Chemiluminscence immunoassay kit of hepatitis E virus IgG antibody and preparation method thereof

Abstract

The invention discloses a chemiluminscence immunoassay kit of a hepatitis E virus IgG antibody and a preparation method thereof. The kit comprises negative and positive reference substances of the hepatitis E virus IgG antibody, a coated solid phase carrier, an enzyme labeling combination, sample diluent, chemiluminescent substrate solution and concentrated cleaning solution. The preparation method of the kit comprises the following steps: the reference substances are prepared according to the negative and the positive serums of the hepatitis E virus IgG antibody; the solid phase carrier is coated by recombining the antigen of the hepatitis E virus; the special anti-human IgG antibody is labeled by enzyme; the sample diluent is prepared; the chemiluminescent substrate solution is prepared; the concentrated cleaning solution is prepared; all the components are subpackaged; and the components are assembled into finished products. The kit can provide the most direct clinical basis for the prevention, the diagnosis and the treatment of the hepatitis E.

Description

technical field [0001] The invention relates to the technical field of in vitro diagnostic immune analysis, and belongs to a chemiluminescent enzyme immunoassay assay kit for detecting hepatitis E IgG antibody in serum (paddle). At the same time, the invention provides a chemiluminescent immunoassay assay kit for IgG antibody to hepatitis E virus and a preparation method thereof. Background technique [0002] Hepatitis E virus (HEV) is a non-enveloped single positive-sense RNA virus transmitted through the fecal-oral route, causing acute hepatitis E (HepatitisE, HE), mostly manifested as acute jaundice hepatitis, prone to It develops into subacute severe hepatitis or cholestatic hepatitis. In recent years, it has shown an upward trend year by year. The patients are mainly adults, and the case fatality rate is high, especially for pregnant women in the last three months of pregnancy, the case fatality rate can reach 10% to 39%, and the harm is serious. Hepatitis E virus wa...

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Problems solved by technology

[0004] At present, most of the chemiluminescence immunoassay kits are imported closed automatic chemiluminescence measurement systems, the equipment is expensive, and the cost of use is high, which limits the promotion and use, and cannot be widely used in clinical diagnosis and scientific research.

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