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

doi:10.1109/OJEMB.2021.3070825

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

^*Corresponding author for this work

Emory University
Georgia Institute of Technology
University of Massachusetts Lowell
Boston Children's Hospital
University of Massachusetts Medical School
Children's Healthcare of Atlanta

Research output: Contribution to journal › Article › peer-review

16 Citations (Scopus)

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.

Original language	English
Article number	9418534
Pages (from-to)	142-151
Number of pages	10
Journal	IEEE Open Journal of Engineering in Medicine and Biology
Volume	2
DOIs	https://doi.org/10.1109/OJEMB.2021.3070825
Publication status	Published - 2021
Externally published	Yes

UN SDGs

This output contributes to the following UN Sustainable Development Goals (SDGs)

SDG 3 Good Health and Well-being

Keywords

COVID-19
Device Testing
RADx

Access to Document

10.1109/OJEMB.2021.3070825

Cite this

Nehl, E., Heilman, S., Ku, D., Gottfried, D., Farmer, S., Mannino, R., Tyburski, E., Sullivan, J., Suessmith, A., Bassit, L., Figueroa, J., Wood, A., Leong, T., Rao, A., Rogers, B., Jerris, R., Park, S., Gonzalez, M., Frediani, J., ... Lam, W. (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. IEEE Open Journal of Engineering in Medicine and Biology, 2, 142-151. Article 9418534. https://doi.org/10.1109/OJEMB.2021.3070825

@article{e6fc2ddefdaa4051bd3b63aa6f1a9d05,

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",

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 = "COVID-19, Device Testing, RADx",

author = "Eric Nehl and Stacy Heilman and David Ku and David Gottfried and Sarah Farmer and Robert Mannino and Erika Tyburski and Julie Sullivan and Allison Suessmith and Leda Bassit and Janet Figueroa and Anna Wood and Traci Leong and Anuradha Rao and Beverly Rogers and Robert Jerris and Sunita Park and Mark Gonzalez and Jennifer Frediani and Claudia Morris and Joshua Levy and Nils Schoof and Maud Mavigner and John Roback and Kristen Herzegh and Natia Saakadze and Jess Ingersoll and Narayana Cheedarla and Andrew Neish and Bradley Hanberry and Christopher Porter and Annette Esper and Russell Kempker and Paulina Rebolledo and Pamela McGuinness and Frederick Balagadde and Rebecca Gore and Ainat Koren and Nira Pollock and Eugene Rogers and Karl Simin and Nathaniel Hafer and Picard, \{Mary Ann\} and Chiara Ghezzi and David McManus and Bryan Buchholz and Christina Rostad and Viviana Claveria and Thanuja Ramachandra and Wang, \{Yun F.\} and Cadeidre Washington and Cheryl Stone and Mark Griffiths and Ray Schinazi and Ann Chahroudi and Miriam Vos and Oliver Brand and Greg Martin and Wilbur Lam",

note = "Publisher Copyright: {\textcopyright} 2020 IEEE.",

year = "2021",

doi = "10.1109/OJEMB.2021.3070825",

language = "English",

volume = "2",

pages = "142--151",

journal = "IEEE Open Journal of Engineering in Medicine and Biology",

issn = "2644-1276",

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Nehl, E, Heilman, S, Ku, D, Gottfried, D, Farmer, S, Mannino, R, Tyburski, E, Sullivan, J, Suessmith, A, Bassit, L, Figueroa, J, Wood, A, Leong, T, Rao, A, Rogers, B, Jerris, R, Park, S, Gonzalez, M, Frediani, J, Morris, C, Levy, J, Schoof, N, Mavigner, M, Roback, J, Herzegh, K, Saakadze, N, Ingersoll, J, Cheedarla, N, Neish, A, Hanberry, B, Porter, C, Esper, A, Kempker, R, Rebolledo, P, McGuinness, P, Balagadde, F, Gore, R, Koren, A, Pollock, N, Rogers, E, Simin, K, Hafer, N, Picard, MA, Ghezzi, C, McManus, D, Buchholz, B, Rostad, C, Claveria, V, Ramachandra, T, Wang, YF, Washington, C, Stone, C, Griffiths, M, Schinazi, R, Chahroudi, A, Vos, M, Brand, O, Martin, G & Lam, W 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', IEEE Open Journal of Engineering in Medicine and Biology, vol. 2, 9418534, pp. 142-151. https://doi.org/10.1109/OJEMB.2021.3070825

TY - JOUR

T1 - The RADx Tech Test Verification Core and the ACME POCT in the Evaluation of COVID-19 Testing Devices

T2 - A Model for Progress and Change

AU - Nehl, Eric

AU - Heilman, Stacy

AU - Ku, David

AU - Gottfried, David

AU - Farmer, Sarah

AU - Mannino, Robert

AU - Tyburski, Erika

AU - Sullivan, Julie

AU - Suessmith, Allison

AU - Bassit, Leda

AU - Figueroa, Janet

AU - Wood, Anna

AU - Leong, Traci

AU - Rao, Anuradha

AU - Rogers, Beverly

AU - Jerris, Robert

AU - Park, Sunita

AU - Gonzalez, Mark

AU - Frediani, Jennifer

AU - Morris, Claudia

AU - Levy, Joshua

AU - Schoof, Nils

AU - Mavigner, Maud

AU - Roback, John

AU - Herzegh, Kristen

AU - Saakadze, Natia

AU - Ingersoll, Jess

AU - Cheedarla, Narayana

AU - Neish, Andrew

AU - Hanberry, Bradley

AU - Porter, Christopher

AU - Esper, Annette

AU - Kempker, Russell

AU - Rebolledo, Paulina

AU - McGuinness, Pamela

AU - Balagadde, Frederick

AU - Gore, Rebecca

AU - Koren, Ainat

AU - Pollock, Nira

AU - Rogers, Eugene

AU - Simin, Karl

AU - Hafer, Nathaniel

AU - Picard, Mary Ann

AU - Ghezzi, Chiara

AU - McManus, David

AU - Buchholz, Bryan

AU - Rostad, Christina

AU - Claveria, Viviana

AU - Ramachandra, Thanuja

AU - Wang, Yun F.

AU - Washington, Cadeidre

AU - Stone, Cheryl

AU - Griffiths, Mark

AU - Schinazi, Ray

AU - Chahroudi, Ann

AU - Vos, Miriam

AU - Brand, Oliver

AU - Martin, Greg

AU - Lam, Wilbur

PY - 2021

Y1 - 2021

N2 - 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.

AB - 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.

KW - COVID-19

KW - Device Testing

KW - RADx

UR - https://www.scopus.com/pages/publications/85121057552

U2 - 10.1109/OJEMB.2021.3070825

DO - 10.1109/OJEMB.2021.3070825

M3 - Article

AN - SCOPUS:85121057552

SN - 2644-1276

VL - 2

SP - 142

EP - 151

JO - IEEE Open Journal of Engineering in Medicine and Biology

JF - IEEE Open Journal of Engineering in Medicine and Biology

M1 - 9418534

ER -

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

Abstract

UN SDGs

Keywords

Access to Document

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