Guidance for studies evaluating the accuracy of rapid tuberculosis drug-susceptibility tests

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Authors

Georghiou, Sophia B.
Schumacher, Samuel G.
Rodwell, Timothy C.
Colman, Rebecca E.
Miotto, Paolo
Gilpin, Christopher
Ismail, Nazir Ahmed
Rodrigues, Camilla
Warren, Rob
Weyer, Karin

Journal Title

Journal ISSN

Volume Title

Publisher

Oxford University Press

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.

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Keywords

Diagnostics, Drug-susceptibility testing, WHO end TB strategy, Tuberculosis (TB), Target product profile, Abbott RealTime MTB, Mycobacterium tuberculosis (MTB), Tuberculosis strain bank, Assays, Performance, Rifampin

Sustainable Development Goals

Citation

Georghiou, S.B., Schumacher, S.G., Rodwell, T.C. et al. 2019, 'Guidance for studies evaluating the accuracy of rapid tuberculosis drug-susceptibility tests', Journal of Infectious Diseases, vol. 220, suppl. 3, pp. S126-S135.