Half of the global population lack access to basic diagnostics

Nearly half (47%) of the global population has limited or no access to key tests and services essential for diagnosing common diseases, such as diabetes, hypertension, HIV, and tuberculosis, or basic tests for pregnant women such as hepatitis B and syphilis. Without access to accurate, high-quality, and affordable diagnostics, many people will be overtreated, undertreated, or not treated at all, or exposed to unnecessary and potentially harmful treatment.

The analysis was led by The Lancet Commission on Diagnostics, an in-depth report bringing together 25 experts from 16 countries to transform global access to diagnostics. The Commission highlights the centrality of diagnostics for any functioning health care system and calls on policymakers to close the diagnostic gap, improve access, and expand the development of diagnostics beyond high-income countries.

As the Commission notes, an early lesson of the COVID-19 pandemic was the crucial importance of timely, accurate diagnosis. Unfortunately, early issues developing tests hampered the understanding of and response to the outbreak, resulting in the rapid emergence of unreliable, inaccurate (even false) tests. Moreover, in high-income countries, the ability to use existing public health laboratories, in addition to the private sector, was critical in ramping up testing capacity. Still, many low and middle-income countries without access to this infrastructure were disadvantaged and left unable to reach total testing capacity.

In much of the world, patients are treated for diseases without access to critical diagnostic tests and services. This is the equivalent of practising medicine blindly. Not only is this potentially harmful to patients, but it is also a significant waste of scarce medical resources. For the first time, the analysis shows the shocking scale of the challenges we are facing, and the report offers recommendations on how we close the gap.

The COVID-19 pandemic has put testing at the top of the political and global health plan, and it must be a turning point in ensuring to prioritise diagnostics for all diseases. Diagnostics include a collection of key tests and services that are essential to understanding a patient's health. These might consist of blood, tissue, or urine samples collected and analysed at the bedside or in a laboratory, or diagnostic imaging such as x-rays, ultrasound, MRI, CT, or nuclear medicine.

The World Health Organisation recommended tests for antenatal care to provide a global estimate on access to essential diagnostics. These tests, including syphilis testing, urine dipsticks, haemoglobin testing, blood glucose testing, and ultrasounds, represent basic diagnostic tests and should be available within a two-hour travel time of the patient.

Diagnostics are fundamental to quality health care, but as the Commission states, this notion is under-recognised, leading to underfunding and inadequate resources at all levels. Globally, they estimate that nearly half (47%) of the population lack access to diagnostics. The diagnostic gap is most significant in primary care. Only about 19% of low- and lower-middle-income populations have access to the simplest diagnostic tests (other than HIV or malaria).

Three things are essential for health security: diagnostics security, vaccine security, and therapeutic security. Robust health systems, and strong public health systems, require all three. Therefore, equity starts with regionalising the production of health security commodities as much as possible – and this includes diagnostics.

At a global level, narrowing the diagnostic gap for just six conditions (diabetes, hypertension, HIV, and tuberculosis, plus hepatitis B and syphilis for pregnant women) from 35-62% to 10% would reduce the annual number of premature deaths in low-income and middle-income countries by 1.1 million.

The COVID-19 pandemic has illustrated the risks involved in relying on a small number of medical suppliers. Therefore, a key priority is expanding diagnostics production by locating more research, development, and production in low- and middle-income countries.

Other recommendations from the Commission included improving affordability, enhancing regulatory frameworks to oversee the quality and safety of diagnostics, and democratising diagnostics (increasing availability of point-of-care tests, self-sampling, and self-testing).