Hepatitis E Virus IgM Antibody Rapid Test - India CDSCO Medical Device Registration

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The reagent is used to detect the Hepatitis E Virus IgM Antibody in serum / plasma / whole blood qualitatively. Hepatitis E is a kind of intestinal infectious disease caused by hepatitis E virus (Feces) with a worldwide distribution.HEV showed a spherical particles shape with 27~34 nm in diameter, icosahedral symmetry consisted of 20 shell particles, containing linear single-strand RNA. The incubation period of hepatitis E virus is 2 to 11 weeks, and on an average of 6 weeks. HEV is a disease with high mortality, mainly transmitted by digestive tract, and the clinical manifestations of which are similar to other acute hepatitis. All people are susceptible to the HEV. There are severe symptoms and high mortality of HEV. Hepatitis IgM is a specific antibody of hepatitis E virus, which can be detected early and disappear quickly. HEV IgM antibody can be detected in a short time later after infected, continue to rise very rapidly, decreasing significantly in 1-2 months, disappear in 5 months. Detection of HEV-IgM antibody can diagnose HEV infection in early stage. Both the immunological detection and virus nucleic acid detection can be used as the basis for laboratory diagnosis of hepatitis E virus