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Hepatitis B surface antibody magnetic particle chemiluminescent immunoassay kit and preparation method thereof

A hepatitis B surface antibody and chemiluminescent immunity technology, which is applied in the fields of chemiluminescence/bioluminescence, analysis through chemical reaction of materials, and measurement devices, which can solve the problems of unstable measurement results, short storage time of reagents, false positives, etc. , to achieve the effects of simple and reliable pre-treatment process, wide linear range of measured values, and easy operation and production

Inactive Publication Date: 2009-12-02
CHEMCLIN DIAGNOSTICS CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0005] Because radioimmunoassay technology uses radioactive elements as markers, it has certain pollution to the environment, and has disadvantages such as high instrument cost, low sensitivity, 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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  • Hepatitis B surface antibody magnetic particle chemiluminescent immunoassay kit and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0036] Example 1 Preparation of hepatitis B surface antibody magnetic particle chemiluminescence immunoassay assay kit of the present invention

[0037] 1. Preparation of a mixture of HBsAg-coated magnetic particles and biotin-labeled HBsAg

[0038] 1. Preparation of HBsAg-coated magnetic particles

[0039] Activate the magnetic particles with a particle size of 1-10 μm with glutaraldehyde, stir at room temperature, mix for 3 hours, apply a magnetic field, let stand for 30 minutes, pour out the supernatant, and use 0.01mol / L phosphate with a pH value of 7.4 Wash with the buffer solution three times, and suspend with the solution, the concentration is 50-100 mg / mL; add 40-100 μg of HBsAg to each ml suspension, stir overnight at 4°C, add a magnetic field, let it stand for 30 minutes, and pour it out. Clear, use 0.02mol / L phosphate buffer (pH 7.2) containing 0.2%~1.0% bovine serum albumin, 10~20% newborn bovine serum to block at room temperature for 3~4 hours; finally use pH value...

Embodiment 2

[0059] Embodiment 2 The using method of kit of the present invention

[0060] 1. Sample preparation

[0061] Collect patient serum for testing using correct medical methods.

[0062] 2. Detection method

[0063] Before using this kit for experiments, it is necessary to take out the mixture of antigen-coated magnetic particles and biotin-labeled antigen, calibrator / sample to be tested, and enzyme-labeled avidin and place them at room temperature for 15-30 minutes to allow them to balance to Room temperature; after that, adjust the incubator or water bath to 37°C; then, prepare a suitable micro-sampler and corresponding tips and check whether the chemiluminescence instrument is working normally.

[0064] The specific operation steps of using the kit of the present invention to carry out the experiment according to the method of embodiment 2 are as follows:

[0065] After numbering the round-bottom polystyrene test tubes, add 50 μL of serum samples or serial calibrator solutio...

Embodiment 3

[0066] The methodological examination of the kit of the present invention of embodiment 3

[0067] 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:

[0068] 1. Determination of kit precision

[0069] (1) Calibrator precision experiment

[0070] Three batches of the kits prepared in Example 1 were taken for the precision test, and 5 kits were taken from each batch. Measure the 80mIU / mL anti-HBs calibrator 10 times with the kit extracted in Example 1. The coefficient of variation of the measured concentration was calculated, and the result showed that the coefficient of variation was between 3.0% and 8.5%.

[0071] 2. Determination of the accuracy of the kit

[0072] The national linear reference product was used for detection, and the deviation of the measured values ​​of the 8 concentration points was less than 10%. The results are shown in Table 1.

[0073] Table 1 ...

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Abstract

The invention discloses a hepatitis B surface antibody (HBsAb) magnetic particle chemiluminescent immunoassay kit and a preparation method thereof and the kit can be used to test the content of HBsAb in human serum fast and accurately. The kit of the invention comprises a mixed liquor of hepatitis B surface antigen (HBsAg) coated with magnetic particle and bioti-labeled HBsAg, horse radish peroxidase-labeled streptavidin, HBsAb calibrator, chemiluminescence substrate, concentrated cleaning solution and reaction tubes. According to the principle of the double antigen sandwich method, the magnetic particle immunity technology, biotin-avidin technology and chemiluminescence immunoassay technology are combined in the kit of the invention which has the advantages that the testing is fast, the linear range of the curve is wide, and the calibrator calibrated by national linear reference can be used to test the content of HBsAb in human serum accurately, thus processing important clinical application value.

Description

technical field [0001] The invention relates to a hepatitis B surface antibody magnetic particle chemiluminescent immunoassay kit and a preparation method thereof. The kit of the invention combines the magnetic particle separation technology, the biotin-avidin amplification technology and the chemiluminescent immunoassay technology. Background technique [0002] Hepatitis B is a serious and common liver disease that affects millions of people worldwide. Among the current global population, more than 2 billion people have been infected with hepatitis B virus (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. There are more than 4 million acute clinical cases of HBV every year, and about 25% of the carriers, that is, 1 million people die each year from chronic active hepatitis, liver cirrhosis or primary l...

Claims

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Application Information

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IPC IPC(8): G01N33/576G01N33/543G01N21/76
Inventor 詹先发应希堂宋胜利胡国茂唐宝军于尚永
Owner CHEMCLIN DIAGNOSTICS CO LTD
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