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Democratizing Diagnostics During COVID-19

By guest contributors Joseph D. Tucker, Catherine J. Wedderburn, Shunmay Yeung, and Rosanna W. Peeling 

COVID-19 has demonstrated the importance of diagnostics, underlining the critical function of diagnostics in clinical care, disease surveillance, outbreak control, and prevention [1, 2]. COVID-19 has enhanced public knowledge and understanding of diagnostics in low-income, middle-income, and high-income countries. Diagnostics regularly feature in news articles and there is widespread availability of test information, empowering people to make their own decisions about testing and what follows. Allowing people to directly decide about testing accelerates democratization. Although technological advances such as high-quality HIV tests have expanded diagnostic access, progress towards truly democratizing diagnostics has been slow [3]. COVID-19 has now fundamentally altered the diagnostic landscape (Table 1). The pandemic has taught us that the public plays an essential role in public health – no one is safe until we are all safe.  Armed with greater diagnostic literacy, the public can be more directly involved in the response to COVID-19. This is the essence of public health.

The democratization of diagnostics has implications for universal health coverage, public engagement, and guideline development beyond COVID-19. Universal health coverage requires community-based, decentralized health service provision in global settings. The expansion of diagnostics out of clinics and into other settings will accelerate programs and policies that support universal health coverage. Second, the new diagnostic paradigm introduces opportunities for public engagement that were not possible before. Crowdsourcing, citizen science, and related participatory activities have flourished during COVID-19 [4, 5], providing new opportunities for the public to directly use diagnostics. For example, the National Health Service mobile phone application provided a way for 16.5 million UK people (28% of the total population) to input their symptoms, test results, and inform real-time responses [6]. Third, along with shaping patient pathways [7], access to diagnostics is now shaping travel and work. The importance of diagnostics is increasingly being recognized outside of the health sector.

Although the evidence base for decentralized diagnostics has expanded [1], there are few guidelines and harmonized regulatory processes to support these new diagnostic approaches. Quality assurance systems and integration of diagnostics within clinical care pathways (ensuring data privacy and security with electronic tracking of results) are increasingly critical. The expanding digital infrastructure of clinical medicine can provide a scaffolding for enhanced connected diagnostics [8]. We need to capitalise on the innovation, demand, and public understanding of diagnostics from COVID-19 and translate lessons learned into action to address antimicrobial resistance and related public health challenges.

CategoryConventional diagnosticsHIV diagnostic innovationsCOVID diagnostic innovations
Public understandingLimited understanding of diagnostics (e.g., PCR) and results (false negative / positive)Expanded understanding of diagnostics among subsets of the population (e.g., key populations)Better understanding of diagnostics among larger numbers of people, including appreciation of different types of tests and concepts of test sensitivity
Diagnostic modelsCentralized testing in specialist laboratoriesPoint-of-care and rapid testing; Self-testing used among key populationsClinic-based, self-testing, self-collection
Location and userNurses and doctors, within health facilities with labs onlyMoving towards decentralized diagnostic services in some settingsAllied health professionals, pharmacists, volunteers, teachers, general population.

Primary care clinics, mobile sites, pharmacies, schools, homes, and other sites
Role of test in societyDiagnose disease (but also surveillance and outbreak response)Diagnose disease, increase clinic seeking behaviourDiagnose disease, increase clinic seeking behaviour, cohorting within health facilities, surveillance (“test and track”), decisions on quarantine and travel, self-care (patient-centered to person-centered)
ScaleOpt-in, exclusive, limited scaleDependent on HIV burden and local contextDiagnose disease, increase clinic seeking behaviour, cohorting within health facilities, surveillance (“test and track”), decisions on quarantine and travel, self-care (patient-centered to person-centered)
Table 1. Overview of how diagnostics has shifted from conventional approaches to HIV innovations and now to COVID innovations.

