AUTHOR=Cabrera Catherine , Pilobello Kanoelani , Dalvin Steven , Bobrow Johanna , Shah Darshi , Garg Lori Freed , Chalise Sujata , Doyle Patrick , Miller Glenn A. , Walt David R. , Suliman Sara , Jolly Pawan TITLE=Systematic Approach to Address Early Pandemic's Diagnostic Unmet Needs JOURNAL=Frontiers in Microbiology VOLUME=13 YEAR=2022 URL=https://www.frontiersin.org/journals/microbiology/articles/10.3389/fmicb.2022.910156 DOI=10.3389/fmicb.2022.910156 ISSN=1664-302X ABSTRACT=

During the first few months of the global Severe Acute Respiratory Syndrome Coronavirus-2 (SARS-CoV-2) pandemic, the medical research community had to expeditiously develop, select, and deploy novel diagnostic methods and tools to address the numerous testing challenges presented by the novel virus. Integrating a systematic approach to diagnostic selection with a rapid validation protocol in a clinical setting can shorten the timeline to bring new technologies to practice. In response to the urgent need to provide tools for identifying SARS-CoV-2-positive individuals, we developed a framework for assessing technologies against a set of prioritized performance metrics to guide device selection. We also developed and proposed clinical validation frameworks for the rapid screening of new technologies. The rubric described here represents a versatile approach that can be extended to future technology assessments and can be implemented in preparation for future emerging pathogens.