient few days later or
test with an alternative test device or method
• The results should only be interpreted in conjunction with other
diagnostic procedures and clinical findings

Technical Support
Contact Info.:
10110 Mesa Rim Rd. San Diego, CA 92121 USA
Email Address: [email protected]
Telephone: 1 (858) 457-8698
Fax: 1 (858) 535-1739

QUALITY . INNOVATION . SIMPLICITY


Slide 8

How To Run
OnSite Chlamydia Ag Rapid Test
(Catalog: R0080C)

C. trachomatis and Chlamydia
• Chlamydia trachomatis (C. trachomatis)
o The most common sexually transmitted
bacterial pathogen
o Major
cause of cervicitis, urethritis,
endometritis, and pelvic inflammatory
disease in women
o urethritis and epididymitis in men
• Chlamydia infection
o 80 million worldwide annually
o At least 3 million new cases in U.S.

Chlamydia Trachomatis

Current Diagnosis Methods
•
•
•
•
•

Cell culture
Direct fluorescence assay (DFA)
Enzyme immunoassays (EIA)
PCR
Immunological antigen test
Method

Rapid Test

DFA

EIA

PCR
> 4 hours

Culture

Time to result

15 minutes

2-3 hours

1-4 hours

>3 days

Facility

General Lab

Special Lab

General Lab Special Lab

Special Lab

Equipment

No

Expensive

PCR machine
Pipette

Incubator,
microscopy

Skill

Minimal

Well trained

Reader,
incubator,
pipette
Moderate

Well trained

Specialist

Comments

Cost effective

Costly

Costly

Costly

Costly

OnSite Chlamydia Ag Rapid Test

Intended Use
• Lateral flow chromatographic immunoassay

• Qualitative detection of C. trachomatis antigen in endocervical or
encourethral swab specimens
• Used as a screening test for diagnosis of infection with C.
trachomatis

Test Principle
• Double antibody-sandwich immunoassay

• A unique pair of Abs to selectively identify C. trachomatis Ag in the
specimen
• Test kit key components:
Test Band

Control Band

Pre-coated with another mouse
monoclonal anti-C. trachomatis Ab

Pe-coated with goat
anti-mouse IgG Ab

Kit Components
• 25 test devices (individually sealed
pouches containing with 1 cassette
device & 1 desiccant)
• 1 Extraction Buffer A (6 mL/vial)
• 1 Extraction Buffer B (6 mL/vial)
• 25 sample extraction tubes
• 1 package insert

Materials Required and Not Provided
• Swab for collecting specimen

• Clock or timer
• Disposable gloves
• Rack to hold extraction tube
• Biohazard container
• Marker pen

Precautions
Precautions

Explanation

Package insert MUST be read completely Pay attention to updated information
before testing
Do NOT open the pouch unless ready to Test device become moisture when
test
expose to humidity air, affect flow

Do NOT use components in any other Component in each kit is unique
type of test kit
Do NOT use expired devices

Expired product gives error result

Bring all reagents to room temperature Cold reagent has different viscosity,
(15-30°C) before use
affect flow migration and results
The testing results should be read within Extend reading time may lead to false
10 minutes after a specimen is applied to positive result.
the sample pad of the device
Do NOT perform the test in a room with Strong air flow causes specimen
strong air flow as the specimens might evaporation during assay, leads to
evaporate before reach
error result

Specimen Collection and Handling
• Consider any materials of human origin as infectious and handle them
using standard biosafety procedures
• Swab specimen should be collected by standard male or female
specimen collection methods
• Swabs should be processed as soon as possible after collection. If
swabs are not processed immediately, they should be placed into a
dry, sterile, tightly capped tube or bottle, and stored at 2-8°C for up to
5 days, preferably in a transportation tube

• Do NOT use bloody swabs
• Do NOT freeze swabs

Preparation for Assay
• Wear protective clothing and
disposable gloves

Preparation for Assay
• Set up work area

• Bring all kit components to room
temperature (15-30°C) prior to
testing

Preparation for Assay
• Double check product’s name
and expiration date
Product Name
Expiration Date

Do not use expired test device

Perform Assay
• Label an extraction tube for each
patient and place in a tube holder
or rack

Perform Assay
• Place specimen swab into the
extraction tube
• Add 4 drops (200 mL) of
Extraction Buffer A while holding
the bottle vertically

All drops must be free falling
with the reagent bottles held
vertically. Do not allow the tips
of the bottles to come in contact
with the extraction cups

Perform Assay
• Twirl briefly to mix the reagent

Perform Assay
• Incubate at room temperature
(15-30°C) for 5 minutes, but no
longer than 10 minutes

Perform Assay
• Add 4 drops (200 mL) of
Extraction Buffer B while holding
the bottle vertically

All drops must be free falling
with the reagent bottles held
vertically. Do not allow the tips
of the bottles to come in contact
with the extraction cups

Perform Assay
• Twirl the swab vigorously for 10 seconds and incubate for 1 minute,
but no longer than 10 minutes

Perform Assay
• Expunge as much liquid as
possible from swab by pressing
and rotating the fiber portion
against the wall of the tube

Perform Assay
• Discard used swab into biohazard
container

Perform Assay
• Cap the tube and mix contents by gentle swirling

• The swab extract can be tested immediately or remain at room
temperature for up to 3 hours without affecting test results

Perform Assay
• Remove a test device from its
protective pouch
• Place the test device on a clean,
flat surface
• Label the device with specimen’s
ID number

Do not open pouch unless ready
to run the test

Perform Assay
• Hold extraction tube vertically

• Dispense 2 drops (100 mL) of
extract to the sample pad

Do not over load samples

Perform Assay
• Set up timer

• Read test result within 15
minutes. Some positive results
may be visible as soon as 1
minute
• Complete reaction time of 15
minutes is required to confirm
negative results

Do not read result after 15 minutes

Read Assay Result
• Negative or non-reactive result
Only C band is developed
• Positive or reactive result
Both C and T bands are developed
• In valid result
No C band is developed

• Samples with positive results should be confirmed with alternative
testing method(s) such as antibody test, PCR and clinical findings
before to make diagnostic decision
• If C band isn’t developed, review whole procedure and repeat the
assay with a new device

Perform Assay
• Discard the used cassette device
and the protection sheet into
biohazard
container
after
interpreting the result

Quality Control
Internal Control

• Built-in control feature, the C band
o Developed C band indicates the procedure is correct
External Control
• Run 1 Positive Control and 1 Negative Control to assure proper
performance of the assay, when:
o a new operator uses the kit
o a new lot of test kit is used
o a new shipment of kits is used
o temperature used during storage of the kit falls outside of 2-30°C
o the temperature of the test area falls outside of 15-30°C
o to verify a higher than expected frequency of positive or negative
result
o to investigate the cause of repeated invalid results

Limitation of Test
• For optimal test performance, proper sample collection and storage
procedures are critical. Failure to follow the procedure may give
inaccurate results
• Limited to the qualitative detection of C. trachomatis antigen in swab
specimens. The intensity of the test band does not correlate with
antigen titer of the specimen
• Do not specifically differentiate between C. Trachomatis, C.
Pneumonia or C. Psittasi
• A negative or non-reactive test result:
o does not preclude the possibility of exposure to C. trachomatis
o It can occur if the concentration of the C. trachomatis antigen
present in the specimen is below the level detectable by the assay,
or the antigen is not present in the specimen or improper sample
treatment procedure
• If the symptom persists, while the result is negative or non-reactive
result, it is recommended to re-sample the patient few days later or
test with an alternative test device or method
• The results should only be interpreted in conjunction with other
diagnostic procedures and clinical findings

Technical Support
Contact Info.:
10110 Mesa Rim Rd. San Diego, CA 92121 USA
Email Address: [email protected]
Telephone: 1 (858) 457-8698
Fax: 1 (858) 535-1739

QUALITY . INNOVATION . SIMPLICITY


Slide 9

How To Run
OnSite Chlamydia Ag Rapid Test
(Catalog: R0080C)

C. trachomatis and Chlamydia
• Chlamydia trachomatis (C. trachomatis)
o The most common sexually transmitted
bacterial pathogen
o Major
cause of cervicitis, urethritis,
endometritis, and pelvic inflammatory
disease in women
o urethritis and epididymitis in men
• Chlamydia infection
o 80 million worldwide annually
o At least 3 million new cases in U.S.

Chlamydia Trachomatis

Current Diagnosis Methods
•
•
•
•
•

Cell culture
Direct fluorescence assay (DFA)
Enzyme immunoassays (EIA)
PCR
Immunological antigen test
Method

Rapid Test

DFA

EIA

PCR
> 4 hours

Culture

Time to result

15 minutes

2-3 hours

1-4 hours

>3 days

Facility

General Lab

Special Lab

General Lab Special Lab

Special Lab

Equipment

No

Expensive

PCR machine
Pipette

Incubator,
microscopy

Skill

Minimal

Well trained

Reader,
incubator,
pipette
Moderate

Well trained

Specialist

Comments

Cost effective

Costly

Costly

Costly

Costly

OnSite Chlamydia Ag Rapid Test

Intended Use
• Lateral flow chromatographic immunoassay

• Qualitative detection of C. trachomatis antigen in endocervical or
encourethral swab specimens
• Used as a screening test for diagnosis of infection with C.
trachomatis

Test Principle
• Double antibody-sandwich immunoassay

• A unique pair of Abs to selectively identify C. trachomatis Ag in the
specimen
• Test kit key components:
Test Band

Control Band

Pre-coated with another mouse
monoclonal anti-C. trachomatis Ab

Pe-coated with goat
anti-mouse IgG Ab

Kit Components
• 25 test devices (individually sealed
pouches containing with 1 cassette
device & 1 desiccant)
• 1 Extraction Buffer A (6 mL/vial)
• 1 Extraction Buffer B (6 mL/vial)
• 25 sample extraction tubes
• 1 package insert

Materials Required and Not Provided
• Swab for collecting specimen

• Clock or timer
• Disposable gloves
• Rack to hold extraction tube
• Biohazard container
• Marker pen

Precautions
Precautions

Explanation

Package insert MUST be read completely Pay attention to updated information
before testing
Do NOT open the pouch unless ready to Test device become moisture when
test
expose to humidity air, affect flow

Do NOT use components in any other Component in each kit is unique
type of test kit
Do NOT use expired devices

Expired product gives error result

Bring all reagents to room temperature Cold reagent has different viscosity,
(15-30°C) before use
affect flow migration and results
The testing results should be read within Extend reading time may lead to false
10 minutes after a specimen is applied to positive result.
the sample pad of the device
Do NOT perform the test in a room with Strong air flow causes specimen
strong air flow as the specimens might evaporation during assay, leads to
evaporate before reach
error result

Specimen Collection and Handling
• Consider any materials of human origin as infectious and handle them
using standard biosafety procedures
• Swab specimen should be collected by standard male or female
specimen collection methods
• Swabs should be processed as soon as possible after collection. If
swabs are not processed immediately, they should be placed into a
dry, sterile, tightly capped tube or bottle, and stored at 2-8°C for up to
5 days, preferably in a transportation tube

• Do NOT use bloody swabs
• Do NOT freeze swabs

Preparation for Assay
• Wear protective clothing and
disposable gloves

Preparation for Assay
• Set up work area

• Bring all kit components to room
temperature (15-30°C) prior to
testing

Preparation for Assay
• Double check product’s name
and expiration date
Product Name
Expiration Date

Do not use expired test device

Perform Assay
• Label an extraction tube for each
patient and place in a tube holder
or rack

Perform Assay
• Place specimen swab into the
extraction tube
• Add 4 drops (200 mL) of
Extraction Buffer A while holding
the bottle vertically

All drops must be free falling
with the reagent bottles held
vertically. Do not allow the tips
of the bottles to come in contact
with the extraction cups

Perform Assay
• Twirl briefly to mix the reagent

Perform Assay
• Incubate at room temperature
(15-30°C) for 5 minutes, but no
longer than 10 minutes

Perform Assay
• Add 4 drops (200 mL) of
Extraction Buffer B while holding
the bottle vertically

All drops must be free falling
with the reagent bottles held
vertically. Do not allow the tips
of the bottles to come in contact
with the extraction cups

Perform Assay
• Twirl the swab vigorously for 10 seconds and incubate for 1 minute,
but no longer than 10 minutes

Perform Assay
• Expunge as much liquid as
possible from swab by pressing
and rotating the fiber portion
against the wall of the tube

Perform Assay
• Discard used swab into biohazard
container

Perform Assay
• Cap the tube and mix contents by gentle swirling

• The swab extract can be tested immediately or remain at room
temperature for up to 3 hours without affecting test results

Perform Assay
• Remove a test device from its
protective pouch
• Place the test device on a clean,
flat surface
• Label the device with specimen’s
ID number

Do not open pouch unless ready
to run the test

Perform Assay
• Hold extraction tube vertically

• Dispense 2 drops (100 mL) of
extract to the sample pad

Do not over load samples

Perform Assay
• Set up timer

• Read test result within 15
minutes. Some positive results
may be visible as soon as 1
minute
• Complete reaction time of 15
minutes is required to confirm
negative results

Do not read result after 15 minutes

Read Assay Result
• Negative or non-reactive result
Only C band is developed
• Positive or reactive result
Both C and T bands are developed
• In valid result
No C band is developed

• Samples with positive results should be confirmed with alternative
testing method(s) such as antibody test, PCR and clinical findings
before to make diagnostic decision
• If C band isn’t developed, review whole procedure and repeat the
assay with a new device

Perform Assay
• Discard the used cassette device
and the protection sheet into
biohazard
container
after
interpreting the result

Quality Control
Internal Control

• Built-in control feature, the C band
o Developed C band indicates the procedure is correct
External Control
• Run 1 Positive Control and 1 Negative Control to assure proper
performance of the assay, when:
o a new operator uses the kit
o a new lot of test kit is used
o a new shipment of kits is used
o temperature used during storage of the kit falls outside of 2-30°C
o the temperature of the test area falls outside of 15-30°C
o to verify a higher than expected frequency of positive or negative
result
o to investigate the cause of repeated invalid results

Limitation of Test
• For optimal test performance, proper sample collection and storage
procedures are critical. Failure to follow the procedure may give
inaccurate results
• Limited to the qualitative detection of C. trachomatis antigen in swab
specimens. The intensity of the test band does not correlate with
antigen titer of the specimen
• Do not specifically differentiate between C. Trachomatis, C.
Pneumonia or C. Psittasi
• A negative or non-reactive test result:
o does not preclude the possibility of exposure to C. trachomatis
o It can occur if the concentration of the C. trachomatis antigen
present in the specimen is below the level detectable by the assay,
or the antigen is not present in the specimen or improper sample
treatment procedure
• If the symptom persists, while the result is negative or non-reactive
result, it is recommended to re-sample the patient few days later or
test with an alternative test device or method
• The results should only be interpreted in conjunction with other
diagnostic procedures and clinical findings

Technical Support
Contact Info.:
10110 Mesa Rim Rd. San Diego, CA 92121 USA
Email Address: [email protected]
Telephone: 1 (858) 457-8698
Fax: 1 (858) 535-1739

QUALITY . INNOVATION . SIMPLICITY


Slide 10

How To Run
OnSite Chlamydia Ag Rapid Test
(Catalog: R0080C)

C. trachomatis and Chlamydia
• Chlamydia trachomatis (C. trachomatis)
o The most common sexually transmitted
bacterial pathogen
o Major
cause of cervicitis, urethritis,
endometritis, and pelvic inflammatory
disease in women
o urethritis and epididymitis in men
• Chlamydia infection
o 80 million worldwide annually
o At least 3 million new cases in U.S.

Chlamydia Trachomatis

Current Diagnosis Methods
•
•
•
•
•

Cell culture
Direct fluorescence assay (DFA)
Enzyme immunoassays (EIA)
PCR
Immunological antigen test
Method

Rapid Test

DFA

EIA

PCR
> 4 hours

Culture

Time to result

15 minutes

2-3 hours

1-4 hours

>3 days

Facility

General Lab

Special Lab

General Lab Special Lab

Special Lab

Equipment

No

Expensive

PCR machine
Pipette

Incubator,
microscopy

Skill

Minimal

Well trained

Reader,
incubator,
pipette
Moderate

Well trained

Specialist

Comments

Cost effective

Costly

Costly

Costly

Costly

OnSite Chlamydia Ag Rapid Test

Intended Use
• Lateral flow chromatographic immunoassay

• Qualitative detection of C. trachomatis antigen in endocervical or
encourethral swab specimens
• Used as a screening test for diagnosis of infection with C.
trachomatis

Test Principle
• Double antibody-sandwich immunoassay

• A unique pair of Abs to selectively identify C. trachomatis Ag in the
specimen
• Test kit key components:
Test Band

Control Band

Pre-coated with another mouse
monoclonal anti-C. trachomatis Ab

Pe-coated with goat
anti-mouse IgG Ab

Kit Components
• 25 test devices (individually sealed
pouches containing with 1 cassette
device & 1 desiccant)
• 1 Extraction Buffer A (6 mL/vial)
• 1 Extraction Buffer B (6 mL/vial)
• 25 sample extraction tubes
• 1 package insert

Materials Required and Not Provided
• Swab for collecting specimen

• Clock or timer
• Disposable gloves
• Rack to hold extraction tube
• Biohazard container
• Marker pen

Precautions
Precautions

Explanation

Package insert MUST be read completely Pay attention to updated information
before testing
Do NOT open the pouch unless ready to Test device become moisture when
test
expose to humidity air, affect flow

Do NOT use components in any other Component in each kit is unique
type of test kit
Do NOT use expired devices

Expired product gives error result

Bring all reagents to room temperature Cold reagent has different viscosity,
(15-30°C) before use
affect flow migration and results
The testing results should be read within Extend reading time may lead to false
10 minutes after a specimen is applied to positive result.
the sample pad of the device
Do NOT perform the test in a room with Strong air flow causes specimen
strong air flow as the specimens might evaporation during assay, leads to
evaporate before reach
error result

Specimen Collection and Handling
• Consider any materials of human origin as infectious and handle them
using standard biosafety procedures
• Swab specimen should be collected by standard male or female
specimen collection methods
• Swabs should be processed as soon as possible after collection. If
swabs are not processed immediately, they should be placed into a
dry, sterile, tightly capped tube or bottle, and stored at 2-8°C for up to
5 days, preferably in a transportation tube

• Do NOT use bloody swabs
• Do NOT freeze swabs

Preparation for Assay
• Wear protective clothing and
disposable gloves

Preparation for Assay
• Set up work area

• Bring all kit components to room
temperature (15-30°C) prior to
testing

Preparation for Assay
• Double check product’s name
and expiration date
Product Name
Expiration Date

Do not use expired test device

Perform Assay
• Label an extraction tube for each
patient and place in a tube holder
or rack

Perform Assay
• Place specimen swab into the
extraction tube
• Add 4 drops (200 mL) of
Extraction Buffer A while holding
the bottle vertically

All drops must be free falling
with the reagent bottles held
vertically. Do not allow the tips
of the bottles to come in contact
with the extraction cups

Perform Assay
• Twirl briefly to mix the reagent

Perform Assay
• Incubate at room temperature
(15-30°C) for 5 minutes, but no
longer than 10 minutes

Perform Assay
• Add 4 drops (200 mL) of
Extraction Buffer B while holding
the bottle vertically

All drops must be free falling
with the reagent bottles held
vertically. Do not allow the tips
of the bottles to come in contact
with the extraction cups

Perform Assay
• Twirl the swab vigorously for 10 seconds and incubate for 1 minute,
but no longer than 10 minutes

Perform Assay
• Expunge as much liquid as
possible from swab by pressing
and rotating the fiber portion
against the wall of the tube

Perform Assay
• Discard used swab into biohazard
container

Perform Assay
• Cap the tube and mix contents by gentle swirling

• The swab extract can be tested immediately or remain at room
temperature for up to 3 hours without affecting test results

Perform Assay
• Remove a test device from its
protective pouch
• Place the test device on a clean,
flat surface
• Label the device with specimen’s
ID number

Do not open pouch unless ready
to run the test

Perform Assay
• Hold extraction tube vertically

• Dispense 2 drops (100 mL) of
extract to the sample pad

Do not over load samples

Perform Assay
• Set up timer

• Read test result within 15
minutes. Some positive results
may be visible as soon as 1
minute
• Complete reaction time of 15
minutes is required to confirm
negative results

Do not read result after 15 minutes

Read Assay Result
• Negative or non-reactive result
Only C band is developed
• Positive or reactive result
Both C and T bands are developed
• In valid result
No C band is developed

• Samples with positive results should be confirmed with alternative
testing method(s) such as antibody test, PCR and clinical findings
before to make diagnostic decision
• If C band isn’t developed, review whole procedure and repeat the
assay with a new device

Perform Assay
• Discard the used cassette device
and the protection sheet into
biohazard
container
after
interpreting the result

Quality Control
Internal Control

• Built-in control feature, the C band
o Developed C band indicates the procedure is correct
External Control
• Run 1 Positive Control and 1 Negative Control to assure proper
performance of the assay, when:
o a new operator uses the kit
o a new lot of test kit is used
o a new shipment of kits is used
o temperature used during storage of the kit falls outside of 2-30°C
o the temperature of the test area falls outside of 15-30°C
o to verify a higher than expected frequency of positive or negative
result
o to investigate the cause of repeated invalid results

Limitation of Test
• For optimal test performance, proper sample collection and storage
procedures are critical. Failure to follow the procedure may give
inaccurate results
• Limited to the qualitative detection of C. trachomatis antigen in swab
specimens. The intensity of the test band does not correlate with
antigen titer of the specimen
• Do not specifically differentiate between C. Trachomatis, C.
Pneumonia or C. Psittasi
• A negative or non-reactive test result:
o does not preclude the possibility of exposure to C. trachomatis
o It can occur if the concentration of the C. trachomatis antigen
present in the specimen is below the level detectable by the assay,
or the antigen is not present in the specimen or improper sample
treatment procedure
• If the symptom persists, while the result is negative or non-reactive
result, it is recommended to re-sample the patient few days later or
test with an alternative test device or method
• The results should only be interpreted in conjunction with other
diagnostic procedures and clinical findings

Technical Support
Contact Info.:
10110 Mesa Rim Rd. San Diego, CA 92121 USA
Email Address: [email protected]
Telephone: 1 (858) 457-8698
Fax: 1 (858) 535-1739

QUALITY . INNOVATION . SIMPLICITY


Slide 11

How To Run
OnSite Chlamydia Ag Rapid Test
(Catalog: R0080C)

C. trachomatis and Chlamydia
• Chlamydia trachomatis (C. trachomatis)
o The most common sexually transmitted
bacterial pathogen
o Major
cause of cervicitis, urethritis,
endometritis, and pelvic inflammatory
disease in women
o urethritis and epididymitis in men
• Chlamydia infection
o 80 million worldwide annually
o At least 3 million new cases in U.S.

