Molecular and point-of-care diagnostics for Ebola and new threats: National POCT policy and guidelines will stop epidemics

ABSTRACT

Introduction: US hospitals that admitted Ebola virus disease (EVD) patients mitigated risk by using point-or-care testing (POCT) for critical support in isolation units. Success proved unequivocally the need for POCT. Additionally, molecular diagnostics have been used to help stop new outbreaks, and even handheld diagnostic solutions are emerging.

Areas covered: This update of ‘Molecular detection and point-of-care testing in Ebola virus disease and other threats’ [Expert Reviews 2015;15(10):1249–1255], assesses the impact of EVD epidemics, documents insights from recent reviews, summarizes evolving POC molecular technologies, presents General Accountability Office (GAO) recommendations, identifies the role of POC Coordinators, and casts a vision for national POCT policies and guidelines. Factual updating comprised summarizing EVD outbreaks including 2017–2018, analyzing reviews and evidence-based publications since the 2014–2016 epidemic, and tabulating published technical and molecular diagnostics. New graphics illustrate POC error mitigation/risk reduction, a framework for national POCT policy and guidelines, modular adaptations for country-specific solutions, and a logic diagram for future progress embedding artificial intelligence.

Expert commentary: The USA is still not prepared for highly infectious diseases. Key is lack of community rapid response and resilience, which must be enhanced not via mechanisms distant, but instead by molecular diagnostics directly at critical points of need.

KEYWORDS:

• Molecular and Point-of-Care Diagnostics, Ebola and New Threats, National POCT Policy and Guidelines, Epidemics

Acknowledgements

The author thanks Amanullah Zadran for gathering preliminary literature and is grateful to the other creative students who participate in the POCT•CTR and contribute substantially to knowledge in point of care. Figures and tables are provided courtesy and permission of Knowledge OptimizationTM, Davis, California.

Disclaimer

Devices must comply with jurisdictional regulations in specific countries, operator use limitations based on patient conditions, federal and state legal statutes, and hospital accreditation requirements. Not all POC devices presented in this article are FDA cleared for use in the USA. The FDA EUA is limited in scope and term. On 29 March 2016, the WHO announced that Ebola in West Africa is no longer a public health emergency and that temporary recommendations are terminated. WHO no longer accepts new IVD applications. However, IVD applications submitted previously will still be assessed under EUAL procedure. Please check with manufacturers within the relevant domain of use for the current status of Ebola, Zika, MERS-CoV, and other threat detection diagnostics and POC tests for the support of critically ill patients.

Declaration of interest

The author has no relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript. This includes employment, consultancies, honoraria, stock ownership or options, expert testimony, grants or patents received or pending, or royalties.

Reviewer disclosures

A reviewer on this manuscript is co-founder of Zalgen Labs (POC Lassa fever and Ebola tests) and Program Manager, Viral hemorrhagic fever consortium (multiple projects on VHF countermeasures)

Additional information

Funding

This work was supported by the Point-of-Care Testing Center for Teaching and Research (POCT•CTR^TM) and by G.J. Kost, its Director.