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Governments can use the List to improve IVD testing services in their country which will translate into increased access to diagnostics and better patient outcomes.

New Hepatitis E, Diabetes Tests Included in WHO’s Essential Diagnostics Lists

EDLs will help countries develop national and international IVD policies to deliver better patient care

World Health Organization
Published:Oct 19, 2023
|3 min read
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The WHO has released its 2023 Essential Diagnostics List (EDL), which is an evidence-based register of in vitro diagnostics (IVD) that supports countries to make national diagnostic choices. This year’s list includes two firsts:

  • Inclusion of three tests for hepatitis E virus (HEV), including a rapid test to aid in the diagnosis and surveillance of HEV infection and

  • Advice to include personal use glucose monitoring devices along with the medical recommendations for diabetes already in existence. 

Hepatitis E occurs around the world both as outbreaks and as sporadic cases. While most people recover completely, a small proportion (up to 4 percent) develop acute liver failure, which is higher in pregnant women (mortality rates 19.3–63.6 percent). Hepatitis E infection is under-reported and the addition of these diagnostics will support governments to manage outbreaks.

Diabetes is a chronic disease causing 1.5 million deaths in 2019 with higher disease incidence and impact in lower–middle-income countries. The disease consequence can be avoided or delayed with diet, physical activity, medication, and regular glucose monitoring. Including personal glucose testing devices on the EDL could lead to better disease management and reduced negative outcomes.

How does the Essential Diagnostics List help?

While not prescriptive, the EDL has the potential to help countries with their plans to improve access to IVD by providing a policy framework to enable informed decision-making for national EDLs. The ambition is that governments can use the List to improve IVD testing services in their country which will translate into increased access to diagnostics and better patient outcomes.

“The rapid development and global deployment of diagnostics early in the COVID-19 pandemic was vital in tracking the spread of the virus, detecting, isolating and treating those infected and protecting those at risk,” said Tedros Adhanom Ghebreyesus, PhD, the WHO director-general. “The WHO Essential Diagnostics List is a critical tool that gives countries evidence-based recommendations to guide local decisions to ensure the most important and reliable diagnostics are available to health workers and patients.”

For the 2023 EDL, the WHO Strategic Advisory Group of Experts on in vitro diagnostics (SAGE IVD) reviewed 12 applications and recommended the addition of eight to IVDs and several edits to previously listed EDL tests, including IVDs for tuberculosis, HIV, and diabetes mellitus. 

Other new tests added to the list include those for endocrine disorders; reproductive, maternal, and newborn health; and cardiovascular health:

  • For endocrine disorders, two new tests were included: Parathyroid hormone as a laboratory-based test to aid in the evaluation of the causes of calcium homeostasis disorders and monitor the effects of treatment; and 17-hydroxyprogesterone as a laboratory-based test to diagnose and monitor congenital adrenal hyperplasia outside of the neonatal period.

  • For reproductive, maternal, and newborn health, two tests were added: Kleihauer Betke (KB) acid-elution test as a general IVD for use in clinical laboratories to aid in the diagnosis and treatment of fetomaternal hemorrhage, and a point-of-care test to determine blood groups and Rhesus factor in the context of maternal healthcare and hemolytic disease of the fetus and newborn.

  • For cardiovascular health: the inclusion of high-sensitivity troponin I and T to aid in the diagnosis of acute myocardial infarction in healthcare facilities with clinical laboratories.

With the recent adoption of the WHA 76.5 resolution on strengthening diagnostics capacity, Member States are urged to consider the establishment of national diagnostics strategies as part of their national health plans, and to consider the development of national essential diagnostics lists, adapting the WHO model list of essential IVD. The WHO is advising and supporting multiple countries across the world in their efforts to develop EDLs, through webinars, workshops, and direct country support.

Updated biennially, the EDL is intended to support national IVD policy development and to improve access to IVD testing and clinical laboratory services. As well as informing national EDLs, it provides advice on the prioritization of IVDs at different levels of the healthcare system. 

Additionally, it informs the United Nations agencies and nongovernment organizations that support IVD selection, procurement, supply, or donation along with guidance to the private health technology and manufacturing sectors about the priorities required to address global health issues.

- This press release was originally published on the World Health Organization website