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目的评价Genotype MTBDR plus快速检测耐多药结核病的临床应用价值。方法对涂阳肺结核患者痰标本和临床分离菌株分别用传统比例法药敏试验和Genotype MTBDR plus进行异烟肼和利福平耐药性检测,以比例法药敏试验为金标准对Genotype MTBDR plus检测结果进行比较分析。结果在368例涂阳痰标本中,比例法药敏试验与Genotype MTBDR plus检测异烟肼、利福平耐药率比较,差异均无统计学意义(P均>0.05);两种方法检测异烟肼和利福平的一致率分别为95.38%(351/368)和97.55%(359/368)。在85例临床分离菌株中,比例法药敏试验与Genotype MTB-DR plus检测异烟肼、利福平耐药率比较,差异均无统计学意义(P均>0.05)。两种方法检测异烟肼和利福平一致率分别为92.94%(79/85)和96.47%(82/85)。与比例法药敏试验比较,Genotype MTBDR plus检测涂阳痰标本和菌株中异烟肼的灵敏度分别为76.32%(29/38)、78.57%(11/14),特异性分别为97.58%(322/330)、95.77%(68/71));检测利福平的灵敏度分别为93.55%(29/31)、91.67%(11/12),特异性分别为97.92%(330/337)、97.26%(71/73)。结论 Genotype MTBDRplus能快速检测结核分枝杆菌对异烟肼、利福平的耐药性,和传统药敏试验比较具有较高的一致性和特异性,是目前快速诊断耐多药结核病的一种较为理想的检测方法,适宜在有条件的实验室开展。
Objective To evaluate the clinical value of Genotype MTBDR plus for rapid detection of multidrug-resistant tuberculosis. Methods Sputum and smear-positive isolates of smear positive pulmonary tuberculosis patients were tested for resistance to isoniazid and rifampicin by traditional proportional drug susceptibility test and Genotype MTBDR plus respectively. Genotype MTBDR plus Test results for comparative analysis. Results There were no significant differences in the drug resistance rates between isoniazid and rifampicin (P> 0.05) in the smear-positive sputum samples of 368 smear positive cases and the Genotype MTBDR plus test (all P> 0.05) The agreement rates of hydrazine and rifampicin were 95.38% (351/368) and 97.55% (359/368), respectively. Among the 85 clinical isolates, there was no significant difference in drug resistance between proportionate drug resistance test and Genotype MTB-DR plus test for isoniazid and rifampin (P> 0.05). The coincidence rates of isoniazid and rifampin between the two methods were 92.94% (79/85) and 96.47% (82/85), respectively. The sensitivity of Genotype MTBDR plus for the detection of isoniazid in sputum samples and strains was 76.32% (29/38) and 78.57% (11/14), respectively, with specificity of 97.58% (322 /330),95.77% (68/71). The sensitivity of detection of rifampicin were 93.55% (29/31), 91.67% (11/12), 97.92% (330/337), 97.26 % (71/73). Conclusion Genotype MTBDRplus can rapidly detect the drug resistance of Mycobacterium tuberculosis to isoniazid and rifampicin and has high consistency and specificity compared with the traditional drug susceptibility test. It is a kind of rapid diagnosis of multidrug-resistant tuberculosis The ideal detection method, suitable for the laboratory in the conditions.