Chlamydia Trachomatis

Current Diagnosis Methods
•
•
•
•
•

Cell culture
Direct fluorescence assay (DFA)
Enzyme immunoassays (EIA)
PCR
Immunological antigen test
Method

Rapid Test

DFA

EIA

PCR
> 4 hours

Culture

Time to result

15 minutes

2-3 hours

1-4 hours

>3 days

Facility

General Lab

Special Lab

General Lab Special Lab

Special Lab

Equipment

No

Expensive

PCR machine
Pipette

Incubator,
microscopy

Skill

Minimal

Well trained

Reader,
incubator,
pipette
Moderate

Well trained

Specialist

Comments

Cost effective

Costly

Costly

Costly

Costly

OnSite Chlamydia Ag Rapid Test

Intended Use
• Lateral flow chromatographic immunoassay

• Qualitative detection of C. trachomatis antigen in endocervical or
encourethral swab specimens
• Used as a screening test for diagnosis of infection with C.
trachomatis

Test Principle
• Double antibody-sandwich immunoassay

• A unique pair of Abs to selectively identify C. trachomatis Ag in the
specimen
• Test kit key components:
Test Band

Control Band

Pre-coated with another mouse
monoclonal anti-C. trachomatis Ab

Pe-coated with goat
anti-mouse IgG Ab

Kit Components
• 25 test devices (individually sealed
pouches containing with 1 cassette
device & 1 desiccant)
• 1 Extraction Buffer A (6 mL/vial)
• 1 Extraction Buffer B (6 mL/vial)
• 25 sample extraction tubes
• 1 package insert

Materials Required and Not Provided
• Swab for collecting specimen

• Clock or timer
• Disposable gloves
• Rack to hold extraction tube
• Biohazard container
• Marker pen

Precautions
Precautions

Explanation

Package insert MUST be read completely Pay attention to updated information
before testing
Do NOT open the pouch unless ready to Test device become moisture when
test
expose to humidity air, affect flow

Do NOT use components in any other Component in each kit is unique
type of test kit
Do NOT use expired devices

Expired product gives error result

Bring all reagents to room temperature Cold reagent has different viscosity,
(15-30°C) before use
affect flow migration and results
The testing results should be read within Extend reading time may lead to false
10 minutes after a specimen is applied to positive result.
the sample pad of the device
Do NOT perform the test in a room with Strong air flow causes specimen
strong air flow as the specimens might evaporation during assay, leads to
evaporate before reach
error result

Specimen Collection and Handling
• Consider any materials of human origin as infectious and handle them
using standard biosafety procedures
• Swab specimen should be collected by standard male or female
specimen collection methods
• Swabs should be processed as soon as possible after collection. If
swabs are not processed immediately, they should be placed into a
dry, sterile, tightly capped tube or bottle, and stored at 2-8°C for up to
5 days, preferably in a transportation tube

• Do NOT use bloody swabs
• Do NOT freeze swabs

Preparation for Assay
• Wear protective clothing and
disposable gloves

Preparation for Assay
• Set up work area

• Bring all kit components to room
temperature (15-30°C) prior to
testing

Preparation for Assay
• Double check product’s name
and expiration date
Product Name
Expiration Date

Do not use expired test device

Perform Assay
• Label an extraction tube for each
patient and place in a tube holder
or rack

Perform Assay
• Place specimen swab into the
extraction tube
• Add 4 drops (200 mL) of
Extraction Buffer A while holding
the bottle vertically

All drops must be free falling
with the reagent bottles held
vertically. Do not allow the tips
of the bottles to come in contact
with the extraction cups

Perform Assay
• Twirl briefly to mix the reagent

Perform Assay
• Incubate at room temperature
(15-30°C) for 5 minutes, but no
longer than 10 minutes

Perform Assay
• Add 4 drops (200 mL) of
Extraction Buffer B while holding
the bottle vertically

All drops must be free falling
with the reagent bottles held
vertically. Do not allow the tips
of the bottles to come in contact
with the extraction cups

Perform Assay
• Twirl the swab vigorously for 10 seconds and incubate for 1 minute,
but no longer than 10 minutes

Perform Assay
• Expunge as much liquid as
possible from swab by pressing
and rotating the fiber portion
against the wall of the tube

Perform Assay
• Discard used swab into biohazard
container

Perform Assay
• Cap the tube and mix contents by gentle swirling

• The swab extract can be tested immediately or remain at room
temperature for up to 3 hours without affecting test results

Perform Assay
• Remove a test device from its
protective pouch
• Place the test device on a clean,
flat surface
• Label the device with specimen’s
ID number

Do not open pouch unless ready
to run the test

Perform Assay
• Hold extraction tube vertically

• Dispense 2 drops (100 mL) of
extract to the sample pad

Do not over load samples

Perform Assay
• Set up timer

• Read test result within 15
minutes. Some positive results
may be visible as soon as 1
minute
• Complete reaction time of 15
minutes is required to confirm
negative results

Do not read result after 15 minutes

Read Assay Result
• Negative or non-reactive result
Only C band is developed
• Positive or reactive result
Both C and T bands are developed
• In valid result
No C band is developed

• Samples with positive results should be confirmed with alternative
testing method(s) such as antibody test, PCR and clinical findings
before to make diagnostic decision
• If C band isn’t developed, review whole procedure and repeat the
assay with a new device

Perform Assay
• Discard the used cassette device
and the protection sheet into
biohazard
container
after
interpreting the result

Quality Control
Internal Control

• Built-in control feature, the C band
o Developed C band indicates the procedure is correct
External Control
• Run 1 Positive Control and 1 Negative Control to assure proper
performance of the assay, when:
o a new operator uses the kit
o a new lot of test kit is used
o a new shipment of kits is used
o temperature used during storage of the kit falls outside of 2-30°C
o the temperature of the test area falls outside of 15-30°C
o to verify a higher than expected frequency of positive or negative
result
o to investigate the cause of repeated invalid results

Limitation of Test
• For optimal test performance, proper sample collection and storage
procedures are critical. Failure to follow the procedure may give
inaccurate results
• Limited to the qualitative detection of C. trachomatis antigen in swab
specimens. The intensity of the test band does not correlate with
antigen titer of the specimen
• Do not specifically differentiate between C. Trachomatis, C.
Pneumonia or C. Psittasi
• A negative or non-reactive test result:
o does not preclude the possibility of exposure to C. trachomatis
o It can occur if the concentration of the C. trachomatis antigen
present in the specimen is below the level detectable by the assay,
or the antigen is not present in the specimen or improper sample
treatment procedure
• If the symptom persists, while the result is negative or non-reactive
result, it is recommended to re-sample the patient few days later or
test with an alternative test device or method
• The results should only be interpreted in conjunction with other
diagnostic procedures and clinical findings

Technical Support
Contact Info.:
10110 Mesa Rim Rd. San Diego, CA 92121 USA
Email Address: [email protected]
Telephone: 1 (858) 457-8698
Fax: 1 (858) 535-1739

QUALITY . INNOVATION . SIMPLICITY


Slide 12

How To Run
OnSite Chlamydia Ag Rapid Test
(Catalog: R0080C)

C. trachomatis and Chlamydia
• Chlamydia trachomatis (C. trachomatis)
o The most common sexually transmitted
bacterial pathogen
o Major
cause of cervicitis, urethritis,
endometritis, and pelvic inflammatory
disease in women
o urethritis and epididymitis in men
• Chlamydia infection
o 80 million worldwide annually
o At least 3 million new cases in U.S.

Chlamydia Trachomatis

Current Diagnosis Methods
•
•
•
•
•

Cell culture
Direct fluorescence assay (DFA)
Enzyme immunoassays (EIA)
PCR
Immunological antigen test
Method

Rapid Test

DFA

EIA

PCR
> 4 hours

Culture

Time to result

15 minutes

2-3 hours

1-4 hours

>3 days

Facility

General Lab

Special Lab

General Lab Special Lab

Special Lab

Equipment

No

Expensive

PCR machine
Pipette

Incubator,
microscopy

Skill

Minimal

Well trained

Reader,
incubator,
pipette
Moderate

Well trained

Specialist

Comments

Cost effective

Costly

Costly

Costly

Costly

OnSite Chlamydia Ag Rapid Test

Intended Use
• Lateral flow chromatographic immunoassay

• Qualitative detection of C. trachomatis antigen in endocervical or
encourethral swab specimens
• Used as a screening test for diagnosis of infection with C.
trachomatis

Test Principle
• Double antibody-sandwich immunoassay

• A unique pair of Abs to selectively identify C. trachomatis Ag in the
specimen
• Test kit key components:
Test Band

Control Band

Pre-coated with another mouse
monoclonal anti-C. trachomatis Ab

Pe-coated with goat
anti-mouse IgG Ab

Kit Components
• 25 test devices (individually sealed
pouches containing with 1 cassette
device & 1 desiccant)
• 1 Extraction Buffer A (6 mL/vial)
• 1 Extraction Buffer B (6 mL/vial)
• 25 sample extraction tubes
• 1 package insert

Materials Required and Not Provided
• Swab for collecting specimen

• Clock or timer
• Disposable gloves
• Rack to hold extraction tube
• Biohazard container
• Marker pen

Precautions
Precautions

Explanation

Package insert MUST be read completely Pay attention to updated information
before testing
Do NOT open the pouch unless ready to Test device become moisture when
test
expose to humidity air, affect flow

Do NOT use components in any other Component in each kit is unique
type of test kit
Do NOT use expired devices

Expired product gives error result

Bring all reagents to room temperature Cold reagent has different viscosity,
(15-30°C) before use
affect flow migration and results
The testing results should be read within Extend reading time may lead to false
10 minutes after a specimen is applied to positive result.
the sample pad of the device
Do NOT perform the test in a room with Strong air flow causes specimen
strong air flow as the specimens might evaporation during assay, leads to
evaporate before reach
error result

Specimen Collection and Handling
• Consider any materials of human origin as infectious and handle them
using standard biosafety procedures
• Swab specimen should be collected by standard male or female
specimen collection methods
• Swabs should be processed as soon as possible after collection. If
swabs are not processed immediately, they should be placed into a
dry, sterile, tightly capped tube or bottle, and stored at 2-8°C for up to
5 days, preferably in a transportation tube

• Do NOT use bloody swabs
• Do NOT freeze swabs

Preparation for Assay
• Wear protective clothing and
disposable gloves

Preparation for Assay
• Set up work area

• Bring all kit components to room
temperature (15-30°C) prior to
testing

Preparation for Assay
• Double check product’s name
and expiration date
Product Name
Expiration Date

Do not use expired test device

Perform Assay
• Label an extraction tube for each
patient and place in a tube holder
or rack

Perform Assay
• Place specimen swab into the
extraction tube
• Add 4 drops (200 mL) of
Extraction Buffer A while holding
the bottle vertically

All drops must be free falling
with the reagent bottles held
vertically. Do not allow the tips
of the bottles to come in contact
with the extraction cups

Perform Assay
• Twirl briefly to mix the reagent

Perform Assay
• Incubate at room temperature
(15-30°C) for 5 minutes, but no
longer than 10 minutes

Perform Assay
• Add 4 drops (200 mL) of
Extraction Buffer B while holding
the bottle vertically

All drops must be free falling
with the reagent bottles held
vertically. Do not allow the tips
of the bottles to come in contact
with the extraction cups

Perform Assay
• Twirl the swab vigorously for 10 seconds and incubate for 1 minute,
but no longer than 10 minutes

Perform Assay
• Expunge as much liquid as
possible from swab by pressing
and rotating the fiber portion
against the wall of the tube

Perform Assay
• Discard used swab into biohazard
container

Perform Assay
• Cap the tube and mix contents by gentle swirling

• The swab extract can be tested immediately or remain at room
temperature for up to 3 hours without affecting test results

Perform Assay
• Remove a test device from its
protective pouch
• Place the test device on a clean,
flat surface
• Label the device with specimen’s
ID number

Do not open pouch unless ready
to run the test

Perform Assay
• Hold extraction tube vertically

• Dispense 2 drops (100 mL) of
extract to the sample pad

Do not over load samples

Perform Assay
• Set up timer

• Read test result within 15
minutes. Some positive results
may be visible as soon as 1
minute
• Complete reaction time of 15
minutes is required to confirm
negative results

Do not read result after 15 minutes

Read Assay Result
• Negative or non-reactive result
Only C band is developed
• Positive or reactive result
Both C and T bands are developed
• In valid result
No C band is developed

• Samples with positive results should be confirmed with alternative
testing method(s) such as antibody test, PCR and clinical findings
before to make diagnostic decision
• If C band isn’t developed, review whole procedure and repeat the
assay with a new device

Perform Assay
• Discard the used cassette device
and the protection sheet into
biohazard
container
after
interpreting the result

Quality Control
Internal Control

• Built-in control feature, the C band
o Developed C band indicates the procedure is correct
External Control
• Run 1 Positive Control and 1 Negative Control to assure proper
performance of the assay, when:
o a new operator uses the kit
o a new lot of test kit is used
o a new shipment of kits is used
o temperature used during storage of the kit falls outside of 2-30°C
o the temperature of the test area falls outside of 15-30°C
o to verify a higher than expected frequency of positive or negative
result
o to investigate the cause of repeated invalid results

Limitation of Test
• For optimal test performance, proper sample collection and storage
procedures are critical. Failure to follow the procedure may give
inaccurate results
• Limited to the qualitative detection of C. trachomatis antigen in swab
specimens. The intensity of the test band does not correlate with
antigen titer of the specimen
• Do not specifically differentiate between C. Trachomatis, C.
Pneumonia or C. Psittasi
• A negative or non-reactive test result:
o does not preclude the possibility of exposure to C. trachomatis
o It can occur if the concentration of the C. trachomatis antigen
present in the specimen is below the level detectable by the assay,
or the antigen is not present in the specimen or improper sample
treatment procedure
• If the symptom persists, while the result is negative or non-reactive
result, it is recommended to re-sample the patient few days later or
test with an alternative test device or method
• The results should only be interpreted in conjunction with other
diagnostic procedures and clinical findings

Technical Support
Contact Info.:
10110 Mesa Rim Rd. San Diego, CA 92121 USA
Email Address: [email protected]
Telephone: 1 (858) 457-8698
Fax: 1 (858) 535-1739

QUALITY . INNOVATION . SIMPLICITY


Slide 13

How To Run
OnSite Chlamydia Ag Rapid Test
(Catalog: R0080C)

C. trachomatis and Chlamydia
• Chlamydia trachomatis (C. trachomatis)
o The most common sexually transmitted
bacterial pathogen
o Major
cause of cervicitis, urethritis,
endometritis, and pelvic inflammatory
disease in women
o urethritis and epididymitis in men
• Chlamydia infection
o 80 million worldwide annually
o At least 3 million new cases in U.S.

Chlamydia Trachomatis

Current Diagnosis Methods
•
•
•
•
•

Cell culture
Direct fluorescence assay (DFA)
Enzyme immunoassays (EIA)
PCR
Immunological antigen test
Method

Rapid Test

DFA

EIA

PCR
> 4 hours

Culture

Time to result

15 minutes

2-3 hours

1-4 hours

>3 days

Facility

General Lab

Special Lab

General Lab Special Lab

Special Lab

Equipment

No

Expensive

PCR machine
Pipette

Incubator,
microscopy

Skill

Minimal

Well trained

Reader,
incubator,
pipette
Moderate

Well trained

Specialist

Comments

Cost effective

Costly

Costly

Costly

Costly

OnSite Chlamydia Ag Rapid Test

Intended Use
• Lateral flow chromatographic immunoassay

• Qualitative detection of C. trachomatis antigen in endocervical or
encourethral swab specimens
• Used as a screening test for diagnosis of infection with C.
trachomatis

Test Principle
• Double antibody-sandwich immunoassay

• A unique pair of Abs to selectively identify C. trachomatis Ag in the
specimen
• Test kit key components:
Test Band

Control Band

Pre-coated with another mouse
monoclonal anti-C. trachomatis Ab

Pe-coated with goat
anti-mouse IgG Ab

Kit Components
• 25 test devices (individually sealed
pouches containing with 1 cassette
device & 1 desiccant)
• 1 Extraction Buffer A (6 mL/vial)
• 1 Extraction Buffer B (6 mL/vial)
• 25 sample extraction tubes
• 1 package insert

Materials Required and Not Provided
• Swab for collecting specimen

• Clock or timer
• Disposable gloves
• Rack to hold extraction tube
• Biohazard container
• Marker pen

Precautions
Precautions

Explanation

Package insert MUST be read completely Pay attention to updated information
before testing
Do NOT open the pouch unless ready to Test device become moisture when
test
expose to humidity air, affect flow

Do NOT use components in any other Component in each kit is unique
type of test kit
Do NOT use expired devices

Expired product gives error result

Bring all reagents to room temperature Cold reagent has different viscosity,
(15-30°C) before use
affect flow migration and results
The testing results should be read within Extend reading time may lead to false
10 minutes after a specimen is applied to positive result.
the sample pad of the device
Do NOT perform the test in a room with Strong air flow causes specimen
strong air flow as the specimens might evaporation during assay, leads to
evaporate before reach
error result

Specimen Collection and Handling
• Consider any materials of human origin as infectious and handle them
using standard biosafety procedures
• Swab specimen should be collected by standard male or female
specimen collection methods
• Swabs should be processed as soon as possible after collection. If
swabs are not processed immediately, they should be placed into a
dry, sterile, tightly capped tube or bottle, and stored at 2-8°C for up to
5 days, preferably in a transportation tube

• Do NOT use bloody swabs
• Do NOT freeze swabs

Preparation for Assay
• Wear protective clothing and
disposable gloves

Preparation for Assay
• Set up work area

• Bring all kit components to room
temperature (15-30°C) prior to
testing

Preparation for Assay
• Double check product’s name
and expiration date
Product Name
Expiration Date

Do not use expired test device

Perform Assay
• Label an extraction tube for each
patient and place in a tube holder
or rack

Perform Assay
• Place specimen swab into the
extraction tube
• Add 4 drops (200 mL) of
Extraction Buffer A while holding
the bottle vertically

All drops must be free falling
with the reagent bottles held
vertically. Do not allow the tips
of the bottles to come in contact
with the extraction cups

Perform Assay
• Twirl briefly to mix the reagent

Perform Assay
• Incubate at room temperature
(15-30°C) for 5 minutes, but no
longer than 10 minutes

Perform Assay
• Add 4 drops (200 mL) of
Extraction Buffer B while holding
the bottle vertically

All drops must be free falling
with the reagent bottles held
vertically. Do not allow the tips
of the bottles to come in contact
with the extraction cups

Perform Assay
• Twirl the swab vigorously for 10 seconds and incubate for 1 minute,
but no longer than 10 minutes

Perform Assay
• Expunge as much liquid as
possible from swab by pressing
and rotating the fiber portion
against the wall of the tube

Perform Assay
• Discard used swab into biohazard
container

Perform Assay
• Cap the tube and mix contents by gentle swirling

• The swab extract can be tested immediately or remain at room
temperature for up to 3 hours without affecting test results

Perform Assay
• Remove a test device from its
protective pouch
• Place the test device on a clean,
flat surface
• Label the device with specimen’s
ID number

Do not open pouch unless ready
to run the test

Perform Assay
• Hold extraction tube vertically

• Dispense 2 drops (100 mL) of
extract to the sample pad

Do not over load samples

Perform Assay
• Set up timer

• Read test result within 15
minutes. Some positive results
may be visible as soon as 1
minute
• Complete reaction time of 15
minutes is required to confirm
negative results

Do not read result after 15 minutes

Read Assay Result
• Negative or non-reactive result
Only C band is developed
• Positive or reactive result
Both C and T bands are developed
• In valid result
No C band is developed

• Samples with positive results should be confirmed with alternative
testing method(s) such as antibody test, PCR and clinical findings
before to make diagnostic decision
• If C band isn’t developed, review whole procedure and repeat the
assay with a new device

Perform Assay
• Discard the used cassette device
and the protection sheet into
biohazard
container
after
interpreting the result

Quality Control
Internal Control

• Built-in control feature, the C band
o Developed C band indicates the procedure is correct
External Control
• Run 1 Positive Control and 1 Negative Control to assure proper
performance of the assay, when:
o a new operator uses the kit
o a new lot of test kit is used
o a new shipment of kits is used
o temperature used during storage of the kit falls outside of 2-30°C
o the temperature of the test area falls outside of 15-30°C
o to verify a higher than expected frequency of positive or negative
result
o to investigate the cause of repeated invalid results

Limitation of Test
• For optimal test performance, proper sample collection and storage
procedures are critical. Failure to follow the procedure may give
inaccurate results
• Limited to the qualitative detection of C. trachomatis antigen in swab
specimens. The intensity of the test band does not correlate with
antigen titer of the specimen
• Do not specifically differentiate between C. Trachomatis, C.
Pneumonia or C. Psittasi
• A negative or non-reactive test result:
o does not preclude the possibility of exposure to C. trachomatis
o It can occur if the concentration of the C. trachomatis antigen
present in the specimen is below the level detectable by the assay,
or the antigen is not present in the specimen or improper sample
treatment procedure
• If the symptom persists, while the result is negative or non-reactive
result, it is recommended to re-sample the patient few days later or
test with an alternative test device or method
• The results should only be interpreted in conjunction with other
diagnostic procedures and clinical findings

Technical Support
Contact Info.:
10110 Mesa Rim Rd. San Diego, CA 92121 USA
Email Address: [email protected]
Telephone: 1 (858) 457-8698
Fax: 1 (858) 535-1739

QUALITY . INNOVATION . SIMPLICITY


Slide 14

How To Run
OnSite Chlamydia Ag Rapid Test
(Catalog: R0080C)

C. trachomatis and Chlamydia
• Chlamydia trachomatis (C. trachomatis)
o The most common sexually transmitted
bacterial pathogen
o Major
cause of cervicitis, urethritis,
endometritis, and pelvic inflammatory
disease in women
o urethritis and epididymitis in men
• Chlamydia infection
o 80 million worldwide annually
o At least 3 million new cases in U.S.

