Expected use
This kit is an enzyme-linked immunosorbent assay (ELISA) for the qualitative determination of IgM class antibodies against hepatitis A virus in human serum or plasma. It is intended for use in clinical laboratories for the diagnosis of acute hepatitis A and the treatment of patients associated with infection with the hepatitis A virus.
Summary and explanation
Hepatitis A is a self-limited disease and the 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 people susceptible to the disease increases. Because the disease is transmitted by the fecal-oral route in densely populated regions, an outbreak can arise from a single contaminated source.The cause of hepatitis A is the hepatitis A virus (HAV), a non-enveloped positive-stranded RNA virus with a linear single-stranded genome, encoding only one known serotype. HAV has four major structural polypeptides and is located exclusively in the cytoplasm of human hepatocytes.
HAV infection induces a strong immune response and elevated levels first of IgM and then IgG are detectable within days of the onset of symptoms. The presence of anti-HAV IgM is an important serological marker for the early detection and observation of the clinical manifestation of the disease. Increasing levels of anti-HAV IgM are detectable approximately three weeks after challenge with the highest titer after four to six weeks later. Within six months of infection, the IgM concentration drops to undetectable levels.
