The RADx Tech Test Verification Core and the ACME POCT in the Evaluation of COVID-19 Testing Devices: A Model for Progress and Change

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 &#x201C;RADx<sup>SM</sup> Tech Test Verification Core&#x201D; and its role in...

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Main Authors: 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
Format: Article
Language:English
Published: IEEE 2021-01-01
Series:IEEE Open Journal of Engineering in Medicine and Biology
Subjects:
Online Access:https://ieeexplore.ieee.org/document/9418534/
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author 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
author_facet 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
author_sort Eric Nehl
collection DOAJ
description 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 &#x201C;RADx<sup>SM</sup> Tech Test Verification Core&#x201D; 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.
format Article
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publisher IEEE
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series IEEE Open Journal of Engineering in Medicine and Biology
spelling doaj-art-97dd1f4fe14142b5900fb67b6edd4cb62025-08-20T03:15:48ZengIEEEIEEE Open Journal of Engineering in Medicine and Biology2644-12762021-01-01214215110.1109/OJEMB.2021.30708259418534The RADx Tech Test Verification Core and the ACME POCT in the Evaluation of COVID-19 Testing Devices: A Model for Progress and ChangeEric Nehl0https://orcid.org/0000-0003-3930-9235Stacy Heilman1https://orcid.org/0000-0003-0214-4262David Ku2https://orcid.org/0000-0002-6034-8004David Gottfried3https://orcid.org/0000-0002-2729-2504Sarah Farmer4Robert Mannino5Erika Tyburski6Julie Sullivan7Allison Suessmith8Leda Bassit9Janet Figueroa10Anna Wood11Traci Leong12Anuradha Rao13Beverly Rogers14Robert Jerris15Sunita Park16Mark Gonzalez17Jennifer Frediani18Claudia Morris19Joshua Levy20Nils Schoof21Maud Mavigner22John Roback23Kristen Herzegh24https://orcid.org/0000-0001-6124-308XNatia Saakadze25Jess Ingersoll26Narayana Cheedarla27Andrew Neish28Bradley Hanberry29Christopher Porter30Annette Esper31Russell Kempker32Paulina Rebolledo33Pamela McGuinness34Frederick Balagadde35Rebecca Gore36Ainat Koren37Nira Pollock38Eugene Rogers39Karl Simin40https://orcid.org/0000-0002-7431-0939Nathaniel Hafer41Mary Ann Picard42Chiara Ghezzi43David McManus44Bryan Buchholz45Christina Rostad46Viviana Claveria47Thanuja Ramachandra48Yun F. Wang49CaDeidre Washington50Cheryl Stone51Mark Griffiths52Ray Schinazi53Ann Chahroudi54Miriam Vos55Oliver Brand56https://orcid.org/0000-0001-7438-1094Greg Martin57Wilbur Lam58Behavioral, Social & Health Education Sciences, Emory University, Atlanta, GA, USAPediatrics, Emory University, Atlanta, GA, USASchool of Mechanical Engineering, Georgia Institute of Technology, Atlanta, GA, USAInstitute for Electronics and Nanotechnology, Georgia Institute of Technology, GA, USAGeorgia Institute of Technology, Atlanta, GA, USABiomedical Engineering, Georgia Institute of Technology, Atlanta, GA, USAThe Atlanta Center for Microsystems-Engineered Point-of-Care Technologies, Georgia Institute of Technology, Atlanta, GA, USAPediatrics, Emory University, Atlanta, GA, USAPediatrics, Emory University, Atlanta, GA, USALaboratory of Biochemical Pharmacology, Emory University, Atlanta, GA, USAPediatrics, Emory University, Atlanta, GA, USAPediatrics, Emory University School of Medicine, Atlanta, GA, USAStatistics, Emory University School of Public Health, Atlanta, GA, USAPediatrics, Emory University School of Medicine, Atlanta, GA, USAPathology and Laboratory Medicine, Emory University School of Medicine, Atlanta, GA, USAPathology and Laboratory Medicine, Emory University School of Medicine, Atlanta, GA, USAChildrens Healthcare of Atlanta, Emory University School of Medicine, Atlanta, GA, USAChildrens Healthcare of Atlanta, Emory University School of Medicine, Atlanta, GA, USAEmory University School of Public Health, Atlanta, GA, USAPediatrics, Emory University School of Medicine, Atlanta, GA, USADepartment of Otolaryngology-Head & Neck Surgery, Emory University School of Medicine, Atlanta, GA, USAPediatrics, Emory University School of Medicine, Atlanta, GA, USAPediatrics, Emory University School of Medicine, Atlanta, GA, USAPathology and Laboratory Medicine, Emory University School of Medicine, Atlanta, GA, USAPediatrics, Emory University School of Medicine, Atlanta, GA, USAPathology and Laboratory Medicine, Emory University School of Medicine, Atlanta, GA, USAPathology and Laboratory Medicine, Emory