Single test for identifying acute infection and protective immunity by detecting and differentiating IgG and IgM anti-HAV Indicates protective immunity by detecting HAV IgG titers ≥70 mIU/mL High confidence as it is traceable to the 2nd WHO International Standard for HAV, and IgM is in agreement with market leading ELISA test: Sensitivity: 94.8%; Specificity: 96.7% Flexible specimen types including serum, plasma, or whole blood which allows testing at any time without special specimen preparation Small sample volume (5 µL) enables multiple testing on the same specimen without having to re-draw the patient. Initial patient care action can begin during the patient’s visit as test results are available in 15 minutes. Easily transported, and can be stored for 24 months at 2-30oC