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RADx-UP Testing Core: Access to COVID-19 Diagnostics in
Community-Engaged Research with Underserved Populations
Shanti Narayanasamy,a,b Timothy H. Veldman,cMark J. Lee,dWilliam A. Glover II,eL. Gayani Tillekeratne,aCoralei E. Neighbors,b
Barrie Harper,fVidya Raghavan,fScott W. Kennedy,fMiranda Carper,gThomas Denny,gEphraim L. Tsalik,aMegan E. Reller,a
Warren A. Kibbe,h,i Giselle Corbie,j,k,l Michael Cohen-Wolkowiez,f,m Christopher W. Woods,a,b Cathy A. Pettia,n
a
Division of Infectious Diseases, Department of Medicine, Duke University, Durham, North Carolina, USA
b
Hubert-Yeargan Center for Global Health, Duke University, Durham, North Carolina, USA
c
Duke Global Health Institute, Durham, North Carolina, USA
d
Department of Pathology, School of Medicine, Duke University School of Medicine, Durham, North Carolina, USA
e
North Carolina State Laboratory of Public Health, North Carolina Department of Health and Human Services, Raleigh, North Carolina, USA
f
Duke Clinical Research Institute, Duke University, Durham, North Carolina, USA
g
Duke Human Vaccine Institute, Duke University, Durham, North Carolina, USA
h
Department of Biostatistics and Bioinformatics, Duke University School of Medicine, Durham, North Carolina, USA
i
Duke Cancer Institute, Duke University School of Medicine, Durham, North Carolina, USA
j
Center for Health Equity Research, University of North Carolina, Chapel Hill, North Carolina, USA
k
Department of Social Medicine and Department of Medicine, University of North Carolina, Chapel Hill, North Carolina, USA
l
Department of Internal Medicine, University of North Carolina, Chapel Hill, North Carolina, USA
m
Department of Pediatrics, Duke University School of Medicine, Durham, North Carolina, USA
n
Healthspring Global Inc., Bradenton, Florida, USA
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 commu-
nity-based research to increase access and uptake of testing among underserved popula-
tions 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 RADx-UP, COVID-19, diagnostics, equity, underserved communities
The COVID-19 pandemic highlighted longstanding structural inequities in society. Barriers
to health care access and resources, structural racism, and historical discrimination have
resulted in a disproportionate rate of illness and death among minority and underserved
Editor Romney M. Humphries, Vanderbilt
University Medical Center
Copyright © 2023 Narayanasamy et al. This is
an open-access article distributed under the
terms of the Creative Commons Attribution 4.0
International license.
Address correspondence to Shanti
Narayanasamy, shanti.narayanasamy@duke.edu.
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.
The views expressed in this article do not
necessarily reflect the views of the journal or
of ASM.
Published 3 July 2023
August 2023 Volume 61 Issue 8 10.1128/jcm.00367-23 1
COMMENTARY
communities (1–3). However, these issues are not new. Historically marginalized commun-
ities in the United States (e.g., communities of color, migrant communities, incarcerated
individuals, and those living in poverty) have been underrepresented in clinical trial recruit-
ment (4), health technology innovation (5), and testing access (6–8). Despite an increased
risk of infection and death from COVID-19, high-risk communities are less likely to be tested
for infection (9, 10). Current approaches to testing have been developed and implemented
primarily in well-resourced populations, but low testing rates in some populations are often
community specific and require a tailored approach (11, 12). Even when barriers to testing
are well elucidated, translating that knowledge to action is critical to breaking down those
barriers. Novel, community-engaged approaches are key to addressing COVID-19 disparities
among these different populations (13).
In the manuscript, we first describe the Rapid Acceleration of Diagnostics-Underserved
Populations (RADx-UP) program and the RADx-UP Testing Core (TC). Second, we discuss the
evolution of the pandemic and how this impacted diagnostic testing imperatives. Finally, we
elaborate on the shifting landscape of the pandemic that changed the TC’sfocusandthesub-
sequent establishment of four strategies (Table 1) that enabled the TC to support the deploy-
ment of large-scale testing for community-based research in underserved populations.
THE RADX-UP PROGRAM
In September 2020, the National Institutes of Health (NIH) committed $1.4 billion to accel-
erate the innovative development and implementation of COVID-19 testing (14). RADx-UP
(15), part of this initiative, represents the single largest investment in health disparities and
community-engaged research in the history of the NIH. NIH established RADx-UP to reduce
disparities in COVID-19 testing by funding community-based research studies in the United
States. As of 1 August 2022, RADx-UP had funded 127 projects across the United States,
including 75 studies that provide SARS-CoV-2 testing directly to participants (see Fig. S1 in the
supplemental material), with a total expected enrollment of .1.5 million participants.
