A multilaboratory, multicountry study to determine MIC quality control ranges for phenotypic drug susceptibility testing of selected first-line antituberculosis dugs, second-line injectables, fluoroquinolones, clofazimine, and linezolid

dc.contributor.authorKaniga, Koné
dc.contributor.authorCirillo, Daniela M.
dc.contributor.authorHoffner, Sven
dc.contributor.authorIsmail, Nazir Ahmed
dc.contributor.authorKaur, Devinder
dc.contributor.authorLounis, Nacer
dc.contributor.authorMetchock, Beverly
dc.contributor.authorPfyffer, Gaby E.
dc.contributor.authorVenter, Amour
dc.date.accessioned2017-04-07T06:49:38Z
dc.date.issued2016-12
dc.description.abstractOBJECTIVES : Our objective was to establish reference minimal inhibitory concentration (MIC) quality control (QC) ranges for drug susceptibility testing of antimycobacterials, including firstline agents, second-line injectables, fluoroquinolones and World Health Organization Category 5 drugs for multidrug-resistant tuberculosis, using a 7H9 broth microdilution MIC method. METHODS : A Tier-2 reproducibility study was conducted in eight participating laboratories using Clinical Laboratory and Standards Institute (CLSI) guidelines. Three lots of custom-made frozen 96-well polystyrene micro titer plates were used and pre-prepared with 2X pre-diluted drugs in 7H9 broth/oleic acid albumin dextrose catalase. The QC reference strain was Mycobacterium tuberculosis (MTB) H37Rv. MIC frequency, mode and geometric mean were calculated for each drug. QC ranges were derived, based on predefined, strict CLSI criteria. Any data lying outside CLSI criteria resulted in exclusion of the entire laboratory dataset. RESULTS : Data from one laboratory were excluded due to higher MIC values than for other laboratories. QC ranges were established for eleven drugs: isoniazid (0.03–0.12 μg/ml), rifampin (0.03–0.25 μg/ml), ethambutol (0.25–2 μg/ml), levofloxacin (0.12–1 μg/ml), moxifloxacin (0.06–0.5 μg/ml), ofloxacin (0.25–2 μg/ml), amikacin (0.25–2 μg/ml), kanamycin (0.25–2 μg/ml), capreomycin (0.5–4 μg/ml), linezolid (0.25–2 μg/ml) and clofazimine (0.03–0.25 μg/ml). QC ranges could not be established for nicotinamide (pyrazinamide surrogate), prothionamide or ethionamide, which were assay non-performers. CONCLUSIONS : Using strict CLSI criteria, QC ranges against the MTB H37Rv reference strain were established for the majority of commonly used antituberculosis drugs, with a convenient 7H9 broth microdilution MIC method suitable for use in resource-limited settings.en_ZA
dc.description.departmentMedical Microbiologyen_ZA
dc.description.embargo2017-06-30
dc.description.librarianhb2017en_ZA
dc.description.sponsorshipAll participating laboratories received funds for this study from Janssen Pharmaceuticals except the Reference Laboratory, Division of TB Elimination, United States Centers for Disease Control and Prevention, Atlanta, GA, USA. Support for medical writing assistance was provided by Janssen Pharmaceuticals.en_ZA
dc.description.urihttp://jcm.asm.orgen_ZA
dc.identifier.citationKaniga, K, Cirillo, DM, Hoffner, S, Ismail, NA, Kaur, D, Lounis, N, Metchock, B, Pfyffer, GE & Venter, A 2016, 'A multilaboratory, multicountry study to determine MIC quality control ranges for phenotypic drug susceptibility testing of selected first-line antituberculosis dugs, second-line injectables, fluoroquinolones, clofazimine, and linezolid', Journal of Clinical Microbiology, vol. 54, no. 12, pp. 2963-2968.en_ZA
dc.identifier.issn0095-1137 (print)
dc.identifier.issn1098-660X (online)
dc.identifier.other10.1128/JCM.01138-16
dc.identifier.urihttp://hdl.handle.net/2263/59700
dc.language.isoenen_ZA
dc.publisherAmerican Society for Microbiologyen_ZA
dc.rights© 2016, American Society for Microbiology. All Rights Reserved.en_ZA
dc.subjectValidationen_ZA
dc.subjectAntimycobacterialsen_ZA
dc.subjectMinimal inhibitory concentration (MIC)en_ZA
dc.subjectQuality control (QC)en_ZA
dc.subjectMycobacterium tuberculosis (MTB)en_ZA
dc.titleA multilaboratory, multicountry study to determine MIC quality control ranges for phenotypic drug susceptibility testing of selected first-line antituberculosis dugs, second-line injectables, fluoroquinolones, clofazimine, and linezoliden_ZA
dc.typePostprint Articleen_ZA

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