GenoType MTBDRplus VER2.0对痰样本结核分枝杆菌及其耐药性检测的应用评价

GenoType MTBDRplus VER2.0 for determining Mycobacterium tuberculosis and drug resistance in sputum specimens

目的评价结核分枝杆菌及耐药基因检测试剂盒——GenoType MTBDRplus VER2.0的检测效果。方法对纳入研究的痰样本同时进行涂片镜检、MGITTM 960液体培养、液体药物敏感性试验和GenoType MTBDRplus VER2.0检测。以MGITTM 960液体培养、液体药物敏感性试验结果为判定标准,分析GenoType MTBDRplus VER2.0检测结核分枝杆菌的敏感性和特异性以及与液体培养方法的一致性,并对不一致的样本进行测序确认。结果与液体培养和液体药物敏感性试验相比,GenoType MTBDRplus VER2.0对痰样本结核分枝杆菌检测的敏感性和特异性分别为90.85%和94.34%,涂片阳性且培养阳性和涂片阴性而培养阳性样本的敏感性分别为93.75%和85.96%,对利福平药物敏感性试验的敏感性和特异性分别为100.00%和97.30%,对异烟肼耐药的敏感性和特异性分别为84.44%和96.94%。结论 GenoType MTBDRplus VER2.0可以满足临床对结核分枝杆菌早期诊断和及时治疗的需求。

Objective To evaluate the performance of GenoType MTBDRplus VER2.0 for determining Mycobacterium tuberculosis and drug resistance in sputum specimens. Methodse Smear,MGITTM 960 liquid culturing,liquid drug susceptibility test and GenoType MTBDRplus VER2.0 were used. Using MGITTM 960 liquid culturing and liquid drug susceptibility test as standards,the sensitivity,specificity of GenoType MTBDRplus VER2.0 and the consistency with MGITTM 960 liquid culturing were analyzed,and the samples with different results were further performed for sequencing. Results Compared with MGITTM 960 liquid culturing and liquid drug susceptibility test,the sensitivity and specificity of GenoType MTBDRplus VER2.0 for the determination of Mycobacterium tuberculosis were 90.85% and 94.34%. The sensitivities for sputum with smear-positive and culturing-positive and sputum with smear-negative and culturing-positive were 93.75% and 85.96%. The sensitivity and specificity of liquid drug susceptibility test to rifampin were 100.00% and 97.3%,and those to isoniazide were 84.44% and 96.94%. Conclusions GenoType MTBDRplus VER2.0 is a rapid and effective method for determining Mycobacterium tuberculosis.