Target product profiles for tuberculosis screening tests

Overview

WHO first published target product profiles (TPPs) for a test to improve the early detection of TB in 2014, to spur the development of novel tools that could detect a significant proportion of prevalent TB cases while also reducing the volume of individuals going on for confirmatory testing. In the decade since, there have been significant and rapid advancements in screening technology, including ultra-portable digital radiographic equipment, and innovations driven by artificial intelligence in computer-aided detection software, which automate the interpretation of chest X-ray for TB screening. These advancements, matched with the wider availability of molecular diagnostic tests, have enabled an important scaleup of screening in high TB burden settings.

The new WHO TPPs for TB screening tests were developed after an extensive consultation of a large cross section of constituencies. They provide manufacturers and other stakeholders in research and development with the latest product- and technology-agnostic guidance that encompass all possible approaches used for TB screening. Any newly developed technology that can meet most or all of the product profile characteristics could, if proven effective, be considered for use in TB screening.