THE RADX-UP TESTING CORE
The RADx-UP TC is one of three RADx-UP Coordination and Data Collection Center (CDCC)
pillars, alongside the Community Engagement and Data Science & Biostatistics cores. Each
pillar provides its relative subject matter expertise within RADx-UP CDCC, and as such, the
TC provides essential technical expertise and scientific guidance on COVID-19 diagnostics
to the NIH, the CDCC, and community-based investigators and their community partners
to solve testing challenges (16). The magnitude and diversity of expertise of the TC are sub-
stantial. The knowledge domains and experience of TC members span clinical and public
health microbiologists, infectious disease physicians, research scientists, regulatory experts,
and leaders in the diagnostic industry. This assembly of experts enables the TC to provide
a deep understanding of the diagnostic, laboratory, and regulatory landscape to imple-
ment guidance at record speed during a pandemic. The central role of the TC is to support
and tailor each study’s SARS-CoV-2 testing goals for their unique populations, test settings,
TABLE 1 Strategies employed by the RADx-UP Testing Core to support large-scale testing for community-based research with underserved
populations during the COVID-19 pandemic
No. Strategy Description
1 Individualize test strategies for each unique study setting
and population
Adaptive and agile standardized assessment tools are needed to support the
individualized testing goals of studies. Monitoring frameworks should be put
in place to continuously monitor test performance and use, and testing
strategies should be responsive to community feedback.
2 Make knowledge accessible and digestible Testing and regulatory expertise needs to be disseminated to investigators in
real time and through accessible methods to support study needs.
3 Build a resilient and adaptable research culture for
unexpected events
Build a research culture that is flexible, resilient, and able to pivot to respond to
changes in a pathogen’s epidemiology, participant recruitment, and test kit
manufacturing supply.
4 Invest in capacity building to create a runway for the future Invest in capacity building for enabling underserved populations to address
future public health challenges through access to health care advancements
and technologies that are community driven.
Commentary Journal of Clinical Microbiology
August 2023 Volume 61 Issue 8 10.1128/jcm.00367-23 2
and needs. This support includes (i) a critical review of protocols to advise on optimal test-
ing strategies that meet project goals, (ii) knowledge distribution about different COVID-19
test targets (viral antigen, viral nucleic acid, immune response) and compliance requirements,
and (iii) opening channels for procurement of test kits, sample collection devices, reagents,
and medical equipment for testing.
The TC held its first meeting in October 2020, at which time 38 projects had been
awarded. The TC recognized the need to balance process-driven policies and procedures
for testing guidance while maintaining an agile response to changes in market dynamics,
advances in testing technologies, regulation and compliance requirements, emergence
of viral variants, and the development of vaccines. Early in the pandemic, the TC realized
that scientific guidance in testing could not be a static process, and research support
required nonlinear analyses of the testing situation for each project. As such, adaptation
and iteration underpinned key behaviors of the TC.
EVOLUTION OF A PANDEMIC: TESTING AND VACCINE WAVES ARE AS IMPORTANT
AS VIRAL WAVES
Period 1: early testing (March 2020 to January 2021). Early in the pandemic, testing
was implemented through two processes, the U.S. Food and Drug Administration’s(FDA’s)
emergency use authorization (EUA) and the FDA’s enforcement discretion of laboratory-
developed tests (LDTs) (Fig. 1). In 2004, legislation was enacted to establish the EUA in
response to threats of bioterrorism and naturally occurring emerging infections (17). Since
then, EUAs have been issued for influenza, Middle East respiratory syndrome coronavirus,
Ebola virus, and Zika virus (18). The COVID-19 pandemic sparked an unprecedented expan-
sion of tests authorized under EUA for in vitro diagnostic products (19). LDTs, in existence
since 1976 and administered by the Centers for Medicare and Medicaid Services under the
Clinical Laboratory Improvement Amendments (CLIA) (20), were also developed rapidly.
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.
Commentary Journal of Clinical Microbiology
August 2023 Volume 61 Issue 8 10.1128/jcm.00367-23 3
During the early testing period of the pandemic, we supported study investigators in
understanding and balancing policies for EUA testing with those for LDTs, particularly
regarding the regulatory aspects of allowable specimen collection and testing locations.
