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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.
- Medical Devices
WHO’s “Global Model Regulatory Framework for Medical Devices...
- Blood Transfusion Safety
The inability to test blood can be due in part to the...
- Blood Products
First-ever WHO list of essential diagnostic tests to improve...
- Regulatory Agencies
Since its inception, regulatory agencies have both supported...
- Performance Evaluation Laboratories
The Stage 1 audit is a desk-top audit. During this audit,...
- Procurement Agencies
The WHO List of Prequalified In Vitro Diagnostic Products...
- Manufacturers
Obtaining prequalification of an in vitro diagnostic (IVD)...
- Health Products Policy and Standards
It is expected that national essential diagnostics lists...
- Medical Devices
29 sty 2021 · 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.
18 paź 2023 · The 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)).
The List of WHO-prequalified In Vitro Diagnostic products contains diagnostics used to diagnose a number of conditions and diseases, and that have been assessed by WHO and found to be acceptable, in principle, for procurement by UN agencies.
I. List of Essential In Vitro Diagnostics (EDL): For community settings and health facilities without laboratories. These lists contain tests for community settings and health facilities that include health posts and centres, doctors’ offices, outreach clinics, ambulatory care and home-based and self-testing.
19 paź 2023 · The selection and use of essential in vitro diagnostics: 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). (WHO Technical Report Series, no. 1053) ISBN 978-92-4-008109-3 (electronic version)
The selection and use of essential in vitro diagnostics: 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)