Enzyme ImmunoAssay (ELISA) for the determination of IgM class antibodies to Hepatitis A Virus in human plasma and sera with the "capture" system. The kit may be used for the identification of the viral agent causing hepatitis in the patient and the follow up of the acute phase of the infection. For “in vitro” diagnostic use only.
Introduction
Hepatitis A continues to be one of the most frequently reported vaccine-preventable diseases in the world, despite the licensure of hepatitis A vaccine in 1995. Widespread vaccination of appropriate susceptible populations would substantially lower disease incidence and potentially eliminate indigenous transmission of hepatitis A virus (HAV) infection. HAV, a 27-nm RNA agent classified as a picornavirus, can produce either asymptomatic or symptomatic infection in humans after an average incubation period of 28 days (range, 15-50 days). The illness caused by HAV infection typically has an abrupt onset of symptoms that can include fever, malaise, anorexia, nausea, abdominal discomfort, dark urine, and jaundice. The likelihood of having symptoms with HAV infection is related to the person's age. In children less than 6 years of age, most (70%) infections are asymptomatic; if illness does occur, it is not usually accompanied by jaundice. Among older children and adults, infection is usually symptomatic, with jaundice occurring in greater than 70% of patients. Signs and symptoms usually last less than 2 months, although 10%-15% of symptomatic persons have prolonged or relapsing disease lasting up to 6 months.