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Validation of Bedaquiline Phenotypic Drug Susceptibility Testing Methods and Breakpoints: a Multilaboratory, Multicountry Study.
Kaniga, Koné; Aono, Akio; Borroni, Emanuele; Cirillo, Daniela Maria; Desmaretz, Christel; Hasan, Rumina; Joseph, Lavania; Mitarai, Satoshi; Shakoor, Sadia; Torrea, Gabriela; Ismail, Nazir Ahmed; Omar, Shaheed V.
Afiliación
  • Kaniga K; Johnson & Johnson Global Public Health, Titusville, New Jersey, USA kkaniga@its.jnj.com.
  • Aono A; Department of Mycobacterium Reference and Research, The Research Institute of Tuberculosis, Japan Anti-tuberculosis Association, Kiyose, Japan.
  • Borroni E; Emerging Bacterial Pathogens Unit, IRCCS San Raffaele Scientific Institute, Milan, Italy.
  • Cirillo DM; Emerging Bacterial Pathogens Unit, IRCCS San Raffaele Scientific Institute, Milan, Italy.
  • Desmaretz C; Department of Biomedical Sciences, Mycobacteriology Unit, Institute of Tropical Medicine, Antwerp, Belgium.
  • Hasan R; Department of Pathology and Laboratory Medicine, The Aga Khan University, Karachi, Pakistan.
  • Joseph L; Faculty of Infectious and Tropical Disease, London School of Hygiene and Tropical Medicine, London, United Kingdom.
  • Mitarai S; Center for Tuberculosis, National and WHO Supranational TB Reference Laboratory, National Institute for Communicable Diseases, National Health Laboratory Services, Johannesburg, South Africa.
  • Shakoor S; Department of Mycobacterium Reference and Research, The Research Institute of Tuberculosis, Japan Anti-tuberculosis Association, Kiyose, Japan.
  • Torrea G; Department of Pathology and Laboratory Medicine, The Aga Khan University, Karachi, Pakistan.
  • Ismail NA; Department of Biomedical Sciences, Mycobacteriology Unit, Institute of Tropical Medicine, Antwerp, Belgium.
  • Omar SV; Center for Tuberculosis, National and WHO Supranational TB Reference Laboratory, National Institute for Communicable Diseases, National Health Laboratory Services, Johannesburg, South Africa.
J Clin Microbiol ; 58(4)2020 03 25.
Article en En | MEDLINE | ID: mdl-31969421
Drug-resistant tuberculosis persists as a major public health concern. Alongside efficacious treatments, validated and standardized drug susceptibility testing (DST) is required to improve patient care. This multicountry, multilaboratory external quality assessment (EQA) study aimed to validate the sensitivity, specificity, and reproducibility of provisional bedaquiline MIC breakpoints and World Health Organization interim critical concentrations (CCs) for categorizing clinical Mycobacterium tuberculosis isolates as susceptible/resistant to the drug. Three methods were used: Middlebrook 7H11 agar proportion (AP) assay, broth microdilution (BMD) assay, and mycobacterial growth indicator tube (MGIT) assay. Each of the five laboratories tested the 40-isolate (20 unique isolates, duplicated) EQA panel at three time points. The study validated the sensitivity and specificity of a bedaquiline MIC susceptibility breakpoint of 0.12 µg/ml for the BMD method and WHO interim CCs of 1 µg/ml for MGIT and 0.25 µg/ml for the 7H11 AP methods. Categorical agreements between observed and expected results and sensitivities/specificities for correctly identifying an isolate as susceptible/resistant were highest at the 0.25, 0.12, and 1 µg/ml bedaquiline concentrations for the AP method, BMD (frozen or dry plates), and MGIT960, respectively. At these concentrations, the very major error rates for erroneously categorizing an isolate as susceptible when it was resistant were the lowest and within CLSI guidelines. The most highly reproducible bedaquiline DST methods were MGIT960 and BMD using dry plates. These findings validate the use of standardized DST methodologies and interpretative criteria to facilitate routine phenotypic bedaquiline DST and to monitor the emergence of bedaquiline resistance.
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Preparaciones Farmacéuticas / Mycobacterium tuberculosis Tipo de estudio: Guideline / Prognostic_studies Límite: Humans Idioma: En Revista: J Clin Microbiol Año: 2020 Tipo del documento: Article País de afiliación: Estados Unidos Pais de publicación: Estados Unidos
Texto completo
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Preparaciones Farmacéuticas / Mycobacterium tuberculosis Tipo de estudio: Guideline / Prognostic_studies Límite: Humans Idioma: En Revista: J Clin Microbiol Año: 2020 Tipo del documento: Article País de afiliación: Estados Unidos Pais de publicación: Estados Unidos