IEEE Open Journal of Engineering in Medicine and Biology (Jan 2021)
The RADx Tech Test Verification Core and the ACME POCT in the Evaluation of COVID-19 Testing Devices: A Model for Progress and Change
- Eric Nehl,
- Stacy Heilman,
- David Ku,
- David Gottfried,
- Sarah Farmer,
- Robert Mannino,
- Erika Tyburski,
- Julie Sullivan,
- Allison Suessmith,
- Leda Bassit,
- Janet Figueroa,
- Anna Wood,
- Traci Leong,
- Anuradha Rao,
- Beverly Rogers,
- Robert Jerris,
- Sunita Park,
- Mark Gonzalez,
- Jennifer Frediani,
- Claudia Morris,
- Joshua Levy,
- Nils Schoof,
- Maud Mavigner,
- John Roback,
- Kristen Herzegh,
- Natia Saakadze,
- Jess Ingersoll,
- Narayana Cheedarla,
- Andrew Neish,
- Bradley Hanberry,
- Christopher Porter,
- Annette Esper,
- Russell Kempker,
- Paulina Rebolledo,
- Pamela McGuinness,
- Frederick Balagadde,
- Rebecca Gore,
- Ainat Koren,
- Nira Pollock,
- Eugene Rogers,
- Karl Simin,
- Nathaniel Hafer,
- Mary Ann Picard,
- Chiara Ghezzi,
- David McManus,
- Bryan Buchholz,
- Christina Rostad,
- Viviana Claveria,
- Thanuja Ramachandra,
- Yun F. Wang,
- CaDeidre Washington,
- Cheryl Stone,
- Mark Griffiths,
- Ray Schinazi,
- Ann Chahroudi,
- Miriam Vos,
- Oliver Brand,
- Greg Martin,
- Wilbur Lam
Affiliations
- Eric Nehl
- ORCiD
- Behavioral, Social & Health Education Sciences, Emory University, Atlanta, GA, USA
- Stacy Heilman
- ORCiD
- Pediatrics, Emory University, Atlanta, GA, USA
- David Ku
- ORCiD
- School of Mechanical Engineering, Georgia Institute of Technology, Atlanta, GA, USA
- David Gottfried
- ORCiD
- Institute for Electronics and Nanotechnology, Georgia Institute of Technology, GA, USA
- Sarah Farmer
- Georgia Institute of Technology, Atlanta, GA, USA
- Robert Mannino
- Biomedical Engineering, Georgia Institute of Technology, Atlanta, GA, USA
- Erika Tyburski
- The Atlanta Center for Microsystems-Engineered Point-of-Care Technologies, Georgia Institute of Technology, Atlanta, GA, USA
- Julie Sullivan
- Pediatrics, Emory University, Atlanta, GA, USA
- Allison Suessmith
- Pediatrics, Emory University, Atlanta, GA, USA
- Leda Bassit
- Laboratory of Biochemical Pharmacology, Emory University, Atlanta, GA, USA
- Janet Figueroa
- Pediatrics, Emory University, Atlanta, GA, USA
- Anna Wood
- Pediatrics, Emory University School of Medicine, Atlanta, GA, USA
- Traci Leong
- Statistics, Emory University School of Public Health, Atlanta, GA, USA
- Anuradha Rao
- Pediatrics, Emory University School of Medicine, Atlanta, GA, USA
- Beverly Rogers
- Pathology and Laboratory Medicine, Emory University School of Medicine, Atlanta, GA, USA
- Robert Jerris
- Pathology and Laboratory Medicine, Emory University School of Medicine, Atlanta, GA, USA
- Sunita Park
- Childrens Healthcare of Atlanta, Emory University School of Medicine, Atlanta, GA, USA
- Mark Gonzalez
- Childrens Healthcare of Atlanta, Emory University School of Medicine, Atlanta, GA, USA
- Jennifer Frediani
- Emory University School of Public Health, Atlanta, GA, USA
- Claudia Morris
- Pediatrics, Emory University School of Medicine, Atlanta, GA, USA
- Joshua Levy
- Department of Otolaryngology-Head & Neck Surgery, Emory University School of Medicine, Atlanta, GA, USA
- Nils Schoof
- Pediatrics, Emory University School of Medicine, Atlanta, GA, USA
- Maud Mavigner
- Pediatrics, Emory University School of Medicine, Atlanta, GA, USA
- John Roback
- Pathology and Laboratory Medicine, Emory University School of Medicine, Atlanta, GA, USA
- Kristen Herzegh
- ORCiD
- Pediatrics, Emory University School of Medicine, Atlanta, GA, USA
- Natia Saakadze
- Pathology and Laboratory Medicine, Emory University School of Medicine, Atlanta, GA, USA
- Jess Ingersoll
- Pathology and Laboratory Medicine, Emory University School of Medicine, Atlanta, GA, USA
- Narayana Cheedarla
- Emory University School of Public Health, Atlanta, GA, USA
- Andrew Neish
- Pathology and Laboratory Medicine, Emory University School of Medicine, Atlanta, GA, USA
