Deadline 21 April 2023, 12PM CEST
WHO is pleased to present draft technical specifications for selection of essential in vitro diagnostics (IVDs) for influenza A and B antigen RDT, influenza A and B antigen instrument-based point-of-care immunoassay and influenza A and B nucleic acid test for use in community settings and health facilities without laboratories listed in the 3rd WHO Model List of Essential In Vitro Diagnostics (EDL).
WHO welcomes organizations and individuals to review and provide comments/suggestions on this document. The reviewers should use the comment column in each technical specifications listed in the Excel file.
Please provide your feedback no later than 21 April 2023, 12PM CEST, by email to EDLsecretariat@who.int. 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 mentioned above.
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 influenza A and B antigen RDT, influenza A and B antigen Instrument-based point-of-care immunoassay and influenza A and B nucleic acid test for use in community settings and health facilities without laboratories.