Transcript OnSite HAV IgM RDT Presentation

OnSite HAV IgM Rapid Test
Upgraded to Revision H for Better Sensitivity
CTK-MK-PPT-R0090 Rev 1.0
HAV Is A Common Infectious Disease
OnSite HAV IgM Rapid Test
Indications
• Intended to be used to detect IgM anti HAV in human serum,
plasma, and whole blood as a screening test
Positive result needs to be confirmed by a secondary method,
such as ELISA
• Indications:
o Jaundice patient
o Abnormal liver function, but negative for HBV
o Personnel with close contact to HAV patient
o Screening for who needs HAV vaccination
OnSite HAV IgM Rapid Test
Product History
• The first version was launched in 2006
• Market leading product
• Continual product improvement according to customer feedback
• Upgraded to Revision H in 2015 and compared with a leading
ELISA kit in Europe as predicate to achieve better sensitivity
OnSite HAV IgM Rapid Test (Rev. H)
Each kit contains:
• 30 x individual test devices
• 30 x 5 μL capillary tubes
• 1 x 5mL sample diluent
• 1 x package insert
Changes to the product
• Improved performance
• Cassette design
• Specimen transfer device
Improvements in Revision H
Parameters
Antigen
Source
Previous Specifications
(Rev G)
New Specifications
(Rev H)
Benefits of Upgrading
E. coli
Mammalian cells
Increased sensitivity
Anti-human IgM
antibody conjugated to
colloidal gold
New and proven
proprietary conjugation
technology
Increased line intensity
Specimen
Type
Serum/plasma
Serum/plasma/whole
blood
More convenient as whole
blood can be directly tested
Specimen
Volume
One drop (30-45 μL)
5 μL
Reduced specimen volume
required for testing
Read time
Read at 15 minutes;
Valid until 15 minutes
Read at 15 minutes;
Valid until 20 minutes
Longer result validity time
Cassette Type
2 wells
3 wells
Increased test sensitivity
Predicate
ELISA kit in China
ELISA kit in Europe
High sensitive
Conjugation
Method
Assay Procedure of Revision H
Specimen line
Step 1:
5 μL Serum/Plasma to the
sample well
15 minutes
20 minutes
Specimen line
Step 1:
5 μL Whole Blood to the
sample well
Step 2:
2 drops of sample diluent
to the buffer well
Read result at 15 minutes
Do not read the result
after 20 minutes
Clinical Performance - High Agreement with ELISA
• A total of 306 patient samples from susceptible subjects were
tested by the OnSite HAV IgM Rapid Test kits (both Rev. H and G)
and by a leading ELISA kit in Europe and other regions.
OnSite HAV IgM
Rapid Test (Rev. H)
OnSite HAV IgM Rapid
Test (Rev. G)
Leading ELISA Kit
Positive
Negative
Positive
Negative
Positive
87
9
33
63
Negative
5
205
12
198
Rev. H: Relative sensitivity: 90.6%, relative specificity: 97.6%, overall agreement: 95.4%
Clinical Performance - Superior to the Competitor RDT
• A total of 306 patient samples from susceptible subjects were
tested by the OnSite HAV IgM Rapid Test, by a competitor rapid
test and by a leading ELISA kit in Europe and other regions.
OnSite HAV IgM Rapid Test (Rev. H)
Competitor Rapid Test
Relative
sensitivity
Relative
Specificity
90.6%
97.6%
(87/96)
(205/210)
39.6%
(38/96)
100%
(210/210)
Clinical Performance - Correctly Detected BBI Panel
• The BBI HAV seroconversion panel PHT903 was tested with OnSite
HAV IgM Rapid Test kits and a competitor rapid test.
BBI panel
PHT903
Abbott AxSYM
HAV IgM S/co
(S/co=1 cut off)
OnSite HAV
IgM Rapid Test
(Rev. H)
OnSite HAV
IgM Rapid Test
(Rev. G)
Competitor
RDT
01
02
03
04
05
06
07
08
09
10
0.1
0.1
4.8
4.8
4.8
4.1
2.0
1.4
1.2
1.3
Negative
Negative
Positive
Positive
Positive
Positive
Positive
Positive
Positive
Positive
Negative
Negative
Positive
Positive
Positive
Positive
Positive
Negative
Negative
Negative
Negative
Negative
Positive
Positive
Positive
Positive
Negative
Negative
Negative
Negative
Revision H correctly detected all positive specimens verified by Abbott ELISA
Clinical Performance - Low Risk of Cross Reactivity
• The OnSite HAV IgM Rapid Test has no false positive on
specimens from patients with other disease states.
Typhi
Dengue
HBV
HCV
HEV
HIV
Malaria
Syphilis
TB
ANA
RF (up to 1,000 IU/mL)
Clinical Performance–No Known Interference
• The OnSite HAV IgM Rapid Test has no interference from common
medicines and blood components.
List of potentially interfering substances and concentrations
tested:
1. Albumin
60 g/L
6. Hemoglobin
2 g/L
2. Bilirubin
20 mg/dL
7. Heparin
3,000 U/L
3. Creatinine 442 µmol/L
8. Salicylic acid
4.34 mmol/L
4. EDTA
3.4 µmol/L
9. Sodium citrate
3.8%
5. Glucose
55 mmol/L
OnSite HAV IgM Rapid Test (Rev. H)
Summary
• Improved Performance
o Comparable to a leading ELISA kit in EU market and other regions
o Superior to the competitor’s rapid test
• Low risky of cross reaction and interference
• Can be used with whole blood specimen
o Can be used at any time and any place
o Only kit suitable for mass screen
HAV IgG/IgM Rapid Test
HEV IgG/IgM Rapid Test
Coming soon!
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
Recommended HAV Diagnostic Algorithm
Jaundice
Abnormal liver function
OnSite
HAV
Support
treatment
Positive
Negative
Confirmatory
Normal live
function
No improvement
OnSite
HBsAg
OnSite
HEV
Positive
Negative
Confirmatory
Other
testing
Positive
confirmatory
Negative
OnSite
HAV –HEV
Screening of HAV Vaccination
Personnel with no
known infection
history
Personnel with close
contact with HAV
patient
OnSite
HAV
Positive
Negative
Confirmatory
Test
Positive
Negative
Vaccination