Reagent device and method for detecting anti-double-stranded-DNA antibody

Abstract

The invention provides a reagent device and a method used for detecting anti-double-stranded-DNA antibodies. The reagent device has a long strip shape, and has a base body comprising 8 hole positions and a handle positioned on one end of the base body. From the end proximal to the handle, the 8 hole positions are sequentially a sample hole, an auxiliary agent hole, an enzyme conjugate hole, a substrate hole, a termination liquid hole, a dilution liquid hole, a reaction hole, and a dilution hole. According to the invention, based on a principle of enzyme-linked immunoassay, anti-double-stranded-DNA antibody is detected by using the reagent device. The method is an independent single-person analysis and detection method. The device can be used in cooperation with a corresponding specific analysis instrument. During a detection process, detection reagents or samples are injected by using a full-automatic precise dosing device. The device and the method have the advantages of automatic operation, precise dosing, high detection result accuracy, high detection result precision, and wide application prospect.

Description

technical field [0001] The application of the present invention relates to a reagent device and method for detecting anti-double-stranded DNA antibodies, belonging to the technical field of clinical immunology detection. Background technique [0002] Systemic lupus erythematosus (SLE) is a chronic inflammatory autoimmune disease that affects the connective tissue of the whole body and damages multiple organs. The disease is a connective tissue disease involving multiple systems, characterized by chronic non-suppurative inflammation, with complex and diverse clinical manifestations. , endocrine factors, drug factors, environmental factors and so on. [0003] Deoxyribonucleic acid (DNA) as an antigen can be double-stranded DNA (dsDNA) or single-stranded DNA (ssDNA), and its antibody also has two types: anti-dsDNA antibody and anti-ssDNA antibody. Anti-dsDNA antibody is an autoantibody that can bind to natural DNA, and anti-dsDNA antibody exists in the serum of more than 90% ...

AI Technical Summary

Problems solved by technology

[0012] (1) Non-specific recognition cannot be distinguished according to the size of the molecular weight when analyzing the results;

[0013] (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;

[0014] (3) The background in the fluorescence measurement is relatively high, and it is difficult to use the fluorescence immunoassay technique for quantitative determination;

[0015] (4) Experienced professionals are required to determine the results, and the objectivity of the analysis results is insufficient;

[0016] (5) Only qualitative detection can be carried out, and quantitative measurement cannot be carried out

[0024] (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;

[0025] (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 only there are many types of reagent bottles, but also the operation of filling reagents is extremely cumbersome;

[0026] (3) There is a lack of corresponding labeling of the testing information, and the production batch number and expiration date information of the testing reagent can only be known or known by checking the label on the outer packaging box of the kit, and the known information is not controlled during the testing process, which has great potential large randomness;

[0027] (4) The detection reagent is in an open space during the detection process, which may easily cause cross-contamination between various reagents and affect the accuracy of the detection result;

[0028] (5) Manual operation is mostly used in the detection process, 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, and the accuracy and precision of the detection results are poor;

[0029] (6) The quantity configuration and use of the complete set of reagents for the test items are the number of items × 48 / 96 persons. If 10 items need to be tested, the configuration and use of the reagents must be 10 × 48 / 96 persons. If Only one sample needs to detect 10 different items, and it also needs to configure reagents for 10×48 / 96 people, which has the disadvantage of not being economical and reasonable

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