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Hepatitis b virus preS2 antigen chemiluminescence immune analysis determination reagent kit and preparing method thereof

A hepatitis B virus and chemiluminescence technology, applied in the field of immunoassay medicine, can solve the problems of radioactive waste pollution hazards, short validity period of radioimmunization reagents, low sensitivity of enzyme immunoassay reagents, etc. Fast, easy-to-use effects

Inactive Publication Date: 2009-03-04
CHEMCLIN DIAGNOSTICS CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0009] The purpose of the present invention is to solve the short validity period of clinical radioimmunoassay reagents, the hazards of radioactive waste pollution, and the low sensitivity and poor precision of enzyme immunoassay reagents.

Method used

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  • Hepatitis b virus preS2 antigen chemiluminescence immune analysis determination reagent kit and preparing method thereof
  • Hepatitis b virus preS2 antigen chemiluminescence immune analysis determination reagent kit and preparing method thereof
  • Hepatitis b virus preS2 antigen chemiluminescence immune analysis determination reagent kit and preparing method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0024] Example 1 Preparation of Hepatitis B Virus Pre-S2 Antigen Chemiluminescence Immunoassay Assay Kit of the present invention

[0025] During the research process of the present invention, the inventors firstly carried out screening tests and quality identification on the raw materials used, including the activities of labeled antibodies and biotinylated antibodies, the adsorption performance and precision of avidinized solid phase carriers, and chemiluminescence strength etc. Then the avidin solid-phase coating system was systematically studied, compared with different coating and blocking buffer systems, the most suitable coating buffer and blocking solution were selected, and the best coating was selected according to square matrix titration. By concentration. The inventor has repeatedly studied the biotin-conjugated antibody process and the alkaline phosphatase labeling process, and screened out a high-yield, low-cost, reliable, simple and easy-to-operate labeling met...

Embodiment 2

[0079] Example 2 Preparation of Hepatitis B Virus Pre-S2 Antigen Chemiluminescence Immunoassay Assay Kit of the present invention

[0080] Except that the plastic tube was used as the solid-phase carrier, the other methods were the same as in Example 1 to prepare the hepatitis B virus pre-S2 antigen chemiluminescent immunoassay assay kit.

Embodiment 3

[0081] Example 3 Preparation of Hepatitis B Virus Pre-S2 Antigen Chemiluminescence Immunoassay Assay Kit of the present invention

[0082] Except that the magnetic particles were used as the solid-phase carrier, and the avidin was coupled to the surface of the magnetic particles by the EDC method, the rest were prepared in the same manner as in Example 1 to prepare the hepatitis B virus pre-S2 antigen chemiluminescent immunoassay assay kit.

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Abstract

The invention discloses a detection kit for detecting hepatitis B virus pre-S2 antigens. The kit provided by the invention comprises calibrators, solid-phase vectors which are coated by avidin, biotinylation antibodies, anti-HBs markers, chemiluminescent substrates and concentrated washing solutions. The preparation of the kit comprises the following steps:1) preparing the calibrators with pure hepatitis B virus pre-S2 antigens, 2) coating the solid-phase vectors with the avidin, 3) biotinylating of hepatitis B virus pre-S2 antigen monoclonal antibodies, 4) marking the anti-HBs monoclonal antibodies with markers, 5) preparing the chemiluminescent substrates, 6) preparing the concentrated washing solutions, 7) packaging the calibrators, the markers, the chemiluminescent substrates and the washing solutions and 8) assembling finished products. The kit of the invention has the advantages of high sensitivity, strong specificity, fast detection speed, simple and convent operation, good repeatability and the like, can specially detect the content of the hepatitis B virus pre-S2 antigens in the human body after being affected by hepatitis B virus, and can be used as an auxiliary means for the diagnosis and the prognosis of hepatitis B.

Description

technical field [0001] The present invention relates to the field of immunoanalysis medicine, specifically, the present invention provides a biotin-avidin indirect coating technology combined with chemiluminescent immunoassay technology to measure hepatitis B virus pre-S2 antigen (HBV Pre-S2Ag) kit and its preparation method. Background technique [0002] Hepatitis B (Hepatitis B, HB) is one of the most prevalent viral infectious diseases in the world. It is caused by hepatitis B virus (Hepatitis B virus, HBV). A kind of infectious disease that has been popular for a long time, spread widely and is seriously harmful. [0003] So far, there has been no breakthrough in the treatment of hepatitis B virus infection, and the public health problems caused by HBV are far from being resolved. Therefore, hepatitis B has become a worldwide disease that seriously threatens human life and health, and the prevention and treatment of hepatitis B has become the primary issue in my countr...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): G01N33/577G01N33/576G01N33/543G01N21/76
Inventor 彭京胜应希堂宋胜利胡国茂郑金来唐宝军
Owner CHEMCLIN DIAGNOSTICS CO LTD
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