Lessons from Ebola Can Enhance Future Diagnostic Preparedness

"Failures" in diagnostic preparedness, including testing capacity, led to delays in identifying the Ebola virus as the culprit of the 2014-2015 epidemic and contributed to the outbreak's spread, according to a viewpoint published online May 31 in The Lancet. The authors say that lessons learned from the Ebola outbreak led to the proposed development of a new partnership model that will speed new assay development and ensure their effective deployment in future outbreaks.

Post-episode reports, including those by the World Health Organization and the European Commission, showed that in the Ebola epidemic it took more than three months to identify that an outbreak was spreading in rural Guinea and it took a year for diagnostic capacity to be fully established. This delay in testing capacity was attributed to the complexity and cost of the technology used (The authors note that the fixed biocontainment laboratories using manual real-time polymerase chain reaction and staffed by those molecular experience cost more than $2 million to establish and operationalize) and contributed to the spread of the disease (Gerardo Chowell, from Arizona State University, previously estimated that diagnosing 60 percent of patients with Ebola within one day instead of five days could have dropped the population attack rate from 80 percent to nearly zero).

The Coalition for Epidemic Preparedness Innovations (CEPI), a multisector alliance between industry, academic, philanthropic, and government organizations, plus the World Health Organization and Médecins Sans Frontières, was officially launched in January with the goal of developing new vaccines to fight potential epidemics, including Ebola and Zika. Its next phase, CEPIdx, expands the focus to include diagnostics development through a partnership with the Foundation for Innovative New Diagnostics (FIND). The CEPIdx framework was explained in The Lancet.

The proposed framework for diagnostic preparedness and response includes four pillars—outbreak detection, research and development, manufacturing and distribution, and implementation of new diagnostic tools—and provides a unified, comprehensive vision for achieving better diagnostic preparedness and response.

"The diagnostic ecosystem for diagnostics research and development must be enabled by a number of cross-cutting systems, including ethically managed specimen repositories, platforms for data sharing and connectivity, sustained and targeted financing, and pre-agreed regulatory approaches," write the authors, led by Mark Perkins, M.D., from FIND (Switzerland).

Other key elements of the framework include:

• Outbreak detection: Pre-agreed logistical arrangements and financing for collection and shipping of samples to reference laboratories.

• Research and development: Focusing on pre-outbreak commercial test development using public investment to compensate for the lack of predictable return on investment associated with these tests. Additionally, efforts need to better define sample ownership, sharing of access to samples, and standardized agreements for ethical collection and use of specimens.

• Implementation: Addressing testing capacity requires diagnostics training, (including specimen collection, handling, and testing, and results reporting), as well as budgeting for laboratory and equipment maintenance.

Takeaway: Lessons learned from the 2014-2015 Ebola outbreak, including those elucidated in the CEPIdx framework, can improve diagnostic preparedness for potential future infectious disease outbreaks.