Guidance for Studies Evaluating the Accuracy of Rapid Tuberculosis Drug-Susceptibility Tests

Sophia B. Georghiou, Samuel G. Schumacher, Timothy C. Rodwell, Rebecca E. Colman, Paolo Miotto, Christopher Gilpin, Nazir Ismail, Camilla Rodrigues, Rob Warren, Karin Weyer, Matteo Zignol, Sonia Arafah, Daniela Maria Cirillo, Claudia M. Denkinger

Research output: Contribution to journalArticlepeer-review

Abstract

The development and implementation of rapid molecular diagnostics for tuberculosis (TB) drug-susceptibility testing is critical to inform treatment of patients and to prevent the emergence and spread of resistance. Optimal trial planning for existing tests and those in development will be critical to rapidly gather the evidence necessary to inform World Health Organization review and to support potential policy recommendations. The evidence necessary includes an assessment of the performance for TB and resistance detection as well as an assessment of the operational characteristics of these platforms. The performance assessment should include analytical studies to confirm the limit of detection and assay ability to detect mutations conferring resistance across globally representative strains. The analytical evaluation is typically followed by multisite clinical evaluation studies to confirm diagnostic performance in sites and populations of intended use. This paper summarizes the considerations for the design of these analytical and clinical studies.

Original languageEnglish
Pages (from-to)S126-S135
JournalJournal of Infectious Diseases
Volume220
DOIs
Publication statusPublished - Oct 8 2019

Keywords

  • diagnostics
  • drug-susceptibility testing
  • target product profile
  • tuberculosis
  • WHO End TB Strategy

ASJC Scopus subject areas

  • Immunology and Allergy
  • Infectious Diseases

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