The World Health Organization (WHO) has released the 2023 Essential Diagnostics List (EDL), an evidence-based registry of in vitro diagnostics (IVDs) to support countries in making national diagnostic choices.
This year’s list includes two firsts:
- Includes three tests for hepatitis E virus (HEV), including a rapid test to help diagnose and monitor HEV infection; and
- Recommendations include blood glucose monitoring devices for personal use as well as existing diabetes medical advice.
Hepatitis E occurs in outbreaks and sporadic cases around the world. Although most people recover completely, a small proportion (up to 4%) develop acute liver failure, with a higher proportion of pregnant women (mortality rate 19.3-63.6%). Hepatitis E infection is underreported and increasing these diagnoses will support governments in controlling the epidemic.
Diabetes is a chronic disease that killed 1.5 million people in 2019, with its incidence and impact higher in low- and middle-income countries. The consequences of the disease can be avoided or delayed through diet, physical activity, medication, and regular blood glucose monitoring. Incorporating personal blood glucose testing devices into the essential diagnostic list may lead to better disease management and fewer negative outcomes.
Although not prescriptive, the Essential Diagnostics List has the potential to assist countries in developing plans to improve in vitro diagnostics by providing a policy framework that will enable informed decision-making on national Essential Diagnostics Lists. Our goal is that governments can use this list to improve in vitro diagnostic testing services in their countries, which will translate into more diagnostic opportunities and better patient outcomes.
“In the early days of the COVID-19 pandemic, the rapid development and global deployment of diagnostics was critical to tracking the spread of the virus, detecting, isolating and treating infected people, and protecting those at risk,” said WHO Director-General Dr. Tedros Adhanom Ghebreyesus. .. “The WHO Essential Diagnostics List is an important tool that provides countries with evidence-based recommendations to guide local decision-making and ensure that health workers and patients have access to the most important and reliable diagnoses.”
For the 2023 Essential Diagnostics List, the WHO Strategic Advisory Group of Experts on In Vitro Diagnostics (SAGE IVD) reviewed 12 applications and recommended the addition of 8 items to IVDs and several edits to previously listed EDL tests, including for IVD Melitus for Tuberculosis, HIV and Diabetes.
Other new tests added to the list include testing for endocrine disorders; reproductive, maternal and newborn health; and cardiovascular health:
- For endocrine disorders, two new tests are included: parathyroid hormone as a laboratory-based test to help evaluate the cause of calcium homeostasis disturbances and monitor the effectiveness of treatment; and 17-hydroxyprogesterone as a laboratory-based test to diagnose and Monitor for congenital adrenal hyperplasia outside the neonatal period;
- For reproductive, maternal, and neonatal health, two tests are included: the Kleihauer-Betke acid elution test as a general IVD, used in clinical laboratories to aid in the diagnosis and treatment of feto-maternal hemorrhage; and the point-of-care test, used for diagnosis and treatment of fetal hemorrhage. Determining blood group and rhesus factors in the context of maternal health and hemolytic disease of the fetus and newborn;
- For cardiovascular health, the inclusion of high-sensitivity troponins I and T aids in the diagnosis of acute myocardial infarction in healthcare facility clinical laboratories.
With the recent adoption of WHA resolution 76.5 on strengthening diagnostic capabilities, Member States are urged to consider developing national diagnostic strategies as part of their national health plans and to consider developing national lists of essential diagnostics, adapting the WHO model list of important in vitro diagnostics. WHO provides advice and support to many countries around the world in their efforts to develop EDLs through webinars, workshops and direct country support.
The Essential Diagnostics List is updated every two years and is designed to support the development of national in vitro diagnostics policy and improve access to in vitro diagnostic testing and clinical laboratory services. In addition to providing information to national EDLs, it also provides recommendations on IVD prioritization at different levels of the health care system. In addition, it provides information to United Nations agencies and non-governmental organizations that support the selection, procurement, supply or donation of IVDs, and provides guidance to the private medical technology and manufacturing sectors on IVD priorities needed to address global health problems.
Please see the link for details on the 2023 WHO EDL and decisions.