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Magnetic particle-based quantitative chemiluminescent assay kit for anti-SLA/LP antibody IgG, and preparation and detection methods thereof

A technology of chemiluminescence and magnetic particles, which is applied in the direction of measuring devices, scientific instruments, instruments, etc., and can solve the problems of anti-SLA/LP antibody IgG immunoassay products that have not been seen in the application

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-SLA / LP antibody IgG immunoassay products has not yet been seen.

Method used

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  • Magnetic particle-based quantitative chemiluminescent assay kit for anti-SLA/LP antibody IgG, and preparation and detection methods thereof
  • Magnetic particle-based quantitative chemiluminescent assay kit for anti-SLA/LP antibody IgG, and preparation and detection methods thereof
  • Magnetic particle-based quantitative chemiluminescent assay kit for anti-SLA/LP antibody IgG, and preparation and detection methods thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0068] Preparation of anti-SLA / LP antibody IgG calibrator:

[0069] a. Prepare anti-SLA / LP antibody IgG calibrator dilution:

[0070] 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-SLA / LP antibody IgG calibrator Diluent, store at 2-8°C until use;

[0071] b. Prepare anti-SLA / LP antibody IgG calibrator:

[0072] Dilute anti-SLA / LP antibody IgG with anti-SLA / LP antibody IgG calibrator diluent to each concentration point of 0, 5, 20, 50, 100, 200 RU / mL.

Embodiment 2

[0074] Preparation of anti-SLA / LP antibody IgG quality control:

[0075] Dilute the anti-SLA / LP antibody IgG with the above-mentioned anti-SLA / LP antibody IgG calibrator diluent to 20, 100 RU / mL at each concentration point.

Embodiment 3

[0077] Preparation of Reagent No. 1:

[0078] a. Prepare reagent No. 1 dilution:

[0079] 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;

[0080] b. Prepare reagent No. 1:

[0081] Dissolve the SLA / LP 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 a biotin solu...

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Abstract

The invention discloses a magnetic particle-based quantitative chemiluminescent assay kit for an anti-SLA / LP antibody IgG. The kit comprises an anti-SLA / LP antibody IgG calibrator, an anti-SLA / LP antibody IgG quality control product, a Tris buffer containing biotin-labeled SLA / LP 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-SLA / LP antibody IgG and a preparation and detection method. Background technique [0002] Autoimmune hepatitis (AIH) is a type of autoimmune reaction-based, with multiple autoantibodies, hyperimmunoglobulinemia, circulating autoantibodies, interface hepatitis and portal area plasma cell infiltration on histology Characterized chronic inflammatory liver disease. [0003] AIH can be divided into type I (ANA, SMA), type II (anti-LKM-1 antibody, anti-LC-1 antibody), and type III (anti-SLA / LP antibody) according to serum immunological examination. Pancreatic antigen (SLA / LP) antibody is the most specific diagnostic marker for autoimmune hepatitis (AIH). Although its positive rate is only 10% to 30%, its positive predictive value is almost 100%. If corresponding clinical symptoms appear...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): G01N33/576
CPCG01N33/5767
Inventor 不公告发明人
Owner 北京贝尔医疗设备有限公司
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