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Mycobacteriology and Aerobic Actinomycetes

A Multilaboratory, Multicountry Study To Determine Bedaquiline MIC Quality Control Ranges for Phenotypic Drug Susceptibility Testing

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
aJanssen Research & Development, LLC, Titusville, New Jersey, USA
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Daniela M. Cirillo
bIRCCS, San Raffaele Scientific Institute, Milan, Italy
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Sven Hoffner
cTB Supranational Reference Laboratory, The Public Health Agency of Sweden, Solna, Sweden
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Nazir A. Ismail
dNational TB Reference Laboratory, Center for Tuberculosis, National Institute of Communicable Diseases, Johannesburg, South Africa
eDepartment of Medical Microbiology, University of Pretoria, Pretoria, South Africa
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Devinder Kaur
fUniversity of Massachusetts Medical School, Massachusetts Supranational TB Reference Laboratory, Boston, Massachusetts, USA
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Nacer Lounis
gJanssen Pharmaceutica NV, Beerse, Belgium
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Beverly Metchock
hReference Laboratory, Division of TB Elimination, United States Centers for Disease Control and Prevention, Atlanta, Georgia, USA
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Gaby E. Pfyffer
iDepartment of Medical Microbiology, Center of Laboratory Medicine, Luzerner Kantonsspital LUKS, Luzern, Switzerland
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Amour Venter
jTASK 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
Roles: Editor
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DOI: 10.1128/JCM.01123-16
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    FIG 1

    Bedaquiline MIC distributions against M. tuberculosis H37Rv and QC ranges. (a) 7H10 agar, including data using all medium lots but excluding data from Lab-5; (b) 7H11 agar, including data from all laboratories and using all medium lots; (c) 7H9 broth using all custom-made microtiter plates lots but excluding Lab-1 data.

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    FIG 2

    Bedaquiline MIC distributions against M. tuberculosis H37Rv according to medium lot (a and b) or 96-well microtiter plate lot (c). (a) 7H10 agar excluding data from Lab-5; (b) 7H11 agar including data from all laboratories and using all medium lots; (c) 7H9 broth including data from all laboratories and using all microtiter plate lots.

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  • TABLE 1

    Bedaquiline MIC QC ranges for Mycobacterium tuberculosis H37Rv

    MediumBedaquiline MIC (μg/ml)
    7H9 broth0.015–0.06
    7H10 agar0.015–0.12
    7H11 agar0.015–0.12

Additional Files

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    • Supplemental file 1 -

      Texts S1 (Specific issues reported by participating laboratories) and S2 (Method for bedaquiline MIC determination using 7H9 broth medium); Tables S1 (7H10 agar dilution raw data from all laboratories for bedaquiline tested against M. tuberculosis H37Rv), S2 (7H11 agar dilution raw data from all laboratories for bedaquiline tested against M. tuberculosis H37Rv), and S3 (7H9 broth microdilution raw data from all laboratories for bedaquiline tested against M. tuberculosis H37Rv); and Fig. S1 (Comparison of bedaquiline MICs in different media against M. tuberculosis H37Rv)

      PDF, 1016K

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A Multilaboratory, Multicountry Study To Determine Bedaquiline MIC Quality Control Ranges for Phenotypic Drug Susceptibility Testing
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) 2956-2962; DOI: 10.1128/JCM.01123-16

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A Multilaboratory, Multicountry Study To Determine Bedaquiline MIC Quality Control Ranges for Phenotypic Drug Susceptibility Testing
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) 2956-2962; DOI: 10.1128/JCM.01123-16
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