To address the
lack of access to tests and testing services in multiple countries, WHO since
2018 has published a yearly essential diagnostics list (EDL), a basket of
recommended in vitro diagnostics that should be available at
point-of-care and in laboratories in all countries to increase timely and life-saving
edition, published today, includes WHO-recommended COVID-19 tests (PCR and
Antigen), expands the suite of tests for vaccine-preventable and infectious
diseases and non-communicable diseases (such as cancer and diabetes), and
introduces a section on endocrinology, which is important for reproductive and
women’s health. For the first time, the list includes tests that should not be
supplied in countries, either because they are not cost-effective, are
unreliable or have been surpassed by newer, easier to use technologies.
quality tests and laboratory services is like having a good radar system that
gets you where you need to go. Without it, you’re flying blind,’ said WHO
Director-General, Dr Tedros Adhanom Ghebreyesus.
‘All countries should pay particular attention to the diagnostics space and use
the essential list to promote better health, keep their populations safe, and
serve the vulnerable.’
The use of
accurate, quality diagnostics is the first step in the development and
implementation of strategies for treatment, control, and in many cases
prevention of disease and outbreaks. Their critical role in the health system
has been brought into sharp focus by the current COVID-19 pandemic.
the majority of medical decisions,’ said Dr Mariângela Simão, WHO
Assistant-Director General for Access to Medicines and Health Products. ‘In all
countries, the use of appropriate diagnostic tests can help inform
evidence-based treatment and responsible use of medicines, resulting in
improved allocation of resources and better health outcomes.’
The EDL is an
evidence-based guide that looks at disease prevalence globally and for each
condition recommends the appropriate test. That guidance aims not only to improve
the health system’s capacity to reach accurate diagnoses, it also saves
precious health resources that would otherwise be wasted on inappropriate
treatment or lengthy hospital stays.
As well as tests
intended for use in laboratories, the EDL recommends numerous diagnostics that
should be available at primary care or community level. This is particularly
important for rural areas in low- and middle-income countries, where medical
facilities and equipment may be lacking and health providers are often forced
to make treatment decisions based solely on patient symptoms.
recommendations in the list are based on robust evidence and take into account
country suitability. The process is overseen by the Strategic Advisory Group of
Experts on In Vitro Diagnostics (SAGE IVD), a group of specialists from around
the world with long standing experience in the field of IVDs and their
implementation, their use, regulation and evaluation. The experts evaluate data
on the usefulness, impact and accuracy of each test considered in order to
decide which should be recommended.
The EDL is not
prescriptive – it is intended as a policy tool for countries to create their
own national lists based on their local context and needs. WHO will shortly
also publish a step-by-step guide to aid countries wishing to develop a
national list. So far, WHO has worked with Nigeria, India, Bangladesh and
Pakistan to support the development of their national EDLs and is currently in
discussions with additional mostly African countries that have requested
assistance to boost their diagnostic services.