onsite hav igm rapid test upgraded to revision h for better sensitivity ctk-mk-ppt-r0090 rev 1.0

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OnSite HAV IgM Rapid Test Upgraded to Revision H for Better Sensitivity CTK-MK-PPT-R0090 Rev 1.0

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Page 1: OnSite HAV IgM Rapid Test Upgraded to Revision H for Better Sensitivity CTK-MK-PPT-R0090 Rev 1.0

OnSite HAV IgM Rapid Test

Upgraded to Revision H for Better Sensitivity

CTK-MK-PPT-R0090 Rev 1.0

Page 2: 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

Page 3: OnSite HAV IgM Rapid Test Upgraded to Revision H for Better Sensitivity CTK-MK-PPT-R0090 Rev 1.0

• 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

Page 4: OnSite HAV IgM Rapid Test Upgraded to Revision H for Better Sensitivity CTK-MK-PPT-R0090 Rev 1.0

• 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

Page 5: OnSite HAV IgM Rapid Test Upgraded to Revision H for Better Sensitivity CTK-MK-PPT-R0090 Rev 1.0

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

Page 6: OnSite HAV IgM Rapid Test Upgraded to Revision H for Better Sensitivity CTK-MK-PPT-R0090 Rev 1.0

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

Page 7: OnSite HAV IgM Rapid Test Upgraded to Revision H for Better Sensitivity CTK-MK-PPT-R0090 Rev 1.0

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

Page 8: OnSite HAV IgM Rapid Test Upgraded to Revision H for Better Sensitivity CTK-MK-PPT-R0090 Rev 1.0

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%

Page 9: OnSite HAV IgM Rapid Test Upgraded to Revision H for Better Sensitivity CTK-MK-PPT-R0090 Rev 1.0

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.

Page 10: OnSite HAV IgM Rapid Test Upgraded to Revision H for Better Sensitivity CTK-MK-PPT-R0090 Rev 1.0

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.

Page 11: OnSite HAV IgM Rapid Test Upgraded to Revision H for Better Sensitivity CTK-MK-PPT-R0090 Rev 1.0

• 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

Page 12: OnSite HAV IgM Rapid Test Upgraded to Revision H for Better Sensitivity CTK-MK-PPT-R0090 Rev 1.0

• 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

Page 13: OnSite HAV IgM Rapid Test Upgraded to Revision H for Better Sensitivity CTK-MK-PPT-R0090 Rev 1.0

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!

Page 14: OnSite HAV IgM Rapid Test Upgraded to Revision H for Better Sensitivity CTK-MK-PPT-R0090 Rev 1.0

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

Page 15: OnSite HAV IgM Rapid Test Upgraded to Revision H for Better Sensitivity CTK-MK-PPT-R0090 Rev 1.0

THANK YOU

QUALITY . INNOVATION . SIMPLICITY

Page 16: OnSite HAV IgM Rapid Test Upgraded to Revision H for Better Sensitivity CTK-MK-PPT-R0090 Rev 1.0

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

Page 17: OnSite HAV IgM Rapid Test Upgraded to Revision H for Better Sensitivity CTK-MK-PPT-R0090 Rev 1.0

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