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目的:探讨耐多药结核病快速诊断试剂盒检验耐药结核分枝杆菌的具体效果。方法:选取50株MTB临床分离株,并采用耐多药结核病快速诊断试剂盒来对其中的耐药MTB进行检测,分析其特异度、敏感度和可重复性,并与传统的试验方法相比较。结果:两种方式的特异度和敏感度对比结果:在50株临床分离株中,药物敏感度的实验结果为限制耐多药菌株32株,单耐异烟肼菌株8株,单耐利福平菌株3株,全敏感菌株5株。而将其用于耐多药结核病快速诊断试剂盒中进行评估,结果为35株利福平耐药菌株中检测出33株,敏感度达到了94.3%;在40株耐异烟肼菌株中检测出33株,敏感度达到了82.5%。而剩余的全敏感菌株全部符合标准,特异度达到了100%。而与测序结果进行比较,50株临床分离株中除了1个奶多样样本的rpoB基因与测序结果不符,其余所有突变位点的测序结果都完全一致,且重复性实验的结果也证实了其重复性达到了100%。结论:耐多药结核病快速诊断试剂盒有着非常出众的效果,对耐利福平具有非常显著的特异度和敏感度,因而具有重要的临床价值,可以在今后的临床工作中被广泛使用。
Objective: To investigate the specific efficacy of multidrug-resistant tuberculosis rapid diagnosis kit for testing drug-resistant Mycobacterium tuberculosis. Methods: Fifty MTB clinical isolates were selected and tested for resistance to MTB by MDR-TB test kit. The specificity, sensitivity and repeatability of MTB were analyzed and compared with the traditional methods . Results: The specificity and sensitivity of the two methods were compared. Among the 50 clinical isolates, the drug susceptibility test results showed that 32 strains were resistant to multidrug-resistant strains, 8 strains were single-isoniazid-resistant strains, 3 strains of flat strains, 5 strains of fully sensitive. However, when it was used in MDR-TB rapid diagnosis kit, 33 strains were detected in 35 rifampicin-resistant strains with a sensitivity of 94.3%. In 40 strains resistant to isoniazid, Out of 33 strains, the sensitivity reached 82.5%. The remaining fully sensitive strains all meet the standard, specificity of 100%. However, compared with the sequencing results, the rpoB gene of 50 clinical isolates except one milk sample did not accord with the sequencing results, and all the other mutation sites were identical in sequencing results, and the results of repetitive experiments also confirmed their repeats Sex reached 100%. Conclusion: The MDR-TB diagnostic kit has a very outstanding effect and has very significant specificity and sensitivity to rifampicin. Therefore, it has important clinical value and can be widely used in clinical work in the future.