Limited or No Access to Essential Diagnostic Tools for Many in Middle- and Low-Income Countries

By Linda Carroll

October 13, 2021

(Reuters Health) - Two new reports highlight the lack of essential diagnostic tools in middle- and low- income countries and suggest that closing the diagnostics gap could save millions of lives annually.

In one study, a panel of experts forming The Lancet Commission on Diagnostics found that nearly half (47%) of the global population has limited or no access to key tests that are essential for diagnosing common diseases, such as diabetes, hypertension, HIV, tuberculosis, as well as hepatitis and syphilis in pregnant women.

A second study focused on 10 countries found the median availability of diagnostics was 19.1% in primary care facilities, 49.2% in advanced primary care facilities, and 68.4% in hospitals.

"In much the same way that there was an international focus on improving access to medicines 40 years ago - and this is highlighted by the 1977 WHO Essential Medicines List - there is a growing international focus on the need to improve access to diagnostics," said Dr. Lee Schroeder, a coauthor of the 10-country study and an associate professor of pathology at the University of Michigan in Ann Arbor. "But it is still just growing. As an example, the Sustainable Development Goals target for Universal Health Coverage included medicines and vaccines, but not diagnostics."

The news wasn't all bad.

"While overall availability gaps were large, there was quite a bit of variability," Dr. Schroeder said in an email. "Our study showed that the availability of some diagnostics were quite high. These included diagnostics supported by vertical programs like those for HIV and malaria. So, I think that's evidence that the situation can improve with prioritization. It's the prioritization that is so critical. We hope that our paper can serve as a benchmark against future initiatives to improve the availability of diagnostics."

For their study, published in The Lancet Global Health, Dr. Schroeder and his team extracted health facility data from the SPA database of USAID, which provides an evaluation of health services capacity in countries including clinical laboratory testing and diagnostic imaging. The researchers focused on Bangladesh, Haiti, Malawi, Namibia, Nepal, Kenya, Rwanda, Senegal, Tanzania, and Uganda.

They found availability varied considerably among diagnostic tools, ranging from 1.2% for ultrasound to 76.7% for malaria lab tests in primary care. Availability in hospitals ranged from 6.1% for CT scans to 91.6% for malaria.

The Lancet Commission authors, 25 experts from 16 countries, called on policy makers to close the diagnostics gap, to improve access, and to expand the development of diagnostics beyond high-income countries.

In their study, published in The Lancet, the commission focused on six indicative "tracer" conditions - diabetes, hypertension, HIV and tuberculosis for the general population, and hepatitis B and syphilis in pregnant women. They found that the diagnostic gap - that is, the proportion of the population with the condition who remain undiagnosed - is, at 35% to 62%, the single largest gap in the care pathway.

The commission's research also found that the diagnostic gap is most severe at the level of primary health care, where only about 19% of populations in low- and middle-income countries have access to the simplest diagnostic tests.

The commission estimated that reducing the diagnostic gap for the six tracer conditions to 10% would reduce the annual number of premature deaths by 1.1 million.

There are a number of things the World Health Organization and others are trying to identify as important for global health, such as essential medicines, said Dr. Ian Lipkin, the John Snow Professor of Epidemiology and Professor of Neurology and Pathology at Columbia University, director of the NIAID Center for Research in Diagnostics and Discovery, and director of the Center for Infection and Immunity at Columbia's Mailman School of Public Health in New York City.

The situation with diagnostics is analogous, said Dr. Lipkin, who wasn't involved in the studies, adding that often the clinical presentation alone is not enough for a diagnosis. "You need blood assays, sputum assays," he noted, pointing to examples such as Zika and COVID-19.

"There should be a universal floor on what diagnostic tests are available," Dr. Lipkin said. "It would have a tremendous impact on morbidity and mortality globally."

Diagnostics almost always seem to draw the short straw, said Dr. David Newman-Toker, a professor of neurology, ophthalmology and Otolaryngology and Director of the Armstrong Institute Center for Diagnostic Excellence at Johns Hopkins Medicine in Baltimore, who also wasn't involved in the studies.

"This is a shocking and tragic state of affairs," Dr. Newman-Toker said. "But for those of us who study this for a living, it isn't the slightest bit surprising," he added.

"Everything we do in medicine is geared around organ systems and diseases and treatments," Dr. Newman-Toker said. "Diagnostics are perceived as a temporary way station on the way to intervention and recovery."

Dr. Newman-Toker points out that while the situation is dire in many low- and middle-income countries, there are parts of the U.S. that are "diagnostic deserts."

SOURCE: and The Lancet, online October 6, 2021; The Lancet Global Health, online October 6, 2021.