Browsing by Subject "COVID-19 Testing"
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Item Open Access A National Decision Point: Effective Testing and Screening for Covid-19(2020-09-09) McClellan, Mark; Silcox, Christina; Anderson, David; Zavodszky, Anna; Borre, Ethan; Dentzer, Susan; Aspinall, MaraThis Duke-Margolis report out provides a framework for public health officials and community leaders in schools, businesses and other institutions on how to use Covid-19 screening test strategies to operate safely and prevent further spread of the virus. A National Decision Point: Effective Testing and Screening for Covid-19, was developed with funding from the Rockefeller Foundation, and aims to be a useful tool to help officials customize screening strategies of asymptomatic people to local circumstances and risk – with a particular focus on higher-risk populations and suppressing community spread.Item Open Access A School-Based SARS-CoV-2 Testing Program: Testing Uptake and Quarantine Length After In-School Exposures.(Pediatrics, 2022-02) Boutzoukas, Angelique E; Zimmerman, Kanecia O; Mann, Tara K; Moorthy, Ganga S; Blakemore, Ashley; McGann, Kathleen A; Smith, Michael J; Nutting, Boen; Kerley, Karen; Brookhart, M Alan; Edwards, Laura; Rak, Zsolt; Benjamin, Daniel K; Kalu, Ibukunoluwa CObjectives
Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2)-related quarantines, which are required after close contact with infected individuals, have substantially disrupted in-person education for kindergarten through 12th grade (K-12) students. In recent recommendations, shortened durations of quarantine are allowed if a negative SARS-CoV-2 test result is obtained at 5 to 7 days postexposure, but access to testing remains limited. We hypothesized that providing access to in-school SARS-CoV-2 testing postexposure would increase testing and reduce missed school days.Methods
This prospective cohort study was conducted in one large public K-12 school district in North Carolina and included 2 periods: preimplementation (March 15, 2021, to April 21, 2021) and postimplementation (April 22, 2021, to June 4, 2021), defined around initiation of an in-school SARS-CoV-2 testing program in which on-site access to testing is provided. Number of quarantined students and staff, testing uptake, test results, and number of missed school days were analyzed and compared between the preimplementation and postimplementation periods.Results
Twenty-four schools, including 12 251 in-person learners, participated in the study. During preimplementation, 446 close contacts were quarantined for school-related exposures; 708 close contacts were quarantined postimplementation. Testing uptake after school-related exposures increased from 6% to 40% (95% confidence interval: 23% to 45%) after implementation, and 89% of tests were conducted in-school. After in-school testing implementation, close contacts missed ∼1.5 fewer days of school (95% confidence interval: -2 to -1).Conclusions
Providing access to in-school testing may be a worthwhile mechanism to increase testing uptake after in-school exposures and minimize missed days of in-person learning, thereby mitigating the pandemic's ongoing impact on children.Item Open Access A Systematic Framework to Rapidly Obtain Data on Patients with Cancer and COVID-19: CCC19 Governance, Protocol, and Quality Assurance.(Cancer cell, 2020-12) COVID-19 and Cancer Consortium. Electronic address: jeremy.warner@vumc.org; COVID-19 and Cancer ConsortiumWhen the COVID-19 pandemic began, formal frameworks to collect data about affected patients were lacking. The COVID-19 and Cancer Consortium (CCC19) was formed to collect granular data on patients with cancer and COVID-19 at scale and as rapidly as possible. CCC19 has grown from five initial institutions to 125 institutions with >400 collaborators. More than 5,000 cases with complete baseline data have been accrued. Future directions include increased electronic health record integration for direct data ingestion, expansion to additional domestic and international sites, more intentional patient involvement, and granular analyses of still-unanswered questions related to cancer subtypes and treatments.Item Open Access An enhanced isothermal amplification assay for viral detection.(Nature communications, 2020-11) Qian, Jason; Boswell, Sarah A; Chidley, Christopher; Lu, Zhi-Xiang; Pettit, Mary E; Gaudio, Benjamin L; Fajnzylber, Jesse M; Ingram, Ryan T; Ward, Rebecca H; Li, Jonathan Z; Springer, MichaelRapid, inexpensive, robust diagnostics are essential to control the spread of infectious diseases. Current state of the art diagnostics are highly sensitive and specific, but slow, and require expensive equipment. Here we report the development of a molecular diagnostic test for SARS-CoV-2 based on an enhanced recombinase polymerase amplification (eRPA) reaction. eRPA has a detection limit on patient samples down to 5 viral copies, requires minimal instrumentation, and is highly scalable and inexpensive. eRPA does not cross-react with other common coronaviruses, does not require RNA purification, and takes ~45 min from sample collection to results. eRPA represents a first step toward at-home SARS-CoV-2 detection and can be adapted to future viruses within days of genomic sequence availability.Item Open Access Assessment of an Online Tool to Simulate the Effect of Pooled Testing for SARS-CoV-2 Detection in Asymptomatic and Symptomatic Populations.(JAMA network open, 2020-12) Polage, Christopher R; Lee, Mark J; Hubbard, Christopher; Rehder, Catherine; Cardona, Diana; Denny, Thomas; Datto, Michael BItem Open Access Early Effects of COVID-19 Pandemic on Neurosurgical Training in the United States: A Case Volume Analysis of 8 Programs.(World neurosurgery, 2021-01) Aljuboori, Zaid S; Young, Christopher C; Srinivasan, Visish M; Kellogg, Ryan T; Quon, Jennifer L; Alshareef, Mohammed A; Chen, Stephanie H; Ivan, Michael; Grant, Gerald A; McEvoy, Sean D; Davanzo, Justin R; Majid, Sonia; Durfy, Sharon; Levitt, Michael R; Sieg, Emily P; Ellenbogen, Richard G; Nauta, Haring JObjective
