UMMS Affiliation

Department of Molecular, Cell, and Cancer Biology; UMass Center for Clinical and Translational Science; Department of Medicine, Division of Cardiovascular Medicine

Publication Date

2021-04-28

Document Type

Article

Disciplines

Biomedical Engineering and Bioengineering | Diagnosis | Health Services Administration | Infectious Disease | Translational Medical Research | Virus Diseases

Abstract

Faced with the COVID-19 pandemic, the US system for developing and testing technologies was challenged in unparalleled ways. This article describes the multi-institutional, transdisciplinary team of the “RADx SM Tech Test Verification Core” and its role in expediting evaluations of COVID-19 testing devices. Expertise related to aspects of diagnostic testing was coordinated to evaluate testing devices with the goal of significantly expanding the ability to mass screen Americans to preserve lives and facilitate the safe return to work and school. Focal points included: laboratory and clinical device evaluation of the limit of viral detection, sensitivity, and specificity of devices in controlled and community settings; regulatory expertise to provide focused attention to barriers to device approval and distribution; usability testing from the perspective of patients and those using the tests to identify and overcome device limitations, and engineering assessment to evaluate robustness of design including human factors, manufacturability, and scalability.

Keywords

COVID-19, Device Testing, RADx, UMCCTS funding

Rights and Permissions

This work is licensed under a Creative Commons Attribution 4.0 License. For more information, see https://creativecommons.org/licenses/by/4.0/

DOI of Published Version

10.1109/OJEMB.2021.3070825

Source

E. J. Nehl et al., "The RADx Tech Test Verification Core and the ACME POCT in the Evaluation of COVID-19 Testing Devices: A Model for Progress and Change," in IEEE Open Journal of Engineering in Medicine and Biology, vol. 2, pp. 142-151, 2021, doi: 10.1109/OJEMB.2021.3070825. View article on publisher's site

Journal/Book/Conference Title

IEEE Open Journal of Engineering in Medicine and Biology

Comments

Full author list omitted for brevity. For the full list of authors, see article.

Creative Commons License

Creative Commons Attribution 4.0 License
This work is licensed under a Creative Commons Attribution 4.0 License.

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