Reagent device for detecting antinuclear antibody and method thereof

Abstract

The invention discloses a reagent device for detecting an antinuclear 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 antinuclear 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 an antinuclear antibody reagent device and a method thereof, which belong to the technical field of clinical immunology detection. Background technique [0002] Autoimmune diseases are the immune system's immune response to the components of autoantibodies, causing damage and causing diseases, which can accumulate in multiple organs and systems, and cause great harm to patients. In recent years, the incidence of autoimmune diseases has increased significantly, accounting for about 3% to 5% of the world's total population. Common autoimmune diseases include: systemic lupus erythematosus, rheumatoid arthritis, rheumatoid arthritis, hard Skin diseases, hyperthyroidism, juvenile diabetes, idiopathic thrombocytopenic purpura, autoimmune hemolytic anemia, ulcerative colitis, and many kinds of skin diseases, chronic liver diseases, etc. [0003] Although different autoimmune diseases have their own specific...

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Problems solved by technology

[0007] (1) Only qualitative and semi-quantitative analysis can be carried out, and the specific amount of the tested substance cannot be obtained

[0008] (2) The operation steps are cumbersome and the test takes a long time

[0009] (3) The detection sensitivity needs to be improved

[0014] (1) Non-specific recognition cannot be distinguished according to the size of the molecular weight when analyzing the results;

[0015] (2) The operation is relatively complicated and requires expensive fluorescence microscopes, which are difficult to popularize in many primary hospitals and are not suitable for laboratories with a large number of specimens;

[0016] (3) The background in the fluorescence measurement is relatively high, and it is difficult to use the fluorescence immunoassay technique for quantitative determination;

[0017] (4) Experienced professionals are required to determine the results, and the objectivity of the analysis results is insufficient;

[0018] (5) Only qualitative detection can be carried out, and quantitative measurement cannot be carried out

[0027] (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;

[0028] (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;

[0029] (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;

[0030] (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;

[0031] (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;

[0032] (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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