Deadline 07 May 2021, 12PM CEST
WHO is pleased to present the draft technical specifications for selection of essential in vitro diagnostics (IVDs) for SARS-CoV-2 included in the Third WHO model list of essential in vitro diagnostics (EDL).
WHO welcomes organizations and individuals to review and provide comments/suggestions on this Draft - Technical specifications for selection of essential in vitro diagnostics for SARS-CoV-2.
Please provide your feedback no later than 07 May 2021, 12PM CEST, by email to [email protected]. It is important that you provide us with your name and affiliation when sending your comments. Please note that comments will only be considered if they are received before the deadline.
Technical specifications for IVDs suggest a set of pre-defined criteria and baseline requirements to ensure good quality, safety, performance and efficacy. They are decisive companions to the WHO Model list of Essential In Vitro Diagnostics (EDL) that will allow Member States, donor agencies and NGOs to select specific products within each test category of the EDL and will guide procurement decisions. The present publication defines the basic generic technical characteristics of IVDs for SARS-CoV-2 Antigen and NAT IVDs.