关键词: 分枝杆菌,结核, 抗体,细菌, 试剂盒,诊断, 参考标准

Abstract:

Objective: To prepare a national reference panel for Mycobacterium tuberculosis antibody detection. Methods: The reference materials were screened and rechecked using colloidal gold and ELISA tuberculosis antibody detection reagents from 9 companies. After subpackage, 9 companies cooperated to calibrate, and finally determined the composition and quality standard of the national reference panel. At the same time, the homogeneity and stability of the reference panel was investigated. Results: The result of positive references varies from different companies and test kits. According to the cooperative calibration results and the principle of proper supervision, the reference panel was determined to be composed of 10 negative samples, 10 positive samples, 5 Limit of Detection (LoD) samples and 1 precision sample. The quality standard requirement of the reference panel was determined as follows: the agreement rate of the negative samples should be 10/10; the agreement rate of positive samples should ≥9/10; in the LoD samples S1-S5, S1 and S2 should be positive, while S3-S5 could be positive or negative. Precision reference sample R should be tested 10 times in parallel, and the results should be all positive, and the coefficient of variation value (CV value) of the test results shall be ≤15%. The homogeneity was that the difference among the sub-packaged samples was not more than 30%, and there was no difference between the stability condition group and the -20 ℃ control group. Conclusion: A set of national reference panel applicable to ELISA and solid-phase protein microarray for Mycobacterium tuberculosis antibody has been established for the first time, which could be used to evaluate the quality of the reagents.

Key words: Mycobacterium tuberculosis, Antibodies, bacterial, Reagent kits, diagnostic, Reference standards