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Title
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Effectiveness of GenoType MTBDRsl in excluding TB drug resistance in a clinical trial
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Author
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Institution/Organisation
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STREAM Collaborators
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Abstract
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| OBJECTIVES: To assess the performance of the Geno-Type MTBDRsl v1, a line-probe assay (LPA), to exclude baseline resistance to fluoroquinolones (FQs) and second-line injectables (SLIs) in the Standard Treatment Regimen of Anti-tuberculosis Drugs for Patients With MDR-TB 1 (STREAM 1) trial. METHODS: Direct sputum MTBDRsl results in the site laboratories were compared to indirect phenotypic drug susceptibility testing (pDST) results in the central laboratory, with DNA sequencing as a reference standard. RESULTS: Of 413 multidrug-resistant TB (MDR-TB) patients tested using MTBDRsl and pDST, 389 (94.2%) were FQ-susceptible and 7 (1.7%) FQ-resistant, while 17 (4.1%) had an inconclusive MTBDRsl result. For SLI, 372 (90.1%) were susceptible, 5 (1.2%) resistant and 36 (8.7%) inconclusive. There were 9 (2.3%) FQ discordant pDST/MTBDRsl results, of which 3 revealed a mutation and 5 (1.3%) SLI discordant pDST/ MTBDRsl results, none of which were mutants on sequencing. Among the 17 FQ- and SLI MTBDRsI-inconclusive samples, sequencing showed 1 FQ- and zero SLI-resistant results, similar to frequencies among the conclusive MTBDRsl. The majority of inconclusive MTBDRsl results were associated with low bacillary load samples (acid-fast bacilli smear-negative or scantily positive) compared to conclusive results (P < 0.001). CONCLUSION: MTBDRsl can facilitate the rapid exclusion of FQ and SLI resistances for enrolment in clinical trials. |
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Language
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English
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Source (journal)
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International journal of tuberculosis and lung disease. - Paris
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Publication
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Paris
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2021
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ISSN
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1027-3719
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DOI
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10.5588/IJTLD.21.0212
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Volume/pages
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25
:10
(2021)
, p. 839-845
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ISI
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000706090100010
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Pubmed ID
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34615581
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Full text (Publisher's DOI)
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