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Lancet Glob Health. 2015 Aug;3(8):e450-e457. doi: 10.1016/S2214-109X(15)00100-X.

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.

Author information

1
Aurum Institute, Johannesburg, South Africa; London School of Hygiene & Tropical Medicine, London, United Kingdom; School of Public Health, University of the Witwatersrand, Johannesburg, South Africa. Electronic address: gchurchyard@auruminstitute.org.
2
National Health Laboratory Service, Johannesburg, South Africa; Department of Molecular Medicine and Haematology, University of the Witwatersrand, Johannesburg, South Africa.
3
TB Cluster, National Department of Health, South Africa.
4
Aurum Institute, Johannesburg, South Africa.
5
National Health Laboratory Service, Johannesburg, South Africa; Division of Medical Microbiology, University of Cape Town, Cape Town, South Africa.
6
National Health Laboratory Service, Johannesburg, South Africa; Division of Public Health Surveillance and Response, National Institute for Communicable Diseases, Johannesburg, South Africa.
7
London School of Hygiene & Tropical Medicine, London, United Kingdom.
8
Health Economics Unit, School of Public Health and Family Medicine, University of Cape Town, Cape Town, South Africa.
9
Division of Medical Microbiology, University of Cape Town, Cape Town, South Africa.
10
World Health Organization, Geneva, Switzerland.
11
London School of Hygiene & Tropical Medicine, London, United Kingdom; School of Public Health, University of the Witwatersrand, Johannesburg, South Africa.

Abstract

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.

FUNDING:

Bill & Melinda Gates Foundation.

PMID:
26187490
DOI:
10.1016/S2214-109X(15)00100-X
[Indexed for MEDLINE]
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