Chemiluminescence immunoassay kit of hepatitis E virus IgM antibody and preparation method thereof

Abstract

The invention relates to a chemiluminescence immunoassay kit of a hepatitis E virus IgM antibody and a preparation method thereof, which belongs to the technical field of clinical in-vitro diagnosis immunoassay. The preparation method of the kit comprises the following steps: the reference substance is prepared according to the negative and the positive serums of the hepatitis E virus IgM antibody; a solid phase carrier is coated by an anti-human-mu chain anti-body (monoclonal antibody or polyclonal antibody); the recombinant antigen of the hepatitis E virus is labeled by enzyme; a chemiluminescent substrate solution acted by the enzyme is prepared; a concentrated cleaning solution is prepared; the negative reference substance, the positive reference substance, the labeled combination, the chemiluminescent substrate and the concentrated cleaning solution of the hepatitis E virus IgM antibody are subpackaged; and all the components are assembled into finished products. The prepared kit has stable performance indexes (specificity, sensitivity and stability) and can be applied to the early diagnosis of the hepatitis E.

Description

technical field [0001] The invention relates to the medical field of clinical in vitro diagnostic immunoanalysis, in particular, the invention provides a hepatitis E virus IgM antibody chemiluminescent immunoassay kit 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 was first discovered in the Indian subcontinent, and there are reports of greater prevalence in Central Asia, Southeast Asia, Africa, ...

AI Technical Summary

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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