IVD's Detecting M. Tuberculosis - Coming Soon to PQT

News

22 December, 2021 - 17:50 (CET)

Announcement

IVD

A Technical Consultation on WHO Prequalification Requirements for Mycobacterium tuberculosis complex (MTBC) NAT assays was held 22-24 November. The purpose of the consultation was to review the draft technical specifications series (TSS) document, which outlines the analytical and clinical performance studies that manufacturers will be required to perform and submit in their product dossier for prequalification assessment. Participants with expertise in manufacturing, laboratory evaluation, regulatory review, procurement of IVDs and use of TB diagnostics in the field were involved in the discussions to further develop the draft TSS document. The In Vitro Diagnostics Assessment Team would like to thank the subject matter experts for the fruitful discussions that took place over the three sessions and look forward to engaging with the panel further throughout Q1 2022 as the TSS document is prepared for publication.

Manufacturers and stakeholders will find in the following link, the DRAFT TSS once it is published:

https://extranet.who.int/pqweb/vitro-diagnostics/technical-specifications-series

If you have a question regarding this page or related to this topic, please do not hesitate to contact the PQ team at diagnostics@who.int

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