Evaluating the performance of the InnowaveDx MTB/RIF/INH for simultaneous detection of Mycobacterium tuberculosis and resistance to rifampicin and isoniazid

Objective To evaluate the diagnostic performance of the InnowaveDx MTB/RIF/INH assay for the simultaneous detection of Mycobacterium tuberculosis and resistance to rifampicin and isoniazid. Methods We evaluated the performance of the InnowaveDx MTB/RIF/INH (InnowaveDx) assay in diagnosing pulmonary tuberculosis and detecting rifampicin and isoniazid resistance at the Zhejiang Hospital of Integrated Traditional Chinese and Western Medicine. Results Using the clinical final diagnosis as the standard, the sensitivity of InnowaveDx was 68.0%, which was higher than that of acid-fast bacilli smear, MGIT culture, and Xpert (P Conclusions The InnowaveDx MTB/RIF/INH assay demonstrates good performance in detecting M. tuberculosis as well as rifampicin and isoniazid resistance. The discrepancies in rifampicin-resistance results and phenotypic resistance are mainly the result of borderline resistance mutations.