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

Matthew Robinson*, Charlotte Gaydos, Barbara Van Der Pol, Sally McFall, Yu Hsiang Hsieh, William Clarke, Robert Murphy, Lea Widdice, Lisa Hirschhorn, Richard Rothman, Chad Achenbach, Claudia Hawkins, Adam Samuta, Laura Gibson, David McManus, Yukari Manabe

*Corresponding author for this work

Research output: Contribution to journalArticlepeer-review

1 Scopus citations

Abstract

The NIH Rapid Acceleration of Diagnostics (RADxSM) 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.

Original languageEnglish (US)
Article number9418532
Pages (from-to)138-141
Number of pages4
JournalIEEE Open Journal of Engineering in Medicine and Biology
Volume2
DOIs
StatePublished - 2021

Keywords

  • COVID-19
  • Rapid Acceleration of Diagnostics program
  • SARS-CoV-2
  • in vitro diagnostics
  • point-of-care testing

ASJC Scopus subject areas

  • Biomedical Engineering

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