Molecular detection and point-of-care testing in Ebola virus disease and other threats: a new global public health framework to stop outbreaks

Abstract

Ultrahigh sensitivity and specificity assays that detect Ebola virus disease or other highly contagious and deadly diseases quickly and successfully upstream in Spatial Care Paths™ can stop outbreaks from escalating into devastating epidemics ravaging communities locally and countries globally. Even had the WHO and CDC responded more quickly and not misjudged the dissemination of Ebola in West Africa and other world regions, mobile rapid diagnostics were, and still are, not readily available for immediate and definitive diagnosis, a stunning strategic flaw that needs correcting worldwide. This article strategizes point-of-care testing for diagnosis, triage, monitoring, recovery and stopping outbreaks in the USA and other countries; reviews Ebola molecular diagnostics, summarizes USA FDA emergency use authorizations and documents why they should not be stop-gaps; and reduces community risk from internal and external infectious disease threats by enabling public health at points of need.

Keywords:

• Ebola diagnostic center
• Ebola
• emergency use authorization
• facilitated-access self-testing
• point-of-care
• public health resilience
• ultrahigh sensitivity
• ultrahigh specificity

Acknowledgements

The authors are grateful to the creative students who participate in the POCT•CTR and contribute substantially to knowledge in point-of-care.

Financial & competing interests disclosure

This work was supported by the Point-of-Care Testing Center for Teaching and Research (POCT•CTR) and by GJ Kost, Director. Spatial Care Path™ is a trademark by W Ferguson and GJ Kost, Knowledge Optimization^®, Davis, CA, USA. The authors have no other 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 apart from those disclosed.

Key issues

• Zoonotic reservoirs sustain major virus threats while enabling jumps to humans, and although vaccination can provide protection, animal reservoirs generally cannot be eliminated, so rapid detection of high morality diseases at points of need is necessary to stop new outbreaks – facilitated-access self-testing point of care (FAST POC^TM) can enable this type of resolution.

• Detection should occur upstream early in the spatial care path in homes (using FAST POC^TM), primary care sites (e.g., clinics) and emergency rooms (to prevent spread like occurred with MERS-CoV in South Korea), before patients disseminate the disease throughout the community, and in particular, waiting for symptomatic patients to present at treatment centers perpetuates outbreaks and unnecessary mortality.

• The value proposition for early rapid diagnosis should be formulated in the context of extraordinary financial losses (e.g., billions of dollars lost in West Africa) incurred when whole nations are afflicted with epidemics, in order to assess cost–effectiveness and return on investment in point-of-care testing.

• The recent Ebola and MERS-CoV outbreaks have motivated significant rethinking, which ideally should manifest as national policies for POC testing, so that appropriate infrastructure can be designed, funded and distributed evenly geographically.

• Public health practitioners, the CDC, the WHO and other organizations should anticipate points of first critical need by assimilating POC know-how and technologies, such as molecular diagnostics and mobile testing, in order to acquire knowledge bases of sensitivity, specificity and predictive values while epidemics are underway – these data will facilitate real-world diagnostic device and assay maturation, refine evidence-based medicine for target diseases and prepare first responders for future outbreaks.

• The advent of hospital isolation units, Ebola treatment centers, national Ebola training sites and community preparation through PPE rehearsals should be coordinated with FDA education in emergency use authorizations, so that as they emerge, the new diagnostic technologies, such as the Orasure POC and Cepheid molecular diagnostic tests for Ebola (see Table 3), can be integrated systematically and efficiently.

• Point-of-care instrument experts, professionally certified POC coordinators and geospatial scientists designing spatial care paths should contribute to collaborative leadership for the development of cohesive national strategies. Transforming public health must occur through education, deep understanding of point-of-care testing and professionally integrated teamwork. Stopping future outbreaks more quickly in the future will demand redefinition of preparedness and current public health practice.

• Ultimately, communities worldwide would be wise to develop alternate care sites equipped with POC testing and diagnostic centers in order to enhance resilience in the event of widespread outbreaks that require quarantine of large groups of people, in part in order to ameliorate civil rights issues by providing well thought out and equitable care.

Notes

Information from [47].