The 2023 Essential Diagnostics List from WHO provides an evidence-based catalog of in vitro diagnostics, with two groundbreaking additions, assisting nations in shaping their diagnostic strategies.

• The list now encompasses three tests designed for hepatitis E virus (HEV), one of which is a rapid diagnostic test intended to facilitate the detection and monitoring of HEV infection.
• The recommendation is to incorporate personal-use glucose monitoring devices into the existing medical guidelines for diabetes management.

Hepatitis E is a global concern, manifesting as both outbreaks and sporadic cases. While most individuals achieve full recovery, a minority (up to 4%) may experience acute liver failure, with a significantly higher risk among pregnant women (mortality rates ranging from 19.3% to 63.6%). Unfortunately, hepatitis E infections are often underreported. The addition of these diagnostics to the list will empower governments to effectively address outbreaks.

Diabetes, a chronic condition, claimed 1.5 million lives in 2019, disproportionately in lower-middle-income countries. Its effects can be mitigated through dietary management, physical activity, medications, and glucose monitoring. The inclusion of personal glucose monitoring devices on the Essential Diagnostics List could improve disease management.

The Essential Diagnostics List is a policy framework that aids nations in improving in vitro diagnostics accessibility. It aids in informed decision-making when creating national Essential Diagnostics Lists, empowering governments to improve testing services within their borders, leading to expanded diagnostic accessibility and improved patient outcomes.

Dr Tedros Adhanom Ghebreyesus, WHO Director-General said, “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. 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.”

In the preparation of the 2023 Essential Diagnostics List, the WHO Strategic Advisory Group of Experts on in vitro diagnostics (SAGE IVD) assessed 12 submissions. They put forth recommendations to incorporate eight new in vitro diagnostics (IVDs) and made various revisions to previously listed tests in the EDL, encompassing IVDs for conditions like tuberculosis, HIV, and diabetes mellitus.

Additionally, the updated list now embraces new tests for endocrine disorders, reproductive and maternal health, as well as neonatal health, and cardiovascular well-being.

• Two novel tests have been integrated into the Essential Diagnostics List for endocrine disorders. These encompass the addition of Parathyroid hormone as a laboratory-based diagnostic, aimed at assisting in the assessment of the origins of calcium homeostasis irregularities and monitoring the impact of treatment. Additionally, 17-Hydroxyprogesterone is now part of the list, serving as a laboratory-based diagnostic for diagnosing and tracking congenital adrenal hyperplasia beyond the neonatal stage.
• Within the realm of reproductive, maternal, and newborn health, the 2023 Essential Diagnostics List introduces two valuable tests. The first is the Kleihauer-Betke acid-elution test, designed as a general in vitro diagnostic (IVD) for utilization in clinical laboratories. It plays a pivotal role in the diagnosis and treatment of fetomaternal hemorrhage. The second addition is a point-of-care test, specifically tailored to determine blood groups and the Rhesus factor in the context of maternal healthcare and the management of hemolytic disease in both the fetus and newborn.
• In the context of cardiovascular health, the 2023 Essential Diagnostics List now features the addition of high-sensitivity troponin I and T. These tests are aimed at facilitating the diagnosis of acute myocardial infarction in healthcare facilities equipped with clinical laboratories.

The Essential Diagnostics List, updated every two years, aids in developing national policies on in vitro diagnostics, improving access to IVD testing and clinical laboratory services. It also provides recommendations on prioritizing IVDs at different healthcare system levels.

The Essential Diagnostics List offers crucial guidance to UN agencies, NGO's, and entities involved in in vitro diagnostics selection, procurement, supply, or donation, as well as insights to private health technology and manufacturing sectors on priority IVDs for global health challenges.