Universidad Peruana Cayetano Heredia

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

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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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