Method for testing anti-SmD1 antibody IgG and reagent device

Abstract

The invention provides a method for immunologically detecting an anti-SmD1 antibody IgG on the basis of an enzyme-linked immunosorbent assay principle and a reagent device , which relate to an analysis method used for enzyme-linked immunosorbent assay of the anti-SmD1 antibody IgG independently, individually and disposably, a reagent device and a matched reagent. In the method, a plurality of reagents required in the enzyme-linked immunosorbent assay of the anti-SmD1 antibody IgG can be contained in one analyzing device; and according to the method, relevant immunological tests can be conveniently conducted according to using requirements on the tested project, and better basis is provided for clinical practice.

Description

technical field [0001] The application of the present invention relates to a method and a reagent device for measuring anti-SmD1 antibody IgG, which belong to the technical field of biological detection. Background technique [0002] Anti-Sm antibody, named after the patient's name (Smith). The target antigen of the anti-Sm antibody is located on a group of molecular particles composed of nucleoprotein and RNA in the nucleus. This group of proteins is called small ribonucleoproteins (snRNPs). Because the snRNP of this group of small molecules is rich in uracil, snRNP is also called UsnRNP. Among them, UsnRNP participates in the maturation process of messenger RNA by forming splice bodies in cells. The protein component of UsnRNP that can be recognized by anti-Sm antibodies is called the Sm "common core". [0003] Anti-Sm antibody is currently recognized as the serum marker antibody of SLE, but the positive rate in systemic lupus erythematosus (SLE) is only 20%-40%. Anti...

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Problems solved by technology

[0010] (1) Non-specific recognition cannot be distinguished according to the size of the molecular weight when analyzing the results

[0011] (2) The operation is relatively complicated and requires a more expensive fluorescence microscope, which is difficult to promote in many primary hospitals and is not suitable for laboratories with a large number of specimens

[0012] (3) The background in the fluorescence measurement is relatively high, and it is difficult to use the fluorescence immunoassay technique for quantitative determination

[0013] (4) Experienced professionals are required to judge the results, and the objectivity of the analysis results is insufficient

[0016] (1) Only qualitative and semi-quantitative analysis can be carried out, and the specific amount of the tested substance cannot be obtained

[0017] (2) The operation steps are cumbersome and the test takes a long time, so it is difficult to carry out this test at the grassroots level

[0018] (3) The sensitivity and specificity of detection need to be improved

[0019] (4) At the same time, because the whole process of extracting the antigen is complicated, time-consuming, requires high equipment and equipment, and the antigen is difficult to preserve for a long time, which is not conducive to clinical promotion and application

[0020] (5) The test results are not easy to judge

[0024] (2) There can be as many as 11 kinds of reagents used for quantitative determination, and each detection reagent should be contained in a reagent bottle, and each time a reagent is used, it is necessary to replace the suction nozzle to add to the microwell plate respectively. In the well, not only are there many types of reagent bottles, but also the operation of adding reagents is extremely cumbersome. If you do not use a fully automatic enzyme immunoassay analyzer, all operations must be done manually, and the price of a fully automatic enzyme immunoassay analyzer is very expensive. , a large investment;

[0025] (3) There is no barcode of reagent information for each test or each test. The production batch number and expiry date information of the test reagent can only be known or known by checking the label on the outer packaging box of the test kit, and the known information is not available during the test process. Controlled, with great discretion;

[0026] (4) The detection reagent is an open method during the detection process, which is likely to cause cross-contamination between various reagents and affect the detection results;

[0027] (5) When the automatic enzyme immunoassay analyzer is not used for detection, the detection process is manual operation, the addition of reagents or samples is not very precise, the operation process is extremely cumbersome and complicated, and operation errors are prone to occur, resulting in inaccurate detection results and high imprecision;

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