Transcript How to run CTK Gonorrhea rapid test Presentation

How To Run
OnSite Gonorrhea Rapid Test (Strip)
(Catalog: R0085S)
N. gonorrhoeae and Gonorrhea
• Gonorrhea infected by Neisseria gonorrhoeae (N.
gonorrhoeae), a gram-negative diplococcus
• After chlamydia, gonorrhea is the most
commonly sexually transmitted disease in the
world
o infect more than 106 million people each year
o 820,000 new cases in U.S. annually
o drug-resistant gonorrhea spreads since 2008
N. gonorrhoeae
Current Diagnosis Methods
Gram Stain
Culture
Isolation
• Sensitive and specific
• Time consuming
• Specialist
Nucleic Acid
Amplification
• Expensive
• Time consuming
• Specialist
OnSite Gonorrhea
Rapid Test
• Biochemistry test
• Non-culture, rapid,
simple, inexpensive
OnSite Gonorrhea Rapid Test
(Swab Test)
Intended Use
• Strip format (swab test)
• Qualitative detection of the oxidase activity of N. gonorrhoeae
o in less than 1 minute
o in the secretary specimen from urogenital system
•
Used as a screening test for diagnosis of infection with N. gonorrhoeae
Test Principle
• Detect the activity of oxidase produced during gonococcus
replication in the infected site
• The test strip is pre-coated with the substrate of oxidase. The swab
specimen if contains the enzyme, will react to the substrate, forming
a color substance
• The result can be visually interpreted by color change
Sample Pad
Kit Components
• Individually sealed foil pouches
containing:
o 1 test strip
o 1 swab
o 1 desiccant
• Package insert
Materials Required and Not Provided
• Protection sheet
• Disposable gloves
• Clock or timer
• Biohazard container
Precautions
Precautions
Read entire package insert before testing
Explanation
Pay attention to updated information
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
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
Preparation for Assay
• Set up work area with a clean
protection sheet
• Wear protective clothing and
disposable gloves
Preparation for Assay
• 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
• Open pouch, and take out the
test strip and swab
• Collect specimen with swab
Do not open pouch unless ready
to run the test
Specimen Collection and Handling
For Male
• Swab discharges from the opening of the urinary tract
• If no discharge is present, insert the swab 2-3 cm into the urinary tract,
gently rotate the swab and retrieve the swab
For Female
• Swab discharges from the vaginal opening
• For more accurate results, insert swab into cervix or vagina for half a
minute, rotate and retrieve the swab
•
•
•
•
•
Soak the swab with saline first if discharge is too viscous
Don’t apply blood, sperm, or others from non-urogenital system
Collect cervical discharges without blood if in menstrual period
Don’t take any vaginal medicine for 3 days prior to this test
Test the specimen immediately. Avoid drying out the specimen
Perform Assay
• Apply the swab onto the orange
sample pad
• Keep the strip flat on the bench
• Set up timer
• wait for 10-20 seconds to read
result
Read Assay Result
Negative Result
orange
light green
Positive Result
dark green
dark blue
• Positive test result should be confirmed by other confirmative tests
• Having sex 3 days prior to testing may lead to false test result
Perform Assay
• Discard the used swab, test strip
and protection sheet into
biohazard
container
after
interpreting the result
Limitation of Test
• The assay procedure and the assay result interpretation MUST be
followed closely when testing the sepecimen from individual subjects.
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 N. gonorrhoeae oxidase in
secretary specimen from urogenital system. The intensity of the test
color does not correlate with the amount of the oxidase in the
specimen
• A negative test result:
o does not preclude the possibility of exposure to or infection with N.
gonorrhoeae
o can occur if the quantity of the oxidase present in the specimen is
below the detection limits of the assay, or is not present during the
stage of disease
• The result 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