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Objectives of the Model List of Essential In Vitro Diagnostics
The EDL outlines a set of IVDs that are recommended by WHO for use at different levels of a tiered national health care system.
The EDL is not intended to be prescriptive with respect to the listed IVDs or the levels at which such IVDs may/should be used.
Rather, country programs should make the final decision about which IVDs to choose and where to implement them, based on national or regional burden of disease, unmet needs, and priorities.
It is expected that the EDL will provide guidance and serve as a reference for member states (including ministries of health, program managers, laboratory managers, procurement authorities and end users such as reimbursement systems).
Who is developing and/or updating the list of national essential IVDs to define universal health coverage interventions as well as select and implement such IVDs?
It will also notify United Nations agencies and non-governmental organizations that support the selection, purchase, supply, donation or provision of IVDs.
Finally, it will inform and guide the medical technology private sector on IVD priorities and IVDs needed to address global health issues.
While the EDL provides a list of critical tests required at various levels of the health care system, it is important to note that without an integrated, connected, tiered laboratory system with adequate human resources, training, laboratory infrastructure and regulatory/quality assurance systems, the EDL by itself cannot make an impact.
The effect also requires Member States to adopt and adapt EDLs and develop national and regional EDLs, as well as implement the necessary selection and supply mechanisms to ensure access to IVDs.
Scope of the first version of EDL
Based on the EDL selection criteria described below, the EDL consists of:
A group of common laboratory tests that can be used alongside routine patient care to detect and diagnose a wide variety of disease conditions – communicable and NCDs.
These IVDs are grouped by test discipline (such as clinical chemistry, serology, hematology, microbiology, and mycology) and by specific test type (such as bilirubin, complete blood count, etc.).
The IVD is designed to detect, diagnose and monitor each of the following WHO keys
Disease areas: HIV, TB, malaria, HBV/HCV, and HPV and syphilis. These IVDs are grouped on the basis of disease area and analysis test.
The EDL does not list specific test brands but rather includes IVDs described according to their biological targets.
Where specific products in the categories of tests included in the EDL have been declared pre-qualified by WHO or recommended by the WHO Disease Programme, a link is provided to that information, which is updated regularly.
EDL Content and Format
For each specific test listed in the first edition of the EDL, the following are described:
Purpose of the test: The purpose for which the test can be used.
Assay format: The assay format or format in which the test is generally available, eg. Enzyme immunoassay, nucleic acid test.
Specimen Type: The types of specimens that can be used for testing.
Facility Level: The level of the tiered health care delivery system for which testing is recommended, as described below.
Link to WHO guidance: If existing WHO guidance is available on the test or category of test, a link is provided to the appropriate location on the WHO website.
WHO PQ or endorsed products: For each specific test for which brands of products are either WHO pre-qualified or otherwise endorsed by WHO, a link is provided.
| Author | WHO |
| Language | English |
| No. of Pages | 30 |
| PDF Size | 1.37MB |
| Category | Health |
| Source/ Credits | who.int |
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