Chlamydia Trachomatis

Current Diagnosis Methods
•
•
•
•
•

Cell culture
Direct fluorescence assay (DFA)
Enzyme immunoassays (EIA)
PCR
Immunological antigen test
Method

Rapid Test

DFA

EIA

PCR
> 4 hours

Culture

Time to result

15 minutes

2-3 hours

1-4 hours

>3 days

Facility

General Lab

Special Lab

General Lab Special Lab

Special Lab

Equipment

No

Expensive

PCR machine
Pipette

Incubator,
microscopy

Skill

Minimal

Well trained

Reader,
incubator,
pipette
Moderate

Well trained

Specialist

Comments

Cost effective

Costly

Costly

Costly

Costly

OnSite Chlamydia Ag Rapid Test

Intended Use
• Lateral flow chromatographic immunoassay

• Qualitative detection of C. trachomatis antigen in endocervical or
encourethral swab specimens
• Used as a screening test for diagnosis of infection with C.
trachomatis

Test Principle
• Double antibody-sandwich immunoassay

• A unique pair of Abs to selectively identify C. trachomatis Ag in the
specimen
• Test kit key components:
Test Band

Control Band

Pre-coated with another mouse
monoclonal anti-C. trachomatis Ab

Pe-coated with goat
anti-mouse IgG Ab

Kit Components
• 25 test devices (individually sealed
pouches containing with 1 cassette
device & 1 desiccant)
• 1 Extraction Buffer A (6 mL/vial)
• 1 Extraction Buffer B (6 mL/vial)
• 25 sample extraction tubes
• 1 package insert

Materials Required and Not Provided
• Swab for collecting specimen

• Clock or timer
• Disposable gloves
• Rack to hold extraction tube
• Biohazard container
• Marker pen

Precautions
Precautions

Explanation

Package insert MUST be read completely Pay attention to updated information
before testing
Do NOT open the pouch unless ready to Test device become moisture when
test
expose to humidity air, affect flow

Do NOT use components in any other Component in each kit is unique
type of test kit
Do NOT use expired devices

Expired product gives error result

Bring all reagents to room temperature Cold reagent has different viscosity,
(15-30°C) before use
affect flow migration and results
The testing results should be read within Extend reading time may lead to false
10 minutes after a specimen is applied to positive result.
the sample pad of the device
Do NOT perform the test in a room with Strong air flow causes specimen
strong air flow as the specimens might evaporation during assay, leads to
evaporate before reach
error result

Specimen Collection and Handling
• Consider any materials of human origin as infectious and handle them
using standard biosafety procedures
• Swab specimen should be collected by standard male or female
specimen collection methods
• Swabs should be processed as soon as possible after collection. If
swabs are not processed immediately, they should be placed into a
dry, sterile, tightly capped tube or bottle, and stored at 2-8°C for up to
5 days, preferably in a transportation tube

• Do NOT use bloody swabs
• Do NOT freeze swabs

Preparation for Assay
• Wear protective clothing and
disposable gloves

Preparation for Assay
• Set up work area

• Bring all kit components to room
temperature (15-30°C) prior to
testing

Preparation for Assay
• Double check product’s name
and expiration date
Product Name
Expiration Date

Do not use expired test device

Perform Assay
• Label an extraction tube for each
patient and place in a tube holder
or rack

Perform Assay
• Place specimen swab into the
extraction tube
• Add 4 drops (200 mL) of
Extraction Buffer A while holding
the bottle vertically

All drops must be free falling
with the reagent bottles held
vertically. Do not allow the tips
of the bottles to come in contact
with the extraction cups

Perform Assay
• Twirl briefly to mix the reagent

Perform Assay
• Incubate at room temperature
(15-30°C) for 5 minutes, but no
longer than 10 minutes

Perform Assay
• Add 4 drops (200 mL) of
Extraction Buffer B while holding
the bottle vertically

All drops must be free falling
with the reagent bottles held
vertically. Do not allow the tips
of the bottles to come in contact
with the extraction cups

Perform Assay
• Twirl the swab vigorously for 10 seconds and incubate for 1 minute,
but no longer than 10 minutes

Perform Assay
• Expunge as much liquid as
possible from swab by pressing
and rotating the fiber portion
against the wall of the tube

Perform Assay
• Discard used swab into biohazard
container

Perform Assay
• Cap the tube and mix contents by gentle swirling

• The swab extract can be tested immediately or remain at room
temperature for up to 3 hours without affecting test results

Perform Assay
• Remove a test device from its
protective pouch
• Place the test device on a clean,
flat surface
• Label the device with specimen’s
ID number

Do not open pouch unless ready
to run the test

Perform Assay
• Hold extraction tube vertically

• Dispense 2 drops (100 mL) of
extract to the sample pad

Do not over load samples

Perform Assay
• Set up timer

• Read test result within 15
minutes. Some positive results
may be visible as soon as 1
minute
• Complete reaction time of 15
minutes is required to confirm
negative results

Do not read result after 15 minutes

Read Assay Result
• Negative or non-reactive result
Only C band is developed
• Positive or reactive result
Both C and T bands are developed
• In valid result
No C band is developed

• Samples with positive results should be confirmed with alternative
testing method(s) such as antibody test, PCR and clinical findings
before to make diagnostic decision
• If C band isn’t developed, review whole procedure and repeat the
assay with a new device

Perform Assay
• Discard the used cassette device
and the protection sheet into
biohazard
container
after
interpreting the result

Quality Control
Internal Control

• Built-in control feature, the C band
o Developed C band indicates the procedure is correct
External Control
• Run 1 Positive Control and 1 Negative Control to assure proper
performance of the assay, when:
o a new operator uses the kit
o a new lot of test kit is used
o a new shipment of kits is used
o temperature used during storage of the kit falls outside of 2-30°C
o the temperature of the test area falls outside of 15-30°C
o to verify a higher than expected frequency of positive or negative
result
o to investigate the cause of repeated invalid results

Limitation of Test
• For optimal test performance, proper sample collection and storage
procedures are critical. Failure to follow the procedure may give
inaccurate results
• Limited to the qualitative detection of C. trachomatis antigen in swab
specimens. The intensity of the test band does not correlate with
antigen titer of the specimen
• Do not specifically differentiate between C. Trachomatis, C.
Pneumonia or C. Psittasi
• A negative or non-reactive test result:
o does not preclude the possibility of exposure to C. trachomatis
o It can occur if the concentration of the C. trachomatis antigen
present in the specimen is below the level detectable by the assay,
or the antigen is not present in the specimen or improper sample
treatment procedure
• If the symptom persists, while the result is negative or non-reactive
result, it is recommended to re-sample the patient few days later or
test with an alternative test device or method
• The results should only be interpreted in conjunction with other
diagnostic procedures and clinical findings

Technical Support
Contact Info.:
10110 Mesa Rim Rd. San Diego, CA 92121 USA
Email Address: [email protected]
Telephone: 1 (858) 457-8698
Fax: 1 (858) 535-1739

QUALITY . INNOVATION . SIMPLICITY


Slide 15

How To Run
OnSite Chlamydia Ag Rapid Test
(Catalog: R0080C)

C. trachomatis and Chlamydia
• Chlamydia trachomatis (C. trachomatis)
o The most common sexually transmitted
bacterial pathogen
o Major
cause of cervicitis, urethritis,
endometritis, and pelvic inflammatory
disease in women
o urethritis and epididymitis in men
• Chlamydia infection
o 80 million worldwide annually
o At least 3 million new cases in U.S.

Chlamydia Trachomatis

Current Diagnosis Methods
•
•
•
•
•

Cell culture
Direct fluorescence assay (DFA)
Enzyme immunoassays (EIA)
PCR
Immunological antigen test
Method

Rapid Test

DFA

EIA

PCR
> 4 hours

Culture

Time to result

15 minutes

2-3 hours

1-4 hours

>3 days

Facility

General Lab

Special Lab

General Lab Special Lab

Special Lab

Equipment

No

Expensive

PCR machine
Pipette

Incubator,
microscopy

Skill

Minimal

Well trained

Reader,
incubator,
pipette
Moderate

Well trained

Specialist

Comments

Cost effective

Costly

Costly

Costly

Costly

OnSite Chlamydia Ag Rapid Test

Intended Use
• Lateral flow chromatographic immunoassay

• Qualitative detection of C. trachomatis antigen in endocervical or
encourethral swab specimens
• Used as a screening test for diagnosis of infection with C.
trachomatis

Test Principle
• Double antibody-sandwich immunoassay

• A unique pair of Abs to selectively identify C. trachomatis Ag in the
specimen
• Test kit key components:
Test Band

Control Band

Pre-coated with another mouse
monoclonal anti-C. trachomatis Ab

Pe-coated with goat
anti-mouse IgG Ab

Kit Components
• 25 test devices (individually sealed
pouches containing with 1 cassette
device & 1 desiccant)
• 1 Extraction Buffer A (6 mL/vial)
• 1 Extraction Buffer B (6 mL/vial)
• 25 sample extraction tubes
• 1 package insert

Materials Required and Not Provided
• Swab for collecting specimen

• Clock or timer
• Disposable gloves
• Rack to hold extraction tube
• Biohazard container
• Marker pen

Precautions
Precautions

Explanation

Package insert MUST be read completely Pay attention to updated information
before testing
Do NOT open the pouch unless ready to Test device become moisture when
test
expose to humidity air, affect flow

Do NOT use components in any other Component in each kit is unique
type of test kit
Do NOT use expired devices

Expired product gives error result

Bring all reagents to room temperature Cold reagent has different viscosity,
(15-30°C) before use
affect flow migration and results
The testing results should be read within Extend reading time may lead to false
10 minutes after a specimen is applied to positive result.
the sample pad of the device
Do NOT perform the test in a room with Strong air flow causes specimen
strong air flow as the specimens might evaporation during assay, leads to
evaporate before reach
error result

Specimen Collection and Handling
• Consider any materials of human origin as infectious and handle them
using standard biosafety procedures
• Swab specimen should be collected by standard male or female
specimen collection methods
• Swabs should be processed as soon as possible after collection. If
swabs are not processed immediately, they should be placed into a
dry, sterile, tightly capped tube or bottle, and stored at 2-8°C for up to
5 days, preferably in a transportation tube

• Do NOT use bloody swabs
• Do NOT freeze swabs

Preparation for Assay
• Wear protective clothing and
disposable gloves

Preparation for Assay
• Set up work area

• Bring all kit components to room
temperature (15-30°C) prior to
testing

Preparation for Assay
• Double check product’s name
and expiration date
Product Name
Expiration Date

Do not use expired test device

Perform Assay
• Label an extraction tube for each
patient and place in a tube holder
or rack

Perform Assay
• Place specimen swab into the
extraction tube
• Add 4 drops (200 mL) of
Extraction Buffer A while holding
the bottle vertically

All drops must be free falling
with the reagent bottles held
vertically. Do not allow the tips
of the bottles to come in contact
with the extraction cups

Perform Assay
• Twirl briefly to mix the reagent

Perform Assay
• Incubate at room temperature
(15-30°C) for 5 minutes, but no
longer than 10 minutes

Perform Assay
• Add 4 drops (200 mL) of
Extraction Buffer B while holding
the bottle vertically

All drops must be free falling
with the reagent bottles held
vertically. Do not allow the tips
of the bottles to come in contact
with the extraction cups

Perform Assay
• Twirl the swab vigorously for 10 seconds and incubate for 1 minute,
but no longer than 10 minutes

Perform Assay
• Expunge as much liquid as
possible from swab by pressing
and rotating the fiber portion
against the wall of the tube

Perform Assay
• Discard used swab into biohazard
container

Perform Assay
• Cap the tube and mix contents by gentle swirling

• The swab extract can be tested immediately or remain at room
temperature for up to 3 hours without affecting test results

Perform Assay
• Remove a test device from its
protective pouch
• Place the test device on a clean,
flat surface
• Label the device with specimen’s
ID number

Do not open pouch unless ready
to run the test

Perform Assay
• Hold extraction tube vertically

• Dispense 2 drops (100 mL) of
extract to the sample pad

Do not over load samples

Perform Assay
• Set up timer

• Read test result within 15
minutes. Some positive results
may be visible as soon as 1
minute
• Complete reaction time of 15
minutes is required to confirm
negative results

Do not read result after 15 minutes

Read Assay Result
• Negative or non-reactive result
Only C band is developed
• Positive or reactive result
Both C and T bands are developed
• In valid result
No C band is developed

• Samples with positive results should be confirmed with alternative
testing method(s) such as antibody test, PCR and clinical findings
before to make diagnostic decision
• If C band isn’t developed, review whole procedure and repeat the
assay with a new device

Perform Assay
• Discard the used cassette device
and the protection sheet into
biohazard
container
after
interpreting the result

Quality Control
Internal Control

• Built-in control feature, the C band
o Developed C band indicates the procedure is correct
External Control
• Run 1 Positive Control and 1 Negative Control to assure proper
performance of the assay, when:
o a new operator uses the kit
o a new lot of test kit is used
o a new shipment of kits is used
o temperature used during storage of the kit falls outside of 2-30°C
o the temperature of the test area falls outside of 15-30°C
o to verify a higher than expected frequency of positive or negative
result
o to investigate the cause of repeated invalid results

Limitation of Test
• For optimal test performance, proper sample collection and storage
procedures are critical. Failure to follow the procedure may give
inaccurate results
• Limited to the qualitative detection of C. trachomatis antigen in swab
specimens. The intensity of the test band does not correlate with
antigen titer of the specimen
• Do not specifically differentiate between C. Trachomatis, C.
Pneumonia or C. Psittasi
• A negative or non-reactive test result:
o does not preclude the possibility of exposure to C. trachomatis
o It can occur if the concentration of the C. trachomatis antigen
present in the specimen is below the level detectable by the assay,
or the antigen is not present in the specimen or improper sample
treatment procedure
• If the symptom persists, while the result is negative or non-reactive
result, it is recommended to re-sample the patient few days later or
test with an alternative test device or method
• The results should only be interpreted in conjunction with other
diagnostic procedures and clinical findings

Technical Support
Contact Info.:
10110 Mesa Rim Rd. San Diego, CA 92121 USA
Email Address: [email protected]
Telephone: 1 (858) 457-8698
Fax: 1 (858) 535-1739

QUALITY . INNOVATION . SIMPLICITY


Slide 16

How To Run
OnSite Chlamydia Ag Rapid Test
(Catalog: R0080C)

C. trachomatis and Chlamydia
• Chlamydia trachomatis (C. trachomatis)
o The most common sexually transmitted
bacterial pathogen
o Major
cause of cervicitis, urethritis,
endometritis, and pelvic inflammatory
disease in women
o urethritis and epididymitis in men
• Chlamydia infection
o 80 million worldwide annually
o At least 3 million new cases in U.S.

Chlamydia Trachomatis

Current Diagnosis Methods
•
•
•
•
•

Cell culture
Direct fluorescence assay (DFA)
Enzyme immunoassays (EIA)
PCR
Immunological antigen test
Method

Rapid Test

DFA

EIA

PCR
> 4 hours

Culture

Time to result

15 minutes

2-3 hours

1-4 hours

>3 days

Facility

General Lab

Special Lab

General Lab Special Lab

Special Lab

Equipment

No

Expensive

PCR machine
Pipette

Incubator,
microscopy

Skill

Minimal

Well trained

Reader,
incubator,
pipette
Moderate

Well trained

Specialist

Comments

Cost effective

Costly

Costly

Costly

Costly

OnSite Chlamydia Ag Rapid Test

Intended Use
• Lateral flow chromatographic immunoassay

• Qualitative detection of C. trachomatis antigen in endocervical or
encourethral swab specimens
• Used as a screening test for diagnosis of infection with C.
trachomatis

Test Principle
• Double antibody-sandwich immunoassay

• A unique pair of Abs to selectively identify C. trachomatis Ag in the
specimen
• Test kit key components:
Test Band

Control Band

Pre-coated with another mouse
monoclonal anti-C. trachomatis Ab

Pe-coated with goat
anti-mouse IgG Ab

Kit Components
• 25 test devices (individually sealed
pouches containing with 1 cassette
device & 1 desiccant)
• 1 Extraction Buffer A (6 mL/vial)
• 1 Extraction Buffer B (6 mL/vial)
• 25 sample extraction tubes
• 1 package insert

Materials Required and Not Provided
• Swab for collecting specimen

• Clock or timer
• Disposable gloves
• Rack to hold extraction tube
• Biohazard container
• Marker pen

Precautions
Precautions

Explanation

Package insert MUST be read completely Pay attention to updated information
before testing
Do NOT open the pouch unless ready to Test device become moisture when
test
expose to humidity air, affect flow

Do NOT use components in any other Component in each kit is unique
type of test kit
Do NOT use expired devices

Expired product gives error result

Bring all reagents to room temperature Cold reagent has different viscosity,
(15-30°C) before use
affect flow migration and results
The testing results should be read within Extend reading time may lead to false
10 minutes after a specimen is applied to positive result.
the sample pad of the device
Do NOT perform the test in a room with Strong air flow causes specimen
strong air flow as the specimens might evaporation during assay, leads to
evaporate before reach
error result

Specimen Collection and Handling
• Consider any materials of human origin as infectious and handle them
using standard biosafety procedures
• Swab specimen should be collected by standard male or female
specimen collection methods
• Swabs should be processed as soon as possible after collection. If
swabs are not processed immediately, they should be placed into a
dry, sterile, tightly capped tube or bottle, and stored at 2-8°C for up to
5 days, preferably in a transportation tube

• Do NOT use bloody swabs
• Do NOT freeze swabs

Preparation for Assay
• Wear protective clothing and
disposable gloves

Preparation for Assay
• Set up work area

• Bring all kit components to room
temperature (15-30°C) prior to
testing

Preparation for Assay
• Double check product’s name
and expiration date
Product Name
Expiration Date

Do not use expired test device

Perform Assay
• Label an extraction tube for each
patient and place in a tube holder
or rack

Perform Assay
• Place specimen swab into the
extraction tube
• Add 4 drops (200 mL) of
Extraction Buffer A while holding
the bottle vertically

All drops must be free falling
with the reagent bottles held
vertically. Do not allow the tips
of the bottles to come in contact
with the extraction cups

Perform Assay
• Twirl briefly to mix the reagent

Perform Assay
• Incubate at room temperature
(15-30°C) for 5 minutes, but no
longer than 10 minutes

Perform Assay
• Add 4 drops (200 mL) of
Extraction Buffer B while holding
the bottle vertically

All drops must be free falling
with the reagent bottles held
vertically. Do not allow the tips
of the bottles to come in contact
with the extraction cups

Perform Assay
• Twirl the swab vigorously for 10 seconds and incubate for 1 minute,
but no longer than 10 minutes

Perform Assay
• Expunge as much liquid as
possible from swab by pressing
and rotating the fiber portion
against the wall of the tube

Perform Assay
• Discard used swab into biohazard
container

Perform Assay
• Cap the tube and mix contents by gentle swirling

• The swab extract can be tested immediately or remain at room
temperature for up to 3 hours without affecting test results

Perform Assay
• Remove a test device from its
protective pouch
• Place the test device on a clean,
flat surface
• Label the device with specimen’s
ID number

Do not open pouch unless ready
to run the test

Perform Assay
• Hold extraction tube vertically

• Dispense 2 drops (100 mL) of
extract to the sample pad

Do not over load samples

Perform Assay
• Set up timer

• Read test result within 15
minutes. Some positive results
may be visible as soon as 1
minute
• Complete reaction time of 15
minutes is required to confirm
negative results

Do not read result after 15 minutes

Read Assay Result
• Negative or non-reactive result
Only C band is developed
• Positive or reactive result
Both C and T bands are developed
• In valid result
No C band is developed

• Samples with positive results should be confirmed with alternative
testing method(s) such as antibody test, PCR and clinical findings
before to make diagnostic decision
• If C band isn’t developed, review whole procedure and repeat the
assay with a new device

Perform Assay
• Discard the used cassette device
and the protection sheet into
biohazard
container
after
interpreting the result

Quality Control
Internal Control

• Built-in control feature, the C band
o Developed C band indicates the procedure is correct
External Control
• Run 1 Positive Control and 1 Negative Control to assure proper
performance of the assay, when:
o a new operator uses the kit
o a new lot of test kit is used
o a new shipment of kits is used
o temperature used during storage of the kit falls outside of 2-30°C
o the temperature of the test area falls outside of 15-30°C
o to verify a higher than expected frequency of positive or negative
result
o to investigate the cause of repeated invalid results

Limitation of Test
• For optimal test performance, proper sample collection and storage
procedures are critical. Failure to follow the procedure may give
inaccurate results
• Limited to the qualitative detection of C. trachomatis antigen in swab
specimens. The intensity of the test band does not correlate with
antigen titer of the specimen
• Do not specifically differentiate between C. Trachomatis, C.
Pneumonia or C. Psittasi
• A negative or non-reactive test result:
o does not preclude the possibility of exposure to C. trachomatis
o It can occur if the concentration of the C. trachomatis antigen
present in the specimen is below the level detectable by the assay,
or the antigen is not present in the specimen or improper sample
treatment procedure
• If the symptom persists, while the result is negative or non-reactive
result, it is recommended to re-sample the patient few days later or
test with an alternative test device or method
• The results should only be interpreted in conjunction with other
diagnostic procedures and clinical findings

Technical Support
Contact Info.:
10110 Mesa Rim Rd. San Diego, CA 92121 USA
Email Address: [email protected]
Telephone: 1 (858) 457-8698
Fax: 1 (858) 535-1739

QUALITY . INNOVATION . SIMPLICITY


Slide 17

How To Run
OnSite Chlamydia Ag Rapid Test
(Catalog: R0080C)

C. trachomatis and Chlamydia
• Chlamydia trachomatis (C. trachomatis)
o The most common sexually transmitted
bacterial pathogen
o Major
cause of cervicitis, urethritis,
endometritis, and pelvic inflammatory
disease in women
o urethritis and epididymitis in men
• Chlamydia infection
o 80 million worldwide annually
o At least 3 million new cases in U.S.

