1. The RADx Tech Test Verification Core and the ACME POCT in the Evaluation of COVID-19 Testing Devices: A Model for Progress and Change
- Author
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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, and Wilbur Lam
- Subjects
COVID-19 ,Device Testing ,RADx ,Computer applications to medicine. Medical informatics ,R858-859.7 ,Medical technology ,R855-855.5 - 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.
- Published
- 2021
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