In vitro diagnostics - Global - World Health Organization (WHO)
2020年2月10日 · In vitro diagnostics are also the first line of defence against the possibility of the re-emergence of eradicated diseases. Smallpox, for example, is unlikely to reappear; however, WHO maintains a network of partnerships around the world dedicated to the rapid diagnosis and containment of any potential cases.
The selection and use of essential in vitro diagnostics: report of the ...
2023年10月18日 · 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 diagnostics (EDL 4)). This report also includes the applications received for the EDL 4 and a summary of the deliberations and recommendations by the SAGE IVD members and the …
Selection, access and use of in vitro diagnostics
2021年1月28日 · It is expected that national essential diagnostics lists will provide similar benefits and improve access to essential in vitro diagnostic tests. It will also contribute towards health systems strengthening and realizing universal health coverage , which is central to Goal 3 of the Sustainable Development Goals (Ensure healthy lives and promote ...
Strategic Advisory Group of Experts on In Vitro Diagnostics (SAGE …
In 2018, the World Health Organization (WHO) established the Strategic Advisory Group of Experts on In Vitro Diagnostics (SAGE IVD) to act as an advisory body to matters of global policies and strategies related to in vitro diagnostics (IVDs).
In vitro diagnostics for COVID-19 - World Health Organization …
2021年6月14日 · WHO Emergency Use Listing (EUL) for in vitro diagnostics WHO / Blink Media - Lisette Poole Patient tested in the COVID-19 Health Centre at the Central de Abasto, main wholesale and retail market for consumer products in the Metropolitan Area.
WHO publishes new Essential Diagnostics List and urges countries …
2021年1月29日 · To address the lack of access to tests and testing services in multiple countries, WHO since 2018 has published a yearly essential diagnostics list (EDL), a basket of recommended in vitro diagnostics that should be available at point-of-care and in laboratories in all countries to increase timely and life-saving diagnoses. The latest edition, published today, …
WHO Global Model Regulatory Framework for Medical Devices …
2017年9月5日 · Overview . The Model recommends guiding principles, harmonized definitions and specifies the attributes of effective and efficient regulation, to be embodied within binding and enforceable law.
The selection and use of essential in vitro diagnostics - TRS 1031
2021年1月29日 · The group also oversees maintenance of the WHO Model List of Essential In Vitro Diagnostics (EDL), which serves as an evidence-based reference point for countries to develop their own national lists to guide how they choose and use IVDs.
In vitro diagnostics: Frequently asked questions
2019年8月6日 · 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 antibodies. These questions and answers provide additional clarity on the procedure and instructions documents published on our website and do not intended to introduce any new requirements …
Emergency Use Listing Procedure for in vitro diagnostics
The WHO Emergency Use Listing (EUL) is open to candidate in vitro diagnostics (IVDs) to detect SARS-CoV-2 (originally called 2019-nCoV). Since 28 February 2020, manufacturers of IVDs for the detection of SARS-CoV-2 nucleic acid are invited to submit an Expression of Interest (EoI) for assessment of candidate IVDs under the EUL procedure.