期刊
FRONTIERS IN MICROBIOLOGY
卷 13, 期 -, 页码 -出版社
FRONTIERS MEDIA SA
DOI: 10.3389/fmicb.2022.910156
关键词
COVID-19; point-of-service; diagnostic; SARS-CoV-2; rubric system
类别
资金
- Massachusetts Consortium on Pathogen Readiness (MassCPR)
- Massachusetts Life Sciences Center, Accelerating Coronavirus Testing Solutions (A.C.T.S)
During the early months of the SARS-CoV-2 pandemic, the medical research community developed diagnostic methods and tools to address testing challenges. They proposed a framework for assessing technologies and clinical validation to guide device selection and application. This approach can be extended to future technology assessments and emerging pathogens.
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.
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