Automated, Miniaturized, and Scalable Screening of Healthcare Workers, First Responders, and Students for SARS-Cov-2 in San Diego County

Sydney C. Morgan,Stefan Aigner,Catelyn Anderson,Pedro Belda-Ferre,Peter De Hoff,Clarisse Marotz,Shashank Sathe,Mark Zeller, Noorsher Ahmed,Xaver Audhya,Nathan A. Baer,Tom Barber,Bethany Barrick,Lakshmi Batachari,Maryann Betty,Steven M. Blue, Brent Brainard,Tyler Buckley,Jamie Case,Anelizze Castro-Martinez,Marisol Chacón,Willi Cheung, LaVonnye Chong,Nicole G. Coufal,Evelyn S. Crescini, Scott DeGrand,David P. Dimmock,J. Joelle Donofrio-Odmann,Emily R. Eisner,Mehrbod Estaki,Lizbeth Franco Vargas, Michelle Freddock,Robert M. Gallant,Andrea Galmozzi,Nina J. Gao,Sheldon Gilmer,Edyta M. Grzelak,Abbas Hakim,Jonathan Hart,Charlotte Hobbs,Gregory Humphrey,Nadja Ilkenhans, Marni Jacobs,Christopher A. Kahn,Bhavika K. Kapadia,Matthew Kim,Sunil Kurian,Alma L. Lastrella,Elijah S. Lawrence,Kari Lee,Qishan Liang,Hanna Liliom,Valentina Lo Sardo,Robert Logan,Michal Machnicki,Celestine G. Magallanes,Clarence K. Mah, Denise Malacki,Ryan J. Marina,Christopher Marsh,Natasha K. Martin,Nathaniel L. Matteson,Daniel J. Maunder,Kyle McBride,Bryan McDonald,Michelle McGraw,Audra R. Meadows,Michelle Meyer,Amber L. Morey,Jasmine R. Mueller,Toan T. Ngo,Viet Nguyen,Laura J. Nicholson,Alhakam Nouri,Victoria Nudell, Eugenio Nunez, Kyle O'Neill,R. Tyler Ostrander,Priyadarshini Pantham,Samuel S. Park,David Picone,Ashley Plascencia,Isaraphorn Pratumchai,Michael Quigley,Michelle Franc Ragsac,Andrew C. Richardson,Refugio Robles-Sikisaka,Christopher A. Ruiz,Justin Ryan,Lisa Sacco,Sharada Saraf,Phoebe Seaver,Leigh Sewall,Elizabeth W. Smoot,Kathleen M. Sweeney,Chandana Tekkatte,Rebecca Tsai,Holly Valentine,Shawn Walsh,August Williams, Min Yi Wu,Bing Xia,Brian Yee,Jason Z. Zhang,Kristian G. Andersen,Lauge Farnaes,Rob Knight,Gene W. Yeo,Louise C. Laurent

SSRN Electronic Journal(2021)

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摘要
Background Successful containment strategies for SARS-CoV-2, the causative virus of the COVID-19 pandemic, have involved widespread population testing that identifies infections early and enables rapid contact tracing. In this study, we developed a rapid and inexpensive RT- qPCR testing pipeline for population-level SARS-CoV-2 detection, and used this pipeline to establish a clinical laboratory dedicated to COVID-19 testing at the University of California San Diego (UCSD) with a processing capacity of 6,000 samples per day and next-day result turnaround times. Methods and findings Using this pipeline, we screened 6,786 healthcare workers and first responders, and 21,220 students, faculty, and staff from UCSD. Additionally, we screened 6,031 preschool-grade 12 students and staff from public and private schools across San Diego County that remained fully or partially open for in-person teaching during the pandemic. Between April 17, 2020 and February 5, 2021, participants provided 161,582 nasal swabs that were tested for the presence of SARS-CoV-2. Overall, 752 positive tests were obtained, yielding a test positivity rate of 0.47%. While the presence of symptoms was significantly correlated with higher viral load, most of the COVID-19 positive participants who participated in symptom surveys were asymptomatic at the time of testing. The positivity rate among preschool-grade 12 schools that remained open for in-person teaching was similar to the positivity rate at UCSD and lower than that of San Diego County, with the children in private schools being less likely to test positive than the adults at these schools. Conclusions Most schools across the United States have been closed for in-person learning for much of the 2020-2021 school year, and their safe reopening is a national priority. However, as there are no vaccines against SARS-CoV-2 currently available to the majority of school-aged children, the traditional strategies of mandatory masking, physical distancing, and repeated viral testing of students and staff remain key components of risk mitigation in these settings. The data presented here suggest that the safety measures and repeated testing actions taken by participating healthcare and educational facilities were effective in preventing outbreaks, and that a similar combination of risk-mitigation strategies and repeated testing may be successfully adopted by other healthcare and educational systems. ### Competing Interest Statement Anterior nares swab samples for clinical validation of the Expedited COVID-19 Identification Environment (EXCITE) Laboratory Developed Tests (LDT) were donated by Helix Opco, LLC. We disclose that Dr. Laurent's spouse is an employee of Helix Opco, LLC. ### Clinical Protocols ### Funding Statement Funding for the SEARCH study was provided by: the Scripps Health COVID-19 Research Fund to CM and Scripps Health collaborators (); a personal donation by the Shekhter Family to the SEARCH study initiative, A Centers for Disease Control and Prevention (CDC) Broad Agency Announcement (BAA) contract to KGA (contract #75D30120C09795), and departmental funds from the UCSD Department of Obstetrics, Gynecology, and Reproductive Sciences to LCL (). The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript. ### Author Declarations I confirm all relevant ethical guidelines have been followed, and any necessary IRB and/or ethics committee approvals have been obtained. Yes The details of the IRB/oversight body that provided approval or exemption for the research described are given below: The University of California San Diego Institutional Review Boards (IRB) provided human subject protection oversight of the SEARCH study (IRB approval #200470). The UCSD Institutional Review Boards (IRB) provided human subject protection oversight of the data obtained by the EXCITE lab (IRB approval #210817X). All necessary patient/participant consent has been obtained and the appropriate institutional forms have been archived. Yes I understand that all clinical trials and any other prospective interventional studies must be registered with an ICMJE-approved registry, such as ClinicalTrials.gov. I confirm that any such study reported in the manuscript has been registered and the trial registration ID is provided (note: if posting a prospective study registered retrospectively, please provide a statement in the trial ID field explaining why the study was not registered in advance). Yes I have followed all appropriate research reporting guidelines and uploaded the relevant EQUATOR Network research reporting checklist(s) and other pertinent material as supplementary files, if applicable. Yes Full datasets, as well as scripts for data analysis and visualization used in this manuscript, are made available at .
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first responders,healthcare workers,scalable screening,sars-cov
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