Evaluation of the GenoType MTBDRsl Version 2.0 Assay for second-line drug resistance detection of Mycobacterium tuberculosis isolates in South Africa

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dc.contributor.author Gardee, Y.
dc.contributor.author Dreyer, A.W.
dc.contributor.author Koornhof, H.J.
dc.contributor.author Omar, S.V.
dc.contributor.author Da Silva, P.
dc.contributor.author Bhyat, Z.
dc.contributor.author Ismail, Nazir Ahmed
dc.date.accessioned 2017-05-24T07:40:03Z
dc.date.issued 2017-03 en
dc.description.abstract Early detection of resistance to second-line antituberculosis drugs is important for the management of multidrug-resistant tuberculosis (MDR-TB). The GenoType MTBDRsl version 2.0 (VER 2.0) line probe assay has been redesigned for molecular detection of resistance-conferring mutations of fluoroquinolones (FLQ) (gyrA and gyrB genes) and second-line injectable drugs (SLID) (rrs and eis genes). The study evaluated the diagnostic performance of the GenoType MTBDRsl VER 2.0 assay for the detection of second-line drug resistance compared with phenotypic drug susceptibility testing (DST), using the Bactec MGIT 960 system on Mycobacterium tuberculosis complex isolates from South Africa. A total of 268 repository isolates collected between 2012 and 2014, which were rifampin monoresistant or MDR based on DST, were selected. MTBDRsl VER 2.0 testing was performed on these isolates and the results analyzed. The MTBDRsl VER 2.0 sensitivity and specificity indices for culture isolates were the following: FLQ, 100% (95% confidence interval [CI] 95.8 to 100%) and 98.9% (95% CI, 96.1 to 99.9%); SLID, 89.2% (95% CI, 79.1 to 95.6%) and 98.5% (95% CI, 95.7 to 99.7%). The sensitivity and specificity observed for individual SLID were the following: amikacin, 93.8% (95% CI, 79.2 to 99.2%) and 98.5% (95% CI, 95.5 to 99.7%); kanamycin, 89.2% (95% CI, 79.1 to 95.6%) and 98.5% (95% CI, 95.5 to 99.7%); and capreomycin, 86.2% (95% CI, 68.3 to 96.1%) and 95.9% (95% CI, 92.2 to 98.2%). An interoperator reproducibility of 100% and an overall interlaboratory performance of 93% to 96% were found. The overall improvement in sensitivity and specificity with excellent reproducibility makes the GenoType MTBDRsl VER 2.0 a highly suitable tool for rapid screening of clinical isolates for second-line drug resistance for use in high-burden TB/HIV settings. en_ZA
dc.description.department Medical Microbiology en
dc.description.embargo 2017-09-30
dc.description.sponsorship CTB NICD/NHLS en
dc.description.uri http://jcm.asm.org en
dc.identifier.citation Gardee Y, Dreyer AW, Koornhof HJ, Omar SV, da Silva P, Bhyat Z, Ismail NA. 2017. Evaluation of the genotype MTBDRsl version 2.0 assay for second-line drug resistance detection of Mycobacterium tuberculosis isolates in South Africa. J Clin Microbiol 55:791 800. https://doi.org/10.1128. en
dc.identifier.issn 1098-660X (online) en
dc.identifier.issn 0095-1137 (print) en
dc.identifier.other 10.1128/JCM.01865-16 en
dc.identifier.uri http://hdl.handle.net/2263/60605
dc.language.iso English en
dc.publisher American Society for Microbiology en
dc.rights © 2017 American Society for Microbiology. All Rights Reserved. en
dc.subject GenoType MTBDRsl version 2.0 en
dc.subject Drug-resistant tuberculosis (DR-TB) en
dc.subject Multidrug-resistant tuberculosis (MDR-TB) en
dc.subject Extensively drug-resistant tuberculosis (XDR-TB) en
dc.subject Line probe assay (LPA) en
dc.subject Fluoroquinolones (FLQ) en
dc.subject Second-line injectable drugs (SLID) en
dc.subject Molecular diagnostic testing en
dc.subject Drug susceptibility testing (DST) en
dc.subject Mycobacterium tuberculosis (MTB) en
dc.title Evaluation of the GenoType MTBDRsl Version 2.0 Assay for second-line drug resistance detection of Mycobacterium tuberculosis isolates in South Africa en
dc.type Postprint Article en


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