The World Health Organisation recently released the third Essential Diagnostics List (EDL), which identifies the most crucial diagnostics low- and middle-income countries (LMICs) should have to fight illnesses ranging from infectious diseases to cancer.
In general, the EDL highlights the importance of broad access to diagnostics and acknowledges its crucial role in securing health for populations. So what are some key updates to the EDL version 3.0 versus its predecessor?
Introduction of a “Do Not Do” negative list: The EDL 3 introduces a list of “Do Not Do” recommendations which lists tests that are not useful in informing clinical management, performing surveillance or informing critical aspects of population health status due to the lack of evidence. Tests on this negative list include Western blot assays to diagnose HIV infection, line immunoassays to diagnose HIV infection and commercial serodiagnostic tests to diagnose TB
Introduction of a Covid 19 section: Recommends antigen detection tests and nucleic acid tests for SARS-CoV-2
Introduction of a new subsection for tests on endocrine disorders, essential for women’s health: Recommends tests for hormones such as the follicle-stimulating hormone, luteinizing hormone, progesterone and prolactin
Expanded list of diagnostics related to cancer and vaccine-preventable diseases: Recommends inclusion of EGFR tests for cancer and specific diagnostics for measles and rubella
Revised indications for several previously included tests: Groups such as Medicins Sans Frontiers, Stop TB or the World Health Organisation generally applied to include or exclude indications for these tests depending on needs seen on the ground.
All applications and decisions on the EDL were made by the SAGE IVD committee, a collection of international experts from LMIC health ministries, NGOs, medical and pathology backgrounds.
SAGE IVD experts are also working on several initiatives such as:
Developing a ‘how-to’ guide: to help countries implement the EDL or develop/update their own national EDLs (NEDL) tailored to country needs.
Creation of a database: that would allow users will be able to search by various criteria (e.g. disease or level of care or clinical intervention) to find information on health products required to carry out the intervention and clinical guidelines for the use of the products and the health workforce required to conduct the intervention.
Consideration for the EDL 4 is already underway and SAGE IVD has identified potentially useful additions, subject to further evidence evaluation. More details about the EDL 3 and decisions on tests are available here.
----------
For more on diagnostics in LMICs, the World Economic Forum has also released a report, titled Diagnostics for Better Health: Considerations for Global Implementation. It raises diagnostic access challenges in these countries and calls for the establishment of a coordinated global alliance for affordable diagnostics.