HAV IgM and IgG Test Cassette is a single use, rapid device intended for qualitative detection of IgM-class and IgG-class antibodies to hepatitis A virus (HAV) in whole blood, serum, plasma or feces samples. It is intended to be used as a screening test and as an aid in the diagnosis of infection with HAV.

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Hepatitis A is a self-limited disease and chronic stage or other complications are rare. Infections occur early in life in areas where sanitation is poor and living conditions are crowded. Because the disease is transmitted through the fecal-oral route in dense populated regions, an outbreak can arise from single contaminated source. The cause of hepatitis A is hepatitis A virus (HAV)-non enveloped positive strand RNA virus with a linear single strand genome, encoding for only one known serotype. HAV has four major, structural polypeptides and it localizes exclusively in the cytoplasm of human hepatocytes. The infection with HAV induces strong immunological response and elevated levels first of IgM and then IgG are detectable within a few days after the onset of the symptoms. The presence of anti–HAV IgM is an important serological marker for early detection and observation of the clinical manifestation of the disease. Increasing levels of anti-HAV IgM are detectable about three weeks after exposure with highest titter after four to six weeks later. Within six months after infection IgM concentration declines to non-detectable levels.