Transition from EUL to prequalification assessment for SARS-CoV-2 NAT and antigen detection RDTs, and an introduction to the technical specification series documents TSS-20 and TSS-21

The WHO Prequalification of IVD team will host a webinar for manufacturers of SARS-CoV-2 IVDs with EUL listed NAT IVDs and antigen detection RDTs. During the webinar, we will:

• Outline the transition plan from EUL to prequalification assessment and highlight the main differences in the assessment procedures.
• Introduce the technical specifications series (TSS) documents recently published for SARS-CoV-2 NAT and antigen detection RDTS which outline the analytical and clinical performance study requirements for prequalification (published on our website Technical Specifications Series | WHO - Prequalification of Medical Products (IVDs, Medicines, Vaccines and Immunization Devices, Vector Control))
• Answer questions

Registration to webinar: https://who.zoom.us/webinar/register/WN_udHmv_23SC-4ECtuojJ73A#/registration   

Please send your questions in advance to diagnostics@who.int so that we can incorporate them into the Q&A session.