Background
Patients at elevated risk of drug-resistant tuberculosis are prioritized for testing with Xpert MTB/RIF® (“Xpert”), though clinical utility in this population is understudied.
Design
From November 2011 to June 2014, consecutive outpatients with history of prior tuberculosis in high-density suburbs of Harare, Zimbabwe were tested with Xpert, solid and liquid culture, and the microscopically-observed drug susceptibility assay. Diagnostic accuracy for rifampin-resistance and time to second-line regimens were ascertained. The rpoB gene was sequenced in cases of culture-confirmed rifampin resistance and genotypic sensitivity.
Results
Among 352 retreatment patients, 71 (20%) had rifampin-resistant, 98 (28%) rifampin-susceptible, 64 (18%) culture-negative/Xpert-positive, and 119 (34%) culture-negative/Xpert-negative TB. Xpert was 86% (95% CI 75-93%) sensitive and 98% (95% CI 92-100%) specific for rifampin-resistant TB. The positive predictive value of Xpert-determined rifampin resistance for MDR-TB was 82% (95% CI 70-91%). Fifty-nine of 71 (83%) participants initiated SLDs, with a median time to regimen initiation of 18 days (IQR, 10-44 days).
Conclusion
The diagnostic accuracy of Xpert for rifampin-resistance is high, though predictive value for MDR-TB is lower than anticipated. Xpert allows for faster SLD initiation under programmatic conditions, relative to culture-based drug susceptibility testing.