关键词: 分枝杆菌, 结核, 抗原, 试剂盒, 诊断, 参考标准, 评价研究

Abstract:

Objective: To establish a national reference panel for tuberculosis antigen detection reagent. Methods: The raw materials were confirmed by microbiologic and molecular tests, then homogenized, diluted, dispensed, and assembled to the panel. The copy numbers of the panel samples were identified using the Mycobacterium tuberculosis nucleic acid detection kit. Two colloidal gold reagents were used for the collaborative calibration study, and accordingly the quality requirement was finally determined. Then the uniformity and stability of the reference material were investigated. Results: The reagents of the two companies both could correctly detect all positive candidate reference samples (5/5) and negative candidate reference samples (5/5); for the reference substance (Rv) after 2-fold serially dilution, both reagents of the two companies could detect positive with 32-fold diluted samples and negative for 64-fold diluted samples. The reference panel consisted of 5 negative and 5 positive samples and one limit of detection (LoD)/precision sample. The acceptable quality requirement of the reference was determined as follows: the agreement rate of the negative samples should be 5/5; the agreement rate of positive samples should be 5/5; The P0 was 2-fold serially diluted to 64-fold, and the test result of 16-fold dilution should be positive. The precision sample P0 was diluted to 8-fold and tested 10 times in parallel, and the test results should all be positive and the color intensity of the strip should be uniform. Conclusion: The national reference panel could be used for performance evaluation and quality control of colloidal gold detection kit for Mycobacterium Tuberculosis antigen.

Key words: Mycobacterium tuberculosis, Antigens, Reagent kits, diagnostic, Reference standards, Evaluation studies