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Assessment of the sensitivity and specificity of Xpert MTB/RIF assay as an early sputum biomarker of response to tuberculosis treatment
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dc.contributor.author | Friedrich, Sven Olaf | |
dc.contributor.author | Rachow, Andrea | |
dc.contributor.author | Saathoff, Elmar | |
dc.contributor.author | Singh, Kasha | |
dc.contributor.author | Mangu, Chacha D | |
dc.contributor.author | Dawson, Rodney | |
dc.contributor.author | Phillips, Patrick | |
dc.contributor.author | Venter, Amour | |
dc.contributor.author | Bateson, Anna | |
dc.contributor.author | Boehme, Catharina C | |
dc.contributor.author | Heinrich, Norbert | |
dc.contributor.author | Hunt, Robert | |
dc.contributor.author | Boeree, Martin J | |
dc.contributor.author | Zumla, Alimudden | |
dc.contributor.author | McHugh, Timothy D | |
dc.contributor.author | Gillespie, Stephen Henry | |
dc.contributor.author | Diacon, Andreas | |
dc.contributor.author | Hoelscher, Michael | |
dc.date.accessioned | 2014-05-14T16:01:03Z | |
dc.date.available | 2014-05-14T16:01:03Z | |
dc.date.issued | 2013 | |
dc.identifier.citation | Friedrich , 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-X | en |
dc.identifier.issn | 2213-2600 | |
dc.identifier.other | PURE: 65971347 | |
dc.identifier.other | PURE UUID: 131074b9-bac1-4176-b97e-1e29ee4a920c | |
dc.identifier.other | Scopus: 84881369293 | |
dc.identifier.other | ORCID: /0000-0001-6537-7712/work/39477811 | |
dc.identifier.uri | https://hdl.handle.net/10023/4792 | |
dc.description | Funding: 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.abstract | Background 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.extent | 9 | |
dc.language.iso | eng | |
dc.relation.ispartof | The Lancet Respiratory Medicine | en |
dc.rights | Copyright © 2013 Elsevier Ltd. All rights reserved. Published open access. | en |
dc.subject | Tuberculosis | en |
dc.subject | Biomarker | en |
dc.subject | Mycobacterium tuberculosis | en |
dc.subject | Sputum | en |
dc.subject | Xpert® MTB/RIF assay | en |
dc.subject | Clinical trials | en |
dc.subject | Tuberculosis drugs | en |
dc.subject | Smear microscopy | en |
dc.subject | Culture | en |
dc.subject | RS Pharmacy and materia medica | en |
dc.subject | SDG 3 - Good Health and Well-being | en |
dc.subject.lcc | RS | en |
dc.title | Assessment of the sensitivity and specificity of Xpert MTB/RIF assay as an early sputum biomarker of response to tuberculosis treatment | en |
dc.type | Journal article | en |
dc.description.version | Publisher PDF | en |
dc.contributor.institution | University of St Andrews. School of Medicine | en |
dc.contributor.institution | University of St Andrews. Gillespie Group | en |
dc.contributor.institution | University of St Andrews. Biomedical Sciences Research Complex | en |
dc.contributor.institution | University of St Andrews. Global Health Implementation Group | en |
dc.contributor.institution | University of St Andrews. Infection Group | en |
dc.identifier.doi | https://doi.org/10.1016/S2213-2600(13)70119-X | |
dc.description.status | Peer reviewed | en |
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