Method for determining antiproteinase 3 antibody IgG (intravenous gamma globulin) and reagent device

Abstract

The invention provides a method for realizing immunization detection of antiproteinase 3 antibody IgG (intravenous gamma globulin) based on the enzyme-linked immunoassay principle and a reagent device therefor; and an analytic method, the reagent device and an assorted reagent are independently, individually and disposably used for detecting the antiproteinase 3 antibody IgG based on enzyme-linked immunoassay. Various reagents needed by the enzyme-linked immunoassay for the antiproteinase 3 antibody IgG are contained in one analytic device; and by using the method, the related immunology detection can be conveniently carried out according to the using requirements of detection items so as to provide better basis for clinical application.

Description

technical field [0001] The application of the present invention relates to a method and a reagent device for measuring anti-protease 3 antibody IgG, which belong to the technical field of biological detection. Background technique [0002] Antineutrophil cytoplasmic antibodies (antineutrophil cytoplasmic antibodies. ANCA) is currently the most important serological detection indicator for the diagnosis of primary vasculitis, and proteinase 3 (PR3) is one of the main target antigens of cANCA , accounting for about 80% to 90% of C-ANCA. [0003] Wegener's granulomatosis (WG) is a special type of necrotizing granulomatous vasculitis. Its clinical complexity and difficulty in diagnosis and treatment have always been problems for rheumatologists. The diagnosis of WG is mainly based on clinical symptoms, and the clinical manifestations are complex and diverse, and vary from person to person. Antineutrophil cytoplasmic antibody (ANCA) is the most diagnostic autoantibody for WG. ...

AI Technical Summary

Problems solved by technology

[0008] (1) False positives may occur using this method

[0009] (2) When analyzing the results, non-specific recognition cannot be distinguished according to the size of the molecular weight

[0010] (3) 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

[0011] (4) The background in fluorescence measurement is high, and it is difficult to use fluorescence immunoassay for quantitative determination

[0012] (5) Experienced professionals are required to determine the results, and the objectivity of the analysis results is insufficient

[0017] (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;

[0018] (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;

[0019] (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;

[0020] (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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