Period 2: viral variants, vaccination, and serological testing (February 2021 to
September 2021). Widespread and broadly available vaccination from January 2021
changed the landscape for SARS-CoV-2 testing. As vaccination increased, the incidence
of COVID-19 infection decreased, as did the rate of testing. Studies that were enrolling
participants experienced a decline in recruitment, and the rationale for testing required
greater emphasis in the setting of increasing vaccine-related immunity. Many studies capital-
ized on existing testing infrastructure to bring vaccines to underserved populations. This pe-
riod was also marked by an increased interest in testing for immune response to SARS-CoV-2
to assess the seroprevalence of individuals with prior infection and prior vaccination.
Community investigators questioned test performance with respect to viral variants. Finally,
rapid swings in the demand for testing influenced by vaccination and viral variants influenced
the ability of test manufacturers to forecast testing supplies, leading to episodic testing short-
ages. The dynamism between virus and vaccination led to the programs developed under
strategies 1 and 2, described below (Table 1).
Period 3: home-based testing (October 2021 to March 2022). The demand for
home-based sample collection and rapid testing increased with the arrival of the Delta
and Omicron SARS-CoV-2 variants. Home testing was viewed as a way to enable safer family
gatherings, remain in school, return to the office, and allow for large public gatherings.
However, as the incidence of COVID-19 infection increased, demand for home-based testing
rapidly outstripped test supply. These unexpected changes coincided with the relaxation of
stringent public health measures as the primary tools to control transmission. This period
illustrated the importance of resilience in community-based research (strategy 3) and the
importance of building innovative laboratory capacity for future community-driven research
(strategy 4) (Table 1).
RADX-UP TESTING CORE GUIDING STRATEGIES
Strategy 1: individualize test strategies for each unique study setting and pop-
ulation. RADx-UP aims to conduct research on how best to ensure equity in access to
community-centered SARS-CoV-2 testing among underserved communities. RADx-UP inves-
tigators are engaging populations that include racial and ethnically diverse communities,
older adults, children, sexual and gender minorities, incarcerated populations, immigrants,
people who use drugs, people with disabilities, people experiencing housing insecurity, peo-
ple living in rural or geographically isolated regions, and pregnant women. The study settings
vary and include rural, urban, tribal lands, schools, long-term care facilities, public housing,
community health centers, in-home, and prisons/correctional facilities. As of August 2022, 75
studies have used NIH funds to provide SARS-CoV-2 testing directly to participants (see Fig. S1
in the supplemental material). Based on the projected enrollment of these studies, the
following populations were represented: 39% (29/75) Hispanic/LatinX, 29% (22/75) Black,
15% (11/75) Asian, 9% (7/75) Alaskan native/Tribal Nations, 11% (8/75) Hawaiian/Pacific
Islander, and 21% (16/75) low income (Fig. 2). The following test settings were projected
by studies: 31% (23/75) community health centers, 24% (18/75) rural communities, 21%
(16/75) schools, 32% (24/75) in-home, and 12% (9/75) public housing (Fig. 2). No significant
trend was observed for type of test (e.g., molecular, antigen), test population, or setting.
We developed adaptive tools to support studies to ensure the safe and effective rollout of
COVID-19 testing across these different study populations and test settings.
(i) Implement adaptive, agile, standardized assessment tools. The TC developed
two standardized assessment tools to support testing by RADx-UP studies. The Testing
Assessment Quality Management Tool (assessment tool) (Fig. S2) ensured that the research
teams’testing strategies met study goals for their target populations. The tool was based on
Good Clinical Practice and Good Laboratory Practice Guidelines for Nonclinical Laboratory
Studies (21, 22). For each research grant, the study protocol, RADx-UP intake survey, and
institutional review board (IRB) documents were carefully reviewed to extract essential ele-
ments. We identified information about the study setting, target population, specimen
Commentary Journal of Clinical Microbiology
August 2023 Volume 61 Issue 8 10.1128/jcm.00367-23 4
collection plan, intended use of testing (diagnosis, screening, contact tracing, or surveil-
lance), and testing location to identify potential operational and regulatory challenges. The
TC used the assessment tool to create brief reports (Fig. S3) that provided specificguidance
to each study for testing deployment. The brief reports were updated and amended
over time to respond to the dynamic regulatory and policy environment and the chang-
ing testing strategies of studies.
