PQ-IVD Technical Specifications: Consultation for hemoglobin POC analyzers and revision of malaria RDTs performance study requirements

News

20 June, 2023 - 20:30 (CEST)

Announcement

IVD

The PQT In Vitro Diagnostics Assessment team held a two day consultation meeting with experts in Geneva to review and finalize proposed performance study requirements for WHO prequalification of hemoglobin analysers. On day two, the existing Technical specifications document (TSS) for malaria RDTs was discussed with specific focus on the use of the new WHO International Standards for Plasmodium spp. and additional clinical studies for products claiming to detect Plasmodium falciparum parasites with HRP2/3 deletions. The resulting draft PQ-IVD Technical specifications documents will be published on the WHO website for public comment.

Find out more about our TSS series here

Featured News

Request for Proposals: Review of cold chain equipment dossier submissions for prequalification

Please visit: https://www.ungm.org/Public/Notice/239857 

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