An open-source molecular diagnostic platform approach for outbreak and epidemic preparedness

Abstract

Background: Diagnostic development for outbreak pathogens has typically followed a disease-specific reactive rather than proactive response. Given the diversity of outbreak pathogens, particularly those prioritised by the World Health Organization Research and Development Blueprint, a more flexible and proactive approach to epidemic preparedness is needed to expand access to critical molecular diagnostic tests in peripheral and resource-constrained deployment settings.Objective: New and more sustainable directives are needed to spur the development of high-quality products, particularly for epidemics more often found in low- and middle-income countries. To leverage and de-risk the development process, we present the benefits and challenges of an open-source business model for co-development of molecular diagnostic tests for decentralised settings.Methods: We identify key outbreak pathogens that are available only for testing in high infrastructure laboratories and compare in-country installed base platforms that could be leveraged for menu expansion. Key strengths and challenges for development are highlighted for both platform and assay developers, with discussion of how to leverage and de-risk the process through an open-source development model.Results: Depending on the specific partner strengths, options for partnership roles are presented. The proposed open-source business model addresses the particular challenges in the detection of outbreak- and epidemic-prone pathogens in low- and middle-income countries, reduces development and deployment risks to support outbreak response, strengthens diagnostic capacity and creates a viable market for product developers.Conclusion: We hope this model for a collaborative and open-source approach for molecular diagnostics serves to encourage stakeholders to consider co-development partnerships to improve outbreak preparedness and epidemic/pandemic response.

African laboratory medicine in the time of COVID-19

“…Additional articles in that special issue also have direct relevance to strengthening testing capabilities in the pandemic. 24,25 To meet the double demands of maintaining peer review and production of regular articles, the submission rate of which continues to rise, and processing pandemic submissions, the pandemic pushed us to alter our operations. AJLM's new normal allows for a regular submission track, and a new fast track for articles containing knowledge that could be applied to the ongoing COVID-19, Lassa fever and Ebola haemorrhagic fever outbreaks.…”

“…Additional articles in that special issue also have direct relevance to strengthening testing capabilities in the pandemic. 24 , 25 …”

Providing On-Site Laboratory and Biosafety Just-In-Time Training Inside a Box-Based Laboratory during the West Africa Ebola Outbreak: Supporting Better Preparedness for Future Health Emergencies

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“… 3 They also discuss some ways to address the changes in reimbursement and ownership that will be needed to support such a system. 3 The article by Ondoa et al presents the initial Africa-wide roll-out of a powerful new tool, the Joint External Evaluation Tool, which allows a country-wide comprehensive evaluation of diagnostic laboratory gaps and capabilities. 4 Finally, the article by Naidoo and Ihekweazu describes how Nigeria built a national referral laboratory and established a country-wide specimen referral network to support national priority diseases including yellow fever, Lassa fever, monkeypox, cerebrospinal meningitis, cholera, influenza and other enteric pathogens.…”