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Kit for quantitative detection of anti-Sm antibody IgG by using magnetic particle chemiluminescence, and preparation method and detection method thereof

A chemiluminescent, quantitative detection technology, applied in the field of immunological detection, can solve problems such as narrow linear range, long reaction time, and low sensitivity

Inactive Publication Date: 2016-04-06
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

[0004] Chinese patent CN103105489A discloses an immunoblotting kit for detecting autoimmune disease antibodies and a preparation method thereof, which relates to a immunoblotting kit for detecting antibodies related to various autoimmune diseases, and solves the problem that currently there is no such kit for various autoimmune diseases Technical deficiencies in immunoblotting products for physical examination screening: the nitrocellulose membrane or nylon membrane contains: respectively composed of dsDNA, Sm / RNP, CCP, SSA, SSB, GAD, ICA, IA-2A, TG, AMA-M2 A total of 10 kinds of at least two natural or recombinant antigens coated with more than two parallel detection lines, 1 high-concentration quality control band, 1 medium-concentration quality control band and 1 low-concentration quality control band bring
The patent discloses a membrane strip immunoassay, which can better explain the problems of low sensitivity, narrow linear range, poor repeatability and long reaction time of the membrane strip immunoassay.

Method used

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  • Kit for quantitative detection of anti-Sm antibody IgG by using magnetic particle chemiluminescence, and preparation method and detection method thereof
  • Kit for quantitative detection of anti-Sm antibody IgG by using magnetic particle chemiluminescence, and preparation method and detection method thereof
  • Kit for quantitative detection of anti-Sm antibody IgG by using magnetic particle chemiluminescence, and preparation method and detection method thereof

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Effect test

Embodiment 1

[0065] A kit for quantitatively detecting anti-Sm antibody IgG using magnetic particle chemiluminescence, the kit comprising: Anti-SmIgG calibrator, Anti-SmIgG reagent No. 1, Anti-SmIgG reagent No. 2, Anti-SmIgG magnetic separation reagent, Anti-SmIgG -SmIgG quality control and wash solution.

[0066] Analytical performance evaluation of kit of the present invention:

[0067] 1) Accuracy evaluation

[0068] Add the anti-Sm antibody IgG sample A with a concentration of about 200RU / mL and allow the concentration deviation of ±20% to the serum sample B liquid, and the volume of A added does not exceed 10% of the total volume A+B, according to the formula ( 1) Calculate the recovery rate R, the recovery rate of this method is in the range of 85-115%, see Table 1 for the data.

[0069] R = C × ( V 0 + ...

Embodiment 2

[0111] A preparation method of a kit for quantitative detection of anti-Sm antibody IgG using magnetic particle chemiluminescence comprises the following steps:

[0112] Step 1. preparing described Anti-SmIgG calibrator comprises: Anti-SmIgG calibrator diluent preparation step and Anti-SmIgG calibrator preparation step:

[0113] The preparation step of described Anti-SmIgG calibrator dilution comprises:

[0114] Add 800mL of purified water and 11.2g of Tris to the container, stir and mix evenly, add 8.5g of sodium chloride and 2mL of Proclin300, stir until completely dissolved, adjust the pH value to 7.0-7.5, add 40g of bovine serum white Put the protein into the container, stir until completely dissolved, then adjust the pH value to 7.0-7.5, dilute to 1L with purified water, filter with a 0.2μm filter, and store the obtained dilution of the calibration product at 2-8°C until use;

[0115] The preparation step of described Anti-SmIgG calibrator comprises:

[0116] Prepare t...

Embodiment 3

[0133] On the basis of Example 2, the kit also includes a cleaning solution, the preparation steps of the cleaning solution:

[0134] Add 800mL of purified water, 12.1g of Tris and 8.5g of NaCl to a 1L container, stir well until completely dissolved; then add 5g of Tween-20 and 5g of Triton100, stir well until completely mixed, adjust the pH value to control At 7.5-8.0, set the volume to 1L, filter with a 0.2μm filter, and store at a temperature of 2-8°C.

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Abstract

The invention relates to the technical field of immunology detection, and particularly relates to a kit for quantitative detection of an anti-Sm antibody IgG by using magnetic particle chemiluminescence, and a preparation method and a detection method thereof. The kit for quantitative detection of the anti-Sm antibody IgG by using magnetic particle chemiluminescence includes an Anti-Sm IgG calibrator, an Anti-Sm IgG reagent No. 1, an Anti-Sm IgG reagent No. 2, an Anti-Sm IgG magnetic separation reagent, an Anti-Sm IgG control material and a cleaning solution. The invention also discloses a preparation method and a detection method of the above kit. Based on the traditional film strip immunoassay and enzyme-linked immunosorbent assay, the detection method increases the sensitivity and linearity range by 3-5 orders of magnitude, achieves the quantitative detection, and has the advantages of high sensitivity and specificity, good accuracy, low cost, simple operation and the objective judgment of results. The method cooperates with an automated chemiluminescence immunoassay analyzer to reach fully automation, and has broad application prospects.

Description

technical field [0001] The invention relates to the technical field of immunological detection, in particular to a kit for quantitatively detecting anti-Sm antibody IgG by using magnetic particle chemiluminescence and a preparation method and a detection method thereof. Background technique [0002] Sm is the abbreviation of a patient's name. This antibody was found for the first time in the serum of a patient diagnosed with lupus erythematosus, hence the name. A large number of reports later confirmed the existence of such antibodies in the serum of patients with lupus erythematosus, which belonged to a class of antinuclear antibodies. The main protein antigens in the Sm system are B, B', D, and E proteins, with a molecular weight of 11-29kD, and there are also proteins such as A, A', B", C, F, G, and 68kD and 150kD. These proteins are related to the proteins containing Small nuclear RNAs (snRNAs) that are very rich in guanosine, that is, UsnRNAs, form complexes. At least ...

Claims

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Application Information

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IPC IPC(8): G01N33/68G01N33/543
CPCG01N33/6854G01N33/54326G01N33/6893G01N2800/104
Inventor 不公告发明人
Owner 北京贝尔医疗设备有限公司
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