onsite hav igm rapid test upgraded to revision h for better sensitivity ctk-mk-ppt-r0090 rev 1.0
TRANSCRIPT
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
• 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 HBVo Personnel with close contact to HAV patient o Screening for who needs HAV vaccination
OnSite HAV IgM Rapid TestIndications
• 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 TestProduct History
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 Previous Specifications (Rev G)
New Specifications (Rev H)
Benefits of Upgrading
Antigen Source
E. coli Mammalian cells Increased sensitivity
Conjugation Method
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
Assay Procedure of Revision H
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
Specimen line
Specimen line
Do not read the result after 20 minutes
15 minutes
20 minutes
Step 1:5 μL Serum/Plasma to the
sample well
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
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.
Rev. H: Relative sensitivity: 90.6%, relative specificity: 97.6%, overall agreement: 95.4%
Clinical Performance - Superior to the Competitor RDT
Relative sensitivity
Relative Specificity
OnSite HAV IgM Rapid Test (Rev. H) 90.6% (87/96)
97.6% (205/210)
Competitor Rapid Test 39.6%(38/96)
100%(210/210)
• 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.
Clinical Performance - Correctly Detected BBI Panel
BBI panelPHT903
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 0.1 Negative Negative Negative02 0.1 Negative Negative Negative03 4.8 Positive Positive Positive04 4.8 Positive Positive Positive05 4.8 Positive Positive Positive06 4.1 Positive Positive Positive07 2.0 Positive Positive Negative08 1.4 Positive Negative Negative09 1.2 Positive Negative Negative10 1.3 Positive Negative Negative
Revision H correctly detected all positive specimens verified by Abbott ELISA
• The BBI HAV seroconversion panel PHT903 was tested with OnSite HAV IgM Rapid Test kits and a competitor rapid test.
• 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 - Low Risk of Cross Reactivity
• 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
Clinical Performance–No Known Interference
OnSite HAV IgM Rapid Test (Rev. H) Summary
• Improved Performance o Comparable to a leading ELISA kit in EU market and other regionso Superior to the competitor’s rapid test
• Low risky of cross reaction and interference
• Can be used with whole blood specimeno 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!
Contact Info.:10110 Mesa Rim Rd. San Diego, CA 92121 USAEmail Address: [email protected] Telephone: 1 (858) 457-8698Fax: 1 (858) 535-1739
Technical Support
THANK YOU
QUALITY . INNOVATION . SIMPLICITY
Recommended HAV Diagnostic Algorithm
Jaundice
OnSite HAV
Positive Negative
OnSite HEV
Positive Negative
Other testing
Abnormal liver function
Support treatment
Normal live function No improvement
OnSite HBsAg
Positive Negative
OnSite HAV –HEV
Confirmatory
Confirmatory
confirmatory
Screening of HAV Vaccination
OnSite HAV
Negative
Personnel with no known infection
history
Personnel with close contact with HAV
patient
Confirmatory Test
Positive Negative
Vaccination
Positive