Background: The XpertÃ?® MTB/RIF (XP) has a higher sensitivity than sputum smear microscopy (70% versus 35%) for\nTB diagnosis and has been endorsed by the WHO for TB high burden countries to increase case finding among HIV\nco-infected presumptive TB patients. Its impact on the diagnosis of smear-negative TB in a routine care setting is\nunclear. We determined the change in diagnosis, treatment and mortality of smear-negative presumptive TB with\nroutine use of Xpert MTB/RIF (XP).\nMethods: Prospective cohort study of HIV-positive smear-negative presumptive TB patients during a 12-month\nperiod after XP implementation in a well-staffed and trained integrated TB/HIV clinic in Kampala, Uganda. Prior to\ntesting clinicians were asked to decide whether they would treat empirically prior to Xpert result; actual treatment\nwas decided upon receipt of the XP result. We compared empirical and XP-informed treatment decisions and\nall-cause mortality in the first year.\nResults: Of 411 smear-negative presumptive TB patients, 175 (43%) received an XP; their baseline characteristics did\nnot differ. XP positivity was similar in patients with a pre-XP empirical diagnosis and those without (9/29 [17%]\nversus 14/142 [10%], P = 0.23). Despite XP testing high levels of empirical treatment prevailed (18%), although XP\nresults did change who ultimately was treated for TB. When adjusted for CD4 count, empirical treatment was not\nassociated with higher mortality compared to no or microbiologically confirmed treatment.\nConclusions: XP usage was lower than expected. The lower sensitivity of XP in smear-negative HIV-positive\npatients led experienced clinicians to use XP as a ââ?¬Å?rule-inââ?¬Â rather than ââ?¬Å?rule-outââ?¬Â test, with the majority of patients\nstill treated empirically.
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