World Health Organization Releases First List of Essential Diagnostics

May 25, 2018

The World Health Organization released its first-ever list of essential diagnostics that will aid countries in selecting more accurate tests to detect diseases.

Like the established Essential Medicines List, which has been in use for four decades, the Essential Diagnostics List is intended to provide evidence-based guidance, and set reference materials for developing national lists of essential in vitro diagnostic tests.

National essential medicines lists have been successful in raising awareness, guiding procurement and regulation policies and facilitating access to affordable medicines, particularly in low-resourced countries, by prioritizing the most important medicines all countries need to make available to their populations.

WHO anticipates that national essential diagnostics lists will provide similar benefits and improve access to essential IVDs.

The diagnostics list was developed following an extensive consultation. The draft list was reviewed by WHO’s Strategic Advisory Group of Experts on In-Vitro Diagnostics (SAGE IVD). The SAGE IVD made recommendations for the content, format and implementation of the first EDL.

The list of 113 products concentrates on in vitro tests, with 58 tests listed for detecting and diagnosing a wide range of conditions. The remaining 55 tests are designed to detect, diagnose and monitor “priority” diseases such as HIV, tuberculosis, malaria, hepatitis B and C, human papillomavirus and syphilis.

Some of the tests are particularly suitable for primary health care facilities, where laboratory services are often poorly resourced and sometimes non-existent, such as tests to rapidly diagnose a child for acute malaria or glucometers to test for diabetes. An estimated 46 percent of adults with Type 2 diabetes worldwide are undiagnosed.

“Our aim is to provide a tool that can be useful to all countries, to test and treat better, but also to use health funds more efficiently by concentrating on the truly essential tests,” said Mariângela Simão, WHO’s assistant director-general for access to medicines, vaccines and pharmaceuticals. “Our other goal is to signal to countries and developers that the tests in the list must be of good quality, safe and affordable.”

For each category of test, the EDL specifies the type of test and intended use, format, and if it is appropriate for primary health care or for health facilities with laboratories. The list also includes links to WHO guidelines and prequalified products.

WHO plans to update the EDL regularly and it will issue a call for applications in the next few months to add categories to the next edition. The list will expand significantly over the next few years as it addresses other key areas including antimicrobial resistance, emerging pathogens, neglected tropical diseases and additional noncommunicable diseases.

Read the list here: www.fdanews.com/05-22-18-WHODxlist.pdf.