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Evaluation on the performance of Genotype MTBDRplus in prefectural tuberculosis hospitals

LI Qiang,OU Xi-chao,XIA Hui,ZHAO Bing,ZHAO Yan-lin National Center for TB Control and Prevention,China CDC,Beijing 102206,China  
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.
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