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Magnetic particle-based quantitative chemiluminescent assay kit for anti-PM-Scl antibody IgG, and preparation and detection methods thereof

A technology of chemiluminescence and magnetic particles, which is applied in chemiluminescence/bioluminescence, biological testing, analysis by making materials undergo chemical reactions, etc., and 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-PM-Scl antibody IgG immunoassay products has not yet been seen.

Method used

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  • Magnetic particle-based quantitative chemiluminescent assay kit for anti-PM-Scl antibody IgG, and preparation and detection methods thereof
  • Magnetic particle-based quantitative chemiluminescent assay kit for anti-PM-Scl antibody IgG, and preparation and detection methods thereof
  • Magnetic particle-based quantitative chemiluminescent assay kit for anti-PM-Scl antibody IgG, and preparation and detection methods thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0063] Preparation of anti-PM-Scl antibody IgG calibrator:

[0064] a. Prepare anti-PM-Scl antibody IgG calibrator dilution:

[0065] 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 value 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-PM-Scl antibody IgG calibrator Diluent, store at 2-8°C until use;

[0066] b. Prepare anti-PM-Scl antibody IgG calibrator:

[0067] Dilute anti-PM-Scl antibody IgG with anti-PM-Scl antibody IgG calibrator diluent to each concentration point of 0, 5, 20, 50, 100, 200 RU / mL.

Embodiment 2

[0069] Preparation of anti-PM-Scl antibody IgG quality control substance:

[0070] Dilute the anti-PM-Scl antibody IgG with the above-mentioned anti-PM-Scl antibody IgG calibrator diluent to 20, 100 RU / mL at each concentration point.

Embodiment 3

[0072] Preparation of Reagent No. 1:

[0073] a. Prepare reagent No. 1 dilution:

[0074] 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;

[0075] b. Prepare reagent No. 1:

[0076] Dissolve the PM-Scl 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 0.5-1.0 mg / ml in a carbonate buffer solution with a pH of 0.2M and a pH of 8.5-9; prepa...

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Abstract

The invention discloses a magnetic particle-based quantitative chemiluminescent assay kit for an anti-PM-Scl antibody IgG. The kit comprises an anti-PM-Scl antibody IgG calibrator, an anti-PM-Scl antibody IgG quality control product, a Tris buffer containing biotin-labeled PM-Scl 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-PM-Scl antibody IgG and a preparation and detection method. Background technique [0002] Anti-PM-Scl antibodies are mainly used for overlap syndrome, these antibodies can be detected in 50-70% of patients with overlap syndrome, in these patients, polymyositis (PM), dermatomyositis (DM) and progressive Systemic sclerosis (Scl). The positive rate of anti-PM-Scl antibody was 3% in progressive systemic sclerosis (diffuse type), and 8% in polymyositis and dermatomyositis. [0003] At present, there are membrane strip immunoassay and enzyme-linked immunosorbent assay for clinical detection of anti-PM-Scl antibody IgG. Membrane immunoassay uses membrane strip chromogenic technology, which is characterized by fixing several items in the same membrane strip for measurement, generally thro...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): G01N33/68G01N21/76
CPCG01N33/6893G01N21/76G01N2800/7095
Inventor 不公告发明人
Owner 北京贝尔医疗设备有限公司
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