Recent advances in the development and evaluation of molecular diagnostics for Ebola virus disease

ABSTRACT

Introduction: The 2014-16 outbreak of ebola virus disease (EVD) in West Africa resulted in 11,308 deaths. During the outbreak only 60% of patients were laboratory confirmed and global health authorities have identified the need for accurate and readily deployable molecular diagnostics as an important component of the ideal response to future outbreaks, to quickly identify and isolate patients.

Areas covered: Currently PCR-based techniques and rapid diagnostic tests (RDTs) that detect antigens specific to EVD infections dominate the diagnostic landscape, but recent advances in biosensor technologies have led to novel approaches for the development of EVD diagnostics. This review summarises the literature and available performance data of currently available molecular diagnostics for ebolavirus, identifies knowledge gaps and maps out future priorities for research in this field.

Expert opinion: While there are now a plethora of diagnostic tests for EVD at various stages of development, there is an acute need for studies to compare their clinical performance, but the sporadic nature of EVD outbreaks makes this extremely challenging, demanding pragmatic new modalities of research funding and ethical/institutional approval, to enable responsive research in outbreak settings. Retrospective head-to-head diagnostic comparisons could also be implemented using biobanked specimens, providing this can be done safely.

KEYWORDS:

• Ebola
• diagnostics
• EVD
• outbreaks
• preparedness

Article highlights

• Rapid molecular diagnostic assays for EVD are a key component of an effective outbreak response.

• Molecular diagnostics for Ebolaviruses are abundant and being rapidly developed, but there is very little evidence to suggest which tests are clinically most accurate and appropriate.

• Validating EVD diagnostic assays against an established gold standard is very difficult in the context of an ongoing outbreak.

• Head-to-head comparison of different diagnostic tests using biobanked specimens requires strong international leadership and equitable collaboration.

• Regular clinical surveillance is necessary and should be affordably embedded into existing national health programs in African countries and beyond.

Acknowledgments

The authors would like to acknowledge the European Developing Countries Clinical Trials Partnership EDCTP support through the Pan African Network for Rapid Response, Research, and Preparedness for Infectious Disease Epidemics PANDORA project.

Declaration of interest

The authors have 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

Peer reviewers on this manuscript have no relevant financial or other relationships to disclose.

Additional information

Funding

This article is part of the EDCTP2 programme supported by the European Union (RIA2016E-1609, PANDORA-ID-NET). The funder was not involved in the preparation, review or approval of the manuscript. G Ippolito received support from the Italian Ministry of Health, grants to Ricerca Corrente linea 1 to INMI.