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Journal of Clinical Microbiology
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Mycobacteriology and Aerobic Actinomycetes

A Multilaboratory, Multicountry Study To Determine MIC Quality Control Ranges for Phenotypic Drug Susceptibility Testing of Selected First-Line Antituberculosis Drugs, Second-Line Injectables, Fluoroquinolones, Clofazimine, and Linezolid

Koné Kaniga, Daniela M. Cirillo, Sven Hoffner, Nazir A. Ismail, Devinder Kaur, Nacer Lounis, Beverly Metchock, Gaby E. Pfyffer, Amour Venter
G. A. Land, Editor
Koné Kaniga
Janssen Research & Development, LLC, Titusville, New Jersey, USA
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Daniela M. Cirillo
IRCCS, San Raffaele Scientific Institute, Milan, Italy
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Sven Hoffner
TB Supranational Reference Laboratory, The Public Health Agency of Sweden, Solna, Sweden
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Nazir A. Ismail
National TB Reference Laboratory, Center for Tuberculosis, National Institute of Communicable Diseases, Johannesburg, South AfricaDepartment of Medical Microbiology, University of Pretoria, Pretoria, South Africa
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Devinder Kaur
University of Massachusetts Medical School, Massachusetts Supranational TB Reference Laboratory, Boston, Massachusetts, USA
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Nacer Lounis
Janssen Pharmaceutica NV, Beerse, Belgium
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Beverly Metchock
Reference Laboratory, Division of TB Elimination, United States Centers for Disease Control and Prevention, Atlanta, Georgia, USA
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Gaby E. Pfyffer
Department of Medical Microbiology, Center of Laboratory Medicine, Luzerner Kantonsspital LUKS, Luzern, Switzerland
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Amour Venter
TASK Applied Science, SA MRC Centre for TB Research, DST/NRF Center of Excellence for Biomedical TB Research, Division of Molecular Biology and Human Genetics, Faculty of Medicine and Health Sciences, Stellenbosch University, Tygerberg, South Africa
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G. A. Land
Carter BloodCare & Baylor University Medical Center
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DOI: 10.1128/JCM.01138-16
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ABSTRACT

Our objective was to establish reference MIC quality control (QC) ranges for drug susceptibility testing of antimycobacterials, including first-line agents, second-line injectables, fluoroquinolones, and World Health Organization category 5 drugs for multidrug-resistant tuberculosis using a 7H9 broth microdilution MIC method. 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 microtiter plates were used and prepared with 2× prediluted drugs in 7H9 broth-oleic acid albumin dextrose catalase. The QC reference strain was Mycobacterium tuberculosis 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 data set. Data from one laboratory were excluded due to higher MIC values than other laboratories. QC ranges were established for 11 drugs: isoniazid (0.03 to 0.12 μg/ml), rifampin (0.03 to 0.25 μg/ml), ethambutol (0.25 to 2 μg/ml), levofloxacin (0.12 to 1 μg/ml), moxifloxacin (0.06 to 0.5 μg/ml), ofloxacin (0.25 to 2 μg/ml), amikacin (0.25 to 2 μg/ml), kanamycin (0.25 to 2 μg/ml), capreomycin (0.5 to 4 μg/ml), linezolid (0.25 to 2 μg/ml), and clofazimine (0.03 to 0.25 μg/ml). QC ranges could not be established for nicotinamide (pyrazinamide surrogate), prothionamide, or ethionamide, which were assay nonperformers. Using strict CLSI criteria, QC ranges against the M. tuberculosis 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.

FOOTNOTES

    • Received 25 May 2016.
    • Returned for modification 24 June 2016.
    • Accepted 19 September 2016.
    • Accepted manuscript posted online 21 September 2016.
  • Supplemental material for this article may be found at http://dx.doi.org/10.1128/JCM.01138-16.

  • For a companion article on this topic, see doi:10.1128/JCM.01123-16.

  • Copyright © 2016, American Society for Microbiology. All Rights Reserved.
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A Multilaboratory, Multicountry Study To Determine MIC Quality Control Ranges for Phenotypic Drug Susceptibility Testing of Selected First-Line Antituberculosis Drugs, Second-Line Injectables, Fluoroquinolones, Clofazimine, and Linezolid
Koné Kaniga, Daniela M. Cirillo, Sven Hoffner, Nazir A. Ismail, Devinder Kaur, Nacer Lounis, Beverly Metchock, Gaby E. Pfyffer, Amour Venter
Journal of Clinical Microbiology Nov 2016, 54 (12) 2963-2968; DOI: 10.1128/JCM.01138-16

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A Multilaboratory, Multicountry Study To Determine MIC Quality Control Ranges for Phenotypic Drug Susceptibility Testing of Selected First-Line Antituberculosis Drugs, Second-Line Injectables, Fluoroquinolones, Clofazimine, and Linezolid
Koné Kaniga, Daniela M. Cirillo, Sven Hoffner, Nazir A. Ismail, Devinder Kaur, Nacer Lounis, Beverly Metchock, Gaby E. Pfyffer, Amour Venter
Journal of Clinical Microbiology Nov 2016, 54 (12) 2963-2968; DOI: 10.1128/JCM.01138-16
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