Magnetic particle-based quantitative chemiluminescent assay kit for anti-double-stranded DNA antibody IgG, and preparation and detection methods thereof

A technology of magnetic particles and reagent kits, applied in chemiluminescence/bioluminescence, analysis by causing chemical reactions of materials, measurement devices, etc., can solve problems such as applications that have not been seen

Inactive Publication Date: 2016-09-07
北京贝尔医疗设备有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

At present, the application of magnetic particle chemiluminescence analysis in anti-double-stranded DNA antibody IgG immunoassay products has not yet been seen.

Method used

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  • Magnetic particle-based quantitative chemiluminescent assay kit for anti-double-stranded DNA antibody IgG, and preparation and detection methods thereof
  • Magnetic particle-based quantitative chemiluminescent assay kit for anti-double-stranded DNA antibody IgG, and preparation and detection methods thereof
  • Magnetic particle-based quantitative chemiluminescent assay kit for anti-double-stranded DNA antibody IgG, and preparation and detection methods thereof

Examples

Experimental program
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Effect test

Embodiment 1

[0066] Preparation of anti-double-stranded DNA antibody IgG calibrator:

[0067] a. Prepare anti-double-stranded DNA antibody IgG calibrator dilution:

[0068] Add 800ml of purified water, 11.2g of Tris, 8.6g of sodium chloride and 2ml of Proclin300 into the container, stir well until completely dissolved; use 4M HCL to adjust the pH of the solution to 7.0-7.5; add 40g of bovine serum albumin Add to the container, stir well until completely dissolved; then adjust the pH of the solution to 7.0-7.5 with 4M HCL; dilute the solution to 1L with purified water, and filter with a 0.2μm filter to obtain the anti-double-stranded DNA antibody IgG calibrator Diluent, store at 2-8°C until use;

[0069] b. Prepare anti-double-stranded DNA antibody IgG calibrator:

[0070] Dilute anti-double-stranded DNA antibody IgG with anti-double-stranded DNA antibody IgG calibrator diluent to each concentration point of 0, 10, 100, 200, 400, 800 IU / mL.

Embodiment 2

[0072] Preparation of anti-double-stranded DNA antibody IgG quality control:

[0073] Dilute the anti-double-stranded DNA antibody IgG with the above-mentioned anti-double-stranded DNA antibody IgG calibrator diluent to 100, 400 IU / mL at each concentration point.

Embodiment 3

[0075] Preparation of Reagent No. 1:

[0076] a. Prepare reagent No. 1 dilution:

[0077] Add 800ml of purified water, 12.1g of Tris, 5.8g of sodium chloride and 2ml of Proclin300 into the container, stir well until completely dissolved; add 5g of bovine serum albumin into the container, stir well until completely dissolved; dissolve the solution with 4M HCL Adjust the pH value of the solution to 7.0-7.5; dilute the solution to 1L with purified water, filter it with a 0.2μm filter to obtain the No. 1 dilution of the reagent, and store it at 2-8°C for later use;

[0078] b. Prepare reagent No. 1:

[0079] Dissolve the double-stranded DNA antigen in purified water, dialyze it with a carbonate buffer solution with a concentration of 0.2M and a pH of 9.0 for 2 hours at 2-8°C, and then concentrate it to an antigen solution with a concentration of 2-4 mg / mL. Prepare a biotin solution with a concentration of 0.5-1.0mg / ml in a carbonate buffer solution of 0.2M and pH 8.5-9; prepare ...

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Abstract

The invention discloses a magnetic particle-based quantitative chemiluminescent assay kit for an anti-double-stranded DNA antibody IgG. The kit comprises an anti-double-stranded DNA antibody IgG calibrator, an anti-double-stranded DNA antibody IgG quality control product, a Tris buffer containing biotin-labeled double-stranded DNA antigen and bovine serum albumin, a Tris buffer containing an alkaline phosphatase-labeled goat anti-human polyclonal antibody and bovine serum albumin, a Tris buffer containing streptavidin-labeled magnetic particles and bovine serum albumin, and a rinsing solution. The detection method using the kit improves sensitivity and a linearity range by 3 to 5 orders of magnitudes on the basis of a traditional membrane strip immunization method and a traditional enzyme linked immunosorbent assay method, realizes real quantitative determination, is rapid in reaction and reliable in results, can be automatically used in cooperation with an automatic chemiluminescence immunity analyzer and is of irreplaceable important value to clinical diagnosis.

Description

technical field [0001] The invention relates to the technical field of biological detection. More specifically, it relates to a magnetic particle chemiluminescent quantitative assay kit for anti-double-stranded DNA antibody IgG and a preparation and detection method. Background technique [0002] Systemic lupus erythematosus (SLE) is a relatively common autoimmune disease in clinical practice. The prominent manifestation of patients is the presence of a variety of autoantibodies, the most important of which is anti-double-stranded DNA antibody, which is a kind of antibody that can bind to natural DNA. autoantibodies, which are detectable almost exclusively in SLE patients. The ups and downs of anti-double-stranded DNA antibody titers are related to the condition changes of SLE patients. The diagnosis of SLE is based on 11 ARA criteria (ARA, American College of Rheumatology), also known as the 1988 ACR criteria (ACR, American College of Rheumatology), which were revised in ...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): G01N33/564G01N21/76
CPCG01N33/564G01N21/76G01N2800/104
Inventor 不公告发明人
Owner 北京贝尔医疗设备有限公司
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