The World Health Organization (WHO) releases the 2023 Essential Diagnostic Test List (in English), an evidence-based register of diagnostic products in vitro Help countries make internal decisions about diagnostic tests.
This year’s list includes two new features:
- Includes three tests for hepatitis E virus, including rapid tests to help diagnose and monitor the infections it causes.
- It is recommended that personal use blood glucose measurement devices be added to existing diabetes care guidelines.
Cases of hepatitis E occur in outbreaks or sporadically around the world. Although most people recover completely, a small number (4%) develop acute renal failure. The rate is higher among pregnant women (mortality rates range from 19.3% to 63.6%). There are a large number of unreported cases of this virus, but increasing these diagnostic tests will help governments control the outbreak.
Diabetes is a chronic disease that killed 1.5 million people in 2019, with higher incidence and impact in low- and middle-income countries. Its consequences can be avoided or delayed with adequate nutrition, medications, physical activity, and regular blood sugar measurements. Incorporating blood glucose testing devices into the list of essential diagnostic tests may lead to better disease management and fewer negative outcomes.
Although the list is not prescriptive, it has the potential to help countries develop plans to improve access to diagnostic products. in vitro Develop a regulatory framework that will enable them to make informed decisions about their listings at the national level.The aim is for governments to use the list to improve diagnostic testing services in vitro This will give patients greater access to diagnostic tests and better outcomes in their countries.
“In the early days of the COVID-19 pandemic, the rapid development and global deployment of diagnostic tests was critical to controlling the spread of the virus, detecting, isolating and treating infected people, and protecting those at risk,” he said. The WHO Director-General added: ” The Essential Diagnostic Test List is an important tool that provides countries with evidence-based recommendations to guide their decision-making and ensure that “healthcare has access to the most important and reliable diagnostic tests for workers and patients.” “
For 2023 List, Diagnostic Testing Strategic Advisory Panel in vitro WHO (SAGE-DIV) received 12 requests and recommended adding 8 diagnostic products in vitro and some revisions to tests on previous lists, including diagnostic equipment for tuberculosis, HIV and diabetes Melitus.
Other new tests added to the list include tests specifically for endocrine conditions, reproductive, maternal and newborn health, and cardiovascular health.
- Regarding endocrine status, two new laboratory tests have been added: parathyroid hormone, which helps evaluate the cause of disease related to calcium homeostasis and observe the effects of treatment; and 17-hydroxyprogesterone, whose purpose is to diagnose and observe in vitro Congenital adrenal hyperplasia. Neonatal period.
- These include two tests for reproductive, maternal and newborn health: Kleihauer-Betke acid elution test as a universal diagnostic product in vitro For use in clinical laboratories to aid in the diagnosis and treatment of maternal and neonatal hemorrhage, and in tests performed in medical facilities to determine blood group and Rh factor in maternal health and hemolytic disease of the fetus and newborn.
- In cardiovascular health, the inclusion of high-sensitivity troponins I and T aids in the diagnosis of acute myocardial infarction in health facilities and clinical laboratories.
The Seventy-sixth World Health Assembly recently adopted a resolution on strengthening diagnostic capacity, encouraging Member States to consider developing national diagnostic strategies as part of their national health plans and to adapt the Essential Diagnostic Test List to develop a list at the national level. WHO advises and supports efforts by countries around the world to develop diagnostic test inventories through webinars, workshops and direct support to countries.
The WHO list is updated every two years and is designed to support the regulatory development of diagnostic products in vitro and improve access to clinical laboratory testing equipment and services. It not only provides information on national inventories but also provides recommendations on which equipment to prioritize at different levels of the health system.In addition, it provides information to United Nations agencies and NGOs involved in the selection, procurement, supply or donation of diagnostic equipment in vitro and guide the private medical technology and manufacturing sector’s diagnostic product priorities to address global health issues.
More information about diagnostic test model list in vitro “WHO 2023 Highlights” and its decisions, please see the link (in English).