Two projects in the early part of the COVID-19 pandemic demonstrate the value of
standardized assessment tools and brief reports in supporting research teams. In 2020,
community-based researchers developed a project to understand the utility of point-of-care
(POC) testing for workplace surveillance in a group of rural coal miners (23). The assessment
tool found that the team planned to use lateral flow antigen testing under health care
supervision in symptomatic and asymptomatic miners before their work shifts. When the
study was developed, federal and state guidance around antigen testing for COVID-19
surveillance and testing without health care supervision was not established. The ability
to rapidly obtain a CLIA waiver was also not available. In partnership with the study team,
the TC facilitated the process to obtain a CLIA waiver for POC testing—an unfamiliar process
for the investigative team. To assist deployment of POC antigen testing, the TC furnished a
FIG 2 RADx-UP communities and settings by test type (projected estimates for studies testing participants
directly).
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August 2023 Volume 61 Issue 8 10.1128/jcm.00367-23 5
recently released, and not yet widely adopted, CDC guidance document to ensure safe
deployment of antigen testing for asymptomatic individuals through serial antigen testing
and, when applicable, confirmatory testing with molecular methods (24). The CDC guid-
ance document became a core tool until FDA EUA antigen tests for asymptomatic individ-
uals were available.
A second project commencing early in the pandemic served as another exemplar of
the importance of agile, adaptive assessment tools. Study investigators were studying the
incidence of COVID-19 among incarcerated persons and correctional staff within prisons
and jails across four states. The setting presented unique logistical and operational challenges,
particularly around optimal specimen type (e.g., nasal or saliva) and collection by a health care
worker. In collaboration with the TC, the research team identified a POC antigen test for nasal
specimens and a PCR saliva-based collection, both of which were authorized for self-collection
with or without health care supervision. The TC also supported POC testing under a CLIA
waiver by providing the study team with resources for training test operators to consistently
and reliably perform POC tests (as specified in CLIA regulations) that could be adopted in a
resource-constrained setting.
(ii) Develop frameworks to continuously monitor test performance and use. The TC
stayed up to date with changes in test performance and use through the emerging literature
(preprint and published), FDA press releases and warning letters on test performance, and
abstracts presented at conference proceedings. This information was rapidly synthesized and
disseminated to study investigators to support their testing choices. In many urban areas,
access to testing was not uniform across the city, with large “testing deserts,”defined as an
area that is at least 10 miles from a testing center, in lower socioeconomic and racially and
ethnically segregated neighborhoods (25). One RADx-UP study sought to increase COVID-19
testing in public housing buildings, an area with high COVID-19-related mortality but low
testing uptake. The target populations were largely LatinX and Black, had limited English pro-
ficiency, and commonly included intergenerational, high-density households. Household
transmission was a key driver of COVID-19 cases in their locale, so a low-cost, sustainable so-
lution to provide the greatest benefit to the public housing community was imperative (26).
While working with this study team, we identified several other research proposals that faced
similar challenges. Home-based antigen testing was limited to telehealth during this time
period, and several investigators were concerned about limited internet access and the ac-
curacy of antigen tests. Molecular-based tests for home use during this early phase of the
pandemic were restricted to home specimen collection shipped to a centralized laboratory
for molecular testing. With this approach, some researchers felt that the benefits of greater
accuracy using PCR tests were eclipsed by participants’limited access to mailboxes, high
costs of testing, and slow time to results. To reduce cost and ensure rapid results, a few
investigators proposed home-based specimen collection with subsequent testing using
an LDT PCR test at their laboratories. However, this approach was not permitted by the
FDA’s LDT policy for SARS-CoV-2 (27).
The NIH policy requiring FDA emergency use authorizations for tests presented an
additional challenge. While this policy was an important stipulation to ensure the quality
and accuracy of tests as well as to protect underserved communities with a history of
research exploitation, it limited testing options for community-based investigators who
often had ready access to LDTs but had challenges in procuring FDA EUA tests during peri-
ods of high demand. The TC helped study teams surmount these challenges by facilitating a
pivot to other testing strategies.
(iii) Testing strategies responsive to community feedback. RADx-UP research teams
sought sustainable, low-cost, and accessible testing solutions for their communities.
For some studies, participants had expressed reluctance in using uncomfortable or on-
erous testing methods, such as nasopharyngeal and nasal swabs. Saliva testing was a
way to surmount this barrier. One study investigated saliva testing in the school setting
for students with intellectual and developmental disabilities, as nasal testing was not fea-
sible in their participant population (28). The TC supported the study’sdecisiontouse
FDA EUA saliva testing through participant self-collection at home and under supervision
Commentary Journal of Clinical Microbiology
August 2023 Volume 61 Issue 8 10.1128/jcm.00367-23 6
at school. This testing approach provided a safe and acceptable collection method in children
and engaged a population that is otherwise underrepresented in clinical research.
