Cargando…
The Clinical Review Committee: Impact of the Development of In Vitro Diagnostic Tests for SARS-CoV-2 Within RADx Tech
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 o...
Formato: | Online Artículo Texto |
---|---|
Lenguaje: | English |
Publicado: |
IEEE
2021
|
Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8118689/ https://www.ncbi.nlm.nih.gov/pubmed/34192285 http://dx.doi.org/10.1109/OJEMB.2021.3070818 |
_version_ | 1783691798932094976 |
---|---|
collection | PubMed |
description | 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. |
format | Online Article Text |
id | pubmed-8118689 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2021 |
publisher | IEEE |
record_format | MEDLINE/PubMed |
spelling | pubmed-81186892021-05-18 The Clinical Review Committee: Impact of the Development of In Vitro Diagnostic Tests for SARS-CoV-2 Within RADx Tech IEEE Open J Eng Med Biol RADx Tech: A New Paradigm for MedTech Development 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. IEEE 2021-03-29 /pmc/articles/PMC8118689/ /pubmed/34192285 http://dx.doi.org/10.1109/OJEMB.2021.3070818 Text en https://creativecommons.org/licenses/by/4.0/This work is licensed under a Creative Commons Attribution 4.0 License. For more information, see https://creativecommons.org/licenses/by/4.0/ |
spellingShingle | RADx Tech: A New Paradigm for MedTech Development The Clinical Review Committee: Impact of the Development of In Vitro Diagnostic Tests for SARS-CoV-2 Within RADx Tech |
title | The Clinical Review Committee: Impact of the Development of In Vitro Diagnostic Tests for SARS-CoV-2 Within RADx Tech |
title_full | The Clinical Review Committee: Impact of the Development of In Vitro Diagnostic Tests for SARS-CoV-2 Within RADx Tech |
title_fullStr | The Clinical Review Committee: Impact of the Development of In Vitro Diagnostic Tests for SARS-CoV-2 Within RADx Tech |
title_full_unstemmed | The Clinical Review Committee: Impact of the Development of In Vitro Diagnostic Tests for SARS-CoV-2 Within RADx Tech |
title_short | The Clinical Review Committee: Impact of the Development of In Vitro Diagnostic Tests for SARS-CoV-2 Within RADx Tech |
title_sort | clinical review committee: impact of the development of in vitro diagnostic tests for sars-cov-2 within radx tech |
topic | RADx Tech: A New Paradigm for MedTech Development |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8118689/ https://www.ncbi.nlm.nih.gov/pubmed/34192285 http://dx.doi.org/10.1109/OJEMB.2021.3070818 |
work_keys_str_mv | AT theclinicalreviewcommitteeimpactofthedevelopmentofinvitrodiagnostictestsforsarscov2withinradxtech AT theclinicalreviewcommitteeimpactofthedevelopmentofinvitrodiagnostictestsforsarscov2withinradxtech AT theclinicalreviewcommitteeimpactofthedevelopmentofinvitrodiagnostictestsforsarscov2withinradxtech AT theclinicalreviewcommitteeimpactofthedevelopmentofinvitrodiagnostictestsforsarscov2withinradxtech AT theclinicalreviewcommitteeimpactofthedevelopmentofinvitrodiagnostictestsforsarscov2withinradxtech AT theclinicalreviewcommitteeimpactofthedevelopmentofinvitrodiagnostictestsforsarscov2withinradxtech AT theclinicalreviewcommitteeimpactofthedevelopmentofinvitrodiagnostictestsforsarscov2withinradxtech AT theclinicalreviewcommitteeimpactofthedevelopmentofinvitrodiagnostictestsforsarscov2withinradxtech AT theclinicalreviewcommitteeimpactofthedevelopmentofinvitrodiagnostictestsforsarscov2withinradxtech AT theclinicalreviewcommitteeimpactofthedevelopmentofinvitrodiagnostictestsforsarscov2withinradxtech AT theclinicalreviewcommitteeimpactofthedevelopmentofinvitrodiagnostictestsforsarscov2withinradxtech AT theclinicalreviewcommitteeimpactofthedevelopmentofinvitrodiagnostictestsforsarscov2withinradxtech AT theclinicalreviewcommitteeimpactofthedevelopmentofinvitrodiagnostictestsforsarscov2withinradxtech AT theclinicalreviewcommitteeimpactofthedevelopmentofinvitrodiagnostictestsforsarscov2withinradxtech AT theclinicalreviewcommitteeimpactofthedevelopmentofinvitrodiagnostictestsforsarscov2withinradxtech AT theclinicalreviewcommitteeimpactofthedevelopmentofinvitrodiagnostictestsforsarscov2withinradxtech AT clinicalreviewcommitteeimpactofthedevelopmentofinvitrodiagnostictestsforsarscov2withinradxtech AT clinicalreviewcommitteeimpactofthedevelopmentofinvitrodiagnostictestsforsarscov2withinradxtech AT clinicalreviewcommitteeimpactofthedevelopmentofinvitrodiagnostictestsforsarscov2withinradxtech AT clinicalreviewcommitteeimpactofthedevelopmentofinvitrodiagnostictestsforsarscov2withinradxtech AT clinicalreviewcommitteeimpactofthedevelopmentofinvitrodiagnostictestsforsarscov2withinradxtech AT clinicalreviewcommitteeimpactofthedevelopmentofinvitrodiagnostictestsforsarscov2withinradxtech AT clinicalreviewcommitteeimpactofthedevelopmentofinvitrodiagnostictestsforsarscov2withinradxtech AT clinicalreviewcommitteeimpactofthedevelopmentofinvitrodiagnostictestsforsarscov2withinradxtech AT clinicalreviewcommitteeimpactofthedevelopmentofinvitrodiagnostictestsforsarscov2withinradxtech AT clinicalreviewcommitteeimpactofthedevelopmentofinvitrodiagnostictestsforsarscov2withinradxtech AT clinicalreviewcommitteeimpactofthedevelopmentofinvitrodiagnostictestsforsarscov2withinradxtech AT clinicalreviewcommitteeimpactofthedevelopmentofinvitrodiagnostictestsforsarscov2withinradxtech AT clinicalreviewcommitteeimpactofthedevelopmentofinvitrodiagnostictestsforsarscov2withinradxtech AT clinicalreviewcommitteeimpactofthedevelopmentofinvitrodiagnostictestsforsarscov2withinradxtech AT clinicalreviewcommitteeimpactofthedevelopmentofinvitrodiagnostictestsforsarscov2withinradxtech AT clinicalreviewcommitteeimpactofthedevelopmentofinvitrodiagnostictestsforsarscov2withinradxtech |