Framework for the evaluation of new tests for tuberculosis infection

Overview

Background

Approximately a quarter of the world’s population is estimated to be infected with Mycobacterium tuberculosis. Treatment of TB infection, also known as tuberculosis preventive treatment (TPT), aims to prevent the development of TB disease, and is one of the critical components to achieve the ambitious targets of the End TB Strategy 2016-2035. At the United Nations High-level Meeting on TB in 2018, countries committed to provide TPT to at least 30 million people in 2018-2022.

Although currently testing for TB infection is not always required before starting TPT, a reliable confirmation of infection would be desirable to target TPT to those who need it most. The development and evaluation of novel tests that perform better than current methods and are easier to scale up is thus critically important.

Overview

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.