Systematic Approach to Address Early Pandemic's Diagnostic Unmet Needs

Autor: Catherine Cabrera, Kanoelani Pilobello, Steven Dalvin, Johanna Bobrow, Darshi Shah, Lori Freed Garg, Sujata Chalise, Patrick Doyle, Glenn A. Miller, David R. Walt, Sara Suliman, Pawan Jolly
Jazyk: angličtina
Rok vydání: 2022
Předmět:
Zdroj: Frontiers in Microbiology, Vol 13 (2022)
Druh dokumentu: article
ISSN: 1664-302X
DOI: 10.3389/fmicb.2022.910156
Popis: 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.
Databáze: Directory of Open Access Journals