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The Clinical Review Committee: Impact of the Development of In Vitro Diagnostic Tests for SARS-CoV-2 Within RADx Tech

dc.contributor.authorRobinson, Matthew L.
dc.contributor.authorGibson, Laura L.
dc.contributor.authorMcManus, David D.
dc.date2022-08-11T08:09:59.000
dc.date.accessioned2022-08-23T16:51:06Z
dc.date.available2022-08-23T16:51:06Z
dc.date.issued2021-04-28
dc.date.submitted2021-05-05
dc.identifier.citation<p>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. <a href="https://doi.org/10.1109/OJEMB.2021.3070818" target="_blank" title="view article on publisher's site">View article on publisher's site</a></p>
dc.identifier.doi10.1109/OJEMB.2021.3070818
dc.identifier.urihttp://hdl.handle.net/20.500.14038/41792
dc.description<p>Full author list omitted for brevity. For the full list of authors, see article.</p>
dc.description.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.
dc.language.isoen_US
dc.rightsThis work is licensed under a Creative Commons Attribution 4.0 License. For more information, see https://creativecommons.org/licenses/by/4.0/
dc.rights.urihttp://creativecommons.org/licenses/by/4.0/
dc.subjectSARS-CoV-2
dc.subjectCOVID-19
dc.subjectin vitro diagnostics
dc.subjectpoint-of-care testing
dc.subjectRapid Acceleration of Diagnostics program
dc.subjectBiomedical Engineering and Bioengineering
dc.subjectDiagnosis
dc.subjectHealth Services Administration
dc.subjectImmunology of Infectious Disease
dc.subjectInfectious Disease
dc.subjectVirus Diseases
dc.titleThe Clinical Review Committee: Impact of the Development of In Vitro Diagnostic Tests for SARS-CoV-2 Within RADx Tech
dc.typeJournal Article
dc.source.journaltitleIEEE Open Journal of Engineering in Medicine and Biology
dc.source.volume2
dc.identifier.legacyfulltexthttps://escholarship.umassmed.edu/cgi/viewcontent.cgi?article=5625&amp;context=oapubs&amp;unstamped=1
dc.identifier.legacycoverpagehttps://escholarship.umassmed.edu/oapubs/4592
dc.identifier.contextkey22800040
refterms.dateFOA2022-08-23T16:51:06Z
html.description.abstract<p>The NIH Rapid Acceleration of Diagnostics (RADx <sup>SM</sup> ) 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.</p>
dc.identifier.submissionpathoapubs/4592
dc.contributor.departmentDepartment of Medicine, Division of Cardiovascular Medicine
dc.contributor.departmentDepartment of Medicine, Division of Infectious Diseases and Immunology
dc.source.pages138-141


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This 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/