Dr. Joseph Tucker is an Associate Professor at the London School of Hygiene and Tropical Medicine and at the University of North Carolina at Chapel Hill. He is Co-Director of the International Diagnostics Centre and has a special interest in public engagement, crowdsourcing, and social innovation. @JosephTucker

Dr. Catherine Wedderburn is a Senior Clinical Research Fellow at the MRC Clinical Trials Unit at University College London, UK and the University of Cape Town, South Africa. She has an interest in Paediatrics, Infectious Diseases, and Neuroscience, and recently completed a Wellcome Trust Research Training Fellowship at the London School of Hygiene & Tropical Medicine examining the effects of exposure to HIV and antiretroviral therapy on child neurodevelopment. @catwedderburn

Dr. Shunmay Yeung is Head of the Clinical Research Department at the London School of Hygiene and Tropical Medicine and an Honorary Consultant in Paediatric Infectious Disease at St Mary’s Hospital, London. She has a long-standing interest in the diagnosis and treatment of acute infections in children.

Dr. Rosanna Peeling is Chair and Professor of Diagnostics at the London School of Hygiene and Tropical Medicine. She is Director of the International Diagnostics Centre and has several decades of experience leading global diagnostics research studies and programmes.


References

1.           Peeling RW, Olliaro PL, Boeras DI, Fongwen N. Scaling up COVID-19 rapid antigen tests: promises and challenges. Lancet Infect Dis. 2021. Epub 2021/02/27. doi: 10.1016/s1473-3099(21)00048-7. PubMed PMID: 33636148; PubMed Central PMCID: PMCPMC7906660.

2.           Boehme C, Hannay E, Pai M. Promoting diagnostics as a global good. Nature Medicine. 2021;27(3):367-8. doi: 10.1038/s41591-020-01215-3.

3.           Fleming KA, Horton S, Wilson ML, Atun R, DeStigter K, Flanigan J, et al. The Lancet Commission on diagnostics: transforming access to diagnostics. Lancet. 2021. Epub 2021/10/10. doi: 10.1016/S0140-6736(21)00673-5. PubMed PMID: 34626542; PubMed Central PMCID: PMCPMC8494468.

4.           Day S, Li C, Hlatshwako TG, Abu-Hijleh F, Han L, Deitelzweig C, et al. Assessment of a Crowdsourcing Open Call for Approaches to University Community Engagement and Strategic Planning During COVID-19. JAMA Netw Open. 2021;4(5):e2110090. Epub 2021/05/15. doi: 10.1001/jamanetworkopen.2021.10090. PubMed PMID: 33988706; PubMed Central PMCID: PMCPMC8122225.

5.           Kpokiri E, Chen E, Li J, Payne S, Shrestha P, Afsana K, et al. Social innovation research checklist: A crowdsourcing open call and digital hackathon to develop a checklist for research to advance social innovation in health. medRxiv. 2020. Epub 2020/11/12. doi: 10.1101/2020.11.03.20225110. PubMed PMID: 33173931; PubMed Central PMCID: PMCPMC7654927.

6.           Wymant C, Ferretti L, Tsallis D, Charalambides M, Abeler-Dörner L, Bonsall D, et al. The epidemiological impact of the NHS COVID-19 app. Nature. 2021. doi: 10.1038/s41586-021-03606-z.

7.           Bose R, Saxon LA. The Democratization of Diagnosis: Bringing the Power of Medical Diagnosis to the Masses. EClinicalMedicine. 2019;8:6-7. doi: 10.1016/j.eclinm.2019.03.004.

8.           Land KJ, Boeras DI, Chen X-S, Ramsay AR, Peeling RW. REASSURED diagnostics to inform disease control strategies, strengthen health systems and improve patient outcomes. Nature Microbiology. 2019;4(1):46-54. doi: 10.1038/s41564-018-0295-3.

Conflicts: None declared.

Contributorship: JT wrote the first draft. All revised the draft, provided critical feedback, and agree with the final version.

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