Reagent device and method for detecting anti-beta2 glycoprotein I antibody

Abstract

The invention provides a reagent device and a method used for detecting anti-beta2 glycoprotein I 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-beta2 glycoprotein I 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-β2 glycoprotein I antibody, belonging to the technical field of clinical immunology detection. Background technique [0002] The main features of antiphospholipid syndrome (APS) are elevated serum antiphospholipid antibodies, thrombosis and / or recurrent abortion. β2 glycoprotein I is a phospholipid-binding protein with a molecular weight of 50 kDa and consists of approximately 326 amino acid residues and 5 homologous domains. Currently considered to be the most clinically relevant antigenic target of antiphospholipid antibodies. [0003] Antiphospholipid antibodies are a group of immunoglobulins that can directly react with negatively charged phospholipids and exist in the serum of patients with antiphospholipid syndrome, one of which is anti-β2 glycoprotein I antibody. Anti-β2 glycoprotein I antibody inhibits the anticoagulant activity of activated pro...

AI Technical Summary

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

[0015] (1) Use 12×8 type, 6×8 type, 8×12 type or whole plate type 96-well special microwell plate as antigen coating equipment and reaction Containers can only be divided into 12 batches, 6 batches, 8 batches or the whole board for one-time use, and independent and single-person testing cannot be carried out;

[0016] (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, it needs to be replaced The liquid suction nozzle is used to fill the microwells of the microwell plate, not only the variety of reagent bottles, but also the operation of adding reagents is extremely cumbersome;

[0017](3) There is a lack of corresponding labeling of the test information, and the production batch number and expiration 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, Moreover, the known information is not controlled during the detection process and has great randomness;

[0018](4) The detection reagent is in an open space during the detection process, which may easily cause cross-contamination among various reagents and affect the accuracy of the detection result;

[0019](5) The detection process is mostly 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. Poor accuracy and precision;

[0020](6) The quantity configuration and use of the complete set of reagents for the test items are the number of items × 48 / 96 servings. If 10 items need to be tested, the reagent’s The number of configuration and use must be 10×48 / 96. If only one sample needs to be tested for 10 different items, it is also necessary to configure 10×48 / 96 reagents, which is not economical and reasonable.

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