INTENDED USE

HAV lgM Rapid Test is a single use, rapid device intended for qualitative detection of lgM-class antibodies to hepatitis A virus (HAV) in serum or plasma samples.
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 lgM Rapid Test must be confirmed with alternative testing method(s) and clinical findings.

SUMMARY

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. With improved sanitation and hygiene, infections are delayed and consequently the number of persons susceptible to the disease increases. 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 lgM and then lgG are detectable within a few days after the onset of the symptoms. The presence of anti-HAV lgM is an important serological marker for early detection and observation of the clinical manifestation of the disease. Increasing levels of anti-HAV lgM are detectable about three weeks after exposure with highest titter after four to six weeks later. Within six months after infection lgM concentration declines to non-detectable levels.

PRINCIPLE

HAV lgM Rapid Test Cassette is based on the principle of agglutinating sera on membrane and utilizes the technique of immunochromatography. The sample pad is coated with HAV antigen. As the test specimen flows through the sample pad assembly of the device, the HAV antigen complex with the HAV specific antibodies in the test specimen. When this complex travels on the conjugated pad which is impregnated with mouse anti-HAV antibody conjugated to colloidal gold, the HAV colloidal gold react with the complex then travels on the membrane due to capillary action. This complex moves further on the membrane to the test region (T) where it is immobilized by anti human lgM antibody coated on the membrane, leading to formation of a pink/purple coloured band. The absence of this band in the test region (T) indicates a negative result. The test contains an internal control (C band) which is coated with goat anti-mouse lgG should exhibit a burgundy colored band regardless of the color development on the T band. Otherwise, the test result is invalid and the specimen must be retested with another device.