The TC also received feedback about the urgent need for testing instructions in Spanish.
In response, our procurement team worked with test manufacturers to identify those with
FDA EUA labeling in languages other than English. Also, some study teams sought tests that
did not require the internet, were suitable for participants with low literacy and numeracy
skills, and did not require the participant to read their results. Following this feedback, we
developed a repository of test options that could be queried and filtered by key perform-
ance features, such as test target (important for serology testing), internet requirements
for testing, available language translations, and health care provider-supported test result
interpretation.
Strategy 2: make knowledge accessible and digestible. The TC observed that di-
gestible knowledge about in vitro testing must be communicated to research teams.
The TC embraced current concepts in adult learning to provide information across mul-
tiple modalities, such as written reports, visual charts, oral online presentations, emails,
flyers, and one-to-one video meetings. We prioritized meeting with individual study
teams, often monthly, to address the testing complexities unique to their target popu-
lation and study settings. Through these face-to-face meetings, we identified common
themes across multiple studies. In response, the TC developed quick reference guides
(QRGs) on POC testing, home testing, saliva testing, and antibody testing (29). The pur-
pose of the QRGs was to provide investigators with highly digestible, concise summa-
ries of test characteristics for FDA EUA testing kits. This approach was data driven, and
QRGs were updated in real time and made available on the RADx-UP website. These
invaluable guides also provided information on recalls, EUA revocations, and, at the
height of testing shortages, the availability of testing kits. We also used email informa-
tionals to update study teams on important emerging topics. This enabled us to inform
teams rapidly and simultaneously about supply chain delays, challenges with test kit
performance (false positives and negatives), and regulatory changes.
Another forum for collaboration and learning was among RADx-UP studies themselves.
Through monthly, program-wide meetings, the TC spotlighted current issues or topics of
particular interest in testing to a large investigator audience. We encouraged and facilitated
peer learning by connecting studies experiencing similar testing challenges. These cross-
study engagements were opportunities to share best practices in result reporting, use of
centralized laboratory testing to identify viral variants, and use of sequencing-based technol-
ogies to study the evolution of viral variants.
Finally, the TC supported investigators who sought to understand the evolving landscape
for non-EUA novel diagnostic technologies. We leveraged existing partnerships with Arizona
State University to provide a web repository of current and emerging technologies in
COVID-19 testing (30). The website supports users in matching test kits with their required
regulatory status, diagnostic targets, collection methods, and test processing locations.
Strategy 3: build a resilient and adaptable research culture for unexpected events.
Clinical research supervised through an IRB has historically followed a linear process. The
study design is clearly defined and approved by the IRB, and any changes to the study
require formal amendments and IRB approval. During the pandemic, evolving testing
tools, changing viral dynamics, test kit shortages, and fluctuating patterns in participant
engagement challenged this linear process.
During the pandemic, the TC supported study teams in negotiating many unexpected
changes, underscoring the importance of specialized and diagnostic expertise during this
transition period. SARS-CoV-2 incidence fluctuated throughout the United States across pop-
ulation groups, test settings, and geographic areas. In 2020, many RADx-UP research teams
were preparing their studies, obtaining IRB approvals, procuring tests, and organizing other
logistics while COVID-19 case incidence was high. As these studies were launching in 2021,
investigators began to face recruitment challenges. COVID-19 infections plummeted with
increased immunity and vaccinations, and community interest in testing rapidly declined.
Many investigators pivoted to vaccine engagement and refined their testing strategies to
study seroprevalence. In response, the TC employed microlearning techniques, including
Commentary Journal of Clinical Microbiology
August 2023 Volume 61 Issue 8 10.1128/jcm.00367-23 7
targeted content through blogs and short reports, to support investigators’knowledge
acquisition and to guide researchers through testing protocol changes and IRB amendments.
(i) Procurement support is essential to navigating shifting supply and demand.
The RADx-UP test procurement team was pivotal in forging communication channels with
testing manufacturers and suppliers. As the EUA approval process became more streamlined,
the team established a curated vendor list of .80suppliersandservedasaliaisonbetween
suppliers and studies. The importance of these relationships was underscored during periods
of testing kit supply shortages. When the Delta and Omicron variants became the dominant
U.S. SARS-CoV-2 variants in 2021 and 2022, shortages in the supply chain for FDA EUA
at-home tests posed a challenge for many investigators. The TC was able to capitalize on
preexisting relationships with manufacturers and other governmental bodies to emphasize
the scientific mission of RADx-UP and encourage suppliers to meet the research needs for
testing in underserved communities. One major test kit manufacturer provided home anti-
gen test kits for free to seven RADx-UP projects. The TC also approached the Department of
Defense, which released and donated over 90,000 test kits to several projects.
