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The World Health Organization (WHO) has issued its first list of essential diagnostic tests to improve diagnosis and treatment outcomes, a move some experts believe could be a game-changer for laboratories in resource-challenged settings.

Clinical Laboratory News recently reported on the genesis of this essential diagnostics list (EDL), a guidance that laboratory experts have anticipated for some time. Similar to an essential medicines list the WHO issued four decades ago, the EDL will serve as a reference tool for countries that want to develop their own lists. “When an international organization like the WHO calls certain diagnostics essential for healthcare, many countries will listen. But to have an impact, each country will need to adapt the WHO EDL into their own, country-level EDL,” Lee Schroeder, MD, PhD, a consult to the WHO essential diagnostics workgroup and director of point-of-care testing and associate director of chemical pathology at the University of Michigan, told CLN Stat. “If this happens, it means the government is aligned to make diagnostics a priority, that the Ministry of Health is willing to put some resources into the provision of diagnostics,” he added.

Schroeder, along with Timothy Amukele, MD, PhD, an assistant professor of pathology at the Johns Hopkins University School of Medicine in Baltimore, will be presenting on this topic during an August 2 plenary session at the 70th AACC Annual Scientific Meeting & Clinical Lab Expo in Chicago.

Focusing on in vitro tests, the list includes 113 diagnostic products, half of which are designed to identify and monitor priority diseases such as malaria, tuberculosis, hepatitis B virus and hepatitis C virus, and sexually transmitted diseases like syphilis, HIV, and human papillomavirus. Other tests address more common conditions, “providing an essential package that can form the basis for screening and management of patients,” WHO indicated in a statement. The EDL specifies how each test should be used and in what setting it should be applied.

In the CLN article, Amukele explained how the EDL would help labs in different countries prioritize diagnostic tests. “It would say for this country, given your disease burden, these are the top 20 tests that we think are most essential. Then everyone would be able to focus on that,” he said.

While some tests are ideal for larger, sophisticated healthcare facilities, others on the list are specifically tailored for low-resource areas where inhabitants don’t have access to laboratories. An example of this is a rapid point-of-care test that could diagnose acute malaria in remote settings.

When health systems do not sufficiently plan for or fund laboratory resources, the result is limited access to care and poor quality of care, Schroeder said. This translates into a diagnostic approach that relies on signs and symptoms alone, an inefficient strategy for patient care, as it leads to missed cases of disease and unnecessary treatment of false diagnoses, he continued. In his view, diagnostic technology could change this. “Strengthening laboratory capacity will also have a big impact on antimicrobial stewardship and resistance as well as control of epidemic prone disease,” he added.

Schroeder hopes that the EDL will encourage governments to regulate laboratories to ensure quality. “It’s not as if there aren’t laboratories in resource-poor countries. There are many, but quality is suspect, and I think that’s mostly because governments aren’t establishing or enforcing regulations,” he observed.

It’s also anticipated that the EDL will align stakeholder priorities. “This means medical directors, ministries of health, regulators, educators, international funders, and advocacy groups will all be focused on the same problem,” Schroeder said. “While it is true that providing laboratory medicine is complicated and many logistical barriers exist, one of the largest barriers is lack of a coherent political will among all those involved. The EDL might be able to overcome that.”

Schroeder emphasized that overall, the EDL could be a massive win for laboratories that want to provide high-quality testing for their patients.