To determine the impact of the 2019 novel coronavirus disease (COVID-19) pandemic on operative case volume in 8 U.S. neurosurgical residency training programs in early 2020 and to survey these programs regarding training activities during this period.Methods
A retrospective review was conducted of monthly operative case volumes and types for 8 residency programs for 2019 and January through April 2020. Cases were grouped as elective cranial, elective spine, and nonelective emergent cases. Programs were surveyed regarding residents' perceptions of the impact of COVID-19 on surgical training, didactics, and research participation. Data were analyzed for individual programs and pooled across programs.Results
Across programs, the 2019 monthly mean ± SD case volume was 211 ± 82; 2020 mean ± SD case volumes for January, February, March, and April were 228 ± 93, 214 ± 84, 180 ± 73, and 107 ± 45. Compared with 2019, March and April 2020 mean cases declined 15% (P = 0.003) and 49% (P = 0.002), respectively. COVID-19 affected surgical case volume for all programs; 75% reported didactics negatively affected, and 90% reported COVID-19 resulted in increased research time. Several neurosurgery residents required COVID-19 testing; however, to our knowledge, only 1 resident from the participating programs tested positive.Conclusions
This study documents a significant reduction in operative volume in 8 neurosurgery residency training programs in early 2020. During this time, neurosurgery residents engaged in online didactics and research-related activities, reporting increased research productivity. Residency programs should collect data to determine the educational impact of the COVID-19 pandemic on residents' operative case volumes, identify deficiencies, and develop plans to mitigate any effects.Item Open Access From Development to Market: Understanding COVID-19 Testing and Its Challenges(2020-08-19) McClellan, Mark; Schneider, Monika; Dentzer, Susan; Sheehan, Sarah; Silcox, Christina; Hamilton Lopez, Marianne; Wosinska, MartaAmid the SARS-CoV-2 pandemic and a crisis over inadequate and delayed testing, this report describes COVID-19 testing methods and applications, the regulatory process for approving tests, how tests are paid for, and how access to testing is obtained. The report also highlights the challenges that stakeholders are facing and will face in the coming months around COVID-19 testing.Item Open Access Legislative and Regulatory Steps for a National COVID-19 Testing Strategy(2020-08-05) McClellan, Mark; Rivers, Caitlin; Silcox, ChristinaThe Duke-Margolis Center for Health Policy report, “Legislative and Regulatory Steps for a National COVID-19 Testing Strategy,” outlines legislative actions and federal appropriation targets that Duke-Margolis and its collaborating experts believe are needed to get a robust, diversified testing strategy in place for the nation by fall 2020.Item Open Access RADx-UP Testing Core: Access to COVID-19 Diagnostics in Community-Engaged Research with Underserved Populations.(Journal of clinical microbiology, 2023-08) Narayanasamy, Shanti; Veldman, Timothy H; Lee, Mark J; Glover, 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 AResearch 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.Item Open Access Test-to-Stay After Exposure to SARS-CoV-2 in K-12 Schools.(Pediatrics, 2022-05) Campbell, Melissa M; Benjamin, Daniel K; Mann, Tara; Fist, Alex; Kim, Hwasoon; Edwards, Laura; Rak, Zsolt; Brookhart, M Alan; Anstrom, Kevin; Moore, Zack; Tilson, Elizabeth Cuervo; Kalu, Ibukunoluwa C; Boutzoukas, Angelique E; Moorthy, Ganga S; Uthappa, Diya; Scott, Zeni; Weber, David J; Shane, Andi L; Bryant, Kristina A; Zimmerman, Kanecia O; ABC SCIENCE COLLABORATIVEObjectives
We evaluated the safety and efficacy of a test-to-stay program for unvaccinated students and staff who experienced an unmasked, in-school exposure to someone with confirmed severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection. Serial testing instead of quarantine was offered to asymptomatic contacts. We measured secondary and tertiary transmission rates within participating schools and in-school days preserved for participants.Methods
Participating staff or students from universally masked districts in North Carolina underwent rapid antigen testing at set intervals up to 7 days after known exposure. Collected data included location or setting of exposure, participant symptoms, and school absences up to 14 days after enrollment. Outcomes included tertiary transmission, secondary transmission, and school days saved among test-to-stay participants. A prespecified interim safety analysis occurred after 1 month of enrollment.Results
We enrolled 367 participants and completed 14-day follow-up on all participants for this analysis. Nearly all (215 of 238, 90%) exposure encounters involved an unmasked index case and an unmasked close contact, with most (353 of 366, 96%) occurring indoors, during lunch (137 of 357, 39%) or athletics (45 of 357, 13%). Secondary attack rate was 1.7% (95% confidence interval: 0.6%-4.7%) based on 883 SARS-CoV-2 serial rapid antigen tests with results from 357 participants; no tertiary cases were identified, and 1628 (92%) school days were saved through test-to-stay program implementation out of 1764 days potentially missed.Conclusion
After unmasked in-school exposure to SARS-CoV-2, even in a mostly unvaccinated population, a test-to-stay strategy is a safe alternative to quarantine.