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

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 Diagnostic...

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Published inJournal of clinical microbiology Vol. 61; no. 8; p. e0036723
Main Authors Narayanasamy, Shanti, Veldman, Timothy H, Lee, Mark J, Glover, 2nd, William A, Tillekeratne, L Gayani, Neighbors, Coralei E, Harper, Barrie, Raghavan, Vidya, Kennedy, Scott W, Carper, Miranda, Denny, Thomas, Tsalik, Ephraim L, Reller, Megan E, Kibbe, Warren A, Corbie, Giselle, Cohen-Wolkowiez, Michael, Woods, Christopher W, Petti, Cathy A
Format Journal Article
LanguageEnglish
Published United States American Society for Microbiology 03.07.2023
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Summary: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.
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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.
ISSN:0095-1137
1098-660X
DOI:10.1128/jcm.00367-23