The World Health Organization (WHO), Geneva, recently published its first Model List of Essential In Vitro Diagnostics, a catalog of the tests needed to diagnose most common conditions as well as a number of global priority diseases.1

“An accurate diagnosis is the first step to getting effective treatment,” says WHO Director-General Tedros Adhanom Ghebreyesus, PhD. “No one should suffer or die because of a lack of diagnostic services, or because the right tests were not available.”

The list concentrates on in vitro diagnostics and includes 113 products. That number includes 58 tests listed for the detection and diagnosis of a wide range of common conditions, providing an essential package that can form the basis of patient screening and care management practices. The remaining 55 tests are designed for the detection, diagnosis, and monitoring of ‘priority’ diseases, such as hepatitis B and C, HIV, human papillomavirus, malaria, syphilis, and tuberculosis.

Some of the tests do not require electricity or trained personnel, and are especially suited for use in primary healthcare settings where laboratory services are often poorly resourced and sometimes nonexistent. WHO cites as examples tests that can rapidly diagnose a child with acute malaria, and glucometers used in diabetes testing. Other tests on the list are more sophisticated, and are therefore intended for larger medical facilities.

“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,” says Mariângela Simão, WHO 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 essential diagnostics list specifies the type and format of the test, its intended use, and whether the test is appropriate for primary healthcare settings or for health facilities with laboratories. The list also provides links to WHO guidelines and publications and, where available, to prequalified products.

Similar to the WHO Model List of Essential Medicines, which has been in use for four decades, the essential diagnostics list is intended to serve as a reference for countries to update or develop their own lists of essential diagnostics.2 In order to truly benefit patients, national governments will need to ensure appropriate and quality-assured supplies, training of healthcare workers, and safe use. To that end, WHO will provide support to countries as they adapt the list to the local context.

The essential diagnostics list was developed following an extensive consultation within WHO and externally. The draft list was then considered for review by WHO’s strategic advisory group of experts on in vitro diagnostics, which is a group of 19 experts with global representation.

WHO will update the essential diagnostics list on a regular basis. In the coming months, WHO will issue a call for applications to add categories to the next edition. The list will expand significantly over the next few years, as it incorporates other important areas, including antimicrobial resistance, emerging pathogens, neglected tropical diseases, and additional noncommunicable diseases.

References

  1. World Health Organization Model List of Essential In Vitro Diagnostics. Geneva: World Health Organization, 2018. Available at: www.who.int/medical_devices/diagnostics/who_edl_2018.pdf?ua=1. Accessed June 14, 2018.
  1. WHO Model List of Essential Medicines. 20th ed. Geneva: World Health Organization, 2017. Available at: www.who.int/medicines/news/2017/20th_essential_med-list/en. Accessed June 14, 2018.