Frontiers in Microbiology (Jun 2022)

Systematic Approach to Address Early Pandemic's Diagnostic Unmet Needs

  • Catherine Cabrera,
  • Kanoelani Pilobello,
  • Steven Dalvin,
  • Johanna Bobrow,
  • Darshi Shah,
  • Lori Freed Garg,
  • Sujata Chalise,
  • Sujata Chalise,
  • Patrick Doyle,
  • Glenn A. Miller,
  • David R. Walt,
  • David R. Walt,
  • David R. Walt,
  • Sara Suliman,
  • Sara Suliman,
  • Sara Suliman,
  • Pawan Jolly

DOI
https://doi.org/10.3389/fmicb.2022.910156
Journal volume & issue
Vol. 13

Abstract

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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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