Since 2021, WHO has recommended the use of computer-aided detection software (CAD) to interpret chest X-rays when screening and triaging for tuberculosis (TB). The recommendation was based on an analysis of the diagnostic accuracy data of this class of software products for detecting pulmonary TB in individuals aged 15 years and older, compared to human interpretation with bacteriological confirmation as reference standard, in populations in which TB screening is recommended.
WHO is now inviting manufacturers to submit CAD products for an assessment of performance by an external expert group. The process will involve an independent evaluation of the software using a digital x-ray library hosted by FIND, as well as the submission of documentation relating to regulatory and marketing aspects. At the end of the assessment WHO will issue an updated list of products that demonstrate adequate accuracy for use in TB screening and triage by member states and implementing partners, as determined by the technical expert group evaluation and based on the benchmarks set by the initial 2021 recommendation. No fees will be charged to manufacturers for these assessments.
Manufacturers interested in participating in this assessment are invited to notify WHO by email (to Cecily Miller at cmiller@who.int) by 24 June 2024. More details about the process, including criteria for submission, deadlines for sending complete documentation, and requirements for installation are available here. Subject to demand, another round of assessments may be held in early 2025, with a deadline of 1 September 2024 for submission of product documentation.