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Chemoluminescence immunoassay measuring kit and preparation method thereof for hepatitis B core antibody magnetic particles

A technology of hepatitis B core antibody and hepatitis B core antigen, which is applied in the field of hepatitis B core antibody magnetic particle chemiluminescence immunoassay assay kit and its preparation field, can solve the problems of unstable measurement results, short storage time of reagents, and many influencing factors, and achieve The pretreatment process is simple and reliable, the pretreatment requirements are low, and the effect is convenient to use

Inactive Publication Date: 2009-09-30
CHEMCLIN DIAGNOSTICS CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0006] Because radioimmunoassay technology uses radioactive elements as markers, it has certain pollution to the environment, and has disadvantages such as complicated operation, unstable measurement results, and short storage time of reagents.
Enzyme immunoassay has low sensitivity and many influencing factors, which can easily cause false negatives and false positives

Method used

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  • Chemoluminescence immunoassay measuring kit and preparation method thereof for hepatitis B core antibody magnetic particles
  • Chemoluminescence immunoassay measuring kit and preparation method thereof for hepatitis B core antibody magnetic particles
  • Chemoluminescence immunoassay measuring kit and preparation method thereof for hepatitis B core antibody magnetic particles

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0038] Example 1 Preparation of Hepatitis B Core Antibody Magnetic Particle Chemiluminescent Immunoassay Assay Kit of the present invention

[0039] 1. Preparation of hepatitis B core antibody calibrator

[0040] Dilute hepatitis B core antibody high-value positive serum with calf serum into calibrator, the concentrations are 0NCN / mL, 0.4NCN / mL, 0.8NCN / mL, 2NCN / mL, 4NCN / mL, 12NCN / mL, 6 bottles in total.

[0041] 2. Preparation of Hepatitis B Core Antigen Coated Magnetic Particles

[0042] Activate the magnetic particles with a particle size of 2-3 μm with glutaraldehyde, stir at room temperature, mix for 3 hours, apply a magnetic field, let stand for 20-25 minutes, pour out the supernatant, and use 0.01mol / L with a pH value of 7.4 Wash three times with phosphate buffer solution, and suspend with the solution, the concentration is 40-80 mg / mL; add 40-100 μg of hepatitis B core progen to each ml of suspension, stir overnight at 4°C, add a magnetic field, and let it stand for 10...

Embodiment 2

[0054] Embodiment 2 The usage method of the kit of the present invention

[0055] 1. Sample pretreatment

[0056] Take human fasting morning serum samples, centrifuge at 3000rpm for 5min, and take 50μL of supernatant for analysis.

[0057] 2. Detection method

[0058] Before using this kit for experiments, it is necessary to take out the antigen-coated magnetic particles, calibrator / sample to be tested, and enzyme-labeled hepatitis B core antibody monoclonal antibody, and place them at room temperature for 15 to 30 minutes; after that, put the incubator or Adjust the water bath to 37°C; then, prepare a suitable micro-sampler and corresponding tips and check whether the chemiluminescence instrument is working normally and prepare a working washing solution.

[0059] The specific operation steps of using this kit to carry out the experiment according to the method of embodiment 2 are as follows:

[0060] After numbering the round-bottomed polystyrene test tubes, add 50 μL of ...

Embodiment 3

[0061] Embodiment 3 The methodological test of the kit of the present invention

[0062] The test kit prepared in Example 1 is tested according to the conventional manufacturing and testing procedures in the art, and the results are as follows:

[0063] 1. Determination of kit accuracy

[0064] Detect the national standard reference product serum according to the test kit of embodiment 1, investigate negative and positive reference product conformity rate, according to national standard, require 15 negative reference product negative rates to be not less than 15 / 15, 15 positive reference product positive rates not less than 15 / 15. Below 14 / 15. The results are shown in Table 1, indicating that the compliance rate of the negative and positive reference products of the kit of Example 1 reaches the national standard.

[0065] Table 1 The kit in Example 1 detects the serum results of national reference products

[0066]

[0067]

[0068] 2. Sensitivity determination of the...

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Abstract

The invention provides a chemoluminescence immunoassay measuring kit and a preparation method thereof for hepatitis B core antibody magnetic particles. The kit comprises a hepatitis B core antibody calibration sample, magnetic particles coated by a hepatitis B core antigen, an enzyme marker, a chemoluminescence substrate and a concentrated washing solution. The invention effectively utilizes a magnetic particle solid separation system and a chemoluminescence immunoassay technology to detect the hepatitis B core antibody. The kit has the advantages of simple and fast detection, high sensitivity, strong specificity, stability, and the like, can well satisfy the requirement of clinic diagnosis and is suitable to be effectively generalized and applied in industry.

Description

technical field [0001] The invention relates to the field of immunoanalysis medicine, specifically, the invention provides a hepatitis B core antibody magnetic particle chemiluminescence immunoassay assay kit and a preparation method thereof. The kit of the invention combines immunomagnetic particle technology and chemiluminescent immunoassay technology. Background technique [0002] Hepatitis B is a serious and common liver disease that affects millions of people worldwide. In the current global population, more than 2 billion people have been infected with HBV at some point in their lives, and about 350 million of them are still chronically infected and become carriers of the virus. Three-quarters of the world's population lives in areas with a high incidence of infection. Acute clinical cases of HBV exceed 4 million annually. About 25% of the carriers, that is, 1 million people die each year from chronic active hepatitis, cirrhosis or primary liver cancer. [0003] At...

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 张黎应希堂宋胜利胡国茂郑金来唐宝军
Owner CHEMCLIN DIAGNOSTICS CO LTD
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