Chlamydia Trachomatis

Current Diagnosis Methods
•
•
•
•
•

Cell culture
Direct fluorescence assay (DFA)
Enzyme immunoassays (EIA)
PCR
Immunological antigen test
Method

Rapid Test

DFA

EIA

PCR
> 4 hours

Culture

Time to result

15 minutes

2-3 hours

1-4 hours

>3 days

Facility

General Lab

Special Lab

General Lab Special Lab

Special Lab

Equipment

No

Expensive

PCR machine
Pipette

Incubator,
microscopy

Skill

Minimal

Well trained

Reader,
incubator,
pipette
Moderate

Well trained

Specialist

Comments

Cost effective

Costly

Costly

Costly

Costly

OnSite Chlamydia Ag Rapid Test

Intended Use
• Lateral flow chromatographic immunoassay

• Qualitative detection of C. trachomatis antigen in endocervical or
encourethral swab specimens
• Used as a screening test for diagnosis of infection with C.
trachomatis

Test Principle
• Double antibody-sandwich immunoassay

• A unique pair of Abs to selectively identify C. trachomatis Ag in the
specimen
• Test kit key components:
Test Band

Control Band

Pre-coated with another mouse
monoclonal anti-C. trachomatis Ab

Pe-coated with goat
anti-mouse IgG Ab

Kit Components
• 25 test devices (individually sealed
pouches containing with 1 cassette
device & 1 desiccant)
• 1 Extraction Buffer A (6 mL/vial)
• 1 Extraction Buffer B (6 mL/vial)
• 25 sample extraction tubes
• 1 package insert

Materials Required and Not Provided
• Swab for collecting specimen

• Clock or timer
• Disposable gloves
• Rack to hold extraction tube
• Biohazard container
• Marker pen

Precautions
Precautions

Explanation

Package insert MUST be read completely Pay attention to updated information
before testing
Do NOT open the pouch unless ready to Test device become moisture when
test
expose to humidity air, affect flow

Do NOT use components in any other Component in each kit is unique
type of test kit
Do NOT use expired devices

Expired product gives error result

Bring all reagents to room temperature Cold reagent has different viscosity,
(15-30°C) before use
affect flow migration and results
The testing results should be read within Extend reading time may lead to false
10 minutes after a specimen is applied to positive result.
the sample pad of the device
Do NOT perform the test in a room with Strong air flow causes specimen
strong air flow as the specimens might evaporation during assay, leads to
evaporate before reach
error result

Specimen Collection and Handling
• Consider any materials of human origin as infectious and handle them
using standard biosafety procedures
• Swab specimen should be collected by standard male or female
specimen collection methods
• Swabs should be processed as soon as possible after collection. If
swabs are not processed immediately, they should be placed into a
dry, sterile, tightly capped tube or bottle, and stored at 2-8°C for up to
5 days, preferably in a transportation tube

• Do NOT use bloody swabs
• Do NOT freeze swabs

Preparation for Assay
• Wear protective clothing and
disposable gloves

Preparation for Assay
• Set up work area

• Bring all kit components to room
temperature (15-30°C) prior to
testing

Preparation for Assay
• Double check product’s name
and expiration date
Product Name
Expiration Date

Do not use expired test device

Perform Assay
• Label an extraction tube for each
patient and place in a tube holder
or rack

Perform Assay
• Place specimen swab into the
extraction tube
• Add 4 drops (200 mL) of
Extraction Buffer A while holding
the bottle vertically

All drops must be free falling
with the reagent bottles held
vertically. Do not allow the tips
of the bottles to come in contact
with the extraction cups

Perform Assay
• Twirl briefly to mix the reagent

Perform Assay
• Incubate at room temperature
(15-30°C) for 5 minutes, but no
longer than 10 minutes

Perform Assay
• Add 4 drops (200 mL) of
Extraction Buffer B while holding
the bottle vertically

All drops must be free falling
with the reagent bottles held
vertically. Do not allow the tips
of the bottles to come in contact
with the extraction cups

Perform Assay
• Twirl the swab vigorously for 10 seconds and incubate for 1 minute,
but no longer than 10 minutes

Perform Assay
• Expunge as much liquid as
possible from swab by pressing
and rotating the fiber portion
against the wall of the tube

Perform Assay
• Discard used swab into biohazard
container

Perform Assay
• Cap the tube and mix contents by gentle swirling

• The swab extract can be tested immediately or remain at room
temperature for up to 3 hours without affecting test results

Perform Assay
• Remove a test device from its
protective pouch
• Place the test device on a clean,
flat surface
• Label the device with specimen’s
ID number

Do not open pouch unless ready
to run the test

Perform Assay
• Hold extraction tube vertically

• Dispense 2 drops (100 mL) of
extract to the sample pad

Do not over load samples

Perform Assay
• Set up timer

• Read test result within 15
minutes. Some positive results
may be visible as soon as 1
minute
• Complete reaction time of 15
minutes is required to confirm
negative results

Do not read result after 15 minutes

Read Assay Result
• Negative or non-reactive result
Only C band is developed
• Positive or reactive result
Both C and T bands are developed
• In valid result
No C band is developed

• Samples with positive results should be confirmed with alternative
testing method(s) such as antibody test, PCR and clinical findings
before to make diagnostic decision
• If C band isn’t developed, review whole procedure and repeat the
assay with a new device

Perform Assay
• Discard the used cassette device
and the protection sheet into
biohazard
container
after
interpreting the result

Quality Control
Internal Control

• Built-in control feature, the C band
o Developed C band indicates the procedure is correct
External Control
• Run 1 Positive Control and 1 Negative Control to assure proper
performance of the assay, when:
o a new operator uses the kit
o a new lot of test kit is used
o a new shipment of kits is used
o temperature used during storage of the kit falls outside of 2-30°C
o the temperature of the test area falls outside of 15-30°C
o to verify a higher than expected frequency of positive or negative
result
o to investigate the cause of repeated invalid results

Limitation of Test
• For optimal test performance, proper sample collection and storage
procedures are critical. Failure to follow the procedure may give
inaccurate results
• Limited to the qualitative detection of C. trachomatis antigen in swab
specimens. The intensity of the test band does not correlate with
antigen titer of the specimen
• Do not specifically differentiate between C. Trachomatis, C.
Pneumonia or C. Psittasi
• A negative or non-reactive test result:
o does not preclude the possibility of exposure to C. trachomatis
o It can occur if the concentration of the C. trachomatis antigen
present in the specimen is below the level detectable by the assay,
or the antigen is not present in the specimen or improper sample
treatment procedure
• If the symptom persists, while the result is negative or non-reactive
result, it is recommended to re-sample the patient few days later or
test with an alternative test device or method
• The results should only be interpreted in conjunction with other
diagnostic procedures and clinical findings

Technical Support
Contact Info.:
10110 Mesa Rim Rd. San Diego, CA 92121 USA
Email Address: [email protected]
Telephone: 1 (858) 457-8698
Fax: 1 (858) 535-1739

QUALITY . INNOVATION . SIMPLICITY


Slide 18

How To Run
OnSite Chlamydia Ag Rapid Test
(Catalog: R0080C)

C. trachomatis and Chlamydia
• Chlamydia trachomatis (C. trachomatis)
o The most common sexually transmitted
bacterial pathogen
o Major
cause of cervicitis, urethritis,
endometritis, and pelvic inflammatory
disease in women
o urethritis and epididymitis in men
• Chlamydia infection
o 80 million worldwide annually
o At least 3 million new cases in U.S.

Chlamydia Trachomatis

Current Diagnosis Methods
•
•
•
•
•

Cell culture
Direct fluorescence assay (DFA)
Enzyme immunoassays (EIA)
PCR
Immunological antigen test
Method

Rapid Test

DFA

EIA

PCR
> 4 hours

Culture

Time to result

15 minutes

2-3 hours

1-4 hours

>3 days

Facility

General Lab

Special Lab

General Lab Special Lab

Special Lab

Equipment

No

Expensive

PCR machine
Pipette

Incubator,
microscopy

Skill

Minimal

Well trained

Reader,
incubator,
pipette
Moderate

Well trained

Specialist

Comments

Cost effective

Costly

Costly

Costly

Costly

OnSite Chlamydia Ag Rapid Test

Intended Use
• Lateral flow chromatographic immunoassay

• Qualitative detection of C. trachomatis antigen in endocervical or
encourethral swab specimens
• Used as a screening test for diagnosis of infection with C.
trachomatis

Test Principle
• Double antibody-sandwich immunoassay

• A unique pair of Abs to selectively identify C. trachomatis Ag in the
specimen
• Test kit key components:
Test Band

Control Band

Pre-coated with another mouse
monoclonal anti-C. trachomatis Ab

Pe-coated with goat
anti-mouse IgG Ab

Kit Components
• 25 test devices (individually sealed
pouches containing with 1 cassette
device & 1 desiccant)
• 1 Extraction Buffer A (6 mL/vial)
• 1 Extraction Buffer B (6 mL/vial)
• 25 sample extraction tubes
• 1 package insert

Materials Required and Not Provided
• Swab for collecting specimen

• Clock or timer
• Disposable gloves
• Rack to hold extraction tube
• Biohazard container
• Marker pen

Precautions
Precautions

Explanation

Package insert MUST be read completely Pay attention to updated information
before testing
Do NOT open the pouch unless ready to Test device become moisture when
test
expose to humidity air, affect flow

Do NOT use components in any other Component in each kit is unique
type of test kit
Do NOT use expired devices

Expired product gives error result

Bring all reagents to room temperature Cold reagent has different viscosity,
(15-30°C) before use
affect flow migration and results
The testing results should be read within Extend reading time may lead to false
10 minutes after a specimen is applied to positive result.
the sample pad of the device
Do NOT perform the test in a room with Strong air flow causes specimen
strong air flow as the specimens might evaporation during assay, leads to
evaporate before reach
error result

Specimen Collection and Handling
• Consider any materials of human origin as infectious and handle them
using standard biosafety procedures
• Swab specimen should be collected by standard male or female
specimen collection methods
• Swabs should be processed as soon as possible after collection. If
swabs are not processed immediately, they should be placed into a
dry, sterile, tightly capped tube or bottle, and stored at 2-8°C for up to
5 days, preferably in a transportation tube

• Do NOT use bloody swabs
• Do NOT freeze swabs

Preparation for Assay
• Wear protective clothing and
disposable gloves

Preparation for Assay
• Set up work area

• Bring all kit components to room
temperature (15-30°C) prior to
testing

Preparation for Assay
• Double check product’s name
and expiration date
Product Name
Expiration Date

Do not use expired test device

Perform Assay
• Label an extraction tube for each
patient and place in a tube holder
or rack

Perform Assay
• Place specimen swab into the
extraction tube
• Add 4 drops (200 mL) of
Extraction Buffer A while holding
the bottle vertically

All drops must be free falling
with the reagent bottles held
vertically. Do not allow the tips
of the bottles to come in contact
with the extraction cups

Perform Assay
• Twirl briefly to mix the reagent

Perform Assay
• Incubate at room temperature
(15-30°C) for 5 minutes, but no
longer than 10 minutes

Perform Assay
• Add 4 drops (200 mL) of
Extraction Buffer B while holding
the bottle vertically

All drops must be free falling
with the reagent bottles held
vertically. Do not allow the tips
of the bottles to come in contact
with the extraction cups

Perform Assay
• Twirl the swab vigorously for 10 seconds and incubate for 1 minute,
but no longer than 10 minutes

Perform Assay
• Expunge as much liquid as
possible from swab by pressing
and rotating the fiber portion
against the wall of the tube

Perform Assay
• Discard used swab into biohazard
container

Perform Assay
• Cap the tube and mix contents by gentle swirling

• The swab extract can be tested immediately or remain at room
temperature for up to 3 hours without affecting test results

Perform Assay
• Remove a test device from its
protective pouch
• Place the test device on a clean,
flat surface
• Label the device with specimen’s
ID number

Do not open pouch unless ready
to run the test

Perform Assay
• Hold extraction tube vertically

• Dispense 2 drops (100 mL) of
extract to the sample pad

Do not over load samples

Perform Assay
• Set up timer

• Read test result within 15
minutes. Some positive results
may be visible as soon as 1
minute
• Complete reaction time of 15
minutes is required to confirm
negative results

Do not read result after 15 minutes

Read Assay Result
• Negative or non-reactive result
Only C band is developed
• Positive or reactive result
Both C and T bands are developed
• In valid result
No C band is developed

• Samples with positive results should be confirmed with alternative
testing method(s) such as antibody test, PCR and clinical findings
before to make diagnostic decision
• If C band isn’t developed, review whole procedure and repeat the
assay with a new device

Perform Assay
• Discard the used cassette device
and the protection sheet into
biohazard
container
after
interpreting the result

Quality Control
Internal Control

• Built-in control feature, the C band
o Developed C band indicates the procedure is correct
External Control
• Run 1 Positive Control and 1 Negative Control to assure proper
performance of the assay, when:
o a new operator uses the kit
o a new lot of test kit is used
o a new shipment of kits is used
o temperature used during storage of the kit falls outside of 2-30°C
o the temperature of the test area falls outside of 15-30°C
o to verify a higher than expected frequency of positive or negative
result
o to investigate the cause of repeated invalid results

Limitation of Test
• For optimal test performance, proper sample collection and storage
procedures are critical. Failure to follow the procedure may give
inaccurate results
• Limited to the qualitative detection of C. trachomatis antigen in swab
specimens. The intensity of the test band does not correlate with
antigen titer of the specimen
• Do not specifically differentiate between C. Trachomatis, C.
Pneumonia or C. Psittasi
• A negative or non-reactive test result:
o does not preclude the possibility of exposure to C. trachomatis
o It can occur if the concentration of the C. trachomatis antigen
present in the specimen is below the level detectable by the assay,
or the antigen is not present in the specimen or improper sample
treatment procedure
• If the symptom persists, while the result is negative or non-reactive
result, it is recommended to re-sample the patient few days later or
test with an alternative test device or method
• The results should only be interpreted in conjunction with other
diagnostic procedures and clinical findings

Technical Support
Contact Info.:
10110 Mesa Rim Rd. San Diego, CA 92121 USA
Email Address: [email protected]
Telephone: 1 (858) 457-8698
Fax: 1 (858) 535-1739

QUALITY . INNOVATION . SIMPLICITY


Slide 19

How To Run
OnSite Chlamydia Ag Rapid Test
(Catalog: R0080C)

C. trachomatis and Chlamydia
• Chlamydia trachomatis (C. trachomatis)
o The most common sexually transmitted
bacterial pathogen
o Major
cause of cervicitis, urethritis,
endometritis, and pelvic inflammatory
disease in women
o urethritis and epididymitis in men
• Chlamydia infection
o 80 million worldwide annually
o At least 3 million new cases in U.S.

Chlamydia Trachomatis

Current Diagnosis Methods
•
•
•
•
•

Cell culture
Direct fluorescence assay (DFA)
Enzyme immunoassays (EIA)
PCR
Immunological antigen test
Method

Rapid Test

DFA

EIA

PCR
> 4 hours

Culture

Time to result

15 minutes

2-3 hours

1-4 hours

>3 days

Facility

General Lab

Special Lab

General Lab Special Lab

Special Lab

Equipment

No

Expensive

PCR machine
Pipette

Incubator,
microscopy

Skill

Minimal

Well trained

Reader,
incubator,
pipette
Moderate

Well trained

Specialist

Comments

Cost effective

Costly

Costly

Costly

Costly

OnSite Chlamydia Ag Rapid Test

Intended Use
• Lateral flow chromatographic immunoassay

• Qualitative detection of C. trachomatis antigen in endocervical or
encourethral swab specimens
• Used as a screening test for diagnosis of infection with C.
trachomatis

Test Principle
• Double antibody-sandwich immunoassay

• A unique pair of Abs to selectively identify C. trachomatis Ag in the
specimen
• Test kit key components:
Test Band

Control Band

Pre-coated with another mouse
monoclonal anti-C. trachomatis Ab

Pe-coated with goat
anti-mouse IgG Ab

Kit Components
• 25 test devices (individually sealed
pouches containing with 1 cassette
device & 1 desiccant)
• 1 Extraction Buffer A (6 mL/vial)
• 1 Extraction Buffer B (6 mL/vial)
• 25 sample extraction tubes
• 1 package insert

Materials Required and Not Provided
• Swab for collecting specimen

• Clock or timer
• Disposable gloves
• Rack to hold extraction tube
• Biohazard container
• Marker pen

Precautions
Precautions

Explanation

Package insert MUST be read completely Pay attention to updated information
before testing
Do NOT open the pouch unless ready to Test device become moisture when
test
expose to humidity air, affect flow

Do NOT use components in any other Component in each kit is unique
type of test kit
Do NOT use expired devices

Expired product gives error result

Bring all reagents to room temperature Cold reagent has different viscosity,
(15-30°C) before use
affect flow migration and results
The testing results should be read within Extend reading time may lead to false
10 minutes after a specimen is applied to positive result.
the sample pad of the device
Do NOT perform the test in a room with Strong air flow causes specimen
strong air flow as the specimens might evaporation during assay, leads to
evaporate before reach
error result

Specimen Collection and Handling
• Consider any materials of human origin as infectious and handle them
using standard biosafety procedures
• Swab specimen should be collected by standard male or female
specimen collection methods
• Swabs should be processed as soon as possible after collection. If
swabs are not processed immediately, they should be placed into a
dry, sterile, tightly capped tube or bottle, and stored at 2-8°C for up to
5 days, preferably in a transportation tube

• Do NOT use bloody swabs
• Do NOT freeze swabs

Preparation for Assay
• Wear protective clothing and
disposable gloves

Preparation for Assay
• Set up work area

• Bring all kit components to room
temperature (15-30°C) prior to
testing

Preparation for Assay
• Double check product’s name
and expiration date
Product Name
Expiration Date

Do not use expired test device

Perform Assay
• Label an extraction tube for each
patient and place in a tube holder
or rack

Perform Assay
• Place specimen swab into the
extraction tube
• Add 4 drops (200 mL) of
Extraction Buffer A while holding
the bottle vertically

All drops must be free falling
with the reagent bottles held
vertically. Do not allow the tips
of the bottles to come in contact
with the extraction cups

Perform Assay
• Twirl briefly to mix the reagent

Perform Assay
• Incubate at room temperature
(15-30°C) for 5 minutes, but no
longer than 10 minutes

Perform Assay
• Add 4 drops (200 mL) of
Extraction Buffer B while holding
the bottle vertically

All drops must be free falling
with the reagent bottles held
vertically. Do not allow the tips
of the bottles to come in contact
with the extraction cups

Perform Assay
• Twirl the swab vigorously for 10 seconds and incubate for 1 minute,
but no longer than 10 minutes

Perform Assay
• Expunge as much liquid as
possible from swab by pressing
and rotating the fiber portion
against the wall of the tube

Perform Assay
• Discard used swab into biohazard
container

Perform Assay
• Cap the tube and mix contents by gentle swirling

• The swab extract can be tested immediately or remain at room
temperature for up to 3 hours without affecting test results

Perform Assay
• Remove a test device from its
protective pouch
• Place the test device on a clean,
flat surface
• Label the device with specimen’s
ID number

Do not open pouch unless ready
to run the test

Perform Assay
• Hold extraction tube vertically

• Dispense 2 drops (100 mL) of
extract to the sample pad

Do not over load samples

Perform Assay
• Set up timer

• Read test result within 15
minutes. Some positive results
may be visible as soon as 1
minute
• Complete reaction time of 15
minutes is required to confirm
negative results

Do not read result after 15 minutes

Read Assay Result
• Negative or non-reactive result
Only C band is developed
• Positive or reactive result
Both C and T bands are developed
• In valid result
No C band is developed

• Samples with positive results should be confirmed with alternative
testing method(s) such as antibody test, PCR and clinical findings
before to make diagnostic decision
• If C band isn’t developed, review whole procedure and repeat the
assay with a new device

Perform Assay
• Discard the used cassette device
and the protection sheet into
biohazard
container
after
interpreting the result

Quality Control
Internal Control

• Built-in control feature, the C band
o Developed C band indicates the procedure is correct
External Control
• Run 1 Positive Control and 1 Negative Control to assure proper
performance of the assay, when:
o a new operator uses the kit
o a new lot of test kit is used
o a new shipment of kits is used
o temperature used during storage of the kit falls outside of 2-30°C
o the temperature of the test area falls outside of 15-30°C
o to verify a higher than expected frequency of positive or negative
result
o to investigate the cause of repeated invalid results

Limitation of Test
• For optimal test performance, proper sample collection and storage
procedures are critical. Failure to follow the procedure may give
inaccurate results
• Limited to the qualitative detection of C. trachomatis antigen in swab
specimens. The intensity of the test band does not correlate with
antigen titer of the specimen
• Do not specifically differentiate between C. Trachomatis, C.
Pneumonia or C. Psittasi
• A negative or non-reactive test result:
o does not preclude the possibility of exposure to C. trachomatis
o It can occur if the concentration of the C. trachomatis antigen
present in the specimen is below the level detectable by the assay,
or the antigen is not present in the specimen or improper sample
treatment procedure
• If the symptom persists, while the result is negative or non-reactive
result, it is recommended to re-sample the patient few days later or
test with an alternative test device or method
• The results should only be interpreted in conjunction with other
diagnostic procedures and clinical findings

Technical Support
Contact Info.:
10110 Mesa Rim Rd. San Diego, CA 92121 USA
Email Address: [email protected]
Telephone: 1 (858) 457-8698
Fax: 1 (858) 535-1739

QUALITY . INNOVATION . SIMPLICITY


Slide 20

How To Run
OnSite Chlamydia Ag Rapid Test
(Catalog: R0080C)

C. trachomatis and Chlamydia
• Chlamydia trachomatis (C. trachomatis)
o The most common sexually transmitted
bacterial pathogen
o Major
cause of cervicitis, urethritis,
endometritis, and pelvic inflammatory
disease in women
o urethritis and epididymitis in men
• Chlamydia infection
o 80 million worldwide annually
o At least 3 million new cases in U.S.

