Performance of GeneXpert MTB/RIF for diagnosing tuberculosis among symptomatic household contacts of index patients in South Africa
Abstract Background We describe the performance of GeneXpert MTB/RIF (Xpert) for diagnosing tuberculosis (TB) among symptomatic household contacts (HHCs) of rifampicin-resistant and drug-sensitive index cases. Methods We conducted a cross-sectional study among HHCs of recently diagnosed (<2 weeks) smear-positive and Xpert-positive index cases in the Bojanala District, South Africa. HHCs were screened for TB symptoms; persons with ≥1 TB symptom provided one sputum for smear microscopy, Xpert and MGIT culture. Diagnostic test performance of Xpert was determined using MGIT as reference standard. Results From August 2013 to July 2015, 619 HHCs from 216 index cases were enrolled: 60.6% were female, median age was 22 years (inter-quartile range: 9, 40) and 126 (20.4%) self-reported/tested HIV-positive. 54.3% (336/619) of contacts had ≥1 TB symptom (cough, fever, night sweats, weight loss), of which 297/336 (88.4%) provided a sputum; 289 (97.3%) had complete testing and 271 were included in the analysis. In total, 42 (6.8%) of 619 HHCs had microbiologically-confirmed TB. MGIT identified 33 HHCs as positive for Mycobacterium tuberculosis (MTB); of these, 7 were positive on Xpert resulting in a sensitivity of 21.2% (95% confidence interval [CI]: 9.0, 38.9), specificity 98.3% (95% CI: 95.6, 99.5), positive predictive value (PPV) 63.6% (95% CI: 30.8, 89.1), negative predictive value (NPV) 90.0 (95% CI: 85.7, 93.4). Conclusions Among symptomatic HHCs investigated for TB, Xpert performed sub-optimally compared to MGIT culture. The poor performance of Xpert for diagnosing TB suggests that a more sensitive test, such a Xpert Ultra or culture, may be needed to improve yield of contact investigation, where feasible.