Xpert MTB/RIF versus sputum microscopy as the initialuddiagnostic test for tuberculosis: a cluster-randomised trialudembedded in South African roll-out of Xpert MTB/RIF

摘要

Background In South Africa, sputum smear microscopy has been replaced with Xpert MTB/RIF as the initialuddiagnostic test for tuberculosis. In a pragmatic parallel cluster-randomised trial, we evaluated the eff ect on patient andudprogramme outcomes.udMethods We randomly allocated 20 laboratories (clusters) in medium-burden districts of South Africa to either an Xpertud(immediate Xpert) or microscopy (Xpert deferred) group (1:1), stratifi ed by province. At two primary care clinics perudlaboratory, a systematic sample of adults giving sputum for tuberculosis investigation was assessed for eligibility. Theudprimary outcome was mortality at 6 months from enrolment. Masking of participants’ group allocation was not possibleudbecause of the pragmatic trial design. The trial is registered with the ISRCTN registry (ISRCTN68905568) and theudSouth African Clinical Trial Register (DOH-27-1011-3849).udFindings Between June and November, 2012, 4972 people were screened, and 4656 (93·6%) enrolled (median ageud36 years; 2891 [62%] female; 2212 [62%] reported being HIV-positive). There was no diff erence between the Xpert andudmicroscopy groups with respect to mortality at 6 months (91/2324 [3·9%] vs 116/2332 [5·0%], respectively; adjustedudrisk ratio [aRR] 1·10, 95% CI 0·75–1·62]).udInterpretation Xpert did not reduce mortality at 6 months compared with sputum microscopy. Improving outcomes inuddrug-sensitive tuberculosis programmes might require not only better diagnostic tests but also better linkage to care.