Reagent device for detecting rheumatoid factor and method thereof

Abstract

The invention discloses a reagent device for detecting rheumatoid factors 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 rheumatoid factor 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 rheumatoid factor, belonging to the technical field of clinical immunology detection. Background technique [0002] Rheumatoid factor (RF) is the earliest discovered autoantibody, named after its related diseases. RF can be found in a variety of systemic autoimmune and infectious diseases, and can also be detected in healthy people. [0003] The C-terminus of the IgG heavy chain constant region, namely the Fc fragment, is the antigenic site of RF. RF can be positive in healthy people as well as in many disease states. The positive rate of untreated rheumatoid arthritis patients was 80%, and the titer was often above 1:160. Clinically, dynamic observation of the titer can be used as an evaluation of lesion activity and curative effect after drug treatment. The positive rate of other rheumatic diseases such as systemic lupus erythematosus (SLE) is 20% to 2...

AI Technical Summary

Problems solved by technology

[0008](1) Only qualitative and semi-quantitative analysis can be carried out, and the specific amount of the tested substance cannot be obtained

[0009](2) The operation steps are cumbersome and the test takes a long time

[0010](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.

Images