WHO plans to launch prequalification assessments of lateral flow urine lipoarabinomannan assays (LF-LAM) for the diagnosis of active tuberculosis in 2024. Prior to expanding the current prequalification assessment eligibility to these products, WHO needs to develop and publish technical specifications (TSS) which outline the performance studies that manufacturers are required to conduct to validate the respective IVD. The purpose of this consultation was to develop a PQ TSS document to provide detailed information regarding the validation studies to be undertaken by the IVD manufacturer seeking WHO PQ.
During this two-day meeting held on 24 and 25 January 2024 a group of 11 subject matter experts from 8 different countries and 9 WHO representatives across the Prequalification In Vitro Diagnostics Assessment Team and the WHO Global TB programme reviewed the proposed requirements for WHO prequalification of TB-LAM IVDs for their dossier submission. Based on the outcomes of the discussion during the consultation meeting the draft TSS will be updated and published on the WHO PQ website for public comment before its publication as final document.