Design, creation, and use of the Test Us Bank (TUB) COVID-19 sample biorepository.

Autor: Broach J; Department of Emergency Medicine, University of Massachusetts Chan Medical School, Worcester, MA, USA. john.broach@umassmemorial.org., Achenbach C; Division of Infectious Diseases, Department of Medicine, Havey Institute for Global Health, Feinberg School of Medicine, Northwestern University, Chicago, Illinois, 94305, USA., Behar S; Program in Digital Medicine, Department of Medicine, University of Massachusetts Chan Medical School, Worcester, MA, USA., O'Connor L; Department of Emergency Medicine, University of Massachusetts Chan Medical School, Worcester, MA, USA., Tarrant S; Program in Digital Medicine, Department of Medicine, University of Massachusetts Chan Medical School, Worcester, MA, USA., Ferranto J; Program in Digital Medicine, Department of Medicine, University of Massachusetts Chan Medical School, Worcester, MA, USA., Wright C; Program in Digital Medicine, Department of Medicine, University of Massachusetts Chan Medical School, Worcester, MA, USA., Hartin P; Program in Digital Medicine, Department of Medicine, University of Massachusetts Chan Medical School, Worcester, MA, USA., Orwig T; Program in Digital Medicine, Department of Medicine, University of Massachusetts Chan Medical School, Worcester, MA, USA., Nanavati J; Center for Clinical and Translational Science, University of Massachusetts, University of Massachusetts Chan Medical School, Worcester, MA, USA., Kalibala B; Center for Clinical and Translational Science, University of Massachusetts, University of Massachusetts Chan Medical School, Worcester, MA, USA., Woods K; Center for Clinical and Translational Science, University of Massachusetts, University of Massachusetts Chan Medical School, Worcester, MA, USA., Shaw B; Center for Clinical and Translational Science, University of Massachusetts, University of Massachusetts Chan Medical School, Worcester, MA, USA., Flahive J; Department of Population and Quantitative Health Sciences, University of Massachusetts Chan Medical School, Worcester, MA, USA., Barton B; Department of Population and Quantitative Health Sciences, University of Massachusetts Chan Medical School, Worcester, MA, USA., Hafer N; Center for Clinical and Translational Science, University of Massachusetts, University of Massachusetts Chan Medical School, Worcester, MA, USA., Herbert C; Program in Digital Medicine, Department of Medicine, University of Massachusetts Chan Medical School, Worcester, MA, USA., Fahey N; Program in Digital Medicine, Department of Medicine, University of Massachusetts Chan Medical School, Worcester, MA, USA.; Department of Population and Quantitative Health Sciences, University of Massachusetts Chan Medical School, Worcester, MA, USA.; Department of Pediatrics, University of Massachusetts Chan Medical School, Worcester, MA, USA., Gibson L; Division of Infectious Diseases and Immunology, Department of Medicine, University of Massachusetts Chan Medical School, Worcester, MA, USA., Simin K; Department of Molecular, Cell, and Cancer Biology, University of Massachusetts Chan Medical School, Worcester, MA, USA., Kowalik T; Department of Microbiology and Physiological Systems, UMass Chan Medical School, Worcester, MA, USA., Ward DV; Department of Microbiology and Physiological Systems, UMass Chan Medical School, Worcester, MA, USA., Mirza AW; Division of Infectious Diseases, Department of Medicine, Johns Hopkins University School of Medicine, Baltimore, MD, USA., Murphy RL; Division of Infectious Diseases, Department of Medicine, Havey Institute for Global Health, Feinberg School of Medicine, Northwestern University, Chicago, Illinois, 94305, USA., Caputo M; Division of Infectious Diseases, Department of Medicine, Havey Institute for Global Health, Feinberg School of Medicine, Northwestern University, Chicago, Illinois, 94305, USA., Buchholz B; Department of Biomedical Engineering, University of Massachusetts Lowell, Lowell, MA, USA., Fantasia H; Susan and Alan Solomont School of Nursing, University of Massachusetts Lowell, Lowell, MA, USA., Koren A; Susan and Alan Solomont School of Nursing, University of Massachusetts Lowell, Lowell, MA, USA., Marchand L; Susan and Alan Solomont School of Nursing, University of Massachusetts Lowell, Lowell, MA, USA., Oludare S; Georgia Arrhythmia Consultants and Research Institute, Macon, GA, USA., Sogade F; Georgia Arrhythmia Consultants and Research Institute, Macon, GA, USA., Ritland D; Urban Family Practice, PC, Marietta, GA, USA., Davis C; Urban Family Practice, PC, Marietta, GA, USA., Grenier A; Department of Family Medicine and Community Health, University of Kansas Medical Center, Kansas, KA, USA., Baron C; Department of Family Medicine and