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dc.contributor.author | Boehme, C.C. | |
dc.contributor.author | Nicol, M.P. | |
dc.contributor.author | Nabeta, P. | |
dc.contributor.author | Michael, J.S. | |
dc.contributor.author | Gotuzzo Herencia, José Eduardo | |
dc.contributor.author | Tahirli, R. | |
dc.contributor.author | Gler, M.T. | |
dc.contributor.author | Blakemore, R. | |
dc.contributor.author | Worodria, W. | |
dc.contributor.author | Gray, C. | |
dc.contributor.author | Huang, L. | |
dc.contributor.author | Cáceres Nakiche, Tatiana | |
dc.contributor.author | Mehdiyev, R. | |
dc.contributor.author | Raymond, L. | |
dc.contributor.author | Whitelaw, A. | |
dc.contributor.author | Sagadevan, K. | |
dc.contributor.author | Alexander, H. | |
dc.contributor.author | Albert, H. | |
dc.contributor.author | Cobelens, F. | |
dc.contributor.author | Cox, H. | |
dc.contributor.author | Alland, D. | |
dc.contributor.author | Perkins, M.D. | |
dc.date.accessioned | 2022-01-18T19:26:48Z | |
dc.date.available | 2022-01-18T19:26:48Z | |
dc.date.issued | 2011 | |
dc.identifier.uri | https://hdl.handle.net/20.500.12866/10897 | |
dc.description.abstract | The Xpert MTB/RIF test (Cepheid, Sunnyvale, CA, USA) can detect tuberculosis and its multidrug-resistant form with very high sensitivity and specificity in controlled studies, but no performance data exist from district and subdistrict health facilities in tuberculosis-endemic countries. We aimed to assess operational feasibility, accuracy, and effectiveness of implementation in such settings. We assessed adults (≥18 years) with suspected tuberculosis or multidrug-resistant tuberculosis consecutively presenting with cough lasting at least 2 weeks to urban health centres in South Africa, Peru, and India, drug-resistance screening facilities in Azerbaijan and the Philippines, and an emergency room in Uganda. Patients were excluded from the main analyses if their second sputum sample was collected more than 1 week after the first sample, or if no valid reference standard or MTB/RIF test was available. We compared one-off direct MTB/RIF testing in nine microscopy laboratories adjacent to study sites with 2-3 sputum smears and 1-3 cultures, dependent on site, and drug-susceptibility testing. We assessed indicators of robustness including indeterminate rate and between-site performance, and compared time to detection, reporting, and treatment, and patient dropouts for the techniques used. We enrolled 6648 participants between Aug 11, 2009, and June 26, . One-off MTB/RIF testing detected 933 (90·3) of 1033 culture-confirmed cases of tuberculosis, compared with 699 (67·1) of 1041 for microscopy. MTB/RIF test sensitivity was 76·9 in smear-negative, culture-positive patients (296 of 385 samples), and 99·0 specific (2846 of 2876 non-tuberculosis samples). MTB/RIF test sensitivity for rifampicin resistance was 94·4 (236 of 250) and specificity was 98·3 (796 of 810). Unlike microscopy, MTB/RIF test sensitivity was not significantly lower in patients with HIV co-infection. Median time to detection of tuberculosis for the MTB/RIF test was 0 days (IQR 0-1), compared with 1 day (0-1) for microscopy, 30 days (23-43) for solid culture, and 16 days (13-21) for liquid culture. Median time to detection of resistance was 20 days (10-26) for line-probe assay and 106 days (30-124) for conventional drug-susceptibility testing. Use of the MTB/RIF test reduced median time to treatment for smear-negative tuberculosis from 56 days (39-81) to 5 days (2-8). The indeterminate rate of MTB/RIF testing was 2·4 (126 of 5321 samples) compared with 4·6 (441 of 9690) for cultures. The MTB/RIF test can effectively be used in low-resource settings to simplify patients' access to early and accurate diagnosis, thereby potentially decreasing morbidity associated with diagnostic delay, dropout and mistreatment. Foundation for Innovative New Diagnostics, Bill & Melinda Gates Foundation, European and Developing Countries Clinical Trials Partnership (TA2007.40200.009), Wellcome Trust (085251/B/08/Z), and UK Department for International Development. | en_US |
dc.language.iso | eng | |
dc.publisher | Elsevier | |
dc.relation.ispartofseries | Lancet | |
dc.rights | info:eu-repo/semantics/restrictedAccess | |
dc.rights.uri | https://creativecommons.org/licenses/by-nc-nd/4.0/deed.es | |
dc.subject | Controlled Study | en_US |
dc.subject | Major Clinical Study | en_US |
dc.subject | Diagnostic Test | en_US |
dc.subject | Endemic Disease | en_US |
dc.subject | Rifampicin | en_US |
dc.subject | Human Immunodeficiency Virus Infection | en_US |
dc.subject | Multicenter Study | en_US |
dc.subject | Diagnostic Test Accuracy Study | en_US |
dc.subject | Sensitivity And Specificity | en_US |
dc.subject | Sputum Culture | en_US |
dc.subject | Sputum Smear | en_US |
dc.subject | Uganda | en_US |
dc.subject | Multidrug Resistant Tuberculosis | en_US |
dc.subject | Mixed Infection | en_US |
dc.subject | Microscopy | en_US |
dc.subject | Multidrug Resistance | en_US |
dc.subject | Antibiotic Sensitivity | en_US |
dc.subject | Feasibility Study | en_US |
dc.subject | Health Care Access | en_US |
dc.subject | Clinical Effectiveness | en_US |
dc.subject | Reference Value | en_US |
dc.subject | Health Care Facility | en_US |
dc.subject | Xpert MTB RIF Test | en_US |
dc.title | Feasibility, diagnostic accuracy, and effectiveness of decentralised use of the Xpert MTB/RIF test for diagnosis of tuberculosis and multidrug resistance: A multicentre implementation study | en_US |
dc.type | info:eu-repo/semantics/article | |
dc.identifier.doi | https://doi.org/10.1016/S0140-6736(11)60438-8 | |
dc.subject.ocde | https://purl.org/pe-repo/ocde/ford#3.01.00 | |
dc.relation.issn | 1474-547X |
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