University School of Medicine, Atlanta, GA, USAEmory University School of Public Health, Atlanta, GA, USAPathology and Laboratory Medicine, Emory University School of Medicine, Atlanta, GA, USAChildrens Healthcare of Atlanta, Emory University School of Medicine, Atlanta, GA, USAPediatrics, Emory University School of Medicine, Atlanta, GA, USAMedicine, Emory University School of Medicine, Atlanta, GA, USAMedicine, Emory University School of Medicine, Atlanta, GA, USAMedicine, Emory University School of Medicine, Atlanta, GA, USAMedical Device Research, University of Massachusetts Lowell, Lowell, MA, USABiomedical Engineering, University of Massachusetts Lowell, Lowell, MA, USABiomedical Engineering, University of Massachusetts Lowell, Lowell, MA, USASchool of Nursing, University of Massachusetts Lowell, Lowell, MA, USADepartment of Pathology, Boston Children&#x0027;s Hospital, Boston, MA, USABiomedical and Nutritional Sciences, University of Massachusetts Lowell, Lowell, MA, USAMolecular, Cell, and Cancer Biology, University of Massachusetts Medical School, Worcester, MA, USAUniversity of Massachusetts Medical School, Worcester, MA, USAMedical Device Research, University of Massachusetts Lowell, Lowell, MA, USABiomedical Engineering, University of Massachusetts Lowell, Lowell, MA, USAMedicine, UMass Medical School, Worcester, MA, USAUniversity of Massachusetts Lowell, Lowell, MA, USAPediatrics, Emory University School of Medicine, Atlanta, GA, USASchool of Mechanical Engineering, Georgia Institute of Technology, Atlanta, GA, USAMedicine, Emory University School of Medicine, Atlanta, GA, USAPathology and Laboratory Medicine, Emory University School of Medicine, Atlanta, GA, USAMedicine, Emory University School of Medicine, Atlanta, GA, USAChildren&#x0027;s Healthcare of Atlanta Inc, Atlanta, GA, USAPediatric Emergency Medicine, Emory University School of Medicine, Atlanta, GA, USAPediatrics, Emory University School of Medicine, Atlanta, GA, USAPediatrics, Emory University School of Medicine, Atlanta, GA, USAPediatrics, Emory University School of Medicine, Atlanta, GA, USAElectrical and Computer Engineering, Georgia Institute of Technology, Atlanta, GA, USAMedicine, Emory University School of Medicine, Atlanta, GA, USAPathology and Laboratory Medicine, Emory University School of Medicine, Atlanta, GA, USAFaced 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 &#x201C;RADx<sup>SM</sup> Tech Test Verification Core&#x201D; 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.https://ieeexplore.ieee.org/document/9418534/COVID-19Device TestingRADx
spellingShingle 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
The RADx Tech Test Verification Core and the ACME POCT in the Evaluation of COVID-19 Testing Devices: A Model for Progress and Change
IEEE Open Journal of Engineering in Medicine and Biology
COVID-19
Device Testing
RADx
title The RADx Tech Test Verification Core and the ACME POCT in the Evaluation of COVID-19 Testing Devices: A Model for Progress and Change
title_full The RADx Tech Test Verification Core and the ACME POCT in the Evaluation of COVID-19 Testing Devices: A Model for Progress and Change
title_fullStr The RADx Tech Test Verification Core and the ACME POCT in the Evaluation of COVID-19 Testing Devices: A Model for Progress and Change
title_full_unstemmed The RADx Tech Test Verification Core and the ACME POCT in the Evaluation of COVID-19 Testing Devices: A Model for Progress and Change
title_short The RADx Tech Test Verification Core and the ACME POCT in the Evaluation of COVID-19 Testing Devices: A Model for Progress and Change
title_sort radx tech test verification core and the acme poct in the evaluation of covid 19 testing devices a model for progress and change
topic COVID-19
Device Testing
RADx
url https://ieeexplore.ieee.org/document/9418534/
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AT rayschinazi radxtechtestverificationcoreandtheacmepoctintheevaluationofcovid19testingdevicesamodelforprogressandchange
AT annchahroudi radxtechtestverificationcoreandtheacmepoctintheevaluationofcovid19testingdevicesamodelforprogressandchange
AT miriamvos radxtechtestverificationcoreandtheacmepoctintheevaluationofcovid19testingdevicesamodelforprogressandchange
AT oliverbrand radxtechtestverificationcoreandtheacmepoctintheevaluationofcovid19testingdevicesamodelforprogressandchange
AT gregmartin radxtechtestverificationcoreandtheacmepoctintheevaluationofcovid19testingdevicesamodelforprogressandchange
AT wilburlam radxtechtestverificationcoreandtheacmepoctintheevaluationofcovid19testingdevicesamodelforprogressandchange