Xpert MTB/RIF versus sputum microscopy as the initial diagnostic test for tuberculosis: a cluster-randomised trial embedded in South African roll-out of Xpert MTB/RIF
Summary
Background
In South Africa, sputum
smear microscopy has been replaced with Xpert MTB/RIF as the
initial diagnostic test for tuberculosis. In a pragmatic
parallel cluster-randomised trial, we evaluated the effect on
patient and programme outcomes.
Methods
We randomly allocated 20
laboratories (clusters) in medium-burden districts of South
Africa to either an Xpert (immediate Xpert) or microscopy (Xpert
deferred) group (1:1), stratified by province. At two primary
care clinics per laboratory, a systematic sample of adults
giving sputum for tuberculosis investigation was assessed for
eligibility. The primary outcome was mortality at 6 months from
enrolment. Masking of participants' group allocation was not
possible because of the pragmatic trial design. The trial is
registered with the ISRCTN registry (ISRCTN68905568) and the
South African Clinical Trial Register (DOH-27-1011-3849).
Findings
Between June and November,
2012, 4972 people were screened, and 4656 (93·6%)
enrolled (median age 36 years; 2891 [62%] female; 2212 [62%]
reported being HIV-positive). There was no difference between
the Xpert and microscopy groups with respect to mortality at 6
months (91/2324 [3·9%] vs 116/2332 [5·0%],
respectively; adjusted risk ratio [aRR] 1·10, 95% CI
0·75–1·62]).
Interpretation
Xpert did not reduce
mortality at 6 months compared with sputum microscopy. Improving
outcomes in drug-sensitive tuberculosis programmes might require
not only better diagnostic tests but also better linkage to
care.
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Source:
The Lancet Global Health