Chlamydia Trachomatis

Current Diagnosis Methods
•
•
•
•
•

Cell culture
Direct fluorescence assay (DFA)
Enzyme immunoassays (EIA)
PCR
Immunological antigen test
Method

Rapid Test

DFA

EIA

PCR
> 4 hours

Culture

Time to result

15 minutes

2-3 hours

1-4 hours

>3 days

Facility

General Lab

Special Lab

General Lab Special Lab

Special Lab

Equipment

No

Expensive

PCR machine
Pipette

Incubator,
microscopy

Skill

Minimal

Well trained

Reader,
incubator,
pipette
Moderate

Well trained

Specialist

Comments

Cost effective

Costly

Costly

Costly

Costly

OnSite Chlamydia Ag Rapid Test

Intended Use
• Lateral flow chromatographic immunoassay

• Qualitative detection of C. trachomatis antigen in endocervical or
encourethral swab specimens
• Used as a screening test for diagnosis of infection with C.
trachomatis

Test Principle
• Double antibody-sandwich immunoassay

• A unique pair of Abs to selectively identify C. trachomatis Ag in the
specimen
• Test kit key components:
Test Band

Control Band

Pre-coated with another mouse
monoclonal anti-C. trachomatis Ab

Pe-coated with goat
anti-mouse IgG Ab

Kit Components
• 25 test devices (individually sealed
pouches containing with 1 cassette
device & 1 desiccant)
• 1 Extraction Buffer A (6 mL/vial)
• 1 Extraction Buffer B (6 mL/vial)
• 25 sample extraction tubes
• 1 package insert

Materials Required and Not Provided
• Swab for collecting specimen

• Clock or timer
• Disposable gloves
• Rack to hold extraction tube
• Biohazard container
• Marker pen

Precautions
Precautions

Explanation

Package insert MUST be read completely Pay attention to updated information
before testing
Do NOT open the pouch unless ready to Test device become moisture when
test
expose to humidity air, affect flow

Do NOT use components in any other Component in each kit is unique
type of test kit
Do NOT use expired devices

Expired product gives error result

Bring all reagents to room temperature Cold reagent has different viscosity,
(15-30°C) before use
affect flow migration and results
The testing results should be read within Extend reading time may lead to false
10 minutes after a specimen is applied to positive result.
the sample pad of the device
Do NOT perform the test in a room with Strong air flow causes specimen
strong air flow as the specimens might evaporation during assay, leads to
evaporate before reach
error result

Specimen Collection and Handling
• Consider any materials of human origin as infectious and handle them
using standard biosafety procedures
• Swab specimen should be collected by standard male or female
specimen collection methods
• Swabs should be processed as soon as possible after collection. If
swabs are not processed immediately, they should be placed into a
dry, sterile, tightly capped tube or bottle, and stored at 2-8°C for up to
5 days, preferably in a transportation tube

• Do NOT use bloody swabs
• Do NOT freeze swabs

Preparation for Assay
• Wear protective clothing and
disposable gloves

Preparation for Assay
• Set up work area

• Bring all kit components to room
temperature (15-30°C) prior to
testing

Preparation for Assay
• Double check product’s name
and expiration date
Product Name
Expiration Date

Do not use expired test device

Perform Assay
• Label an extraction tube for each
patient and place in a tube holder
or rack

Perform Assay
• Place specimen swab into the
extraction tube
• Add 4 drops (200 mL) of
Extraction Buffer A while holding
the bottle vertically

All drops must be free falling
with the reagent bottles held
vertically. Do not allow the tips
of the bottles to come in contact
with the extraction cups

Perform Assay
• Twirl briefly to mix the reagent

Perform Assay
• Incubate at room temperature
(15-30°C) for 5 minutes, but no
longer than 10 minutes

Perform Assay
• Add 4 drops (200 mL) of
Extraction Buffer B while holding
the bottle vertically

All drops must be free falling
with the reagent bottles held
vertically. Do not allow the tips
of the bottles to come in contact
with the extraction cups

Perform Assay
• Twirl the swab vigorously for 10 seconds and incubate for 1 minute,
but no longer than 10 minutes

Perform Assay
• Expunge as much liquid as
possible from swab by pressing
and rotating the fiber portion
against the wall of the tube

Perform Assay
• Discard used swab into biohazard
container

Perform Assay
• Cap the tube and mix contents by gentle swirling

• The swab extract can be tested immediately or remain at room
temperature for up to 3 hours without affecting test results

Perform Assay
• Remove a test device from its
protective pouch
• Place the test device on a clean,
flat surface
• Label the device with specimen’s
ID number

Do not open pouch unless ready
to run the test

Perform Assay
• Hold extraction tube vertically

• Dispense 2 drops (100 mL) of
extract to the sample pad

Do not over load samples

Perform Assay
• Set up timer

• Read test result within 15
minutes. Some positive results
may be visible as soon as 1
minute
• Complete reaction time of 15
minutes is required to confirm
negative results

Do not read result after 15 minutes

Read Assay Result
• Negative or non-reactive result
Only C band is developed
• Positive or reactive result
Both C and T bands are developed
• In valid result
No C band is developed

• Samples with positive results should be confirmed with alternative
testing method(s) such as antibody test, PCR and clinical findings
before to make diagnostic decision
• If C band isn’t developed, review whole procedure and repeat the
assay with a new device

Perform Assay
• Discard the used cassette device
and the protection sheet into
biohazard
container
after
interpreting the result

Quality Control
Internal Control

• Built-in control feature, the C band
o Developed C band indicates the procedure is correct
External Control
• Run 1 Positive Control and 1 Negative Control to assure proper
performance of the assay, when:
o a new operator uses the kit
o a new lot of test kit is used
o a new shipment of kits is used
o temperature used during storage of the kit falls outside of 2-30°C
o the temperature of the test area falls outside of 15-30°C
o to verify a higher than expected frequency of positive or negative
result
o to investigate the cause of repeated invalid results

Limitation of Test
• For optimal test performance, proper sample collection and storage
procedures are critical. Failure to follow the procedure may give
inaccurate results
• Limited to the qualitative detection of C. trachomatis antigen in swab
specimens. The intensity of the test band does not correlate with
antigen titer of the specimen
• Do not specifically differentiate between C. Trachomatis, C.
Pneumonia or C. Psittasi
• A negative or non-reactive test result:
o does not preclude the possibility of exposure to C. trachomatis
o It can occur if the concentration of the C. trachomatis antigen
present in the specimen is below the level detectable by the assay,
or the antigen is not present in the specimen or improper sample
treatment procedure
• If the symptom persists, while the result is negative or non-reactive
result, it is recommended to re-sample the patient few days later or
test with an alternative test device or method
• The results should only be interpreted in conjunction with other
diagnostic procedures and clinical findings

Technical Support
Contact Info.:
10110 Mesa Rim Rd. San Diego, CA 92121 USA
Email Address: [email protected]
Telephone: 1 (858) 457-8698
Fax: 1 (858) 535-1739

QUALITY . INNOVATION . SIMPLICITY


Slide 21

How To Run
OnSite Chlamydia Ag Rapid Test
(Catalog: R0080C)

C. trachomatis and Chlamydia
• Chlamydia trachomatis (C. trachomatis)
o The most common sexually transmitted
bacterial pathogen
o Major
cause of cervicitis, urethritis,
endometritis, and pelvic inflammatory
disease in women
o urethritis and epididymitis in men
• Chlamydia infection
o 80 million worldwide annually
o At least 3 million new cases in U.S.

Chlamydia Trachomatis

Current Diagnosis Methods
•
•
•
•
•

Cell culture
Direct fluorescence assay (DFA)
Enzyme immunoassays (EIA)
PCR
Immunological antigen test
Method

Rapid Test

DFA

EIA

PCR
> 4 hours

Culture

Time to result

15 minutes

2-3 hours

1-4 hours

>3 days

Facility

General Lab

Special Lab

General Lab Special Lab

Special Lab

Equipment

No

Expensive

PCR machine
Pipette

Incubator,
microscopy

Skill

Minimal

Well trained

Reader,
incubator,
pipette
Moderate

Well trained

Specialist

Comments

Cost effective

Costly

Costly

Costly

Costly

OnSite Chlamydia Ag Rapid Test

Intended Use
• Lateral flow chromatographic immunoassay

• Qualitative detection of C. trachomatis antigen in endocervical or
encourethral swab specimens
• Used as a screening test for diagnosis of infection with C.
trachomatis

Test Principle
• Double antibody-sandwich immunoassay

• A unique pair of Abs to selectively identify C. trachomatis Ag in the
specimen
• Test kit key components:
Test Band

Control Band

Pre-coated with another mouse
monoclonal anti-C. trachomatis Ab

Pe-coated with goat
anti-mouse IgG Ab

Kit Components
• 25 test devices (individually sealed
pouches containing with 1 cassette
device & 1 desiccant)
• 1 Extraction Buffer A (6 mL/vial)
• 1 Extraction Buffer B (6 mL/vial)
• 25 sample extraction tubes
• 1 package insert

Materials Required and Not Provided
• Swab for collecting specimen

• Clock or timer
• Disposable gloves
• Rack to hold extraction tube
• Biohazard container
• Marker pen

Precautions
Precautions

Explanation

Package insert MUST be read completely Pay attention to updated information
before testing
Do NOT open the pouch unless ready to Test device become moisture when
test
expose to humidity air, affect flow

Do NOT use components in any other Component in each kit is unique
type of test kit
Do NOT use expired devices

Expired product gives error result

Bring all reagents to room temperature Cold reagent has different viscosity,
(15-30°C) before use
affect flow migration and results
The testing results should be read within Extend reading time may lead to false
10 minutes after a specimen is applied to positive result.
the sample pad of the device
Do NOT perform the test in a room with Strong air flow causes specimen
strong air flow as the specimens might evaporation during assay, leads to
evaporate before reach
error result

Specimen Collection and Handling
• Consider any materials of human origin as infectious and handle them
using standard biosafety procedures
• Swab specimen should be collected by standard male or female
specimen collection methods
• Swabs should be processed as soon as possible after collection. If
swabs are not processed immediately, they should be placed into a
dry, sterile, tightly capped tube or bottle, and stored at 2-8°C for up to
5 days, preferably in a transportation tube

• Do NOT use bloody swabs
• Do NOT freeze swabs

Preparation for Assay
• Wear protective clothing and
disposable gloves

Preparation for Assay
• Set up work area

• Bring all kit components to room
temperature (15-30°C) prior to
testing

Preparation for Assay
• Double check product’s name
and expiration date
Product Name
Expiration Date

Do not use expired test device

Perform Assay
• Label an extraction tube for each
patient and place in a tube holder
or rack

Perform Assay
• Place specimen swab into the
extraction tube
• Add 4 drops (200 mL) of
Extraction Buffer A while holding
the bottle vertically

All drops must be free falling
with the reagent bottles held
vertically. Do not allow the tips
of the bottles to come in contact
with the extraction cups

Perform Assay
• Twirl briefly to mix the reagent

Perform Assay
• Incubate at room temperature
(15-30°C) for 5 minutes, but no
longer than 10 minutes

Perform Assay
• Add 4 drops (200 mL) of
Extraction Buffer B while holding
the bottle vertically

All drops must be free falling
with the reagent bottles held
vertically. Do not allow the tips
of the bottles to come in contact
with the extraction cups

Perform Assay
• Twirl the swab vigorously for 10 seconds and incubate for 1 minute,
but no longer than 10 minutes

Perform Assay
• Expunge as much liquid as
possible from swab by pressing
and rotating the fiber portion
against the wall of the tube

Perform Assay
• Discard used swab into biohazard
container

Perform Assay
• Cap the tube and mix contents by gentle swirling

• The swab extract can be tested immediately or remain at room
temperature for up to 3 hours without affecting test results

Perform Assay
• Remove a test device from its
protective pouch
• Place the test device on a clean,
flat surface
• Label the device with specimen’s
ID number

Do not open pouch unless ready
to run the test

Perform Assay
• Hold extraction tube vertically

• Dispense 2 drops (100 mL) of
extract to the sample pad

Do not over load samples

Perform Assay
• Set up timer

• Read test result within 15
minutes. Some positive results
may be visible as soon as 1
minute
• Complete reaction time of 15
minutes is required to confirm
negative results

Do not read result after 15 minutes

Read Assay Result
• Negative or non-reactive result
Only C band is developed
• Positive or reactive result
Both C and T bands are developed
• In valid result
No C band is developed

• Samples with positive results should be confirmed with alternative
testing method(s) such as antibody test, PCR and clinical findings
before to make diagnostic decision
• If C band isn’t developed, review whole procedure and repeat the
assay with a new device

Perform Assay
• Discard the used cassette device
and the protection sheet into
biohazard
container
after
interpreting the result

Quality Control
Internal Control

• Built-in control feature, the C band
o Developed C band indicates the procedure is correct
External Control
• Run 1 Positive Control and 1 Negative Control to assure proper
performance of the assay, when:
o a new operator uses the kit
o a new lot of test kit is used
o a new shipment of kits is used
o temperature used during storage of the kit falls outside of 2-30°C
o the temperature of the test area falls outside of 15-30°C
o to verify a higher than expected frequency of positive or negative
result
o to investigate the cause of repeated invalid results

Limitation of Test
• For optimal test performance, proper sample collection and storage
procedures are critical. Failure to follow the procedure may give
inaccurate results
• Limited to the qualitative detection of C. trachomatis antigen in swab
specimens. The intensity of the test band does not correlate with
antigen titer of the specimen
• Do not specifically differentiate between C. Trachomatis, C.
Pneumonia or C. Psittasi
• A negative or non-reactive test result:
o does not preclude the possibility of exposure to C. trachomatis
o It can occur if the concentration of the C. trachomatis antigen
present in the specimen is below the level detectable by the assay,
or the antigen is not present in the specimen or improper sample
treatment procedure
• If the symptom persists, while the result is negative or non-reactive
result, it is recommended to re-sample the patient few days later or
test with an alternative test device or method
• The results should only be interpreted in conjunction with other
diagnostic procedures and clinical findings

Technical Support
Contact Info.:
10110 Mesa Rim Rd. San Diego, CA 92121 USA
Email Address: [email protected]
Telephone: 1 (858) 457-8698
Fax: 1 (858) 535-1739

QUALITY . INNOVATION . SIMPLICITY


Slide 22

How To Run
OnSite Chlamydia Ag Rapid Test
(Catalog: R0080C)

C. trachomatis and Chlamydia
• Chlamydia trachomatis (C. trachomatis)
o The most common sexually transmitted
bacterial pathogen
o Major
cause of cervicitis, urethritis,
endometritis, and pelvic inflammatory
disease in women
o urethritis and epididymitis in men
• Chlamydia infection
o 80 million worldwide annually
o At least 3 million new cases in U.S.

Chlamydia Trachomatis

Current Diagnosis Methods
•
•
•
•
•

Cell culture
Direct fluorescence assay (DFA)
Enzyme immunoassays (EIA)
PCR
Immunological antigen test
Method

Rapid Test

DFA

EIA

PCR
> 4 hours

Culture

Time to result

15 minutes

2-3 hours

1-4 hours

>3 days

Facility

General Lab

Special Lab

General Lab Special Lab

Special Lab

Equipment

No

Expensive

PCR machine
Pipette

Incubator,
microscopy

Skill

Minimal

Well trained

Reader,
incubator,
pipette
Moderate

Well trained

Specialist

Comments

Cost effective

Costly

Costly

Costly

Costly

OnSite Chlamydia Ag Rapid Test

Intended Use
• Lateral flow chromatographic immunoassay

• Qualitative detection of C. trachomatis antigen in endocervical or
encourethral swab specimens
• Used as a screening test for diagnosis of infection with C.
trachomatis

Test Principle
• Double antibody-sandwich immunoassay

• A unique pair of Abs to selectively identify C. trachomatis Ag in the
specimen
• Test kit key components:
Test Band

Control Band

Pre-coated with another mouse
monoclonal anti-C. trachomatis Ab

Pe-coated with goat
anti-mouse IgG Ab

Kit Components
• 25 test devices (individually sealed
pouches containing with 1 cassette
device & 1 desiccant)
• 1 Extraction Buffer A (6 mL/vial)
• 1 Extraction Buffer B (6 mL/vial)
• 25 sample extraction tubes
• 1 package insert

Materials Required and Not Provided
• Swab for collecting specimen

• Clock or timer
• Disposable gloves
• Rack to hold extraction tube
• Biohazard container
• Marker pen

Precautions
Precautions

Explanation

Package insert MUST be read completely Pay attention to updated information
before testing
Do NOT open the pouch unless ready to Test device become moisture when
test
expose to humidity air, affect flow

Do NOT use components in any other Component in each kit is unique
type of test kit
Do NOT use expired devices

Expired product gives error result

Bring all reagents to room temperature Cold reagent has different viscosity,
(15-30°C) before use
affect flow migration and results
The testing results should be read within Extend reading time may lead to false
10 minutes after a specimen is applied to positive result.
the sample pad of the device
Do NOT perform the test in a room with Strong air flow causes specimen
strong air flow as the specimens might evaporation during assay, leads to
evaporate before reach
error result

Specimen Collection and Handling
• Consider any materials of human origin as infectious and handle them
using standard biosafety procedures
• Swab specimen should be collected by standard male or female
specimen collection methods
• Swabs should be processed as soon as possible after collection. If
swabs are not processed immediately, they should be placed into a
dry, sterile, tightly capped tube or bottle, and stored at 2-8°C for up to
5 days, preferably in a transportation tube

• Do NOT use bloody swabs
• Do NOT freeze swabs

Preparation for Assay
• Wear protective clothing and
disposable gloves

Preparation for Assay
• Set up work area

• Bring all kit components to room
temperature (15-30°C) prior to
testing

Preparation for Assay
• Double check product’s name
and expiration date
Product Name
Expiration Date

Do not use expired test device

Perform Assay
• Label an extraction tube for each
patient and place in a tube holder
or rack

Perform Assay
• Place specimen swab into the
extraction tube
• Add 4 drops (200 mL) of
Extraction Buffer A while holding
the bottle vertically

All drops must be free falling
with the reagent bottles held
vertically. Do not allow the tips
of the bottles to come in contact
with the extraction cups

Perform Assay
• Twirl briefly to mix the reagent

Perform Assay
• Incubate at room temperature
(15-30°C) for 5 minutes, but no
longer than 10 minutes

Perform Assay
• Add 4 drops (200 mL) of
Extraction Buffer B while holding
the bottle vertically

All drops must be free falling
with the reagent bottles held
vertically. Do not allow the tips
of the bottles to come in contact
with the extraction cups

Perform Assay
• Twirl the swab vigorously for 10 seconds and incubate for 1 minute,
but no longer than 10 minutes

Perform Assay
• Expunge as much liquid as
possible from swab by pressing
and rotating the fiber portion
against the wall of the tube

Perform Assay
• Discard used swab into biohazard
container

Perform Assay
• Cap the tube and mix contents by gentle swirling

• The swab extract can be tested immediately or remain at room
temperature for up to 3 hours without affecting test results

Perform Assay
• Remove a test device from its
protective pouch
• Place the test device on a clean,
flat surface
• Label the device with specimen’s
ID number

Do not open pouch unless ready
to run the test

Perform Assay
• Hold extraction tube vertically

• Dispense 2 drops (100 mL) of
extract to the sample pad

Do not over load samples

Perform Assay
• Set up timer

• Read test result within 15
minutes. Some positive results
may be visible as soon as 1
minute
• Complete reaction time of 15
minutes is required to confirm
negative results

Do not read result after 15 minutes

Read Assay Result
• Negative or non-reactive result
Only C band is developed
• Positive or reactive result
Both C and T bands are developed
• In valid result
No C band is developed

• Samples with positive results should be confirmed with alternative
testing method(s) such as antibody test, PCR and clinical findings
before to make diagnostic decision
• If C band isn’t developed, review whole procedure and repeat the
assay with a new device

Perform Assay
• Discard the used cassette device
and the protection sheet into
biohazard
container
after
interpreting the result

Quality Control
Internal Control

• Built-in control feature, the C band
o Developed C band indicates the procedure is correct
External Control
• Run 1 Positive Control and 1 Negative Control to assure proper
performance of the assay, when:
o a new operator uses the kit
o a new lot of test kit is used
o a new shipment of kits is used
o temperature used during storage of the kit falls outside of 2-30°C
o the temperature of the test area falls outside of 15-30°C
o to verify a higher than expected frequency of positive or negative
result
o to investigate the cause of repeated invalid results

Limitation of Test
• For optimal test performance, proper sample collection and storage
procedures are critical. Failure to follow the procedure may give
inaccurate results
• Limited to the qualitative detection of C. trachomatis antigen in swab
specimens. The intensity of the test band does not correlate with
antigen titer of the specimen
• Do not specifically differentiate between C. Trachomatis, C.
Pneumonia or C. Psittasi
• A negative or non-reactive test result:
o does not preclude the possibility of exposure to C. trachomatis
o It can occur if the concentration of the C. trachomatis antigen
present in the specimen is below the level detectable by the assay,
or the antigen is not present in the specimen or improper sample
treatment procedure
• If the symptom persists, while the result is negative or non-reactive
result, it is recommended to re-sample the patient few days later or
test with an alternative test device or method
• The results should only be interpreted in conjunction with other
diagnostic procedures and clinical findings

Technical Support
Contact Info.:
10110 Mesa Rim Rd. San Diego, CA 92121 USA
Email Address: [email protected]
Telephone: 1 (858) 457-8698
Fax: 1 (858) 535-1739

QUALITY . INNOVATION . SIMPLICITY


Slide 23

How To Run
OnSite Chlamydia Ag Rapid Test
(Catalog: R0080C)

C. trachomatis and Chlamydia
• Chlamydia trachomatis (C. trachomatis)
o The most common sexually transmitted
bacterial pathogen
o Major
cause of cervicitis, urethritis,
endometritis, and pelvic inflammatory
disease in women
o urethritis and epididymitis in men
• Chlamydia infection
o 80 million worldwide annually
o At least 3 million new cases in U.S.

