Validation of Bedaquiline Phenotypic Drug Susceptibility Testing Methods and Breakpoints: a Multilaboratory, Multicountry Study

Author:

Kaniga Koné1,Aono Akio2,Borroni Emanuele3ORCID,Cirillo Daniela Maria3ORCID,Desmaretz Christel4,Hasan Rumina56,Joseph Lavania7,Mitarai Satoshi2,Shakoor Sadia5,Torrea Gabriela4,Ismail Nazir Ahmed789,Omar Shaheed V.7

Affiliation:

1. Johnson & Johnson Global Public Health, Titusville, New Jersey, USA

2. Department of Mycobacterium Reference and Research, The Research Institute of Tuberculosis, Japan Anti-tuberculosis Association, Kiyose, Japan

3. Emerging Bacterial Pathogens Unit, IRCCS San Raffaele Scientific Institute, Milan, Italy

4. Department of Biomedical Sciences, Mycobacteriology Unit, Institute of Tropical Medicine, Antwerp, Belgium

5. Department of Pathology and Laboratory Medicine, The Aga Khan University, Karachi, Pakistan

6. Faculty of Infectious and Tropical Disease, London School of Hygiene and Tropical Medicine, London, United Kingdom

7. Center for Tuberculosis, National and WHO Supranational TB Reference Laboratory, National Institute for Communicable Diseases, National Health Laboratory Services, Johannesburg, South Africa

8. Department of Medical Microbiology, University of Pretoria, Pretoria, South Africa

9. Department of Internal Medicine, University of Witwatersrand, Johannesburg, South Africa

Abstract

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.

Funder

Janssen Pharmaceutica, NV

Bill and Melinda Gates Foundation

Publisher

American Society for Microbiology

Subject

Microbiology (medical)

Reference35 articles.

1. World Health Organization. 2018. Global tuberculosis report 2018 (WHO/CDS/TB/2018.20). WHO, Geneva, Switzerland. http://apps.who.int/iris/bitstream/handle/10665/274453/9789241565646-eng.pdf?ua=1. Accessed 19 June 2019.

2. Molecular Diagnosis of Drug-Resistant Tuberculosis; A Literature Review

3. A Diarylquinoline Drug Active on the ATP Synthase of Mycobacterium tuberculosis

4. Multidrug-Resistant Tuberculosis and Culture Conversion with Bedaquiline

5. Bedaquiline-based treatment regimen for multidrug-resistant tuberculosis

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