Kit and method for detecting tp antibodies

By using a fusion protein of enzyme and TP antigenic protein in the detection of Treponema pallidum TP antibody, the problems of complex operation and non-uniform molar ratio of chemical activation cross-linking method are solved, achieving higher detection accuracy and simplified operation.

CN114502959BActive Publication Date: 2025-10-24SHENZHEN MINDRAY BIO MEDICAL ELECTRONICS CO LTD
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Patent Information

Application Number
CN201980101128.8
Authority / Receiving Office
CN · China
Patent Type
Patents(China)
Current Assignee / Owner
Filing Date
2019-10-14
Publication Date
2025-10-24
Estimated Expiration
2039-10-14

AI Technical Summary

Technical Problem

Among existing TP enzyme immunoassay methods, the chemical activation cross-linking method is complex and difficult to control, resulting in non-uniform molar ratios of enzyme and antigen molecules, which affects the production control of syphilis test kits and causes large batch-to-batch differences in test results.

Method used

A fusion protein of the enzyme and TP antigen was prepared by recombinant expression technology and used in an immunoassay kit for Treponema pallidum TP antibody, avoiding chemical activation and cross-linking.

Benefits of technology

A uniform molar ratio of labeling enzyme to TP antigenic protein was achieved, reducing batch-to-batch variability in test results, improving the differentiation between positive and negative samples and the sample concordance rate, and simplifying the operation process.

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Abstract

An enzyme label used in an immunodetection of Treponema pallidum (TP) antibody, the enzyme label being a fusion protein of a labeling enzyme and a TP antigenic protein. A kit for detecting a TP antibody and a method for detecting an antibody produced after infection with Treponema pallidum (TP) in a sample, the kit including a fusion protein of a labeling enzyme and a TP antigenic protein. The antigenic protein contains one or more of TP15 antigen, TP17 antigen, TP47 antigen, and TP45 antigen, or a fusion antigen of two or more thereof.
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