Chlamydia Trachomatis

Current Diagnosis Methods
•
•
•
•
•

Cell culture
Direct fluorescence assay (DFA)
Enzyme immunoassays (EIA)
PCR
Immunological antigen test
Method

Rapid Test

DFA

EIA

PCR
> 4 hours

Culture

Time to result

15 minutes

2-3 hours

1-4 hours

>3 days

Facility

General Lab

Special Lab

General Lab Special Lab

Special Lab

Equipment

No

Expensive

PCR machine
Pipette

Incubator,
microscopy

Skill

Minimal

Well trained

Reader,
incubator,
pipette
Moderate

Well trained

Specialist

Comments

Cost effective

Costly

Costly

Costly

Costly

OnSite Chlamydia Ag Rapid Test

Intended Use
• Lateral flow chromatographic immunoassay

• Qualitative detection of C. trachomatis antigen in endocervical or
encourethral swab specimens
• Used as a screening test for diagnosis of infection with C.
trachomatis

Test Principle
• Double antibody-sandwich immunoassay

• A unique pair of Abs to selectively identify C. trachomatis Ag in the
specimen
• Test kit key components:
Test Band

Control Band

Pre-coated with another mouse
monoclonal anti-C. trachomatis Ab

Pe-coated with goat
anti-mouse IgG Ab

Kit Components
• 25 test devices (individually sealed
pouches containing with 1 cassette
device & 1 desiccant)
• 1 Extraction Buffer A (6 mL/vial)
• 1 Extraction Buffer B (6 mL/vial)
• 25 sample extraction tubes
• 1 package insert

Materials Required and Not Provided
• Swab for collecting specimen

• Clock or timer
• Disposable gloves
• Rack to hold extraction tube
• Biohazard container
• Marker pen

Precautions
Precautions

Explanation

Package insert MUST be read completely Pay attention to updated information
before testing
Do NOT open the pouch unless ready to Test device become moisture when
test
expose to humidity air, affect flow

Do NOT use components in any other Component in each kit is unique
type of test kit
Do NOT use expired devices

Expired product gives error result

Bring all reagents to room temperature Cold reagent has different viscosity,
(15-30°C) before use
affect flow migration and results
The testing results should be read within Extend reading time may lead to false
10 minutes after a specimen is applied to positive result.
the sample pad of the device
Do NOT perform the test in a room with Strong air flow causes specimen
strong air flow as the specimens might evaporation during assay, leads to
evaporate before reach
error result

Specimen Collection and Handling
• Consider any materials of human origin as infectious and handle them
using standard biosafety procedures
• Swab specimen should be collected by standard male or female
specimen collection methods
• Swabs should be processed as soon as possible after collection. If
swabs are not processed immediately, they should be placed into a
dry, sterile, tightly capped tube or bottle, and stored at 2-8°C for up to
5 days, preferably in a transportation tube

• Do NOT use bloody swabs
• Do NOT freeze swabs

Preparation for Assay
• Wear protective clothing and
disposable gloves

Preparation for Assay
• Set up work area

• Bring all kit components to room
temperature (15-30°C) prior to
testing

Preparation for Assay
• Double check product’s name
and expiration date
Product Name
Expiration Date

Do not use expired test device

Perform Assay
• Label an extraction tube for each
patient and place in a tube holder
or rack

Perform Assay
• Place specimen swab into the
extraction tube
• Add 4 drops (200 mL) of
Extraction Buffer A while holding
the bottle vertically

All drops must be free falling
with the reagent bottles held
vertically. Do not allow the tips
of the bottles to come in contact
with the extraction cups

Perform Assay
• Twirl briefly to mix the reagent

Perform Assay
• Incubate at room temperature
(15-30°C) for 5 minutes, but no
longer than 10 minutes

Perform Assay
• Add 4 drops (200 mL) of
Extraction Buffer B while holding
the bottle vertically

All drops must be free falling
with the reagent bottles held
vertically. Do not allow the tips
of the bottles to come in contact
with the extraction cups

Perform Assay
• Twirl the swab vigorously for 10 seconds and incubate for 1 minute,
but no longer than 10 minutes

Perform Assay
• Expunge as much liquid as
possible from swab by pressing
and rotating the fiber portion
against the wall of the tube

Perform Assay
• Discard used swab into biohazard
container

Perform Assay
• Cap the tube and mix contents by gentle swirling

• The swab extract can be tested immediately or remain at room
temperature for up to 3 hours without affecting test results

Perform Assay
• Remove a test device from its
protective pouch
• Place the test device on a clean,
flat surface
• Label the device with specimen’s
ID number

Do not open pouch unless ready
to run the test

Perform Assay
• Hold extraction tube vertically

• Dispense 2 drops (100 mL) of
extract to the sample pad

Do not over load samples

Perform Assay
• Set up timer

• Read test result within 15
minutes. Some positive results
may be visible as soon as 1
minute
• Complete reaction time of 15
minutes is required to confirm
negative results

Do not read result after 15 minutes

Read Assay Result
• Negative or non-reactive result
Only C band is developed
• Positive or reactive result
Both C and T bands are developed
• In valid result
No C band is developed

• Samples with positive results should be confirmed with alternative
testing method(s) such as antibody test, PCR and clinical findings
before to make diagnostic decision
• If C band isn’t developed, review whole procedure and repeat the
assay with a new device

Perform Assay
• Discard the used cassette device
and the protection sheet into
biohazard
container
after
interpreting the result

Quality Control
Internal Control

• Built-in control feature, the C band
o Developed C band indicates the procedure is correct
External Control
• Run 1 Positive Control and 1 Negative Control to assure proper
performance of the assay, when:
o a new operator uses the kit
o a new lot of test kit is used
o a new shipment of kits is used
o temperature used during storage of the kit falls outside of 2-30°C
o the temperature of the test area falls outside of 15-30°C
o to verify a higher than expected frequency of positive or negative
result
o to investigate the cause of repeated invalid results

Limitation of Test
• For optimal test performance, proper sample collection and storage
procedures are critical. Failure to follow the procedure may give
inaccurate results
• Limited to the qualitative detection of C. trachomatis antigen in swab
specimens. The intensity of the test band does not correlate with
antigen titer of the specimen
• Do not specifically differentiate between C. Trachomatis, C.
Pneumonia or C. Psittasi
• A negative or non-reactive test result:
o does not preclude the possibility of exposure to C. trachomatis
o It can occur if the concentration of the C. trachomatis antigen
present in the specimen is below the level detectable by the assay,
or the antigen is not present in the specimen or improper sample
treatment procedure
• If the symptom persists, while the result is negative or non-reactive
result, it is recommended to re-sample the patient few days later or
test with an alternative test device or method
• The results should only be interpreted in conjunction with other
diagnostic procedures and clinical findings

Technical Support
Contact Info.:
10110 Mesa Rim Rd. San Diego, CA 92121 USA
Email Address: [email protected]
Telephone: 1 (858) 457-8698
Fax: 1 (858) 535-1739

QUALITY . INNOVATION . SIMPLICITY


Slide 24

How To Run
OnSite Chlamydia Ag Rapid Test
(Catalog: R0080C)

C. trachomatis and Chlamydia
• Chlamydia trachomatis (C. trachomatis)
o The most common sexually transmitted
bacterial pathogen
o Major
cause of cervicitis, urethritis,
endometritis, and pelvic inflammatory
disease in women
o urethritis and epididymitis in men
• Chlamydia infection
o 80 million worldwide annually
o At least 3 million new cases in U.S.

Chlamydia Trachomatis

Current Diagnosis Methods
•
•
•
•
•

Cell culture
Direct fluorescence assay (DFA)
Enzyme immunoassays (EIA)
PCR
Immunological antigen test
Method

Rapid Test

DFA

EIA

PCR
> 4 hours

Culture

Time to result

15 minutes

2-3 hours

1-4 hours

>3 days

Facility

General Lab

Special Lab

General Lab Special Lab

Special Lab

Equipment

No

Expensive

PCR machine
Pipette

Incubator,
microscopy

Skill

Minimal

Well trained

Reader,
incubator,
pipette
Moderate

Well trained

Specialist

Comments

Cost effective

Costly

Costly

Costly

Costly

OnSite Chlamydia Ag Rapid Test

Intended Use
• Lateral flow chromatographic immunoassay

• Qualitative detection of C. trachomatis antigen in endocervical or
encourethral swab specimens
• Used as a screening test for diagnosis of infection with C.
trachomatis

Test Principle
• Double antibody-sandwich immunoassay

• A unique pair of Abs to selectively identify C. trachomatis Ag in the
specimen
• Test kit key components:
Test Band

Control Band

Pre-coated with another mouse
monoclonal anti-C. trachomatis Ab

Pe-coated with goat
anti-mouse IgG Ab

Kit Components
• 25 test devices (individually sealed
pouches containing with 1 cassette
device & 1 desiccant)
• 1 Extraction Buffer A (6 mL/vial)
• 1 Extraction Buffer B (6 mL/vial)
• 25 sample extraction tubes
• 1 package insert

Materials Required and Not Provided
• Swab for collecting specimen

• Clock or timer
• Disposable gloves
• Rack to hold extraction tube
• Biohazard container
• Marker pen

Precautions
Precautions

Explanation

Package insert MUST be read completely Pay attention to updated information
before testing
Do NOT open the pouch unless ready to Test device become moisture when
test
expose to humidity air, affect flow

Do NOT use components in any other Component in each kit is unique
type of test kit
Do NOT use expired devices

Expired product gives error result

Bring all reagents to room temperature Cold reagent has different viscosity,
(15-30°C) before use
affect flow migration and results
The testing results should be read within Extend reading time may lead to false
10 minutes after a specimen is applied to positive result.
the sample pad of the device
Do NOT perform the test in a room with Strong air flow causes specimen
strong air flow as the specimens might evaporation during assay, leads to
evaporate before reach
error result

Specimen Collection and Handling
• Consider any materials of human origin as infectious and handle them
using standard biosafety procedures
• Swab specimen should be collected by standard male or female
specimen collection methods
• Swabs should be processed as soon as possible after collection. If
swabs are not processed immediately, they should be placed into a
dry, sterile, tightly capped tube or bottle, and stored at 2-8°C for up to
5 days, preferably in a transportation tube

• Do NOT use bloody swabs
• Do NOT freeze swabs

Preparation for Assay
• Wear protective clothing and
disposable gloves

Preparation for Assay
• Set up work area

• Bring all kit components to room
temperature (15-30°C) prior to
testing

Preparation for Assay
• Double check product’s name
and expiration date
Product Name
Expiration Date

Do not use expired test device

Perform Assay
• Label an extraction tube for each
patient and place in a tube holder
or rack

Perform Assay
• Place specimen swab into the
extraction tube
• Add 4 drops (200 mL) of
Extraction Buffer A while holding
the bottle vertically

All drops must be free falling
with the reagent bottles held
vertically. Do not allow the tips
of the bottles to come in contact
with the extraction cups

Perform Assay
• Twirl briefly to mix the reagent

Perform Assay
• Incubate at room temperature
(15-30°C) for 5 minutes, but no
longer than 10 minutes

Perform Assay
• Add 4 drops (200 mL) of
Extraction Buffer B while holding
the bottle vertically

All drops must be free falling
with the reagent bottles held
vertically. Do not allow the tips
of the bottles to come in contact
with the extraction cups

Perform Assay
• Twirl the swab vigorously for 10 seconds and incubate for 1 minute,
but no longer than 10 minutes

Perform Assay
• Expunge as much liquid as
possible from swab by pressing
and rotating the fiber portion
against the wall of the tube

Perform Assay
• Discard used swab into biohazard
container

Perform Assay
• Cap the tube and mix contents by gentle swirling

• The swab extract can be tested immediately or remain at room
temperature for up to 3 hours without affecting test results

Perform Assay
• Remove a test device from its
protective pouch
• Place the test device on a clean,
flat surface
• Label the device with specimen’s
ID number

Do not open pouch unless ready
to run the test

Perform Assay
• Hold extraction tube vertically

• Dispense 2 drops (100 mL) of
extract to the sample pad

Do not over load samples

Perform Assay
• Set up timer

• Read test result within 15
minutes. Some positive results
may be visible as soon as 1
minute
• Complete reaction time of 15
minutes is required to confirm
negative results

Do not read result after 15 minutes

Read Assay Result
• Negative or non-reactive result
Only C band is developed
• Positive or reactive result
Both C and T bands are developed
• In valid result
No C band is developed

• Samples with positive results should be confirmed with alternative
testing method(s) such as antibody test, PCR and clinical findings
before to make diagnostic decision
• If C band isn’t developed, review whole procedure and repeat the
assay with a new device

Perform Assay
• Discard the used cassette device
and the protection sheet into
biohazard
container
after
interpreting the result

Quality Control
Internal Control

• Built-in control feature, the C band
o Developed C band indicates the procedure is correct
External Control
• Run 1 Positive Control and 1 Negative Control to assure proper
performance of the assay, when:
o a new operator uses the kit
o a new lot of test kit is used
o a new shipment of kits is used
o temperature used during storage of the kit falls outside of 2-30°C
o the temperature of the test area falls outside of 15-30°C
o to verify a higher than expected frequency of positive or negative
result
o to investigate the cause of repeated invalid results

Limitation of Test
• For optimal test performance, proper sample collection and storage
procedures are critical. Failure to follow the procedure may give
inaccurate results
• Limited to the qualitative detection of C. trachomatis antigen in swab
specimens. The intensity of the test band does not correlate with
antigen titer of the specimen
• Do not specifically differentiate between C. Trachomatis, C.
Pneumonia or C. Psittasi
• A negative or non-reactive test result:
o does not preclude the possibility of exposure to C. trachomatis
o It can occur if the concentration of the C. trachomatis antigen
present in the specimen is below the level detectable by the assay,
or the antigen is not present in the specimen or improper sample
treatment procedure
• If the symptom persists, while the result is negative or non-reactive
result, it is recommended to re-sample the patient few days later or
test with an alternative test device or method
• The results should only be interpreted in conjunction with other
diagnostic procedures and clinical findings

Technical Support
Contact Info.:
10110 Mesa Rim Rd. San Diego, CA 92121 USA
Email Address: [email protected]
Telephone: 1 (858) 457-8698
Fax: 1 (858) 535-1739

QUALITY . INNOVATION . SIMPLICITY


Slide 25

How To Run
OnSite Chlamydia Ag Rapid Test
(Catalog: R0080C)

C. trachomatis and Chlamydia
• Chlamydia trachomatis (C. trachomatis)
o The most common sexually transmitted
bacterial pathogen
o Major
cause of cervicitis, urethritis,
endometritis, and pelvic inflammatory
disease in women
o urethritis and epididymitis in men
• Chlamydia infection
o 80 million worldwide annually
o At least 3 million new cases in U.S.

Chlamydia Trachomatis

Current Diagnosis Methods
•
•
•
•
•

Cell culture
Direct fluorescence assay (DFA)
Enzyme immunoassays (EIA)
PCR
Immunological antigen test
Method

Rapid Test

DFA

EIA

PCR
> 4 hours

Culture

Time to result

15 minutes

2-3 hours

1-4 hours

>3 days

Facility

General Lab

Special Lab

General Lab Special Lab

Special Lab

Equipment

No

Expensive

PCR machine
Pipette

Incubator,
microscopy

Skill

Minimal

Well trained

Reader,
incubator,
pipette
Moderate

Well trained

Specialist

Comments

Cost effective

Costly

Costly

Costly

Costly

OnSite Chlamydia Ag Rapid Test

Intended Use
• Lateral flow chromatographic immunoassay

• Qualitative detection of C. trachomatis antigen in endocervical or
encourethral swab specimens
• Used as a screening test for diagnosis of infection with C.
trachomatis

Test Principle
• Double antibody-sandwich immunoassay

• A unique pair of Abs to selectively identify C. trachomatis Ag in the
specimen
• Test kit key components:
Test Band

Control Band

Pre-coated with another mouse
monoclonal anti-C. trachomatis Ab

Pe-coated with goat
anti-mouse IgG Ab

Kit Components
• 25 test devices (individually sealed
pouches containing with 1 cassette
device & 1 desiccant)
• 1 Extraction Buffer A (6 mL/vial)
• 1 Extraction Buffer B (6 mL/vial)
• 25 sample extraction tubes
• 1 package insert

Materials Required and Not Provided
• Swab for collecting specimen

• Clock or timer
• Disposable gloves
• Rack to hold extraction tube
• Biohazard container
• Marker pen

Precautions
Precautions

Explanation

Package insert MUST be read completely Pay attention to updated information
before testing
Do NOT open the pouch unless ready to Test device become moisture when
test
expose to humidity air, affect flow

Do NOT use components in any other Component in each kit is unique
type of test kit
Do NOT use expired devices

Expired product gives error result

Bring all reagents to room temperature Cold reagent has different viscosity,
(15-30°C) before use
affect flow migration and results
The testing results should be read within Extend reading time may lead to false
10 minutes after a specimen is applied to positive result.
the sample pad of the device
Do NOT perform the test in a room with Strong air flow causes specimen
strong air flow as the specimens might evaporation during assay, leads to
evaporate before reach
error result

Specimen Collection and Handling
• Consider any materials of human origin as infectious and handle them
using standard biosafety procedures
• Swab specimen should be collected by standard male or female
specimen collection methods
• Swabs should be processed as soon as possible after collection. If
swabs are not processed immediately, they should be placed into a
dry, sterile, tightly capped tube or bottle, and stored at 2-8°C for up to
5 days, preferably in a transportation tube

• Do NOT use bloody swabs
• Do NOT freeze swabs

Preparation for Assay
• Wear protective clothing and
disposable gloves

Preparation for Assay
• Set up work area

• Bring all kit components to room
temperature (15-30°C) prior to
testing

Preparation for Assay
• Double check product’s name
and expiration date
Product Name
Expiration Date

Do not use expired test device

Perform Assay
• Label an extraction tube for each
patient and place in a tube holder
or rack

Perform Assay
• Place specimen swab into the
extraction tube
• Add 4 drops (200 mL) of
Extraction Buffer A while holding
the bottle vertically

All drops must be free falling
with the reagent bottles held
vertically. Do not allow the tips
of the bottles to come in contact
with the extraction cups

Perform Assay
• Twirl briefly to mix the reagent

Perform Assay
• Incubate at room temperature
(15-30°C) for 5 minutes, but no
longer than 10 minutes

Perform Assay
• Add 4 drops (200 mL) of
Extraction Buffer B while holding
the bottle vertically

All drops must be free falling
with the reagent bottles held
vertically. Do not allow the tips
of the bottles to come in contact
with the extraction cups

Perform Assay
• Twirl the swab vigorously for 10 seconds and incubate for 1 minute,
but no longer than 10 minutes

Perform Assay
• Expunge as much liquid as
possible from swab by pressing
and rotating the fiber portion
against the wall of the tube

Perform Assay
• Discard used swab into biohazard
container

Perform Assay
• Cap the tube and mix contents by gentle swirling

• The swab extract can be tested immediately or remain at room
temperature for up to 3 hours without affecting test results

Perform Assay
• Remove a test device from its
protective pouch
• Place the test device on a clean,
flat surface
• Label the device with specimen’s
ID number

Do not open pouch unless ready
to run the test

Perform Assay
• Hold extraction tube vertically

• Dispense 2 drops (100 mL) of
extract to the sample pad

Do not over load samples

Perform Assay
• Set up timer

• Read test result within 15
minutes. Some positive results
may be visible as soon as 1
minute
• Complete reaction time of 15
minutes is required to confirm
negative results

Do not read result after 15 minutes

Read Assay Result
• Negative or non-reactive result
Only C band is developed
• Positive or reactive result
Both C and T bands are developed
• In valid result
No C band is developed

• Samples with positive results should be confirmed with alternative
testing method(s) such as antibody test, PCR and clinical findings
before to make diagnostic decision
• If C band isn’t developed, review whole procedure and repeat the
assay with a new device

Perform Assay
• Discard the used cassette device
and the protection sheet into
biohazard
container
after
interpreting the result

Quality Control
Internal Control

• Built-in control feature, the C band
o Developed C band indicates the procedure is correct
External Control
• Run 1 Positive Control and 1 Negative Control to assure proper
performance of the assay, when:
o a new operator uses the kit
o a new lot of test kit is used
o a new shipment of kits is used
o temperature used during storage of the kit falls outside of 2-30°C
o the temperature of the test area falls outside of 15-30°C
o to verify a higher than expected frequency of positive or negative
result
o to investigate the cause of repeated invalid results

Limitation of Test
• For optimal test performance, proper sample collection and storage
procedures are critical. Failure to follow the procedure may give
inaccurate results
• Limited to the qualitative detection of C. trachomatis antigen in swab
specimens. The intensity of the test band does not correlate with
antigen titer of the specimen
• Do not specifically differentiate between C. Trachomatis, C.
Pneumonia or C. Psittasi
• A negative or non-reactive test result:
o does not preclude the possibility of exposure to C. trachomatis
o It can occur if the concentration of the C. trachomatis antigen
present in the specimen is below the level detectable by the assay,
or the antigen is not present in the specimen or improper sample
treatment procedure
• If the symptom persists, while the result is negative or non-reactive
result, it is recommended to re-sample the patient few days later or
test with an alternative test device or method
• The results should only be interpreted in conjunction with other
diagnostic procedures and clinical findings

Technical Support
Contact Info.:
10110 Mesa Rim Rd. San Diego, CA 92121 USA
Email Address: [email protected]
Telephone: 1 (858) 457-8698
Fax: 1 (858) 535-1739

QUALITY . INNOVATION . SIMPLICITY


Slide 26

How To Run
OnSite Chlamydia Ag Rapid Test
(Catalog: R0080C)

C. trachomatis and Chlamydia
• Chlamydia trachomatis (C. trachomatis)
o The most common sexually transmitted
bacterial pathogen
o Major
cause of cervicitis, urethritis,
endometritis, and pelvic inflammatory
disease in women
o urethritis and epididymitis in men
• Chlamydia infection
o 80 million worldwide annually
o At least 3 million new cases in U.S.

