Genotype MTBDR plus快速检测耐多药结核病的临床应用

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。

Evaluation of Genotype MTBDR plus assay for rapid detection of multidrug-resistant tuberculosis

Objective To detect the clinical application value of Genotype MTBDR plus assay in rapid detecting multidrug-resistant tuberculosis (MDR-TB).Methods The sputum samples and Mycobacterium tuberculosis strains from smear-positive patients with pulmonary tuberculosis (TB) were examined for rifampicin-and isoniazid-resistance by the conventional drug susceptibility test (DST) and Genotype MTBDR plus assay.The conventional DST results by the ratio method were served as the gold standard.Results In 368 smear-positive sputum specimens,the isoniazid-and rifampicin-resistant rates from the Genotype MTBDR plus assay had no significant difference with those from the conventional DST (P ＞ 0.05).Their concordance rates were 95.38％ (351/368) for the isoniazid resistance and 97.55％ (359/368) for the rifampicin resistance respectively.In 85 M.tuberculosis strains,the isoniazid-and rifampicin-resistant rates from the Genotype MTBDR plus assay had no significant difference with those from the conventional DST (P ＞ 0.05).Their concordance rates were 92.94％ (79/85) for the isoniazid resistance and 96.47％ (82/85) for the rifampicin resistance respectively.The sensitivities of isoniazid for smear positive sputum specimens and M.tuberculosis strains by Genotype MTBDR plus assay were 76.32％ (29/38) and 78.57％ (11/14),respectively.The specificities were 97.58％ (322/330) and 95.77％ (68/7 i),respectively.The sensitivities of rifampicin for smear positive sputum specimens and M.tuberculosis strains by Genotype MTBDR plus assay were 93.55％ (29/31) and 91.67％ (11/12),respectively.The specificities were 97.92％ (330/337) and 97.26％ (71/73),respectively.Conclusion The Genotype MTBDR plus assay is a rapid,ideal diagnostic method for rifampicin-and isoniazid-resistance.It is suitable for the conditional laboratory.