In vitro diagnostics - Global - World Health Organization (WHO)
Feb 10, 2020 · In vitro diagnostics (IVDs) are tests that can detect disease, conditions and infections. In vitro simply means ‘in glass’, meaning these tests are typically conducted in test …
Call for experts: Strategic Advisory Group of Experts on In Vitro ...
Issued on: 11 April 2025 New Deadline: 20 May 2025 The World Health Organization (WHO) is seeking experts to serve as members of the Strategic Advisory Group of Experts on In Vitro …
Specialized Technical Assistance - IVDs
Feb 14, 2023 · For some manufacturers, meeting requirements for WHO prequalification (PQ) or emergency use listing (EUL) can be challenging. In addition, global initiatives to harmonize …
Health products policy and standards - World Health Organization …
Jan 28, 2021 · The World Health Organization (WHO) has established a Strategic Advisory Group of Experts on In Vitro Diagnostics (SAGE IVD) to act as an advisory body on matters of global …
In vitro diagnostics: Frequently asked questions
Aug 29, 2022 · This page provides answers to frequently asked questions relating to EUL assessment of in vitro diagnostics (IVD) to detect SARS-CoV-2 or anti-SARS-CoV-2 …
WHO approves first mpox diagnostic test for emergency use, …
Oct 3, 2024 · The Alinity m MPXV assay is a real-time PCR test that enables detection of monkeypox virus (clade I/II) DNA from human skin lesion swabs. It is specifically designed for …
PQT_IVD_Q&A_200806version1 Page 1 of 3. PQT-IVD Questions and Answers document 06 August 2020 version 1 . This page provides answers to frequently asked questions relating to …
Regulation and Prequalification - World Health Organization (WHO)
The EUL procedure is developed to expedite the availability of IVDs needed in public health emergency situations. It is intended to assist interested procurement agencies and Member …
4th Meeting of the Strategic Advisory Group of Experts on IVDs
Nov 18, 2022 · The 4th SAGE IVD meeting was held on 14–18 November 2022 in a virtual format. On the first day of the meeting, the WHO EDL Secretariat organized an open webinar session …
The selection and use of essential in vitro diagnostics: report of the ...
Oct 18, 2023 · Technical report of the fourth meeting of the WHO Strategic Advisory Group of Experts on In Vitro Diagnostics, 2022 (including the fourth WHO model list of essential in vitro …