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

2. HAV Is A Common Infectious Disease

3. 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 Indications

4. 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 Product History

5. 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

6. Improvements in Revision H ParametersPrevious Specifications (Rev G) New Specifications (Rev H) Benefits of Upgrading Antigen Source E. coliMammalian cellsIncreased sensitivity Conjugation Method Anti-human IgM antibody conjugated to colloidal gold New and proven proprietary conjugation technology Increased line intensity Specimen Type Serum/plasmaSerum/plasma/whole blood More convenient as whole blood can be directly tested Specimen Volume One drop (30-45 μL)5 μLReduced 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 wells3 wellsIncreased test sensitivity Predicate ELISA kit in ChinaELISA kit in EuropeHigh sensitive

7. 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 Do not read the result after 20 minutes 15 minutes 20 minutes Step 1: 5 μL Serum/Plasma to the sample well

8. OnSite HAV IgM Rapid Test (Rev. H) OnSite HAV IgM Rapid Test (Rev. G) Leading ELISA KitPositiveNegativePositiveNegative Positive8793363 Negative520512198 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%

9. 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.

10. Clinical Performance - Correctly Detected BBI Panel 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 010.1Negative 020.1Negative 034.8Positive 044.8Positive 054.8Positive 064.1Positive 072.0Positive Negative 081.4PositiveNegative 091.2PositiveNegative 101.3PositiveNegative 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.

11. 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

12. 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

13. 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!

14. Contact Info.: 10110 Mesa Rim Rd. San Diego, CA 92121 USA Email Address: tech@ctkbiotech.com Telephone: 1 (858) 457-8698 Fax: 1 (858) 535-1739tech@ctkbiotech.com Technical Support

15. QUALITY. INNOVATION. SIMPLICITY

16. Recommended HAV Diagnostic Algorithm Jaundice OnSite HAV PositiveNegative OnSite HEV PositiveNegative Other testing Abnormal liver function Support treatment Normal live function No improvement OnSite HBsAg PositiveNegative OnSite HAV –HEV Confirmatory confirmatory

17. 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