The HAV IgM Rapid Test is a lateral flow chromatographic immunoassay for the qualitative detection of IgM antibody to Hepatit is A virus (HAV) in human serum or plasma. It is intended to be used as a screening test and as an aid in the diagnosis of infection with HAV. Any reactive specimen with the HAV IgM Rapid Test must be confirmed with alternative testing method(s) and clinical findings.
The HAV IgM Rapid Test is to be used to detect IgM anti-HAV in less than 15 min by untrained or minimally skilled personnel, without cumbersome laboratory equipment.
All reagents are ready to use as supplied. Store unused test device unopened at 2°C-30°C. The positive and negative controls should be kept at 2°C-8°C. If stored at 2°C-8°C, ensure that the test device is brought to room temperature before opening.
A total of 400 samples from susceptible subjects were tested by the HAV IgM Rapid Test and by a commercial EIA test.
Relative Specificity: 94%