Screening of tuberculosis using computer aided detection software

This technical specifications document provides guidance for manufacturers seeking World Health Organization prequalification of computer aided detection (CAD) software intended for tuberculosis (TB) screening using chest radiographs. Developed within the WHO Technical Specifications Series for medical device assessment, the publication defines the minimum performance, quality management and documentation requirements for software as a medical device designed to interpret digital chest X-ray images suggestive of pulmonary TB. The document focuses on CAD products intended to replace trained human readers in screening activities among individuals aged 15 years and older, in line with WHO recommendations on systematic TB screening.

The publication describes administrative, technical, non-clinical and clinical evidence requirements necessary for prequalification submissions, including software verification and validation, cybersecurity, risk management, interoperability, usability and post-market surveillance. It also outlines requirements related to labelling, intended use, quality management systems and clinical performance evaluation. Particular attention is given to machine learning–based software, data quality, image compatibility and the need to demonstrate safe and effective operation across different settings, including low- and middle-income countries. The document aims to support consistent assessment of TB CAD technologies and promote safe, reliable and high-quality implementation of AI-assisted TB screening tools.