Chlamydia Trachomatis

Current Diagnosis Methods
•
•
•
•
•

Cell culture
Direct fluorescence assay (DFA)
Enzyme immunoassays (EIA)
PCR
Immunological antigen test
Method

Rapid Test

DFA

EIA

PCR
> 4 hours

Culture

Time to result

15 minutes

2-3 hours

1-4 hours

>3 days

Facility

General Lab

Special Lab

General Lab Special Lab

Special Lab

Equipment

No

Expensive

PCR machine
Pipette

Incubator,
microscopy

Skill

Minimal

Well trained

Reader,
incubator,
pipette
Moderate

Well trained

Specialist

Comments

Cost effective

Costly

Costly

Costly

Costly

OnSite Chlamydia Ag Rapid Test

Intended Use
• Lateral flow chromatographic immunoassay

• Qualitative detection of C. trachomatis antigen in endocervical or
encourethral swab specimens
• Used as a screening test for diagnosis of infection with C.
trachomatis

Test Principle
• Double antibody-sandwich immunoassay

• A unique pair of Abs to selectively identify C. trachomatis Ag in the
specimen
• Test kit key components:
Test Band

Control Band

Pre-coated with another mouse
monoclonal anti-C. trachomatis Ab

Pe-coated with goat
anti-mouse IgG Ab

Kit Components
• 25 test devices (individually sealed
pouches containing with 1 cassette
device & 1 desiccant)
• 1 Extraction Buffer A (6 mL/vial)
• 1 Extraction Buffer B (6 mL/vial)
• 25 sample extraction tubes
• 1 package insert

Materials Required and Not Provided
• Swab for collecting specimen

• Clock or timer
• Disposable gloves
• Rack to hold extraction tube
• Biohazard container
• Marker pen

Precautions
Precautions

Explanation

Package insert MUST be read completely Pay attention to updated information
before testing
Do NOT open the pouch unless ready to Test device become moisture when
test
expose to humidity air, affect flow

Do NOT use components in any other Component in each kit is unique
type of test kit
Do NOT use expired devices

Expired product gives error result

Bring all reagents to room temperature Cold reagent has different viscosity,
(15-30°C) before use
affect flow migration and results
The testing results should be read within Extend reading time may lead to false
10 minutes after a specimen is applied to positive result.
the sample pad of the device
Do NOT perform the test in a room with Strong air flow causes specimen
strong air flow as the specimens might evaporation during assay, leads to
evaporate before reach
error result

Specimen Collection and Handling
• Consider any materials of human origin as infectious and handle them
using standard biosafety procedures
• Swab specimen should be collected by standard male or female
specimen collection methods
• Swabs should be processed as soon as possible after collection. If
swabs are not processed immediately, they should be placed into a
dry, sterile, tightly capped tube or bottle, and stored at 2-8°C for up to
5 days, preferably in a transportation tube

• Do NOT use bloody swabs
• Do NOT freeze swabs

Preparation for Assay
• Wear protective clothing and
disposable gloves

Preparation for Assay
• Set up work area

• Bring all kit components to room
temperature (15-30°C) prior to
testing

Preparation for Assay
• Double check product’s name
and expiration date
Product Name
Expiration Date

Do not use expired test device

Perform Assay
• Label an extraction tube for each
patient and place in a tube holder
or rack

Perform Assay
• Place specimen swab into the
extraction tube
• Add 4 drops (200 mL) of
Extraction Buffer A while holding
the bottle vertically

All drops must be free falling
with the reagent bottles held
vertically. Do not allow the tips
of the bottles to come in contact
with the extraction cups

Perform Assay
• Twirl briefly to mix the reagent

Perform Assay
• Incubate at room temperature
(15-30°C) for 5 minutes, but no
longer than 10 minutes

Perform Assay
• Add 4 drops (200 mL) of
Extraction Buffer B while holding
the bottle vertically

All drops must be free falling
with the reagent bottles held
vertically. Do not allow the tips
of the bottles to come in contact
with the extraction cups

Perform Assay
• Twirl the swab vigorously for 10 seconds and incubate for 1 minute,
but no longer than 10 minutes

Perform Assay
• Expunge as much liquid as
possible from swab by pressing
and rotating the fiber portion
against the wall of the tube

Perform Assay
• Discard used swab into biohazard
container

Perform Assay
• Cap the tube and mix contents by gentle swirling

• The swab extract can be tested immediately or remain at room
temperature for up to 3 hours without affecting test results

Perform Assay
• Remove a test device from its
protective pouch
• Place the test device on a clean,
flat surface
• Label the device with specimen’s
ID number

Do not open pouch unless ready
to run the test

Perform Assay
• Hold extraction tube vertically

• Dispense 2 drops (100 mL) of
extract to the sample pad

Do not over load samples

Perform Assay
• Set up timer

• Read test result within 15
minutes. Some positive results
may be visible as soon as 1
minute
• Complete reaction time of 15
minutes is required to confirm
negative results

Do not read result after 15 minutes

Read Assay Result
• Negative or non-reactive result
Only C band is developed
• Positive or reactive result
Both C and T bands are developed
• In valid result
No C band is developed

• Samples with positive results should be confirmed with alternative
testing method(s) such as antibody test, PCR and clinical findings
before to make diagnostic decision
• If C band isn’t developed, review whole procedure and repeat the
assay with a new device

Perform Assay
• Discard the used cassette device
and the protection sheet into
biohazard
container
after
interpreting the result

Quality Control
Internal Control

• Built-in control feature, the C band
o Developed C band indicates the procedure is correct
External Control
• Run 1 Positive Control and 1 Negative Control to assure proper
performance of the assay, when:
o a new operator uses the kit
o a new lot of test kit is used
o a new shipment of kits is used
o temperature used during storage of the kit falls outside of 2-30°C
o the temperature of the test area falls outside of 15-30°C
o to verify a higher than expected frequency of positive or negative
result
o to investigate the cause of repeated invalid results

Limitation of Test
• For optimal test performance, proper sample collection and storage
procedures are critical. Failure to follow the procedure may give
inaccurate results
• Limited to the qualitative detection of C. trachomatis antigen in swab
specimens. The intensity of the test band does not correlate with
antigen titer of the specimen
• Do not specifically differentiate between C. Trachomatis, C.
Pneumonia or C. Psittasi
• A negative or non-reactive test result:
o does not preclude the possibility of exposure to C. trachomatis
o It can occur if the concentration of the C. trachomatis antigen
present in the specimen is below the level detectable by the assay,
or the antigen is not present in the specimen or improper sample
treatment procedure
• If the symptom persists, while the result is negative or non-reactive
result, it is recommended to re-sample the patient few days later or
test with an alternative test device or method
• The results should only be interpreted in conjunction with other
diagnostic procedures and clinical findings

Technical Support
Contact Info.:
10110 Mesa Rim Rd. San Diego, CA 92121 USA
Email Address: [email protected]
Telephone: 1 (858) 457-8698
Fax: 1 (858) 535-1739

QUALITY . INNOVATION . SIMPLICITY


Slide 27

How To Run
OnSite Chlamydia Ag Rapid Test
(Catalog: R0080C)

C. trachomatis and Chlamydia
• Chlamydia trachomatis (C. trachomatis)
o The most common sexually transmitted
bacterial pathogen
o Major
cause of cervicitis, urethritis,
endometritis, and pelvic inflammatory
disease in women
o urethritis and epididymitis in men
• Chlamydia infection
o 80 million worldwide annually
o At least 3 million new cases in U.S.

Chlamydia Trachomatis

Current Diagnosis Methods
•
•
•
•
•

Cell culture
Direct fluorescence assay (DFA)
Enzyme immunoassays (EIA)
PCR
Immunological antigen test
Method

Rapid Test

DFA

EIA

PCR
> 4 hours

Culture

Time to result

15 minutes

2-3 hours

1-4 hours

>3 days

Facility

General Lab

Special Lab

General Lab Special Lab

Special Lab

Equipment

No

Expensive

PCR machine
Pipette

Incubator,
microscopy

Skill

Minimal

Well trained

Reader,
incubator,
pipette
Moderate

Well trained

Specialist

Comments

Cost effective

Costly

Costly

Costly

Costly

OnSite Chlamydia Ag Rapid Test

Intended Use
• Lateral flow chromatographic immunoassay

• Qualitative detection of C. trachomatis antigen in endocervical or
encourethral swab specimens
• Used as a screening test for diagnosis of infection with C.
trachomatis

Test Principle
• Double antibody-sandwich immunoassay

• A unique pair of Abs to selectively identify C. trachomatis Ag in the
specimen
• Test kit key components:
Test Band

Control Band

Pre-coated with another mouse
monoclonal anti-C. trachomatis Ab

Pe-coated with goat
anti-mouse IgG Ab

Kit Components
• 25 test devices (individually sealed
pouches containing with 1 cassette
device & 1 desiccant)
• 1 Extraction Buffer A (6 mL/vial)
• 1 Extraction Buffer B (6 mL/vial)
• 25 sample extraction tubes
• 1 package insert

Materials Required and Not Provided
• Swab for collecting specimen

• Clock or timer
• Disposable gloves
• Rack to hold extraction tube
• Biohazard container
• Marker pen

Precautions
Precautions

Explanation

Package insert MUST be read completely Pay attention to updated information
before testing
Do NOT open the pouch unless ready to Test device become moisture when
test
expose to humidity air, affect flow

Do NOT use components in any other Component in each kit is unique
type of test kit
Do NOT use expired devices

Expired product gives error result

Bring all reagents to room temperature Cold reagent has different viscosity,
(15-30°C) before use
affect flow migration and results
The testing results should be read within Extend reading time may lead to false
10 minutes after a specimen is applied to positive result.
the sample pad of the device
Do NOT perform the test in a room with Strong air flow causes specimen
strong air flow as the specimens might evaporation during assay, leads to
evaporate before reach
error result

Specimen Collection and Handling
• Consider any materials of human origin as infectious and handle them
using standard biosafety procedures
• Swab specimen should be collected by standard male or female
specimen collection methods
• Swabs should be processed as soon as possible after collection. If
swabs are not processed immediately, they should be placed into a
dry, sterile, tightly capped tube or bottle, and stored at 2-8°C for up to
5 days, preferably in a transportation tube

• Do NOT use bloody swabs
• Do NOT freeze swabs

Preparation for Assay
• Wear protective clothing and
disposable gloves

Preparation for Assay
• Set up work area

• Bring all kit components to room
temperature (15-30°C) prior to
testing

Preparation for Assay
• Double check product’s name
and expiration date
Product Name
Expiration Date

Do not use expired test device

Perform Assay
• Label an extraction tube for each
patient and place in a tube holder
or rack

Perform Assay
• Place specimen swab into the
extraction tube
• Add 4 drops (200 mL) of
Extraction Buffer A while holding
the bottle vertically

All drops must be free falling
with the reagent bottles held
vertically. Do not allow the tips
of the bottles to come in contact
with the extraction cups

Perform Assay
• Twirl briefly to mix the reagent

Perform Assay
• Incubate at room temperature
(15-30°C) for 5 minutes, but no
longer than 10 minutes

Perform Assay
• Add 4 drops (200 mL) of
Extraction Buffer B while holding
the bottle vertically

All drops must be free falling
with the reagent bottles held
vertically. Do not allow the tips
of the bottles to come in contact
with the extraction cups

Perform Assay
• Twirl the swab vigorously for 10 seconds and incubate for 1 minute,
but no longer than 10 minutes

Perform Assay
• Expunge as much liquid as
possible from swab by pressing
and rotating the fiber portion
against the wall of the tube

Perform Assay
• Discard used swab into biohazard
container

Perform Assay
• Cap the tube and mix contents by gentle swirling

• The swab extract can be tested immediately or remain at room
temperature for up to 3 hours without affecting test results

Perform Assay
• Remove a test device from its
protective pouch
• Place the test device on a clean,
flat surface
• Label the device with specimen’s
ID number

Do not open pouch unless ready
to run the test

Perform Assay
• Hold extraction tube vertically

• Dispense 2 drops (100 mL) of
extract to the sample pad

Do not over load samples

Perform Assay
• Set up timer

• Read test result within 15
minutes. Some positive results
may be visible as soon as 1
minute
• Complete reaction time of 15
minutes is required to confirm
negative results

Do not read result after 15 minutes

Read Assay Result
• Negative or non-reactive result
Only C band is developed
• Positive or reactive result
Both C and T bands are developed
• In valid result
No C band is developed

• Samples with positive results should be confirmed with alternative
testing method(s) such as antibody test, PCR and clinical findings
before to make diagnostic decision
• If C band isn’t developed, review whole procedure and repeat the
assay with a new device

Perform Assay
• Discard the used cassette device
and the protection sheet into
biohazard
container
after
interpreting the result

Quality Control
Internal Control

• Built-in control feature, the C band
o Developed C band indicates the procedure is correct
External Control
• Run 1 Positive Control and 1 Negative Control to assure proper
performance of the assay, when:
o a new operator uses the kit
o a new lot of test kit is used
o a new shipment of kits is used
o temperature used during storage of the kit falls outside of 2-30°C
o the temperature of the test area falls outside of 15-30°C
o to verify a higher than expected frequency of positive or negative
result
o to investigate the cause of repeated invalid results

Limitation of Test
• For optimal test performance, proper sample collection and storage
procedures are critical. Failure to follow the procedure may give
inaccurate results
• Limited to the qualitative detection of C. trachomatis antigen in swab
specimens. The intensity of the test band does not correlate with
antigen titer of the specimen
• Do not specifically differentiate between C. Trachomatis, C.
Pneumonia or C. Psittasi
• A negative or non-reactive test result:
o does not preclude the possibility of exposure to C. trachomatis
o It can occur if the concentration of the C. trachomatis antigen
present in the specimen is below the level detectable by the assay,
or the antigen is not present in the specimen or improper sample
treatment procedure
• If the symptom persists, while the result is negative or non-reactive
result, it is recommended to re-sample the patient few days later or
test with an alternative test device or method
• The results should only be interpreted in conjunction with other
diagnostic procedures and clinical findings

Technical Support
Contact Info.:
10110 Mesa Rim Rd. San Diego, CA 92121 USA
Email Address: [email protected]
Telephone: 1 (858) 457-8698
Fax: 1 (858) 535-1739

QUALITY . INNOVATION . SIMPLICITY


Slide 28

How To Run
OnSite Chlamydia Ag Rapid Test
(Catalog: R0080C)

C. trachomatis and Chlamydia
• Chlamydia trachomatis (C. trachomatis)
o The most common sexually transmitted
bacterial pathogen
o Major
cause of cervicitis, urethritis,
endometritis, and pelvic inflammatory
disease in women
o urethritis and epididymitis in men
• Chlamydia infection
o 80 million worldwide annually
o At least 3 million new cases in U.S.

Chlamydia Trachomatis

Current Diagnosis Methods
•
•
•
•
•

Cell culture
Direct fluorescence assay (DFA)
Enzyme immunoassays (EIA)
PCR
Immunological antigen test
Method

Rapid Test

DFA

EIA

PCR
> 4 hours

Culture

Time to result

15 minutes

2-3 hours

1-4 hours

>3 days

Facility

General Lab

Special Lab

General Lab Special Lab

Special Lab

Equipment

No

Expensive

PCR machine
Pipette

Incubator,
microscopy

Skill

Minimal

Well trained

Reader,
incubator,
pipette
Moderate

Well trained

Specialist

Comments

Cost effective

Costly

Costly

Costly

Costly

OnSite Chlamydia Ag Rapid Test

Intended Use
• Lateral flow chromatographic immunoassay

• Qualitative detection of C. trachomatis antigen in endocervical or
encourethral swab specimens
• Used as a screening test for diagnosis of infection with C.
trachomatis

Test Principle
• Double antibody-sandwich immunoassay

• A unique pair of Abs to selectively identify C. trachomatis Ag in the
specimen
• Test kit key components:
Test Band

Control Band

Pre-coated with another mouse
monoclonal anti-C. trachomatis Ab

Pe-coated with goat
anti-mouse IgG Ab

Kit Components
• 25 test devices (individually sealed
pouches containing with 1 cassette
device & 1 desiccant)
• 1 Extraction Buffer A (6 mL/vial)
• 1 Extraction Buffer B (6 mL/vial)
• 25 sample extraction tubes
• 1 package insert

Materials Required and Not Provided
• Swab for collecting specimen

• Clock or timer
• Disposable gloves
• Rack to hold extraction tube
• Biohazard container
• Marker pen

Precautions
Precautions

Explanation

Package insert MUST be read completely Pay attention to updated information
before testing
Do NOT open the pouch unless ready to Test device become moisture when
test
expose to humidity air, affect flow

Do NOT use components in any other Component in each kit is unique
type of test kit
Do NOT use expired devices

Expired product gives error result

Bring all reagents to room temperature Cold reagent has different viscosity,
(15-30°C) before use
affect flow migration and results
The testing results should be read within Extend reading time may lead to false
10 minutes after a specimen is applied to positive result.
the sample pad of the device
Do NOT perform the test in a room with Strong air flow causes specimen
strong air flow as the specimens might evaporation during assay, leads to
evaporate before reach
error result

Specimen Collection and Handling
• Consider any materials of human origin as infectious and handle them
using standard biosafety procedures
• Swab specimen should be collected by standard male or female
specimen collection methods
• Swabs should be processed as soon as possible after collection. If
swabs are not processed immediately, they should be placed into a
dry, sterile, tightly capped tube or bottle, and stored at 2-8°C for up to
5 days, preferably in a transportation tube

• Do NOT use bloody swabs
• Do NOT freeze swabs

Preparation for Assay
• Wear protective clothing and
disposable gloves

Preparation for Assay
• Set up work area

• Bring all kit components to room
temperature (15-30°C) prior to
testing

Preparation for Assay
• Double check product’s name
and expiration date
Product Name
Expiration Date

Do not use expired test device

Perform Assay
• Label an extraction tube for each
patient and place in a tube holder
or rack

Perform Assay
• Place specimen swab into the
extraction tube
• Add 4 drops (200 mL) of
Extraction Buffer A while holding
the bottle vertically

All drops must be free falling
with the reagent bottles held
vertically. Do not allow the tips
of the bottles to come in contact
with the extraction cups

Perform Assay
• Twirl briefly to mix the reagent

Perform Assay
• Incubate at room temperature
(15-30°C) for 5 minutes, but no
longer than 10 minutes

Perform Assay
• Add 4 drops (200 mL) of
Extraction Buffer B while holding
the bottle vertically

All drops must be free falling
with the reagent bottles held
vertically. Do not allow the tips
of the bottles to come in contact
with the extraction cups

Perform Assay
• Twirl the swab vigorously for 10 seconds and incubate for 1 minute,
but no longer than 10 minutes

Perform Assay
• Expunge as much liquid as
possible from swab by pressing
and rotating the fiber portion
against the wall of the tube

Perform Assay
• Discard used swab into biohazard
container

Perform Assay
• Cap the tube and mix contents by gentle swirling

• The swab extract can be tested immediately or remain at room
temperature for up to 3 hours without affecting test results

Perform Assay
• Remove a test device from its
protective pouch
• Place the test device on a clean,
flat surface
• Label the device with specimen’s
ID number

Do not open pouch unless ready
to run the test

Perform Assay
• Hold extraction tube vertically

• Dispense 2 drops (100 mL) of
extract to the sample pad

Do not over load samples

Perform Assay
• Set up timer

• Read test result within 15
minutes. Some positive results
may be visible as soon as 1
minute
• Complete reaction time of 15
minutes is required to confirm
negative results

Do not read result after 15 minutes

Read Assay Result
• Negative or non-reactive result
Only C band is developed
• Positive or reactive result
Both C and T bands are developed
• In valid result
No C band is developed

• Samples with positive results should be confirmed with alternative
testing method(s) such as antibody test, PCR and clinical findings
before to make diagnostic decision
• If C band isn’t developed, review whole procedure and repeat the
assay with a new device

Perform Assay
• Discard the used cassette device
and the protection sheet into
biohazard
container
after
interpreting the result

Quality Control
Internal Control

• Built-in control feature, the C band
o Developed C band indicates the procedure is correct
External Control
• Run 1 Positive Control and 1 Negative Control to assure proper
performance of the assay, when:
o a new operator uses the kit
o a new lot of test kit is used
o a new shipment of kits is used
o temperature used during storage of the kit falls outside of 2-30°C
o the temperature of the test area falls outside of 15-30°C
o to verify a higher than expected frequency of positive or negative
result
o to investigate the cause of repeated invalid results

Limitation of Test
• For optimal test performance, proper sample collection and storage
procedures are critical. Failure to follow the procedure may give
inaccurate results
• Limited to the qualitative detection of C. trachomatis antigen in swab
specimens. The intensity of the test band does not correlate with
antigen titer of the specimen
• Do not specifically differentiate between C. Trachomatis, C.
Pneumonia or C. Psittasi
• A negative or non-reactive test result:
o does not preclude the possibility of exposure to C. trachomatis
o It can occur if the concentration of the C. trachomatis antigen
present in the specimen is below the level detectable by the assay,
or the antigen is not present in the specimen or improper sample
treatment procedure
• If the symptom persists, while the result is negative or non-reactive
result, it is recommended to re-sample the patient few days later or
test with an alternative test device or method
• The results should only be interpreted in conjunction with other
diagnostic procedures and clinical findings

Technical Support
Contact Info.:
10110 Mesa Rim Rd. San Diego, CA 92121 USA
Email Address: [email protected]
Telephone: 1 (858) 457-8698
Fax: 1 (858) 535-1739

QUALITY . INNOVATION . SIMPLICITY


Slide 29

How To Run
OnSite Chlamydia Ag Rapid Test
(Catalog: R0080C)

C. trachomatis and Chlamydia
• Chlamydia trachomatis (C. trachomatis)
o The most common sexually transmitted
bacterial pathogen
o Major
cause of cervicitis, urethritis,
endometritis, and pelvic inflammatory
disease in women
o urethritis and epididymitis in men
• Chlamydia infection
o 80 million worldwide annually
o At least 3 million new cases in U.S.

