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WHO Expands Prequalification Assessment for TB Molecular Test Developers

NEW YORK – The World Health Organization on Tuesday expanded an invitation for tuberculosis molecular diagnostic prequalification assessment to include manufacturers of qualitative assays. The eligibility expansion will become effective on Sept. 22, 2022.

Prequalification of in vitro diagnostic medical devices involves a comprehensive quality assessment of products through a standardized procedure, WHO said in a statement. The assessment is coordinated through the WHO Prequalification Unit and focuses on IVDs for priority diseases and their suitability for use in resource-limited settings.

In a document, the WHO invited manufacturers of in vitro diagnostic medical devices used for the qualitative detection of Mycobacterium tuberculosis complex DNA and mutations associated with drug-resistant tuberculosis to send a pre-submission form. The WHO will also hold a virtual workshop to describe the application process on Sept. 21.