August 13, 2020
This framework for evaluation of new immunodiagnostic tests for the detection of TB infection aims to promote and direct research by identifying standard study designs and evaluation protocols. As such it should facilitate their standardized evaluation and accelerate adoption into global and national policy and subsequent scale-up.
The focus of this framework is on evaluation of diagnostic performance of tests for TB infection and provides guidance on study design, populations, reference standards, sample size calculation and data analysis. Additionally, it covers technical issues that should be considered when evaluating new tests for TB infection, evaluation of safety for skin tests, costs to the health system patients, preferred features and operational characteristics.
The document is intended for test manufacturers, researchers, research funders, regulators, TB programme coordinators, civil society and other stakeholders.