Strategy 4: invest in capacity building to create a runway for the future. Access
to health care advancements and technologies is challenging for underserved communities
during national emergencies. The RADx-UP Rapid Research Pilot Program (RP2) was estab-
lished to help address this disparity. Pilot projects were awarded through the TC to provide an
opportunity to study novel EUA-authorized POC methods, home collection devices, and
at-home testing. RP2 investigators work in underserved communities and collaborate with
technology innovators to improve access and uptake of innovative technologies. Sixteen
RP2 projects have been approved through August 2022, with plans to fund nine more.
One RP2 project leverages crowdsourcing of innovative technologies that will help en-
couragecommunityengagementandamplifytheproject’s ability to identify novel test
tools. Another project uses crowdsourcing and “designathons”to engage youth and teen
populations, often overlooked or considered superspreaders, to create innovative strat-
egies for participatory self-testing. A third awardee is studying the use of a mobile labora-
tory to understand the feasibility of providing convenient, accessible testing to local
homeless and transitional populations. These innovative methods show great promise
and could be scaled up to provide sustainable, widely accessible testing and essential tools
for managing future pandemics in underserved communities.
CONCLUSION
RADx-UP has shown that increased access and uptake of testing among underserved
populations can be successfully accomplished during a pandemic when community-based
research is supported with tools, resources, and the wide expertise of a centralized, testing-
specific coordinating center. In the setting of tremendous uncertainty and a rapidly evolving
public health crisis, 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 both on a large scale and at the com-
munity level, specifically for future health crises that invariably affect populations inequitably.
The COVID-19 pandemic acutely highlights the importance of diagnostic testing expertise
and dissemination of knowledge. Testing knowledge that is readily accessible, digestible,
continuous, and responsive supports investigators in navigating the shifting policy, regula-
tory, and clinical landscapes. Innovation and rapid adaptation will remain the cornerstone of
progress as the TC now navigates solutions to link test results to care interventions, such as
oral antivirals and other therapeutics. Community-based research is critical to elucidating
theuniquebarriersandchallengesfacedbyspecific populations, and results from RADx-UP
studies will better inform local, state, and federal public health policies to optimize testing
strategies and access.
SUPPLEMENTAL MATERIAL
Supplemental material is available online only.
SUPPLEMENTAL FILE 1, DOCX file, 0.8 MB.
Commentary Journal of Clinical Microbiology
August 2023 Volume 61 Issue 8 10.1128/jcm.00367-23 8
ACKNOWLEDGMENTS
Ephraim L. 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), the National Institute of Allergy and Infectious
Diseases (HHSN272201500006I, 1K24-AI143971), the U.S. Food and Drug Administration
(5U18-FD006298), and the industry for drug development in adults and children. Cathy A.
Petti receives consulting fees from Abbott Molecular and Rapid Diagnostics. Christopher
W. Woods reports consulting fees from Arena Pharmaceuticals, BioFire, FHI Clinical, Giner,
Karius, and SeLux Diagnostics. All other authors report no conflicts of interest.
The RADx-UP CDCC is funded through the National Institutes of Health (NIH) emergency
cooperative agreement 1U24MD016258. Funding for the RADx-UP program is provided
by the Paycheck Protection Program and Health Care Enhancement Act of 2020 and the
American Rescue Plan Act of 2021 (NIH grant U24 MD016258).
No funding source had any role in designing the study; the collection, analysis, and
interpretation of data; the writing of the report; or the decision to submit the paper for
publication.
The content is solely the responsibility of the authors and does not necessarily
represent the official views of the NIH.
S.N., T.H.V., M.J.L., W.A.G., L.G.T., C.E.N., B.H., V.R., S.W.K., M.C., T.D., E.L.T., W.A.K., G.C.,
M.C.-W., C.W.W., and C.A.P. conceived of the work or acquired, analyzed, or interpreted
data for the work, revised it critically for important intellectual content, reviewed and approved
the manuscript for submission, and agree to be accountable for all aspects of the work and
ensure that questions of accuracy and integrity are investigated. S.N. and C.A.P. drafted the
initial manuscript.
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