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.
