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

A hepatitis E virus, chemiluminescence immunity technology, applied in chemiluminescence/bioluminescence, analysis by chemical reaction of materials, measurement devices, etc., can solve the problems of expensive equipment, high use cost, limited promotion and use, etc. Achieve the effect of ensuring sensitivity, easy operation and production, and high sensitivity

Inactive Publication Date: 2009-10-07
CHEMCLIN DIAGNOSTICS CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

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.

Method used

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

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0013] Embodiment 1 Preparation of Hepatitis E virus IgG antibody chemiluminescence immunoassay assay kit of the present invention

[0014] In the research process of the present invention, the inventors of the present invention firstly carried out screening experiment and quality identification to the raw materials used, including the activity of labeled antibody and coated antibody, the adsorption of carrier (such as opaque white microwell plate) Performance and variation size, HRP activity, luminescence intensity and luminescence duration of chemiluminescence substrate, etc. Then the coating method was studied, experiments were carried out with different coating buffers and protection solutions, the most suitable coating buffer and protection solutions were selected, and the best concentration conditions were found through experiments with different coating concentrations of antibodies. There are different methods for HRP labeling. Through repeated exploration and comparati...

Embodiment 2～3

[0040] Embodiment 2~3 preparation hepatitis E virus IgG antibody chemiluminescence immunoassay assay kit of the present invention

[0041] Except that the hepatitis E virus antibody was labeled with alkaline phosphatase, AMPPD was used as the chemiluminescent substrate, plastic beads and plastic tubes were used as the carrier, the pH value of the coating solution was 4.5, and the pH value of the blocking solution was 7.5. The hepatitis E virus IgG antibody chemiluminescent immunoassay assay kit was prepared in the same manner as in Example 1.

Embodiment 4

[0042] Example 4 Preparation of Hepatitis E virus IgG antibody chemiluminescence immunoassay assay kit of the present invention

[0043] Except that the magnetic particles were used as the solid phase carrier and the magnetic particle antigen solid phase carrier was prepared by the EDC coupling method, the hepatitis E virus IgG antibody chemiluminescence immunoassay assay kit was prepared in the same manner as in Example 1.

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PUM

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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...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): G01N33/576G01N21/76G01N33/543G01N33/577
Inventor 杨俊峰应希堂宋胜利胡国茂郑金来于尚永
Owner CHEMCLIN DIAGNOSTICS CO LTD
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