WHO's Essential Diagnostics List updated for COVID-19

Regulatory NewsRegulatory News | 01 February 2021 |  By 

The World Health Organization (WHO) updated its list of essential diagnostics for 2021 on Friday to include recommendations for polymerase chain reaction and antigen-based diagnostic tests for COVID-19.
In making this and other recommendations to the “basket of recommended in vitro diagnostics” that makes up the organization’s Essential Diagnostic List (EDL), WHO also recommended additional tests that detect disease preventable by vaccines and other infectious diseases, as well as more tests for such non-communicable diseases as cancer and diabetes. New endocrine tests are also on the list to address reproductive and women’s health needs.
“Access to quality tests and laboratory services is like having a good radar system that gets you where you need to go. Without it, you’re flying blind,” said WHO Director-General Tedros Adhanom Ghebreyesus in a press release announcing the annual update. (RELATED: WHO updates lists of essential medicines, diagnostics, Regulatory Focus 09 July 2019)
In keeping with WHO’s mission and scope, the list is not intended to be prescriptive, but rather to be used as a policy tool so that countries can each formulate their own lists “based on their local context and needs,” according to the press release. WHO also plans to release a step-by-step aid to help countries in the process of developing their individual lists of essential diagnostic tests.
In addition to working directly with Nigeria, India, Bangladesh and Pakistan in developing their own national lists of essential diagnostics, WHO is also discussing list formulations with several other countries located mostly in Africa.
The 2021 edition of the EDL also debuts a list of tests that should not be offered; a test might land on this list if it is not cost-effective, if it is unreliable, or if it’s become outmoded and has been supplanted by a newer, easier-to-use test, according to WHO.
“In all countries, the use of appropriate diagnostic tests can help inform evidence-based treatment and responsible use of medicines, resulting in improved allocation of resources and better health outcomes,” said Mariângela Simão, WHO Assistant-Director General for Access to Medicines and Health Products in the press release.
In addition to tests that must be performed at a full clinical laboratory, point-of-care tests that WHO says should be available at the local level through primary care offices or community health efforts are also included on the list.
The EDL falls under the purview of WHO’s in vitro diagnostics Strategic Advisory Group of Experts (SAGE IVD), which has met annually since the EDL’s 2018 inception to review submissions and make recommendations. The SAGE IVD group weighs “usefulness, impact and accuracy” of tests when they are considered for inclusion.


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Tags: coronavirus, IVD, WHO

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