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

A chemiluminescence immunoassay and chemiluminescence technology, applied in the field of immunoassay, can solve the problems of false positive, complicated operation, low sensitivity, etc., and achieve the effect of large surface area and good repeatability

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 e antibody magnetic particle chemiluminescent immunoassay kit and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0023] Embodiment 1 Preparation of hepatitis B e antibody magnetic particle chemiluminescence immunoassay assay kit of the present invention

[0024] 1. Preparation of a mixture of hepatitis B e antibody-coated magnetic particles and horseradish peroxidase-labeled hepatitis B e antibody

[0025] 1. Preparation of hepatitis B e antibody-coated magnetic particles

[0026] 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 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 50-100 mg / mL; add 40-100 μg of hepatitis B e antibody to each ml of suspension, stir overnight at 4°C, add a magnetic field, and let it stand for 10-15 minutes , pour out the supernatant, and block with phosphate buffer (pH 7.2) containing 0.2% to 1.0% bovine serum al...

Embodiment 2

[0046] Embodiment 2 The using method of kit of the present invention

[0047] 1. Sample preparation

[0048] Collect patient serum for testing using correct medical methods.

[0049] 2. Detection method

[0050] 1. Before using this kit for experiments, it is necessary to take out the mixture of antibody-coated magnetic particles and horseradish peroxidase-labeled antibody, hepatitis B e antigen, calibrator / sample to be tested, and enzyme-labeled avidin at room temperature. Leave them for 15-30 minutes to allow them to balance to room temperature; and pay attention to 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.

[0051] 2. Number the reaction tubes, add 50 μL of serum samples or serial calibrator solutions to the reaction tubes, add 0NCU / mL, 2NCU / mL, 4NCU / mL, 8NCU / mL, 16NCU / mL, 32NCU / mL each 50 μL.

[0052] 3. Add 50 μL of the mixture of ant...

Embodiment 3

[0057] The methodological examination of the kit of the present invention of embodiment 3

[0058] 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:

[0059] 1. Determination of kit precision

[0060] (1) Calibrator precision experiment

[0061] Three batches of the kits prepared in Example 1 were taken for the precision test, and 10 kits were taken from each batch. Measure the 4NCU / mL HBeAb calibrator 5 times with the kit extracted in Example 1. The coefficient of variation was calculated, and the result showed that the coefficient of variation was between 4.6% and 7.7%.

[0062] 2. Determination of the accuracy of the kit

[0063] Detected with 4NCU / ml quality control serum of hepatitis B e antibody from clinical inspection center, and the deviation of the measured value was less than 10%.

[0064] 3. Kit specificity and sensitivity experiments

[0065] There is no...

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Abstract

The invention belongs to the immunoassay technical field and relates to a hepatitis B e antibody magnetic particle chemiluminescent immunoassay kit. The kit of the invention comprises a mixed liquor of hepatitis B e antibody coated with magnetic particle and horse radish peroxidase-labeled hepatitis B e antibody, hepatitis B e antigen, hepatitis B e antibody calibrator, chemiluminescence substrate solution, concentrated cleaning solution and reaction tubes. The invention can be used to test the content of hepatitis B e antibody in human serum and has the advantages of simple and fast operation, good repetitiveness and the like.

Description

technical field [0001] The invention relates to the field of immune analysis, in particular, the invention provides a hepatitis B e antibody magnetic particle chemiluminescent immunoassay kit and a preparation method thereof. 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 liver cancer. [0003] For HBsAg-positive patients with chronic infection, HBeAg and Anti-HBe can be used to d...

Claims

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Application Information

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Patent Type & Authority Applications(China)
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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