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Kit for magnetic particle chemiluminescent quantitative detection of anti-SS-B antibody IgG and its preparation method and detection method

A chemiluminescence, quantitative detection technology, applied in the field of immunological detection, can solve the problems of poor repeatability, narrow linear range, long reaction time and so on

Active Publication Date: 2016-02-24
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

[0006] 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 the immunoblotting products for physical examination screening: the nitrocellulose membrane or nylon membrane contains: respectively composed of dsDNA, SS-B / RNP, CCP, SSA, SSB, GAD, ICA, IA-2A, Two or more parallel detection lines coated with at least two natural or recombinant antigens out of 10 kinds of TG and AMA-M2, 1 high-concentration quality control band, 1 medium-concentration quality control band and 1 low-concentration quality control band Quality control tape
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 magnetic particle chemiluminescent quantitative detection of anti-SS-B antibody IgG and its preparation method and detection method
  • Kit for magnetic particle chemiluminescent quantitative detection of anti-SS-B antibody IgG and its preparation method and detection method
  • Kit for magnetic particle chemiluminescent quantitative detection of anti-SS-B antibody IgG and its preparation method and detection method

Examples

Experimental program
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Effect test

Embodiment 1

[0066] A kit for quantitatively detecting anti-SS-B antibody IgG using magnetic particle chemiluminescence, the kit comprising: Anti-SS-B IgG calibrator, Anti-SS-B IgG reagent No. 1, Anti-SS-B IgG reagent No. 2, Anti-SS-BIgG Magnetic Separation Reagent, Anti-SS-BIgG Quality Control and Cleaning Solution.

[0067] Analytical performance evaluation of kit of the present invention:

[0068] 1) Accuracy evaluation

[0069] Add the anti-SS-B antibody IgG sample A solution with a concentration of about 200RU / mL and allow the concentration deviation of ±20% to the serum-based sample B solution, and the volume of sample A solution added should not exceed the total volume A+ 10% of B, calculate the recovery rate R according to the formula (1), the recovery rate of this method is in the range of 85-115%, and the data are shown in Table 1.

[0070] R = C × ( V ...

Embodiment 2

[0112] A preparation method of a kit for quantitative detection of anti-SS-B antibody IgG using magnetic particle chemiluminescence comprises the following steps:

[0113] Step 1. preparing described Anti-SS-BIgG calibrator comprises: Anti-SS-BIgG calibrator diluent preparation step and Anti-SS-BIgG calibrator preparation step:

[0114] The preparation step of described Anti-SS-BIgG calibrator dilution comprises:

[0115] 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;

[0116] The preparation step of described Anti-SS-BIgG calibrator comprises:

[011...

Embodiment 3

[0134] On the basis of Example 2, the kit also includes a cleaning concentrate, and the preparation steps of the cleaning concentrate:

[0135] Add 800mL of purified water, Tris12.1g and NaCl8.5g to a 1L container, stir until completely dissolved; then add 5g of Tween-20 and 5g of Triton100, stir until completely mixed, and adjust the pH value to 7.5 -8.0, constant volume 1L, filtered with a 0.2μm filter, and stored at a temperature range of 2-8°C.

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Abstract

The invention relates to the technical field of immunological detection and concretely relates to a kit for magnetic particle chemiluminescent quantitative detection of an anti-SS-B antibody IgG and its preparation method and detection method. The kit for magnetic particle chemiluminescent quantitative detection of an anti-SS-B antibody IgG comprises an Anti-SS-B IgG calibration material, an anti-SS-B IgG regent 1, an anti-SS-B IgG regent 2, an anti-SS-B IgG magnetic separation regent, an anti-SS-B IgG quality control material and a cleaning liquid. The invention also discloses a preparation method and detection method of the kit. Based on the traditional membrane stripe immunization method and enzyme-linked immunosorbent assay, the detection method improves sensitivity and a linear range by 3-5 orders of magnitudes, realizes quantitative determination, has the advantages of high sensitivity, good specificity, good accuracy, low cost, simple operation and objective result determination, realizes full automation by a full-automatic chemiluminescence immunity analyzer and has a wide application prospect.

Description

technical field [0001] The invention relates to the technical field of immunological detection, in particular to a kit for quantitatively detecting anti-SS-B antibody IgG by using magnetic particle chemiluminescence, and a preparation method and detection method thereof. Background technique [0002] The detection rate of anti-SS-B antibody IgG is 40%-95% in Sjogren's syndrome patients. They often coexist with anti-SS-A antibodies. Anti-SS-B antibodies are also found in 5%-35% of patients with systemic lupus erythematosus (SLE) and in 75%-80% of neonatal lupus erythematosus (neonatal lupus syndrome). When the mother's anti-SS-A antibody or anti-SS-B antibody is positive (I-III grade), these antibodies can be passed to the fetus through the placenta, and in addition to causing an inflammatory response, they often cause congenital atrioventricular block. However, the serum of SLE patients generally still contains a variety of other antibodies, such as Sm antibody and U1RNP a...

Claims

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Application Information

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IPC IPC(8): G01N21/76G01N33/543
Inventor 不公告发明人
Owner 北京贝尔医疗设备有限公司
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