The EDL lists IVDs that are recommended by WHO for use in countries to improve access to IVD testing. The list is not intended to be prescriptive with respect to the specific tests or levels at which IVDs should be used. Rather, it aims to serve as a reference for programme and laboratory managers, procurement officers and reimbursement officers who are developing or updating their own national lists of essential diagnostics within the framework of UHC. In all cases, countries are expected to decide for themselves which IVDs to select and where to use them, depending on their epidemiology, funding, human
resources and infrastructure. The EDL is also used by UN agencies and nongovernmental organizations
to support selection, procurement, supply, donation or provision of IVDs, and can be used by the private medical technology sector to gain insight into the diagnostic priorities and related IVDs needed to address global health issues.
The first EDL (EDL 1), which was published in 2018, comprised 62 test categories and 107 test formats that were considered essential to every health care system in the world. It included general diagnostic tests and diseasespecific tests as well as tests for screening blood donations for transfusion
purposes. EDL 1 defined several features of each test, including relevant health care setting, test purpose, assay format and specimen type, alongside a list of any related WHO guidance and recommendations. In 2019, the list was updated to cover 122 test categories, based on proposed additions and changes submitted by stakeholders and reviewed by SAGE IVD. This second EDL (EDL 2) included a selection of IVDs that were
listed conditionally, pending further evidence of test performance, clinical utility
or acceptability. The third EDL similarly reflects additions and edits submitted by stakeholders and reviewed by SAGE IVD. Importantly, and following a SAGE IVD recommendation in 2019, EDL 3 introduces a
list of “Do Not Do” recommendations to identify tests that are not useful in informing clinical management, performing surveillance or informing critical aspects of population health status (see Section 5). SAGE IVD recommends against the procurement or use of any IVD category listed in the Do Not Do
recommendations. SAGE IVD members conducted a thorough review of the list and further
harmonized terms used to describe test purposes. In addition, given the ongoing COVID-19 pandemic, SAGE IVD requested the EDL Secretariat to consider the addition of SARS-CoV-2 tests to the EDL 3 through the normal submission process. Two extraordinary sessions were held to address these tests, causing a
delayed release of EDL 3.
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