Accuracy of cobas MTB and MTB-RIF/INH for detection of M. tuberculosis and drug resistance.

This study evaluated the performance of cobas MTB and cobas MTB-RIF/INH for the diagnosis of tuberculosis (TB) and detection of rifampicin (RIF) and isoniazid (INH) resistance. Adults presenting with pulmonary TB symptoms were recruited in South Africa, Moldova and India. Performance of cobas MTB was assessed using culture as reference, while cobas MTB-RIF/INH was assessed using phenotypic drug susceptibility testing and whole genome sequencing as composite reference standards. Xpert MTB/RIF (Xpert) or Xpert MTB/RIF Ultra (Ultra) were used as comparators. The overall sensitivity and specificity of cobas MTB was 95% (95% CI, 93%-96%) and 96% (95% CI, 95%-97%). Among smear-negatives, sensitivity of cobas MTB was 75% (95% CI, 66%-83%). Among participants tested with both cobas MTB and Xpert, sensitivity was 96% (95% CI, 94%-97%) for cobas MTB and 95% (95% CI, 93%-97%) for Xpert. Among participants tested with both cobas MTB and Ultra, sensitivity was 88% (95% CI, 81%-92%) for cobas MTB and 89% (95% CI, 83%-93%) for Ultra. Sensitivity and specificity of cobas MTB-RIF/INH for RIF and INH detection was 90% (95% CI, 84%-94%) and 100% (95% CI, 99%-100), and 89% (95% CI, 84%-93%) and 99.5% (95% CI, 98%-100%). The cobas MTB and cobas MTB-RIF/INH assays exhibited high performance in a diverse population and present a suitable option for molecular detection of TB and both RIF and INH resistance.

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