Hepatitis B virus e antigen quantitative detection kit, preparation method and detection method thereof

Abstract

The present invention discloses a hepatitis B virus e antigen detection kit, which comprises a hepatitis B e antigen calibration substance, an anti-HBe monoclonal antibody coated plate, europium labeled anti-HBe monoclonal antibody, an assay buffer liquid, a fluorescence enhanced liquid and a concentrated washing liquid. The present invention further discloses a preparation method of the kit, and a method for detecting hepatitis B virus e antigen by using the kit. According to the present invention, the kit has advantages of high detection sensitivity, good specificity, simple operation, no pollution, and low cost, can be used for quantitative detection of the HBeAg content in human serum/plasma, and provides precise reference for the clinical hepatitis B individualized management treatment program.

Description

technical field [0001] The invention relates to the field of in vitro diagnosis and detection, in particular to a kit for quantitative detection of hepatitis B virus e antigen (HBeAg) by time-resolved immunofluorescence analysis. Background technique [0002] In recent years, the most clinically used HBV e antigen detection methods mainly include enzyme-linked immunoassay (Enzyme Immunoassay, EIA), chemiluminescence immunoassay (Chemiluminescent Immunoassay, CLIA) and time-resolved immunofluorescence assay (Time- resolved Immunofluorometric Assay, TRFIMA). [0003] The advantages of EIA are its non-pollution, simple operation, long validity period of reagents, and good specificity. However, its application in microimmunoquantitative analysis is limited due to its relatively low sensitivity and relatively narrow measurement range. [0004] The advantage of CLIA lies in its high sensitivity and wide detection range, but since most plate-type CLIA kits still use the same enzym...

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Problems solved by technology

[0003] The advantages of EIA are its non-pollution, simple operation, long validity period of reagents, and good specificity, etc., but its application in microimmunoquantitative analysis is limited due to its relatively low sensitivity and relatively narrow measurement range.

[0004] The advantage of CLIA lies in its high sensitivity and wide detection range, but since most plate-type CLIA kits still use the same enzymatic reaction as EIA, cross-linking antibodies with horseradish enzyme or alkaline phosphatase, using luminol or adamantane As a substrate, the detection is dynamic luminescence, which leads to rapid attenuation of the detection signal value and inconsistent signal attenuation speeds between high concentration and low concentration, which limits its low-end detection sensitivity, stability and repeatability in immunoquantitative analysis

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