The World Health Organization (WHO) has released a Model List of Essential Diagnostics in an effort to strengthen clinical diagnostic testing in low- and middle-income countries. In these regions, particularly in sub-Saharan Africa, the issue of insufficient laboratory testing capacity to support hospitals and primary care is widely known.

This morning, Lee Schroeder, MD, PhD, Assistant Professor at the University of Michigan and Timothy Amukele, PhD, MD, Assistant Professor at Johns Hopkins University, will present a roadmap to the creation and implementation of the essential diagnostics list in their plenary session, “Essential Diagnostics: Meeting the Needs of a Global Population.”

“We hope to pull back the curtain on the advocacy work that supported this movement and show what it takes to move an issue forward,” Amukele said. “The idea of a list of essential diagnostics has moved quickly—from a proposal in a high-impact journal to a WHO recommendation.” 

Children with pneumonia, malaria, or bacterial sepsis can be indistinguishable in their clinical presentation, but if diagnosed properly, would have very different courses of treatment. In low-resource settings, patients must be diagnosed solely on their clinical symptoms, and healthcare providers are unable to use the power of diagnostic testing to direct their treatment. As a result, there is widespread overuse of antibiotics fueling resistance, patients may receive the unnecessary or the wrong treatment, and have poorer outcomes. Without proper diagnostic testing, clinicians are “left with poor-quality healthcare, wasted money, and unnecessary suffering,” Amukele said.

Taking a public health approach, the essential diagnostics list identifies a broad list of essential high-quality in vitro diagnostic tests for healthcare facilities with and without clinical laboratories. The essential diagnostics list prioritizes diagnostic testing for high-burden diseases in routine patient care such as HIV, tuberculosis, malaria, hepatitis B and C viruses, human papilloma virus, and syphilis. It also includes tests useful for common conditions like diabetes, cardiovascular disease, and liver disease.

The speakers will illustrate how the essential diagnostics list is critical to the delivery of effective and efficient clinical diagnostics in resource-poor health systems and discuss the barriers healthcare professionals in these settings must overcome. Schroeder will describe how laboratory medicine has too often been deprioritized as compared to therapeutics, when public health authorities dedicate resources. “The creation of the essential diagnostics list has firmly established laboratory diagnostics as essential to the global health agenda and it cements the value of diagnostics in the care cascade,” Schroeder said. “We hope people gain a deeper understanding of the value our discipline brings to patients, in all settings.”

Like the WHO Model List of Essential Medicines, the essential diagnostics list aims to streamline funding mechanisms and focus the efforts of governments and other stakeholders to make the most effective investments in laboratory medicine. Supporters believe that it will help facilitate building and maintaining infrastructure: improve supply chains, identify necessary target products, and ensure high-quality testing. The essential diagnostics list will be updated annually and expanded significantly over the next few years, incorporating other important conditions. Additionally, the WHO will be accepting applications for tests to be added, such that anyone can have an impact on the provision of global laboratory diagnostics.