- Bradley Hanberry
- Childrens Healthcare of Atlanta, Emory University School of Medicine, Atlanta, GA, USA
- Christopher Porter
- Pediatrics, Emory University School of Medicine, Atlanta, GA, USA
- Annette Esper
- Medicine, Emory University School of Medicine, Atlanta, GA, USA
- Russell Kempker
- Medicine, Emory University School of Medicine, Atlanta, GA, USA
- Paulina Rebolledo
- Medicine, Emory University School of Medicine, Atlanta, GA, USA
- Pamela McGuinness
- Medical Device Research, University of Massachusetts Lowell, Lowell, MA, USA
- Frederick Balagadde
- Biomedical Engineering, University of Massachusetts Lowell, Lowell, MA, USA
- Rebecca Gore
- Biomedical Engineering, University of Massachusetts Lowell, Lowell, MA, USA
- Ainat Koren
- School of Nursing, University of Massachusetts Lowell, Lowell, MA, USA
- Nira Pollock
- Department of Pathology, Boston Children's Hospital, Boston, MA, USA
- Eugene Rogers
- Biomedical and Nutritional Sciences, University of Massachusetts Lowell, Lowell, MA, USA
- Karl Simin
- ORCiD
- Molecular, Cell, and Cancer Biology, University of Massachusetts Medical School, Worcester, MA, USA
- Nathaniel Hafer
- University of Massachusetts Medical School, Worcester, MA, USA
- Mary Ann Picard
- Medical Device Research, University of Massachusetts Lowell, Lowell, MA, USA
- Chiara Ghezzi
- Biomedical Engineering, University of Massachusetts Lowell, Lowell, MA, USA
- David McManus
- Medicine, UMass Medical School, Worcester, MA, USA
- Bryan Buchholz
- University of Massachusetts Lowell, Lowell, MA, USA
- Christina Rostad
- Pediatrics, Emory University School of Medicine, Atlanta, GA, USA
- Viviana Claveria
- School of Mechanical Engineering, Georgia Institute of Technology, Atlanta, GA, USA
- Thanuja Ramachandra
- Medicine, Emory University School of Medicine, Atlanta, GA, USA
- Yun F. Wang
- Pathology and Laboratory Medicine, Emory University School of Medicine, Atlanta, GA, USA
- CaDeidre Washington
- Medicine, Emory University School of Medicine, Atlanta, GA, USA
- Cheryl Stone
- Children's Healthcare of Atlanta Inc, Atlanta, GA, USA
- Mark Griffiths
- Pediatric Emergency Medicine, Emory University School of Medicine, Atlanta, GA, USA
- Ray Schinazi
- Pediatrics, Emory University School of Medicine, Atlanta, GA, USA
- Ann Chahroudi
- Pediatrics, Emory University School of Medicine, Atlanta, GA, USA
- Miriam Vos
- Pediatrics, Emory University School of Medicine, Atlanta, GA, USA
- Oliver Brand
- ORCiD
- Electrical and Computer Engineering, Georgia Institute of Technology, Atlanta, GA, USA
- Greg Martin
- Medicine, Emory University School of Medicine, Atlanta, GA, USA
- Wilbur Lam
- Pathology and Laboratory Medicine, Emory University School of Medicine, Atlanta, GA, USA
- DOI
- https://doi.org/10.1109/OJEMB.2021.3070825
- Journal volume & issue
-
Vol. 2
pp. 142 – 151
Abstract
Faced with the COVID-19 pandemic, the US system for developing and testing technologies was challenged in unparalleled ways. This article describes the multi-institutional, transdisciplinary team of the “RADxSM Tech Test Verification Core” and its role in expediting evaluations of COVID-19 testing devices. Expertise related to aspects of diagnostic testing was coordinated to evaluate testing devices with the goal of significantly expanding the ability to mass screen Americans to preserve lives and facilitate the safe return to work and school. Focal points included: laboratory and clinical device evaluation of the limit of viral detection, sensitivity, and specificity of devices in controlled and community settings; regulatory expertise to provide focused attention to barriers to device approval and distribution; usability testing from the perspective of patients and those using the tests to identify and overcome device limitations, and engineering assessment to evaluate robustness of design including human factors, manufacturability, and scalability.
Keywords
