The Clinical Review Committee: Impact of the Development of In Vitro Diagnostic Tests for SARS-CoV-2 Within RADx Tech
UMass Chan AffiliationsDepartment of Medicine, Division of Cardiovascular Medicine
Department of Medicine, Division of Infectious Diseases and Immunology
Document TypeJournal Article
in vitro diagnostics
Rapid Acceleration of Diagnostics program
Biomedical Engineering and Bioengineering
Health Services Administration
Immunology of Infectious Disease
MetadataShow full item record
AbstractThe 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.
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
Permanent Link to this Itemhttp://hdl.handle.net/20.500.14038/41792
Full author list omitted for brevity. For the full list of authors, see article.
RightsThis work is licensed under a Creative Commons Attribution 4.0 License. For more information, see https://creativecommons.org/licenses/by/4.0/
Except where otherwise noted, this item's license is described as This work is licensed under a Creative Commons Attribution 4.0 License. For more information, see https://creativecommons.org/licenses/by/4.0/