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Hepatitis B virus pre-s1 antigen quantitative assay kit and preparation method thereof

A technology for quantitative determination of hepatitis B virus, applied in the field of immunodiagnosis, to achieve the effect of high sensitivity and good specificity

Active Publication Date: 2016-05-11
威海威高生物科技有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, there is no microparticle chemiluminescence diagnostic reagent for the quantitative detection of the pre-S1 antigen in China. At present, there is an urgent need for a microparticle chemiluminescence diagnostic reagent with high sensitivity and specificity, which can be used as a substitute for ELISA reagents and colloidal gold reagents. , for the diagnosis of pre-S1 antigen

Method used

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Embodiment Construction

[0021] The kit of the invention adopts microparticle chemiluminescence immunoassay technology to detect whether there is pre-S1 antigen in serum or plasma. The pre-S1 antigen quantitative assay kit and its preparation method are specifically described below.

[0022] A hepatitis B virus pre-S1 antigen quantitative determination kit, which comprises the detection of PreS1 magnetic particles, detection of PreS1 tracer conjugates, calibrator, analysis buffer, sample diluent. The PreS1 magnetic particles are magnetic particles marked with PreS1 monoclonal antibody; the PreS1 tracer conjugate is isoluminol marked with another PreS1 monoclonal antibody; the analysis buffer and sample diluent are respectively containing bovine Serum albumin in phosphate buffered saline; the calibrator is a solution with a low content of pre-S1 antigen and a solution with a high content of pre-S1 antigen, which are used for calibration of the master curve stored in the analyzer.

[0023] The preparat...

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PUM

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Abstract

The invention belongs to the technical field of immune diagnosis, and in particular relates to a hepatitis B virus PreS1 antigen quantitative determination kit based on a micro-particle chemiluminescence method and a preparation method of the quantitative determination kit. The kit consists of PreS1 determination magnetic particles, PreS1 determination tracing conjugates, a calibrator, an assay buffer solution and a sample diluent. The invention also discloses the preparation method of the quantitative determination kit. By the adoption of a micro-particle chemiluminescence immune assay technology, the method is superior to an ELISA (enzyme-linked immunosorbent assay) in terms of sensitivity and specificity, is suitable for clinical auxiliary diagnosis on hepatitis B, and fills in gaps of national detection on the production of PreS1 antigen detection reagents by virtue of the micro-particle chemiluminescence method.

Description

technical field [0001] The invention relates to an immunodiagnostic technique, in particular to a quantitative assay kit for hepatitis B virus pre-S1 antigen with magnetic particles as a carrier and a preparation method thereof. Background technique [0002] my country is a large hepatitis country with a large number of patients, and the number of hepatitis B virus infections alone reaches 120 million. Accounting for about 10% of the total population in our country, the course of hepatitis B is protracted, and if it is not treated in time and effectively, it will develop into liver cirrhosis or even liver cancer, which is commonly referred to as the "trilogy of hepatitis B development". Statistics show that 1 million people die every year due to hepatitis B virus infection worldwide, accounting for the ninth cause of global disease death. It can be seen that hepatitis B is one of the diseases that seriously endanger human health. [0003] The complete hepatitis B virus is a...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): G01N33/577G01N33/531G01N33/532
CPCG01N33/54326G01N33/56983G01N33/5764
Inventor 蒙红胜刘京伟林芳芳王凌凌赵海英
Owner 威海威高生物科技有限公司
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