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INTRODUCTION: GeneXpert® MTB/RIF (Xpert) is now widely distributed in high human immunodeficiency virus (HIV)/tuberculosis (TB)-burden countries. Yet, whether the test improves patient-important outcomes within HIV treatment programs in limited resource settings is unknown. METHODS: To investigate whether use of Xpert for TB screening prior to initiation of antiretroviral treatment (ART) improves patient-important outcomes, in a pragmatic randomized controlled trial we assigned 424 patients to Xpert or fluorescence sputum smear microscopy (FM) at ART initiation. The primary endpoint was a composite of 3-month mortality and ART-associated TB. RESULTS: There was no difference in overall TB diagnosis at ART initiation (20% [n = 43] Xpert vs 21% [n = 45] FM; P = .80), with most patients in both groups treated empirically. There was no difference in time to TB treatment initiation {5 days (interquartile range [IQR], 3-13) vs 8 days [IQR, 3-23; P = .26]} or loss to follow-up (32 [15%] vs 38 [18%]; P = 0.38). Although a nonsignificant reduction in mortality occurred in the Xpert group (11 [6%] vs 17 [10%]; 95% CI, -9% to 2%; P = .19), there was no difference in the composite outcome (9% [n = 17] Xpert vs 12% [n = 21] FM; difference -3%; 95% CI, -9% to 4%). CONCLUSIONS: Among HIV-infected initiating ART, centralized TB screening with Xpert did not reduce the rate of ART-associated TB and mortality, compared with fluorescence microscopy.
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OBJECTIVE: To evaluate a commercially available antigen capture enzyme-linked immunosorbent assay (ELISA) based on detecting lipoarabinomannan (LAM) in urine for the diagnosis of tuberculosis (TB). DESIGN: Consenting TB suspects and registering TB patients prospectively recruited from three hospitals were asked for two sputum specimens for microscopy and culture, urine for LAM testing and blood for human immunodeficiency virus (HIV) testing, with radiological and clinical follow-up for 2 months. RESULTS: Of 427 participants, complete data were available from 397 (307 adult and 23 adolescent TB suspects, and 67 registering TB patients). HIV prevalence was 77%. TB was diagnosed in 195 (49%), including 161 culture-positive patients, and confidently excluded in 114 (29%) participants. LAM ELISA sensitivity was 44% (95%CI 36-52) for culture-confirmed TB (52% in smear-positive patients). Specificity was 89% (95%CI 81-94). Sensitivity was significantly higher in HIV-related TB (52%, 95%CI 43-62, P < 0.001) compared to HIV-negative TB (21%, 95%CI 9-37). Sensitivity in smear-negative patients was low (28%, 95%CI 13-43) for combined HIV-positive and -negative patients. CONCLUSION: Our findings confirm greater sensitivity of urine LAM detection for HIV-related TB. However, both sensitivity and specificity were suboptimal, suggesting that this version cannot confirm or exclude TB in either HIV-infected or non-infected patients.
