Reagent device for detecting anti-glomerular basement membrane antibody and method thereof

Abstract

The invention discloses a reagent device for detecting an anti-glomerular basement membrane antibody and a method thereof; the reagent device is long strip-shaped, comprises a substrate with eight hole sites and a handle disposed at one end of the substrate; the eight hole sites comprise a sample hole, an adjuvant hole, an enzyme conjugate hole, a substrate hole, a stopping solution hole, a diluent hole, a reaction hole, and a dilution hole, which are arranged in sequence from the end near the handle. The reagent device of the invention realizes anti-glomerular basement membrane antibody detection with the device based on a principle of enzyme-linked immunoassay, is an independent, single-sample analytic detection method, and can be used cooperatively with corresponding specific analytical instruments; during detection, a detection reagent or a sample is injected by using a full automatic precision liquid filling device, which provides advantages of operation automation, accurate filling amount, high accuracy and precision of detection results; and the reagent device has wide application prospects.

Description

technical field [0001] The application of the present invention relates to a reagent device and a method for detecting anti-glomerular basement membrane antibodies, belonging to the technical field of clinical immunology detection. Background technique [0002] Goodpascal syndrome is an autoimmune disease with kidney damage as the main cause, and it is a proliferative glomerulonephritis with fatal pulmonary hemorrhage. The main manifestations are the triad of glomerulonephritis, pulmonary hemorrhage, and formation of anti-glomerular basement membrane antibodies. Histology is characterized by continuous deposition of immunoglobulin along the glomerular basement membrane. Its incidence rate is 0.5 to 1 case per 1,000,000 residents per year. It is an acute disease. If it is not treated, renal failure and respiratory failure will occur, and the case fatality rate is as high as 75% to 90%. [0003] The glomerular basement membrane (GBM) is anatomically constructed as a barrier ...

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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 expensive fluorescence microscopes, which are difficult to promote in many primary hospitals and are 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 determine the results, and the objectivity of the analysis results is insufficient;

[0014] (5) Only qualitative detection can be carried out, and quantitative measurement cannot be carried out

[0017] (1) Use 12×8 type, 6×8 type, 8×12 type or full-plate type 96-well special microwell plate as antigen coating equipment and reaction container, which can only be divided into 12 batches and 6 batches when used , 8 batches or the whole board can be used at one time, and independent and single-person testing cannot be carried out;

[0018] (2) There are many kinds of reagents used in quantitative determination, and each detection reagent must be contained in a reagent bottle, and each time a reagent is used, the suction nozzle needs to be replaced to fill the microwells of the microwell plate respectively , not

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