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Publication Detail
Effectiveness of GenoType MTBDRsl in excluding TB drug resistance in a clinical trial.
  • Publication Type:
    Journal article
  • Publication Sub Type:
    Article
  • Authors:
    Ejo M, Van Deun A, Nunn A, Meredith S, Ahmed S, Dalai D, Tumenbayar O, Tsogt B, Dat PT, Ha DTM, Hang PT, Kokebu D, Teferi M, Mebrahtu T, Ngubane N, Moodliar R, Duckworth L, Conradie F, Enduwamahoro E, Keysers J, De Rijk P, Mulders W, Diro E, Rigouts L, de Jong BC, Torrea G
  • Publisher:
    International Union Against Tuberculosis and Lung Disease
  • Publication date:
    01/10/2021
  • Pagination:
    839, 845
  • Journal:
    International Journal of Tuberculosis and Lung Disease
  • Volume:
    25
  • Issue:
    10
  • Status:
    Published
  • Country:
    France
  • Print ISSN:
    1027-3719
  • Language:
    eng
Abstract
OBJECTIVES: To assess the performance of the GenoType 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 MTBDRsl-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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