Reagent device and method for detecting anti-mitochondrial antibodies type M2 antibody

Abstract

The invention provides a reagent device and a method used for detecting anti-mitochondrial antibodies type M2 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-mitochondrial antibodies type M2 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 a method for detecting the M2 type of anti-mitochondrial antibody, belonging to the technical field of clinical immunology detection. Background technique [0002] Primary biliary cirrhosis (PBC) is a chronic progressive disease, which is more common in women. It is due to the progressive destruction of small and medium bile ducts in the liver accompanied by inflammatory changes in the portal vein, and further develops into fibrosis and cirrhosis. , clinically manifested as progressive liver dysfunction. In the early stage, it manifests as skin itching, lethargy, and dull pain in the liver area, and in the late stage, jaundice, hepatic ascites, and liver cirrhosis appear. PBC is an autoimmune disease, and 80% of patients are accompanied by other immune diseases. Anti-mitochondrial (AMA) antibody M2 type, anti-nuclear antibody, anti-nuclear pore complex antibody and other autoant...

AI Technical Summary

Problems solved by technology

[0007] (1) Non-specific recognition cannot be distinguished according to the size of the molecular weight when analyzing the results;

[0008] (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;

[0009] (3) The background in the fluorescence measurement is relatively high, and it is difficult to use the fluorescence immunoassay technique for quantitative determination;

[0010] (4) Experienced professionals are required to determine the results, and the objectivity of the analysis results is insufficient;

[0011] (5) Only qualitative detection can be carried out, and quantitative measurement cannot be carried out

[0014] (1) Only qualitative and semi-quantitative analysis can be carried out, and the specific amount of the tested substance cannot be obtained

[0015] (2) The operation steps are cumbersome and the test takes a long time

[0016] (3) The detection sensitivity needs to be improved

[0019] (1) Use 12×8 type, 6×8 type, 8×12 type or whole plate type 96-well special microwell plate as the 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;

[0020] (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;

[0021] (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;

[0022] (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;

[0023] (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;

[0024] (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 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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