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. 2023 Aug 23;61(8):e0036723.
doi: 10.1128/jcm.00367-23. Epub 2023 Jul 3.

RADx-UP Testing Core: Access to COVID-19 Diagnostics in Community-Engaged Research with Underserved Populations

Shanti Narayanasamy  1   2 , Timothy H Veldman  3 , Mark J Lee  4 , William A Glover 2nd  5 , L Gayani Tillekeratne  1 , Coralei E Neighbors  2 , Barrie Harper  6 , Vidya Raghavan  6 , Scott W Kennedy  6 , Miranda Carper  7 , Thomas Denny  7 , Ephraim L Tsalik  1 , Megan E Reller  1 , Warren A Kibbe  8   9 , Giselle Corbie  10   11   12 , Michael Cohen-Wolkowiez  6   13 , Christopher W Woods  1   2 , Cathy A Petti  1   14
Affiliations

RADx-UP Testing Core: Access to COVID-19 Diagnostics in Community-Engaged Research with Underserved Populations

Shanti Narayanasamy et al. J Clin Microbiol. .

Abstract

Research on the COVID-19 pandemic revealed a disproportionate burden of COVID-19 infection and death among underserved populations and exposed low rates of SARS-CoV-2 testing in these communities. A landmark National Institutes of Health (NIH) funding initiative, the Rapid Acceleration of Diagnostics-Underserved Populations (RADx-UP) program, was developed to address the research gap in understanding the adoption of COVID-19 testing in underserved populations. This program is the single largest investment in health disparities and community-engaged research in the history of the NIH. The RADx-UP Testing Core (TC) provides community-based investigators with essential scientific expertise and guidance on COVID-19 diagnostics. This commentary describes the first 2 years of the TC's experience, highlighting the challenges faced and insights gained to safely and effectively deploy large-scale diagnostics for community-initiated research in underserved populations during a pandemic. The success of RADx-UP shows that community-based research to increase access and uptake of testing among underserved populations can be accomplished during a pandemic with tools, resources, and multidisciplinary expertise provided by a centralized testing-specific coordinating center. We developed adaptive tools to support individual testing strategies and frameworks for these diverse studies and ensured continuous monitoring of testing strategies and use of study data. In a rapidly evolving setting of tremendous uncertainty, the TC provided essential and real-time technical expertise to support safe, effective, and adaptive testing. The lessons learned go beyond this pandemic and can serve as a framework for rapid deployment of testing in response to future crises, especially when populations are affected inequitably.

Keywords: COVID-19; RADx-UP; diagnostics; equity; underserved communities.

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Conflict of interest statement

The authors declare a conflict of interest. Ephraim Tsalik has been a consultant for Biomeme, Inc.; has a patent pending for Methods to Diagnose and Treat Acute Respiratory Infections (US20180245154A1); and is currently employed by Danaher Corp. Michael Cohen-Wolkowiez receives support for research from the NIH [1U24-MD016258]; National Institute of Allergy and Infectious Diseases [HHSN272201500006I, 1K24-AI143971]; U.S. Food and Drug Administration [5U18-FD006298]; and industry for drug development in adults and children. Cathy A Petti receives consulting fees from Abbott Molecular and Rapid Diagnostics. Christopher Woods reports consulting fees from Arena Pharmaceuticals, BioFire, FHI Clinical, Giner, Karius, and SeLux Diagnostics. All other authors report no conflicts of interests.

Figures

FIG 1
FIG 1
Timeline of RADx-UP Testing Core activities during the COVID-19 pandemic. CDC, Centers for Disease Control and Prevention; FDA, U.S. Food and Drug Administration; HHS, U.S. Department of Health and Human Services; LDT, laboratory-developed tests; OTC, over the counter; POC, point-of-care; PREP, public readiness and emergency preparedness; WHO, World Health Organization.
FIG 2
FIG 2
RADx-UP communities and settings by test type (projected estimates for studies testing participants directly).
See this image and copyright information in PMC

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References

    1. Landman JM, Steger-May K, Joynt Maddox KE, Hammond G, Gupta A, Rauseo AM, Zhao M, Foraker RE. 2021. Estimating the effects of race and social vulnerability on hospital admission and mortality from COVID-19. JAMIA Open 4:ooab111. doi:10.1093/jamiaopen/ooab111. - DOI - PMC - PubMed
    1. Braveman PA, Arkin E, Proctor D, Kauh T, Holm N. 2022. Systemic and structural racism: definitions, examples, health damages, and approaches to dismantling. Health Aff (Millwood) 41:171–178. doi:10.1377/hlthaff.2021.01394. - DOI - PubMed
    1. Homan PA, Brown TH. 2022. Sick and tired of being excluded: structural racism in disenfranchisement as a threat to population health equity. Health Aff (Millwood) 41:219–227. doi:10.1377/hlthaff.2021.01414. - DOI - PubMed
    1. Heller C, Balls-Berry JE, Nery JD, Erwin PJ, Littleton D, Kim M, Kuo WP. 2014. Strategies addressing barriers to clinical trial enrollment of underrepresented populations: a systematic review. Contemp Clin Trials 39:169–182. doi:10.1016/j.cct.2014.08.004. - DOI - PMC - PubMed
    1. Chokshi DA. 2018. The health innovation we need. JAMA 320:427–429. doi:10.1001/jama.2018.9545. - DOI - PubMed

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