Rohit Shishodia    
The World Health Organization (WHO) has revised the in vitro diagnostics that should be available at point-of-care and in laboratories in all countries to increase timely and life-saving diagnoses. The WHO has made an appeal to countries to invest in the diagnostics to provide effective healthcare services.

The latest revised list includes Covid Rapid Antigen and RT-PCR tests and 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.

The new list can be reached on WHO's website. The name of the downloadable list is -The Selection and Use of Essential in Vitro Diagnostics.  

The WHO has informed that, for the first time, the list includes tests that should not be supplied in countries, either because they are not cost-effective, are not reliable or have been surpassed by newer, easier to use technologies.

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

“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,” he added.

The UN agency has asserted that 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.

Dr Mariângela Simão, WHO Assistant-Director General for Access to Medicines and Health Products, said, “Testing affects the majority of medical decisions. 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.”

According to WHO, the list is an evidence-based guide that looks at disease prevalence worldwide 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,” reads the WHO press release.

The WHO emphasized that the recommendations in the list are based on robust evidence and take into account country suitability while 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 WHO has pointed out that the list 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.

The agency has informed that WHO will shortly also publish a step-by-step guide to aid countries wishing to develop a national list.