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

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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