Technical consultation on WHO PQ requirements for HBV virus load and HBsAg detection assays

WHO prequalification of IVDs is a comprehensive quality assessment of individual IVDs through a standardized procedure aimed at determining whether the product meets WHO prequalification requirements. The findings of WHO prequalification are used to assess the safety, quality and performance of commercially available IVDs for the purpose of providing guidance to interested United Nations (UN) agencies and WHO Member States in their procurement decisions. The purpose of the WHO Prequalification Technical Specifications Series is to provide technical guidance to IVD manufacturers seeking WHO prequalification. In 2019, a request was made to expand the current scope of WHO Prequalification to include HBV nucleic acid detection assays to determine virus load. It is expected that prequalification assessments of HBV VL assays will be announced at the beginning of 2020. This meeting of experts will review and finalise the proposed requirements for WHO prequalification of serological and molecular HBV assays. The objectives of the meeting is to review and ratify dossier requirements for WHO prequalification of hepatitis B virus load assays as well as RDTs and EIAs designed to detect HBsAg: •Technical Specification Series TSS-13 “IVDs used for the quantitative detection of Hepatitis B nucleic acid”; •Technical Specifications Series TSS-14 “Rapid diagnostic tests (RDTs) used for detection of hepatitis B antigen”; •Technical Specifications Series TSS-15 “Enzyme immunoassays to detect hepatitis B antigen”