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 J. Nehl, Stacy Heilman, David N. Ku, David Gottfried, Sarah Farmer, Robert G. Mannino, Erika A. Tyburski, Julie Sullivan, Allison Suessmith, Leda Bassit, Janet Figueroa, Anna Wood, Traci Leong, Anuradha Rao, Beverly Barton Rogers, Robert C. Jerris, Sunita Park, Mark D. Gonzalez, Jennifer K. Frediani, Claudia R. Morris, Joshua M. Levy, Nils Schoof, Maud Mavigner, John D. Roback, Kristen Herzegh, Natia Saakadze, Jess M. Ingersoll, Narayanaiah Cheedarla, Andrew S. Neish, Bradley S. Hanberry, Christopher C. Porter, Annette Esper, Russell R. Kempker, Paulina A. Rebolledo, Pamela D. McGuinness, Frederick Balagadde, Rebecca Gore, Ainat Koren, Nira R. Pollock, Eugene Rogers, Karl Simin, Nathaniel Hafer, Mary Ann Picard, Chiara E. Ghezzi, David D. McManus, Bryan Buchholz, Christina A. Rostad, Viviana Clavería, Thanuja Ramachandra, Yun F. Wang, CaDeidre Washington, Cheryl Stone, Mark Griffiths, Ray Schinazi, Ann Chahroudi, Miriam B. Vos, Oliver Brand, Greg S. Martin, Wilbur A. Lam
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 “RADx <sup xmlns:mml="http://www.w3.org/1998/Math/MathML" xmlns:xlink="http://www.w3.org/1999/xlink">SM</sup> 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.