International Clinical Practice Guidelines: 2018 Midyear Review

John Anello; Brian Feinberg; John Heinegg; Yonah Korngold; Richard Lindsey; Cristina Wojdylo; Olivia Wong, DO


July 10, 2018

In This Article

Essential Diagnostic Tests

World Health Organization

The Essential Diagnostics List (EDL) focuses on in vitro diagnostic tests and contains 113 tests. Fifty-eight are general laboratory tests used in routine patient care for diagnosis and monitoring of a wide array of common conditions such as diabetes, cardiovascular disease, and anemia.

The other 55 tests are for detection, diagnosis, and monitoring of global "priority" diseases, including hepatitis B and C, HIV, human papillomavirus (HPV), malaria, syphilis, and tuberculosis.

The first edition of the EDL is presented by health care facility level in two tiers:

Tier I: For primary health care, with section a for general IVDs and section b for specific diseases.

Tier II: For health care facilities with clinical laboratories, with section a for general IVDs and section b for specific diseases.


Recognizing the importance of tests for a wide variety of diseases, SAGE-IVD (Strategic Advisory Group on In Vitro Diagnostics) reviewed and agreed on a proposal for the first EDL, which should include a broad list of basic laboratory tests, as well as tests for the following initial set of diseases pursuant to WHO policy and for which there is high quality guidance: HIV, TB, malaria, HBV/HCV, and HPV and syphilis infections.

Consider the following tests be included in future editions of the EDL: antimicrobial resistance, neglected tropical diseases, noncommunicable diseases (NCDs), outbreaks/emergencies and sepsis.

Include a detailed preface to the EDL to explain the objectives, limitations, and guidance for its use. The preface should include the scope of the EDL; a definition of the health service levels referred to; the rationale for the contents; and stress the need to adapt the list to local or regional settings and conditions (one size does not fit all).

Emphasize that while the EDL provides a list of important tests required at various levels of the health system, the list itself cannot have an impact without an integrated, connected, tiered laboratory system, with adequate human resources, training, laboratory infrastructure, and regulatory and quality assurance systems.

Member States can adapt the EDL and develop national or regional EDLs, as well as implement the mechanisms necessary to ensure impact.

Revise and update various WHO technical documents that constitute a resource for EDL to make them relevant and current. This task should be prioritized and, if need be, supported by WHO collaborating centers, other institutions, and SAGE-IVD.

Support EDL via a dedicated web page that harmonizes all IVDs information available on the WHO website.

Review and acknowledge that the WHO prequalification process plays an important role in increasing access to IVDs of assured quality, safety, and performance. SAGE-IVD appreciates that EDL and the WHO Prequalification of In Vitro Diagnostics Programme (PQ) are complementary processes in improving access to IVDs for Member States.



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