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Implementing the Xpert(R) MTB/RIF diagnostic test for tuberculosis and rifampicin resistance: outcomes and lessons learned in 18 countries

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dc.contributor.author Ardizzoni, E.
dc.contributor.author Fajardo, E.
dc.contributor.author Saranchuk, P.
dc.contributor.author Casenghi, M.
dc.contributor.author Page, A. L.
dc.contributor.author Varaine, F.
dc.contributor.author Kosack, C. S.
dc.contributor.author Hepple, P.
dc.date.accessioned 2016-03-11T10:30:52Z
dc.date.available 2016-03-11T10:30:52Z
dc.date.issued 2015
dc.identifier.issn 1932-6203
dc.identifier.doi http://dx.doi.org/10.1371/journal.pone.0144656
dc.identifier.other ITG-B1B
dc.identifier.other DBM
dc.identifier.other U-MYCOB
dc.identifier.other JIF
dc.identifier.other DOI
dc.identifier.other FTA
dc.identifier.other OAJ
dc.identifier.other Abstract
dc.identifier.other UPD60
dc.identifier.uri http://hdl.handle.net/10390/8730
dc.description.abstract BACKGROUND: The Xpert(R) MTB/RIF (Xpert) is an automated molecular test for simultaneous detection of tuberculosis (TB) and rifampicin resistance, recommended by the World Health Organization as the preferred diagnostic method for individuals presumed to have multi-drug resistant TB (MDR-TB) or HIV-associated TB. We describe the performance of Xpert and key lessons learned during two years of implementation under routine conditions in 33 projects located in 18 countries supported by Medecins Sans Frontieres across varied geographic, epidemiological and clinical settings. METHODS: Xpert was used following three strategies: the first being as the initial test, with microscopy in parallel, for all presumptive TB cases; the second being only for patients at risk of MDR-TB, or with HIV- associated TB, or presumptive paediatric TB; and the third being as the initial test for these high-risk patients plus as an add-on test to microscopy in others. Routine laboratory data were collected, using laboratory registers. Qualitative data such as logistic aspects, human resources, and tool acceptance were collected using a questionnaire. FINDINGS: In total, 52,863 samples underwent Xpert testing from April 2011 to December 2012. The average MTB detection rate was 18.5%, 22.3%, and 11.6% for the three different strategies respectively. Analysis of the results on samples tested in parallel showed that using Xpert as add-on test to microscopy would have increased laboratory TB confirmation by 49.7%, versus 42.3% for Xpert replacing microscopy. The main limitation of the test was the high rate of inconclusive results, which correlated with factors such as defective modules, cartridge version (G3 vs. G4) and staff experience. Operational and logistical hurdles included infrastructure renovation, basic computer training, regular instrument troubleshooting and maintenance, all of which required substantial and continuous support. CONCLUSION: The implementation of Xpert was feasible and significantly increased TB detection compared to microscopy, despite the high rate of inconclusive results. Xpert implementation was accompanied by considerable operational and logistical challenges. To further decentralize diagnosis, simpler, low-cost TB technologies well-suited to low-resource settings are still urgently needed. en_US
dc.language English en_US
dc.subject Bacterial diseases en_US
dc.subject Tuberculosis en_US
dc.subject Mycobacterium tuberculosis en_US
dc.subject Molecular diagnostic techniques en_US
dc.subject Drug resistance en_US
dc.subject Rifampicin en_US
dc.subject Detection en_US
dc.subject Performance en_US
dc.subject Implementation en_US
dc.subject International collaboration en_US
dc.subject Comparison en_US
dc.subject Microscopy en_US
dc.subject Organization en_US
dc.subject Human resources en_US
dc.subject Acceptability en_US
dc.subject Tools en_US
dc.subject Feasibility en_US
dc.subject Africa, General en_US
dc.subject Asia, General en_US
dc.subject Europe, East en_US
dc.title Implementing the Xpert(R) MTB/RIF diagnostic test for tuberculosis and rifampicin resistance: outcomes and lessons learned in 18 countries en_US
dc.type Article-E en_US
dc.citation.issue 12 en_US
dc.citation.jtitle PLoS ONE en_US
dc.citation.volume 10 en_US
dc.citation.pages e0144656 en_US
dc.identifier.pmid http://www.ncbi.nlm.nih.gov/pubmed/26670929
dc.citation.jabbreviation PLoS ONE en_US


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