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

Churchyard, Gavin J.; Stevens, Wendy; Mametja, L D; McCarthy, Kerrigan; Chihota, Violet; Nicol, Mark P.; Erasmus, Linda; Ndjeka, Norbert; Mvusi, Lindiwe; Vassall, Anna; Sinanovic, Edina; Cox, Helen; Dye, Christopher; Grant, Alison D.; Fielding, Katherine

doi:10.1016/s2214-109x(15)00100-x

Cited by 197 publications

(232 citation statements)

References 9 publications

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“…The XTEND study found no evidence of a difference in mortality risk (91 [4%] of 2324 vs 116 [5%] of 2332; adjusted risk ratio 1·10, 95% CI 0·75-1·62). 11 We estimated the years lived with disability of its participants using the number of days with tuberculosis symptoms, assuming symptoms either stopped 2 weeks into treatment, continued to death, or stopped within 2 weeks of not returning to care. We applied disability weights used in the Global Burden of Disease 2010.…”

Section: Discussionmentioning

confidence: 99%

“…First, by reducing time with tuberculosis, Xpert might reduce the transmission of tuberculosis. However, the XTEND study 11 found no evidence for differences in time to treatment, the factor most likely to affect transmission. Second, increased diagnosis and survival from tuberculosis might increase antiretroviral therapy costs.…”

Section: Study Design and Participantsmentioning

confidence: 93%

“…The Xpert group were less likely to have a body-mass index of less than 18·5 kg/m² and to report tuberculosis symptoms. 11 Further details of the study population can be found in the appendix.…”

Section: Study Design and Participantsmentioning

confidence: 99%

“…10 The National Department of Health, South Africa agreed to stage the roll-out of Xpert to allow for a pragmatic cluster-randomised trial, the XTEND study, 11 to assess the effect on mortality and costeffectiveness of Xpert's introduction across South Africa. The XTEND study found no evidence that the Xpert introduction reduced 6 month mortality risk in adult clinic attendees being investigated for tuberculosis 11 as Xpert was scaled up nationally. We present a cost analysis and economic evaluation comparing Xpert with sputum smear microscopy as an initial diagnosis for tuberculosis.…”

Section: Introductionmentioning

confidence: 99%

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Cost-effectiveness of Xpert MTB/RIF for tuberculosis diagnosis in South Africa: A real-world cost analysis and economic evaluation

2017

Indian Journal of Tuberculosis

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Section: Discussionmentioning

confidence: 99%

Section: Study Design and Participantsmentioning

confidence: 93%

Section: Study Design and Participantsmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

See 2 more Smart Citations

Cost-effectiveness of Xpert MTB/RIF for tuberculosis diagnosis in South Africa: A real-world cost analysis and economic evaluation

2017

Indian Journal of Tuberculosis

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“…), and lack of impact assessment have also hampered its rollout. Insufficient focus has been afforded to effective linkage to care of diagnosed patients, and clinical impact has been blunted by weak health-care delivery systems, as shown by pragmatic trials in high burden settings [6,7]. In many countries, the private sector plays a major role in TB care, yet this sector has limited access to subsidized pricing [8].…”

Section: Who-endorsed Molecular Tb Testsmentioning

confidence: 99%

Molecular diagnosis of tuberculosis: we need solutions that span the healthcare value chain

MacLean

Huddart

Pai

2016

Expert Review of Molecular Diagnostics

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Xpert MTB/RIF and Xpert MTB/RIF Ultra for pulmonary tuberculosis and rifampicin resistance in adults

Horne

Kohli

Zifodya

et al. 2019

Cochrane Database of Systematic Reviews

187

157

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Background Xpert MTB/RIF (Xpert MTB/RIF) and Xpert MTB/RIF Ultra (Xpert Ultra), the newest version, are the only World Health Organization (WHO)‐recommended rapid tests that simultaneously detect tuberculosis and rifampicin resistance in persons with signs and symptoms of tuberculosis, at lower health system levels. A previous Cochrane Review found Xpert MTB/RIF sensitive and specific for tuberculosis ( ). Since the previous review, new studies have been published. We performed a review update for an upcoming WHO policy review. Objectives To determine diagnostic accuracy of Xpert MTB/RIF and Xpert Ultra for tuberculosis in adults with presumptive pulmonary tuberculosis (PTB) and for rifampicin resistance in adults with presumptive rifampicin‐resistant tuberculosis. Search methods We searched the Cochrane Infectious Diseases Group Specialized Register, MEDLINE, Embase, Science Citation Index, Web of Science, Latin American Caribbean Health Sciences Literature, Scopus, the WHO International Clinical Trials Registry Platform, the International Standard Randomized Controlled Trial Number Registry, and ProQuest, to 11 October 2018, without language restriction. Selection criteria Randomized trials, cross‐sectional, and cohort studies using respiratory specimens that evaluated Xpert MTB/RIF, Xpert Ultra, or both against the reference standard, culture for tuberculosis and culture‐based drug susceptibility testing or MTBDR plus for rifampicin resistance. Data collection and analysis Four review authors independently extracted data using a standardized form. When possible, we also extracted data by smear and HIV status. We assessed study quality using QUADAS‐2 and performed meta‐analyses to estimate pooled sensitivity and specificity separately for tuberculosis and rifampicin resistance. We investigated potential sources of heterogeneity. Most analyses used a bivariate random‐effects model. For tuberculosis detection, we first estimated accuracy using all included studies and then only the subset of studies where participants were unselected, i.e. not selected based on prior microscopy testing. Main results We identified in total 95 studies (77 new studies since the previous review): 86 studies (42,091 participants) evaluated Xpert MTB/RIF for tuberculosis and 57 studies (8287 participants) for rifampicin resistance. One study compared Xpert MTB/RIF and Xpert Ultra on the same participant specimen. Tuberculosis detection Of the total 86 studies, 45 took place in high tuberculosis burden and 50 in high TB/HIV burden countries. Most studies had low risk of bias. Xpert MTB/RIF pooled sensitivity and specificity (95% credible Interval (CrI)) were 85% (82% to 88%) and 98% (97% to 98%), (70 studies, 37,237 unselected participants; high‐certainty evidence). We found similar accuracy when ...

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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

Abstract: Bill & Melinda Gates Foundation.

Cited by 197 publications

References 9 publications

Cost-effectiveness of Xpert MTB/RIF for tuberculosis diagnosis in South Africa: A real-world cost analysis and economic evaluation

Cost-effectiveness of Xpert MTB/RIF for tuberculosis diagnosis in South Africa: A real-world cost analysis and economic evaluation

Molecular diagnosis of tuberculosis: we need solutions that span the healthcare value chain

Xpert MTB/RIF and Xpert MTB/RIF Ultra for pulmonary tuberculosis and rifampicin resistance in adults

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