he World Health Organization (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%) develop acute liver failure, which is higher in pregnant women (mortality rates 19.3-63.6%). 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 Essential Diagnostics List could lead to better disease management and reduced negative outcomes.
While not prescriptive, the Essential Diagnostics List has the potential to help countries with their plans to improve access to in vitro diagnostics by providing a policy framework to enable informed decision-making for national Essential Diagnostics Lists. The ambition is that governments can use the List to improve in vitro diagnostics 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 Dr Tedros Adhanom Ghebreyesus, 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 Essential Diagnostics List, the WHO Strategic Advisory Group of Experts on in vitro diagnostics (SAGE IVD) reviewed 12 applications and recommended the addition of eight in 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 new-born 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, the inclusion of two tests: Kleihauer-Betke acid-elution test as a general IVD for use in clinical laboratories to aid in the diagnosis and treatment of fetomaternal haemorrhage, and a point-of-care test to determine blood groups and Rhesus factor in the context of maternal health care and haemolytic 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 health care 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 in vitro diagnostics. WHO is advising and supporting multiple countries across the world on their efforts to develop EDLs, through webinars, workshops and direct country support.
Updated biennially, the Essential Diagnostics List is intended to support national in vitro diagnostics policy development and to improve access to IVD testing and clinical laboratory services. As well as informing national EDLs, it provides advice on prioritization of IVDs at different levels of the healthcare system. Additionally, it informs United Nations agencies and non-government organizations that support the selection, procurement, supply or donation of In Vitro Diagnostics along with guidance to the private health technology and manufacturing sectors about the IVDs priorities required to address global health issues.
