First WHO Model List of Essential In Vitro Diagnostics. Geneva: World Health Organization; 2019 (WHO Technical Report Series, No. 1017)
(2019; 29 pages)

This List is the definitive Model List of Essential In Vitro Diagnostics and replaces two previous versions that were published on the WHO website in May and November 2018. The WHO Model List of Essential Medicines published in 2017 included a recommendation by the Expert Committee on the Selection of Essential Medicines that WHO prepare a list of essential in vitro diagnostics, which will make an important contribution to universal health coverage. Like the Model List of Essential Medicines, the Model List of Essential In Vitro Diagnostics (“essential diagnostics list”, EDL) is intended to provide evidence-based guidance to countries for creating their own lists of essential in vitro diagnostic tests. National essential medicines lists have been successful in facilitating access to treatment, particularly in low-resourced countries, by prioritizing the most important medicines all countries should make available to their populations. It is expected that national EDLs will provide the same benefits for in vitro diagnostic tests. It should be noted that EDLs may be included in national lists of essential / priority medical devices that are used for public procurement, reimbursement or for universal health coverage. The EDL comprises a group of IVDs that are recommended by WHO for use at various levels of a tiered national health care system. The List is not intended to be prescriptive with respect to the IVDs nor the levels at which they can or should be used. Countries should make their own decisions about which IVDs to select and where they are to be used on the basis of the national or regional burden of the disease, unmet needs, available resources and priorities. The EDL will provide guidance and serve as a reference to ministries of health, programme managers, users such as laboratory managers, procurement officers and reimbursement systems in Member States, who are establishing or updating national lists of essential IVDs for universal health coverage. It will also inform United Nations agencies and nongovernmental organizations that support the selection, procurement, supply, donations or provision of IVDs. Finally, it will inform and guide the private sector for medical technology on IVD priorities and the IVDs needed to address global health issues. While the EDL provides a list of tests required at various levels of the health care system, the EDL cannot be useful without an integrated, connected, tiered laboratory system, with adequate human resources, training, laboratory infrastructure and regulatory and quality-assurance systems. Its impact also requires adoption and adaptation of the EDL by Member States, establishment of national and regional EDLs and the selection and supply mechanisms necessary to ensure access to the IVDs. This report presents the first EDL and describes the process by which it was established and proposed next steps.
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