Treponema pallidum antibody detection kit and detection method thereof

Abstract

The invention discloses a treponema pallidum antibody detection kit. The kit comprises a magnetic separation reagent, a biotin antigen, an enzyme-labeled reagent comprising a detection antigen and a detection antibody coupled alkaline phosphatase, a negative control, a positive control and a calibration solution. The biotin antigen and detection antigen are recombinant antigens. The detection antibodies comprise a mouse monoclonal antibody and a mouse second antibody. The calibration solution contains an antibody to be detected. The invention discloses a detection method of the kit. Through combination of an indirect method and a double antigen sandwiching method, double antigen sandwiching method specificity is guaranteed and the problem that according to the double antigen sandwiching method, two solid phase antigens or two tracer-labeled antigens are bonded to the same antibody so that detection is unsuccessful and false positive or false negative detection result is avoided. The combined indirect method and double antigen sandwiching method produce effects better than those of the single indirect method or double antigen sandwiching method.

Description

Technical field [0001] The invention relates to a magnetic particle chemiluminescence method Treponema pallidum antibody determination kit and a detection method thereof. Background technique [0002] As a traditional infectious disease item, Treponema pallidum antibody plays an important role in disease screening, blood transfusion and preoperative examination. This type of infectious disease also requires high accuracy of test results. At present, the hospital’s inspection process is generally divided into two steps: First, use toluLized red unheated serum test (TRUST) or TP-ELISA for preliminary screening; then use TPPA for the positive samples. Method to confirm. Since TRUST is not a syphilis-specific antibody, the specificity is poor. Therefore, more and more hospitals are beginning to use the TP-ELISA method for preliminary screening. [0003] As a more mature detection method, ELISA has obvious advantages, that is, the specificity of antigen and antibody is very high, and ...

AI Technical Summary

Problems solved by technology

Generally speaking, since the double-antigen sandwich method uses two specific antigens, not only can IgG and IgM be detected simultaneously, but also the accuracy of the results is better than that of the indirect method. All antigens can bind to the same antibody, which will cause the antibody to fail to produce a signal and result in the failure of the test result. At the same time, two tracer-labeled antigens may bind to the same antibody (one-step method), so that the antibody cannot be detected. Binds to solid phase, thus making results inaccurate

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