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dc.contributor.authorFriedrich, Sven Olaf
dc.contributor.authorRachow, Andrea
dc.contributor.authorSaathoff, Elmar
dc.contributor.authorSingh, Kasha
dc.contributor.authorMangu, Chacha D
dc.contributor.authorDawson, Rodney
dc.contributor.authorPhillips, Patrick
dc.contributor.authorVenter, Amour
dc.contributor.authorBateson, Anna
dc.contributor.authorBoehme, Catharina C
dc.contributor.authorHeinrich, Norbert
dc.contributor.authorHunt, Robert
dc.contributor.authorBoeree, Martin J
dc.contributor.authorZumla, Alimudden
dc.contributor.authorMcHugh, Timothy D
dc.contributor.authorGillespie, Stephen Henry
dc.contributor.authorDiacon, Andreas
dc.contributor.authorHoelscher, Michael
dc.date.accessioned2014-05-14T16:01:03Z
dc.date.available2014-05-14T16:01:03Z
dc.date.issued2013
dc.identifier.citationFriedrich , S O , Rachow , A , Saathoff , E , Singh , K , Mangu , C D , Dawson , R , Phillips , P , Venter , A , Bateson , A , Boehme , C C , Heinrich , N , Hunt , R , Boeree , M J , Zumla , A , McHugh , T D , Gillespie , S H , Diacon , A & Hoelscher , M 2013 , ' Assessment of the sensitivity and specificity of Xpert MTB/RIF assay as an early sputum biomarker of response to tuberculosis treatment ' , The Lancet Respiratory Medicine , vol. 1 , no. 6 , pp. 462-470 . https://doi.org/10.1016/S2213-2600(13)70119-Xen
dc.identifier.issn2213-2600
dc.identifier.otherPURE: 65971347
dc.identifier.otherPURE UUID: 131074b9-bac1-4176-b97e-1e29ee4a920c
dc.identifier.otherScopus: 84881369293
dc.identifier.otherORCID: /0000-0001-6537-7712/work/39477811
dc.identifier.urihttps://hdl.handle.net/10023/4792
dc.descriptionFunding: PanACEA is funded by the European and Developing Countries Clinical Trials Partnership (grants numbers CT.2004.32011.001, IP.2007.32011.011, IP.2007.32011.012, IP.2007.32011.013), Global Alliance for TB Drug Development, Bill & Melinda Gates Foundation, UK Medical Research Council, and German Ministry of Science and Technology (grant number 01KA0901).en
dc.description.abstractBackground An accurate biomarker for monitoring response to treatment of pulmonary tuberculosis is urgently needed. The Xpert® MTB/RIF assay is a commercially available real-time PCR that detects Mycobacterium tuberculosis-specific DNA sequences in sputum samples. Methods Sputum samples from 221 patients with smear-positive tuberculosis enrolled in a multi-centre randomized clinical trial of anti-tuberculosis treatment were analysed weekly (weeks 0 to 8), then at weeks 12, 17, 22, 26 after treatment initiation. The Xpert® MTB/RIF results over time were compared with the results of standard smear and culture methods. Findings Xpert® MTB/RIF positivity rates declined slower than those of standard methods. At week 8, smear, solid culture, liquid culture, and the Xpert® MTB/RIF were positive in 29·2%, 26·3%, 42·1% and 84·1%, respectively, and at 26 weeks in 5·0%, 2·5%, 4·1%, and 26·5%, respectively. The decline of quantitative M. tuberculosis DNA detection via the Xpert® MTB/RIF correlated with smear grades (rho=-0·74; P<0·01), solid culture grades (rho=-0·73; P<0·01), and liquid culture time to positivity (rho=0·73; P<0·01). Compared to combined binary smear and culture results as reference standard, the Xpert® MTB/RIF assay had high sensitivity (97·0%) but poor specificity (48·6%). Interpretation Quantitative Xpert® MTB/RIF readouts correlate well with M tuberculosis smear and culture results during anti-tuberculosis treatment. The poor specificity precludes the use of Xpert® MTB/RIF assay as a biomarker for tuberculosis treatment monitoring.
dc.format.extent9
dc.language.isoeng
dc.relation.ispartofThe Lancet Respiratory Medicineen
dc.rightsCopyright © 2013 Elsevier Ltd. All rights reserved. Published open access.en
dc.subjectTuberculosisen
dc.subjectBiomarkeren
dc.subjectMycobacterium tuberculosisen
dc.subjectSputumen
dc.subjectXpert® MTB/RIF assayen
dc.subjectClinical trialsen
dc.subjectTuberculosis drugsen
dc.subjectSmear microscopyen
dc.subjectCultureen
dc.subjectRS Pharmacy and materia medicaen
dc.subjectSDG 3 - Good Health and Well-beingen
dc.subject.lccRSen
dc.titleAssessment of the sensitivity and specificity of Xpert MTB/RIF assay as an early sputum biomarker of response to tuberculosis treatmenten
dc.typeJournal articleen
dc.description.versionPublisher PDFen
dc.contributor.institutionUniversity of St Andrews. School of Medicineen
dc.contributor.institutionUniversity of St Andrews. Gillespie Groupen
dc.contributor.institutionUniversity of St Andrews. Biomedical Sciences Research Complexen
dc.contributor.institutionUniversity of St Andrews. Global Health Implementation Groupen
dc.contributor.institutionUniversity of St Andrews. Infection Groupen
dc.identifier.doihttps://doi.org/10.1016/S2213-2600(13)70119-X
dc.description.statusPeer revieweden


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