Community Health, University of Kansas Medical Center, Kansas, KA, USA., Brent E; Department of Family Medicine and Community Health, University of Kansas Medical Center, Kansas, KA, USA., McKenney JB; Fredonia Family Care, Fredonia, KA, USA., Elder N; Oregon Rural Practice-based Research Network, Oregon Health and Science University, Portland, OR, USA., Michaels L; Oregon Rural Practice-based Research Network, Oregon Health and Science University, Portland, OR, USA., Ferrara L; Oregon Rural Practice-based Research Network, Oregon Health and Science University, Portland, OR, USA., Theron G; DSI-NRF Centre of Excellence for Biomedical Tuberculosis Research, South African Medical Research Council Centre for Tuberculosis Research, Division of Molecular Biology and Human Genetics, Stellenbosch University, Cape Town, MA, South Africa., Palmer Z; DSI-NRF Centre of Excellence for Biomedical Tuberculosis Research, South African Medical Research Council Centre for Tuberculosis Research, Division of Molecular Biology and Human Genetics, Stellenbosch University, Cape Town, MA, South Africa., Levy B; Department of Family Medicine, University of Massachusetts Chan Medical School, Iowa, IA, USA., Daly J; Department of Family Medicine, University of Massachusetts Chan Medical School, Iowa, IA, USA., Parang K; Department of Family Medicine, University of Massachusetts Chan Medical School, Iowa, IA, USA., Schmidt M; Department of Community and Behavioral Health, College of Public Health, University of Iowa, Iowa, IA, USA., Buxton D; National Heart, Lung, and Blood Institute, National Institutes of Health, Bethesda, MA, USA., Heetderks W; Department of Emergency Medicine, National Heart, Lung, and Blood institute, NIH, via contract with Guidehousel, Bethesd, MD, USA., Manabe YC; Division of Infectious Diseases, Department of Medicine, Johns Hopkins University School of Medicine, Baltimore, MD, USA., Soni A; Program in Digital Medicine, Department of Medicine, University of Massachusetts Chan Medical School, Worcester, MA, USA.; Center for Clinical and Translational Science, University of Massachusetts, University of Massachusetts Chan Medical School, Worcester, MA, USA., McManus D; Program in Digital Medicine, Department of Medicine, University of Massachusetts Chan Medical School, Worcester, MA, USA.; Division of Cardiology, Department of Medicine, University of Massachusetts Chan Medical School, Worcester, MA, USA.
Jazyk: angličtina
Zdroj: BMC infectious diseases [BMC Infect Dis] 2024 Nov 12; Vol. 24 (1), pp. 1282. Date of Electronic Publication: 2024 Nov 12.
DOI: 10.1186/s12879-024-10154-0
Abstrakt: Shortly after the first case of SARS-CoV-2 was diagnosed a public health emergency (PHE) was declared and a multi-agency response was initiated within the US federal government to create and propagate testing capacity. As part of this response, an unprecedented program designated Rapid Acceleration of Diagnostics (RADx) Tech was established by the National Institutes of Health (NIH) to facilitate the development of point-of-care tests for the COVID-19. The RADx Tech Clinical Studies Core (CSC), located at the University of Massachusetts Chan Medical School (UMass Chan), with partnering academic, private, and non-governmental organizations around the country, was tasked with developing clinical studies to support this work. This manuscript details development of a biorepository specifically focused on the collection and storage of samples designed for diagnostic platform development. It highlights the unified collection and annotation process that enabled gathering a diverse set of samples. This diversity encompasses the geography and backgrounds of the participants as well as sample characteristics such as variant type and RT-PCR cycle threshold (CT) value of the corresponding reference sample on a uniform clinical reference platform.
Competing Interests: Declarations Ethics approval and consent to participate This study was approved by the UMass Chan Institutional Review Board reference number [H00022475]. Informed consent for participation was obtained from all participants. In the case of pediatric participants, informed consent was obtained from the parent or legal guardian as well as assent from the child. Clinical trial number: not applicable. Consent for publication Not applicable. Competing interests The views expressed in this article are those of the authors and do not necessarily represent the views of the National Institute of Biomedical Imaging and Bioengineering; the National Heart, Lung, and Blood Institute; the National Institutes of Health (NIH); or the U.S. Department of Health and Human Services.
(© 2024. The Author(s).)
Databáze: MEDLINE
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