Chlamydia Trachomatis

Current Diagnosis Methods
•
•
•
•
•

Cell culture
Direct fluorescence assay (DFA)
Enzyme immunoassays (EIA)
PCR
Immunological antigen test
Method

Rapid Test

DFA

EIA

PCR
> 4 hours

Culture

Time to result

15 minutes

2-3 hours

1-4 hours

>3 days

Facility

General Lab

Special Lab

General Lab Special Lab

Special Lab

Equipment

No

Expensive

PCR machine
Pipette

Incubator,
microscopy

Skill

Minimal

Well trained

Reader,
incubator,
pipette
Moderate

Well trained

Specialist

Comments

Cost effective

Costly

Costly

Costly

Costly

OnSite Chlamydia Ag Rapid Test

Intended Use
• Lateral flow chromatographic immunoassay

• Qualitative detection of C. trachomatis antigen in endocervical or
encourethral swab specimens
• Used as a screening test for diagnosis of infection with C.
trachomatis

Test Principle
• Double antibody-sandwich immunoassay

• A unique pair of Abs to selectively identify C. trachomatis Ag in the
specimen
• Test kit key components:
Test Band

Control Band

Pre-coated with another mouse
monoclonal anti-C. trachomatis Ab

Pe-coated with goat
anti-mouse IgG Ab

Kit Components
• 25 test devices (individually sealed
pouches containing with 1 cassette
device & 1 desiccant)
• 1 Extraction Buffer A (6 mL/vial)
• 1 Extraction Buffer B (6 mL/vial)
• 25 sample extraction tubes
• 1 package insert

Materials Required and Not Provided
• Swab for collecting specimen

• Clock or timer
• Disposable gloves
• Rack to hold extraction tube
• Biohazard container
• Marker pen

Precautions
Precautions

Explanation

Package insert MUST be read completely Pay attention to updated information
before testing
Do NOT open the pouch unless ready to Test device become moisture when
test
expose to humidity air, affect flow

Do NOT use components in any other Component in each kit is unique
type of test kit
Do NOT use expired devices

Expired product gives error result

Bring all reagents to room temperature Cold reagent has different viscosity,
(15-30°C) before use
affect flow migration and results
The testing results should be read within Extend reading time may lead to false
10 minutes after a specimen is applied to positive result.
the sample pad of the device
Do NOT perform the test in a room with Strong air flow causes specimen
strong air flow as the specimens might evaporation during assay, leads to
evaporate before reach
error result

Specimen Collection and Handling
• Consider any materials of human origin as infectious and handle them
using standard biosafety procedures
• Swab specimen should be collected by standard male or female
specimen collection methods
• Swabs should be processed as soon as possible after collection. If
swabs are not processed immediately, they should be placed into a
dry, sterile, tightly capped tube or bottle, and stored at 2-8°C for up to
5 days, preferably in a transportation tube

• Do NOT use bloody swabs
• Do NOT freeze swabs

Preparation for Assay
• Wear protective clothing and
disposable gloves

Preparation for Assay
• Set up work area

• Bring all kit components to room
temperature (15-30°C) prior to
testing

Preparation for Assay
• Double check product’s name
and expiration date
Product Name
Expiration Date

Do not use expired test device

Perform Assay
• Label an extraction tube for each
patient and place in a tube holder
or rack

Perform Assay
• Place specimen swab into the
extraction tube
• Add 4 drops (200 mL) of
Extraction Buffer A while holding
the bottle vertically

All drops must be free falling
with the reagent bottles held
vertically. Do not allow the tips
of the bottles to come in contact
with the extraction cups

Perform Assay
• Twirl briefly to mix the reagent

Perform Assay
• Incubate at room temperature
(15-30°C) for 5 minutes, but no
longer than 10 minutes

Perform Assay
• Add 4 drops (200 mL) of
Extraction Buffer B while holding
the bottle vertically

All drops must be free falling
with the reagent bottles held
vertically. Do not allow the tips
of the bottles to come in contact
with the extraction cups

Perform Assay
• Twirl the swab vigorously for 10 seconds and incubate for 1 minute,
but no longer than 10 minutes

Perform Assay
• Expunge as much liquid as
possible from swab by pressing
and rotating the fiber portion
against the wall of the tube

Perform Assay
• Discard used swab into biohazard
container

Perform Assay
• Cap the tube and mix contents by gentle swirling

• The swab extract can be tested immediately or remain at room
temperature for up to 3 hours without affecting test results

Perform Assay
• Remove a test device from its
protective pouch
• Place the test device on a clean,
flat surface
• Label the device with specimen’s
ID number

Do not open pouch unless ready
to run the test

Perform Assay
• Hold extraction tube vertically

• Dispense 2 drops (100 mL) of
extract to the sample pad

Do not over load samples

Perform Assay
• Set up timer

• Read test result within 15
minutes. Some positive results
may be visible as soon as 1
minute
• Complete reaction time of 15
minutes is required to confirm
negative results

Do not read result after 15 minutes

Read Assay Result
• Negative or non-reactive result
Only C band is developed
• Positive or reactive result
Both C and T bands are developed
• In valid result
No C band is developed

• Samples with positive results should be confirmed with alternative
testing method(s) such as antibody test, PCR and clinical findings
before to make diagnostic decision
• If C band isn’t developed, review whole procedure and repeat the
assay with a new device

Perform Assay
• Discard the used cassette device
and the protection sheet into
biohazard
container
after
interpreting the result

Quality Control
Internal Control

• Built-in control feature, the C band
o Developed C band indicates the procedure is correct
External Control
• Run 1 Positive Control and 1 Negative Control to assure proper
performance of the assay, when:
o a new operator uses the kit
o a new lot of test kit is used
o a new shipment of kits is used
o temperature used during storage of the kit falls outside of 2-30°C
o the temperature of the test area falls outside of 15-30°C
o to verify a higher than expected frequency of positive or negative
result
o to investigate the cause of repeated invalid results

Limitation of Test
• For optimal test performance, proper sample collection and storage
procedures are critical. Failure to follow the procedure may give
inaccurate results
• Limited to the qualitative detection of C. trachomatis antigen in swab
specimens. The intensity of the test band does not correlate with
antigen titer of the specimen
• Do not specifically differentiate between C. Trachomatis, C.
Pneumonia or C. Psittasi
• A negative or non-reactive test result:
o does not preclude the possibility of exposure to C. trachomatis
o It can occur if the concentration of the C. trachomatis antigen
present in the specimen is below the level detectable by the assay,
or the antigen is not present in the specimen or improper sample
treatment procedure
• If the symptom persists, while the result is negative or non-reactive
result, it is recommended to re-sample the patient few days later or
test with an alternative test device or method
• The results should only be interpreted in conjunction with other
diagnostic procedures and clinical findings

Technical Support
Contact Info.:
10110 Mesa Rim Rd. San Diego, CA 92121 USA
Email Address: [email protected]
Telephone: 1 (858) 457-8698
Fax: 1 (858) 535-1739

QUALITY . INNOVATION . SIMPLICITY


Slide 30

How To Run
OnSite Chlamydia Ag Rapid Test
(Catalog: R0080C)

C. trachomatis and Chlamydia
• Chlamydia trachomatis (C. trachomatis)
o The most common sexually transmitted
bacterial pathogen
o Major
cause of cervicitis, urethritis,
endometritis, and pelvic inflammatory
disease in women
o urethritis and epididymitis in men
• Chlamydia infection
o 80 million worldwide annually
o At least 3 million new cases in U.S.

Chlamydia Trachomatis

Current Diagnosis Methods
•
•
•
•
•

Cell culture
Direct fluorescence assay (DFA)
Enzyme immunoassays (EIA)
PCR
Immunological antigen test
Method

Rapid Test

DFA

EIA

PCR
> 4 hours

Culture

Time to result

15 minutes

2-3 hours

1-4 hours

>3 days

Facility

General Lab

Special Lab

General Lab Special Lab

Special Lab

Equipment

No

Expensive

PCR machine
Pipette

Incubator,
microscopy

Skill

Minimal

Well trained

Reader,
incubator,
pipette
Moderate

Well trained

Specialist

Comments

Cost effective

Costly

Costly

Costly

Costly

OnSite Chlamydia Ag Rapid Test

Intended Use
• Lateral flow chromatographic immunoassay

• Qualitative detection of C. trachomatis antigen in endocervical or
encourethral swab specimens
• Used as a screening test for diagnosis of infection with C.
trachomatis

Test Principle
• Double antibody-sandwich immunoassay

• A unique pair of Abs to selectively identify C. trachomatis Ag in the
specimen
• Test kit key components:
Test Band

Control Band

Pre-coated with another mouse
monoclonal anti-C. trachomatis Ab

Pe-coated with goat
anti-mouse IgG Ab

Kit Components
• 25 test devices (individually sealed
pouches containing with 1 cassette
device & 1 desiccant)
• 1 Extraction Buffer A (6 mL/vial)
• 1 Extraction Buffer B (6 mL/vial)
• 25 sample extraction tubes
• 1 package insert

Materials Required and Not Provided
• Swab for collecting specimen

• Clock or timer
• Disposable gloves
• Rack to hold extraction tube
• Biohazard container
• Marker pen

Precautions
Precautions

Explanation

Package insert MUST be read completely Pay attention to updated information
before testing
Do NOT open the pouch unless ready to Test device become moisture when
test
expose to humidity air, affect flow

Do NOT use components in any other Component in each kit is unique
type of test kit
Do NOT use expired devices

Expired product gives error result

Bring all reagents to room temperature Cold reagent has different viscosity,
(15-30°C) before use
affect flow migration and results
The testing results should be read within Extend reading time may lead to false
10 minutes after a specimen is applied to positive result.
the sample pad of the device
Do NOT perform the test in a room with Strong air flow causes specimen
strong air flow as the specimens might evaporation during assay, leads to
evaporate before reach
error result

Specimen Collection and Handling
• Consider any materials of human origin as infectious and handle them
using standard biosafety procedures
• Swab specimen should be collected by standard male or female
specimen collection methods
• Swabs should be processed as soon as possible after collection. If
swabs are not processed immediately, they should be placed into a
dry, sterile, tightly capped tube or bottle, and stored at 2-8°C for up to
5 days, preferably in a transportation tube

• Do NOT use bloody swabs
• Do NOT freeze swabs

Preparation for Assay
• Wear protective clothing and
disposable gloves

Preparation for Assay
• Set up work area

• Bring all kit components to room
temperature (15-30°C) prior to
testing

Preparation for Assay
• Double check product’s name
and expiration date
Product Name
Expiration Date

Do not use expired test device

Perform Assay
• Label an extraction tube for each
patient and place in a tube holder
or rack

Perform Assay
• Place specimen swab into the
extraction tube
• Add 4 drops (200 mL) of
Extraction Buffer A while holding
the bottle vertically

All drops must be free falling
with the reagent bottles held
vertically. Do not allow the tips
of the bottles to come in contact
with the extraction cups

Perform Assay
• Twirl briefly to mix the reagent

Perform Assay
• Incubate at room temperature
(15-30°C) for 5 minutes, but no
longer than 10 minutes

Perform Assay
• Add 4 drops (200 mL) of
Extraction Buffer B while holding
the bottle vertically

All drops must be free falling
with the reagent bottles held
vertically. Do not allow the tips
of the bottles to come in contact
with the extraction cups

Perform Assay
• Twirl the swab vigorously for 10 seconds and incubate for 1 minute,
but no longer than 10 minutes

Perform Assay
• Expunge as much liquid as
possible from swab by pressing
and rotating the fiber portion
against the wall of the tube

Perform Assay
• Discard used swab into biohazard
container

Perform Assay
• Cap the tube and mix contents by gentle swirling

• The swab extract can be tested immediately or remain at room
temperature for up to 3 hours without affecting test results

Perform Assay
• Remove a test device from its
protective pouch
• Place the test device on a clean,
flat surface
• Label the device with specimen’s
ID number

Do not open pouch unless ready
to run the test

Perform Assay
• Hold extraction tube vertically

• Dispense 2 drops (100 mL) of
extract to the sample pad

Do not over load samples

Perform Assay
• Set up timer

• Read test result within 15
minutes. Some positive results
may be visible as soon as 1
minute
• Complete reaction time of 15
minutes is required to confirm
negative results

Do not read result after 15 minutes

Read Assay Result
• Negative or non-reactive result
Only C band is developed
• Positive or reactive result
Both C and T bands are developed
• In valid result
No C band is developed

• Samples with positive results should be confirmed with alternative
testing method(s) such as antibody test, PCR and clinical findings
before to make diagnostic decision
• If C band isn’t developed, review whole procedure and repeat the
assay with a new device

Perform Assay
• Discard the used cassette device
and the protection sheet into
biohazard
container
after
interpreting the result

Quality Control
Internal Control

• Built-in control feature, the C band
o Developed C band indicates the procedure is correct
External Control
• Run 1 Positive Control and 1 Negative Control to assure proper
performance of the assay, when:
o a new operator uses the kit
o a new lot of test kit is used
o a new shipment of kits is used
o temperature used during storage of the kit falls outside of 2-30°C
o the temperature of the test area falls outside of 15-30°C
o to verify a higher than expected frequency of positive or negative
result
o to investigate the cause of repeated invalid results

Limitation of Test
• For optimal test performance, proper sample collection and storage
procedures are critical. Failure to follow the procedure may give
inaccurate results
• Limited to the qualitative detection of C. trachomatis antigen in swab
specimens. The intensity of the test band does not correlate with
antigen titer of the specimen
• Do not specifically differentiate between C. Trachomatis, C.
Pneumonia or C. Psittasi
• A negative or non-reactive test result:
o does not preclude the possibility of exposure to C. trachomatis
o It can occur if the concentration of the C. trachomatis antigen
present in the specimen is below the level detectable by the assay,
or the antigen is not present in the specimen or improper sample
treatment procedure
• If the symptom persists, while the result is negative or non-reactive
result, it is recommended to re-sample the patient few days later or
test with an alternative test device or method
• The results should only be interpreted in conjunction with other
diagnostic procedures and clinical findings

Technical Support
Contact Info.:
10110 Mesa Rim Rd. San Diego, CA 92121 USA
Email Address: [email protected]
Telephone: 1 (858) 457-8698
Fax: 1 (858) 535-1739

QUALITY . INNOVATION . SIMPLICITY


Slide 31

How To Run
OnSite Chlamydia Ag Rapid Test
(Catalog: R0080C)

C. trachomatis and Chlamydia
• Chlamydia trachomatis (C. trachomatis)
o The most common sexually transmitted
bacterial pathogen
o Major
cause of cervicitis, urethritis,
endometritis, and pelvic inflammatory
disease in women
o urethritis and epididymitis in men
• Chlamydia infection
o 80 million worldwide annually
o At least 3 million new cases in U.S.

Chlamydia Trachomatis

Current Diagnosis Methods
•
•
•
•
•

Cell culture
Direct fluorescence assay (DFA)
Enzyme immunoassays (EIA)
PCR
Immunological antigen test
Method

Rapid Test

DFA

EIA

PCR
> 4 hours

Culture

Time to result

15 minutes

2-3 hours

1-4 hours

>3 days

Facility

General Lab

Special Lab

General Lab Special Lab

Special Lab

Equipment

No

Expensive

PCR machine
Pipette

Incubator,
microscopy

Skill

Minimal

Well trained

Reader,
incubator,
pipette
Moderate

Well trained

Specialist

Comments

Cost effective

Costly

Costly

Costly

Costly

OnSite Chlamydia Ag Rapid Test

Intended Use
• Lateral flow chromatographic immunoassay

• Qualitative detection of C. trachomatis antigen in endocervical or
encourethral swab specimens
• Used as a screening test for diagnosis of infection with C.
trachomatis

Test Principle
• Double antibody-sandwich immunoassay

• A unique pair of Abs to selectively identify C. trachomatis Ag in the
specimen
• Test kit key components:
Test Band

Control Band

Pre-coated with another mouse
monoclonal anti-C. trachomatis Ab

Pe-coated with goat
anti-mouse IgG Ab

Kit Components
• 25 test devices (individually sealed
pouches containing with 1 cassette
device & 1 desiccant)
• 1 Extraction Buffer A (6 mL/vial)
• 1 Extraction Buffer B (6 mL/vial)
• 25 sample extraction tubes
• 1 package insert

Materials Required and Not Provided
• Swab for collecting specimen

• Clock or timer
• Disposable gloves
• Rack to hold extraction tube
• Biohazard container
• Marker pen

Precautions
Precautions

Explanation

Package insert MUST be read completely Pay attention to updated information
before testing
Do NOT open the pouch unless ready to Test device become moisture when
test
expose to humidity air, affect flow

Do NOT use components in any other Component in each kit is unique
type of test kit
Do NOT use expired devices

Expired product gives error result

Bring all reagents to room temperature Cold reagent has different viscosity,
(15-30°C) before use
affect flow migration and results
The testing results should be read within Extend reading time may lead to false
10 minutes after a specimen is applied to positive result.
the sample pad of the device
Do NOT perform the test in a room with Strong air flow causes specimen
strong air flow as the specimens might evaporation during assay, leads to
evaporate before reach
error result

Specimen Collection and Handling
• Consider any materials of human origin as infectious and handle them
using standard biosafety procedures
• Swab specimen should be collected by standard male or female
specimen collection methods
• Swabs should be processed as soon as possible after collection. If
swabs are not processed immediately, they should be placed into a
dry, sterile, tightly capped tube or bottle, and stored at 2-8°C for up to
5 days, preferably in a transportation tube

• Do NOT use bloody swabs
• Do NOT freeze swabs

Preparation for Assay
• Wear protective clothing and
disposable gloves

Preparation for Assay
• Set up work area

• Bring all kit components to room
temperature (15-30°C) prior to
testing

Preparation for Assay
• Double check product’s name
and expiration date
Product Name
Expiration Date

Do not use expired test device

Perform Assay
• Label an extraction tube for each
patient and place in a tube holder
or rack

Perform Assay
• Place specimen swab into the
extraction tube
• Add 4 drops (200 mL) of
Extraction Buffer A while holding
the bottle vertically

All drops must be free falling
with the reagent bottles held
vertically. Do not allow the tips
of the bottles to come in contact
with the extraction cups

Perform Assay
• Twirl briefly to mix the reagent

Perform Assay
• Incubate at room temperature
(15-30°C) for 5 minutes, but no
longer than 10 minutes

Perform Assay
• Add 4 drops (200 mL) of
Extraction Buffer B while holding
the bottle vertically

All drops must be free falling
with the reagent bottles held
vertically. Do not allow the tips
of the bottles to come in contact
with the extraction cups

Perform Assay
• Twirl the swab vigorously for 10 seconds and incubate for 1 minute,
but no longer than 10 minutes

Perform Assay
• Expunge as much liquid as
possible from swab by pressing
and rotating the fiber portion
against the wall of the tube

Perform Assay
• Discard used swab into biohazard
container

Perform Assay
• Cap the tube and mix contents by gentle swirling

• The swab extract can be tested immediately or remain at room
temperature for up to 3 hours without affecting test results

Perform Assay
• Remove a test device from its
protective pouch
• Place the test device on a clean,
flat surface
• Label the device with specimen’s
ID number

Do not open pouch unless ready
to run the test

Perform Assay
• Hold extraction tube vertically

• Dispense 2 drops (100 mL) of
extract to the sample pad

Do not over load samples

Perform Assay
• Set up timer

• Read test result within 15
minutes. Some positive results
may be visible as soon as 1
minute
• Complete reaction time of 15
minutes is required to confirm
negative results

Do not read result after 15 minutes

Read Assay Result
• Negative or non-reactive result
Only C band is developed
• Positive or reactive result
Both C and T bands are developed
• In valid result
No C band is developed

• Samples with positive results should be confirmed with alternative
testing method(s) such as antibody test, PCR and clinical findings
before to make diagnostic decision
• If C band isn’t developed, review whole procedure and repeat the
assay with a new device

Perform Assay
• Discard the used cassette device
and the protection sheet into
biohazard
container
after
interpreting the result

Quality Control
Internal Control

• Built-in control feature, the C band
o Developed C band indicates the procedure is correct
External Control
• Run 1 Positive Control and 1 Negative Control to assure proper
performance of the assay, when:
o a new operator uses the kit
o a new lot of test kit is used
o a new shipment of kits is used
o temperature used during storage of the kit falls outside of 2-30°C
o the temperature of the test area falls outside of 15-30°C
o to verify a higher than expected frequency of positive or negative
result
o to investigate the cause of repeated invalid results

Limitation of Test
• For optimal test performance, proper sample collection and storage
procedures are critical. Failure to follow the procedure may give
inaccurate results
• Limited to the qualitative detection of C. trachomatis antigen in swab
specimens. The intensity of the test band does not correlate with
antigen titer of the specimen
• Do not specifically differentiate between C. Trachomatis, C.
Pneumonia or C. Psittasi
• A negative or non-reactive test result:
o does not preclude the possibility of exposure to C. trachomatis
o It can occur if the concentration of the C. trachomatis antigen
present in the specimen is below the level detectable by the assay,
or the antigen is not present in the specimen or improper sample
treatment procedure
• If the symptom persists, while the result is negative or non-reactive
result, it is recommended to re-sample the patient few days later or
test with an alternative test device or method
• The results should only be interpreted in conjunction with other
diagnostic procedures and clinical findings

Technical Support
Contact Info.:
10110 Mesa Rim Rd. San Diego, CA 92121 USA
Email Address: [email protected]
Telephone: 1 (858) 457-8698
Fax: 1 (858) 535-1739

QUALITY . INNOVATION . SIMPLICITY