Technical Specification Series (TSS ) Update Ute Ströher, PhD

Technical Specification Series (TSS ) Update Ute Ströher, PhD Virtual Joint Meeting 08 – 10 March 2022 1

Technical specification series (TSS) - published since the last UN joint meeting TSS-10: In Vitro Diagnostic (IVDs) medical devices used for the qualitative and quantitative detection of Hepatitis C RNA TSS-11: In Vitro Diagnostic (IVDs) medical devices used for the quantitative detection of HIV-1 nucleic acid TSS-12: In Vitro Diagnostic (IVDs) medical devices used for the qualitative detection of HIV-1 and HIV-2 nucleic acid TSS-16: Hepatitis C rapid diagnostic tests for professional use and/or selftesting (replaces TSS-7) Virtual Joint Meeting 08 – 10 March 2022 2

Technical specification series (TSS) - in development Public consultation closed (Q1 2020): TSS-13: Rapid diagnostic tests to detect Hepatitis B virus surface antigen TSS-14: Immunoassays to detect Hepatitis B virus surface antigen TSS-15: In vitro diagnostic medical devices used for the quantitative detection of Hepatitis B virus nucleic acid Finalization pending – Q3 2022 Virtual Joint Meeting 08 – 10 March 2022 3

Technical specification series (TSS) - public consultation- TSS-17: In vitro diagnostic (IVD) medical devices used for the qualitative detection of Mycobacterium tuberculosis complex (MTBC DNA) and mutations associated with drug-resistant tuberculosis (DR-TB) https://extranet.who.int/pqweb/news/draft-tss-17-submitted-comments-de adline-comments-18-april-2022 Virtual Joint Meeting 08 – 10 March 2022 4

Technical specification series (TSS) -in preparation TSS-18: POC IVD to detect haemoglobin (quantitative) TSS-19: Blood glucose meters (self-test) TSS-20: Point-of-care HbA1c tests Virtual Joint Meeting 08 – 10 March 2022 WHO / Andrew Esiebo 5

This Photo by Unknown Author is licensed under CC BY-SA-NC Virtual Joint Meeting 08 – 10 March 2022 6