UMMS Affiliation
Department of Medicine, Division of Infectious Diseases and Immunology; Department of Medicine, Division of Cardiovascular Medicine
Publication Date
2021-04-28
Document Type
Article
Disciplines
Biomedical Engineering and Bioengineering | Diagnosis | Health Services Administration | Immunology of Infectious Disease | Infectious Disease | Virus Diseases
Abstract
The NIH Rapid Acceleration of Diagnostics (RADx SM ) Tech Program was created to speed the development, validation, and commercialization of innovative point-of-care (POC) and home-based tests, and to improve clinical laboratory tests, that can directly detect SARS-CoV-2. Leveraging the experience of the Point-of-Care Technologies Research Network, a Clinical Review Committee (CRC) composed of clinicians, bioengineers, regulatory experts, and laboratorians was created to provide structured feedback to SARS-CoV-2 diagnostic innovators. The CRC convened 53 meetings with 49 companies offering SARS-CoV-2 tests in POC and reference laboratory formats as well as collection materials. The CRC identified common barriers to device design finalization including biosafety, workflow, result reporting, regulatory requirements, sample type, supply chain, limit of detection, lack of relevant validation data, and price-performance-use mismatch. Feedback from companies participating was positive.
Keywords
SARS-CoV-2, COVID-19, in vitro diagnostics, point-of-care testing, Rapid Acceleration of Diagnostics program
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.2021.3070818
Source
M. L. Robinson et al., "The Clinical Review Committee: Impact of the Development of In Vitro Diagnostic Tests for SARS-CoV-2 Within RADx Tech," in IEEE Open Journal of Engineering in Medicine and Biology, vol. 2, pp. 138-141, 2021, doi: 10.1109/OJEMB.2021.3070818. View article on publisher's site
Journal/Book/Conference Title
IEEE Open Journal of Engineering in Medicine and Biology
Repository Citation
Robinson ML, Gibson LL, McManus DD. (2021). The Clinical Review Committee: Impact of the Development of In Vitro Diagnostic Tests for SARS-CoV-2 Within RADx Tech. Open Access Publications by UMMS Authors. https://doi.org/10.1109/OJEMB.2021.3070818. Retrieved from https://escholarship.umassmed.edu/oapubs/4592
Creative Commons License
This work is licensed under a Creative Commons Attribution 4.0 License.
Included in
Biomedical Engineering and Bioengineering Commons, Diagnosis Commons, Health Services Administration Commons, Immunology of Infectious Disease Commons, Infectious Disease Commons, Virus Diseases Commons
Comments
Full author list omitted for brevity. For the full list of authors, see article.