Genotype MTBDRplus快速耐药诊断方法在地市级结核病医院应用的评估研究

Evaluation on the performance of Genotype MTBDRplus in prefectural tuberculosis hospitals

目的评价地市级结核病医院线性探针(LPA)快速耐药诊断试剂Genotype MTBDRplus的效能。方法以LPA技术在初诊涂阳肺结核病人中发现耐多药结核病的灵敏度不低于70%估算,大概需要纳入耐多药病例72例。在4个省选4个地市连续纳入1 653例初诊涂阳肺结核病人,收集痰样本,同时采用LPA方法和传统药敏试验方法检测利福平和异烟肼的耐药性,以传统药敏结果为标准,评价GenotypeMTBDRplus的检测效能。结果与传统方法比较,检测结核分枝杆菌利福平耐药的灵敏度、特异性、阳性预测值和阴性预测值分别为75.00%,94.69%,76.70%和96.16%,差异有统计学意义(P<0.05);检测结核分枝杆菌异烟肼耐药的灵敏度、特异性、阳性预测值和阴性预测值分别为70.95%,97.36%,83.24%和94.78%,差异无统计学意义(P>0.05);检测耐多药结核病灵敏度、特异性、阳性预测值和阴性预测值分别为66.39%,97.72%,73.83%和96.78%,差异无统计学意义(P>0.05)。结论线性探针技术可以在地市级专科医院应用快速诊断耐多药结核病,但是在开展过程中,必须对人员强化培训,加强督导。

Objective The aim of this study is to assess the performance of a commercially available Genotype MTBDRplus line probe assay（LPA） for rapid detection of rifampicin and isonizid resistance in prefectural tuberculosis hospitals in China.Methods We assessed the performance of a commercial line probe assay（Genotype MTBDRplus）for rapid detection of rifampicin and isoniazid resistance directly on smear-positive sputum specimens from 1 653 patients diagnosed in 4 prefectural tuberculosis hospitals in 4 provinces,China.Results were compared with conventional drug susceptibility testing（DST）.Results Compared to the results of conventional DST,the sensitivity,specificity,positive and negative predictive values were 75%,94.69%,76.7% and 96.16% determined by LPA for detection of rifampicin resistance,which had significant difference,and 70.95%,97.36%,83.24% and 94.78% for isoniazid resistance,which had no difference.They were 66.39%,97.72%,73.83% and 96.78% for detection of multidrug-resistance which also showed no difference compared with conventional results.Conclusions Genotype MTBDRplus can be used for rapid detection of MDR-TB in prefectural tuberculosis hospitals and has the potential to substantially reduce the turnaround time of DST.But performers need to be trained and supervised to ensure high quality results.