2020年2月10日 · 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 tubes and similar equipment, as opposed to in vivo tests, which are conducted in the body itself.

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, …

2021年6月14日 · "The Access to COVID-19 Tools ACT-Accelerator, is a new, groundbreaking global collaboration to accelerate the development, production, and equitable access to COVID-19 diagnostics, therapeutics, and vaccines. It was set up in response to a call from G20 leaders in March and launched by the WHO, EC, France and The Bill & Melinda Gates Foundation in …

On 3 July the EUL pipeline was further expanded to antibody detection enzyme immunoassays (EIAs). Invitation to manufacturers of in vitro diagnostics for SARS-CoV-2 to submit an application for emergency use listing by WHO The EUL procedure is developed to expedite the availability of IVDs needed in public health emergency situations.

The List recognizes that in vitro diagnostics (IVDs) are essential for advancing universal health coverage, addressing health emergencies and promoting healthier populations, which are the three strategic priorities of the Thirteenth WHO General Programme of Work, 2019–2023.

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 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 methodologist that …

The WHO Emergency Use Listing Procedure (EUL) is a risk-based procedure for assessing and listing unlicensed vaccines, therapeutics and in vitro diagnostics with the ultimate aim of expediting the availability of these products to people affected by a public health emergency.

Overview Report of the third meeting of the WHO Strategic Advisory Group of Experts on In Vitro Diagnostics, 2020 (including the third WHO model list of essential in vitro diagnostics) SAGE IVD advises the Director-General of WHO in the area of in vitro diagnostics (IVDs). With members appointed from a roster of experts, the group provides WHO with technical advice on global …

The applicability of each of these four methods is discussed below. Detailed information is provided on conducting an assessment of equivalence studies using pharmacokinetic measurements and in vitro methods, which are currently the methods most often used to document equivalence for most orally administered pharmaceutical products for systemic ...

As part of ongoing efforts to enhance quality-assured testing options, the World Health Organization (WHO) has listed two additional mpox in vitro diagnostics under its Emergency Use Listing (EUL) procedure.