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Oct . 31, 2023 17:43 Back to list

WHO releases new list of essential diagnostics

The 2023 Essential Diagnostics List (EDL), an evidence-based registry of in vitro diagnostics (IVDs) that helps countries make diagnostic decisions at the national level, was recently announced by the World Health Organization (WHO).
There are two firsts in this year's list:
The inclusion of three hepatitis E virus (HEV) tests, one of which is a rapid test to help detect and monitor HEV infection; and a recommendation to add personal glucose monitoring devices to current medical guidelines for diabetes.

 

Worldwide, hepatitis E occurs both infrequently and in outbreaks. While the majority of patients recover completely, up to 4% develop acute liver failure, which is more common in pregnant women (mortality rates: 19.3-63.6%).  As hepatitis E infection is under-reported, the availability of these diagnostics would help governments to control epidemics.
 
Diabetes is a chronic disease that will kill 1.5 million people in 2019. Its incidence and impact are higher in low- and middle-income countries. Regular diabetes monitoring, along with medication, physical activity and diet, can help prevent or delay the consequences of the disease. Inclusion of personal glucose meters in the Essential Diagnostic List can improve disease management and reduce adverse outcomes.
 
The WHO Strategic Advisory Group of Experts on in vitro diagnostics (SAGE IVD) reviewed 12 applications for the 2023 Essential Diagnostics List and proposed the addition of eight new IVDs and numerous modifications to tests already on the list. These included IVDs for diabetes mellitus, HIV and tuberculosis.
 
The following additional tests have been added to the list: those for cardiovascular health; endocrine diseases; and reproductive, maternal and newborn health:
●Two new tests have been included for endocrine disorders: 17-hydroxyprogesterone was included as a point-of-care test to diagnose and follow up congenital adrenal hyperplasia outside the neonatal period, and parathyroid hormone was included as a point-of-care test to help evaluate the causes of calcium homeostasis disorders and monitor the effects of treatment;
●Two tests for reproductive, maternal and neonatal health should be included: a point-of-care test for blood grouping and rhesus factor in relation to maternal health care and haemolytic disorders of the foetus and newborn, and the Kleihauer-Betke acid-elution test as a general IVD for use in clinical laboratories to aid in the diagnosis and management of fetomaternal haemorrhage;
●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.
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