1. Design, creation, and use of the Test Us Bank (TUB) COVID-19 sample biorepository.
- Author
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Broach J, Achenbach C, Behar S, O'Connor L, Tarrant S, Ferranto J, Wright C, Hartin P, Orwig T, Nanavati J, Kalibala B, Woods K, Shaw B, Flahive J, Barton B, Hafer N, Herbert C, Fahey N, Gibson L, Simin K, Kowalik T, Ward DV, Mirza AW, Murphy RL, Caputo M, Buchholz B, Fantasia H, Koren A, Marchand L, Oludare S, Sogade F, Ritland D, Davis C, Grenier A, Baron C, Brent E, McKenney JB, Elder N, Michaels L, Ferrara L, Theron G, Palmer Z, Levy B, Daly J, Parang K, Schmidt M, Buxton D, Heetderks W, Manabe YC, Soni A, and McManus D
- Subjects
- Humans, United States, COVID-19 Testing methods, Point-of-Care Testing, National Institutes of Health (U.S.), COVID-19 diagnosis, COVID-19 epidemiology, Biological Specimen Banks organization & administration, Specimen Handling methods, SARS-CoV-2 isolation & purification
- Abstract
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).)
- Published
- 2024
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