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Direct Comparison of SARS-CoV-2 Analytical Limits of Detection across Seven Molecular Assays.

  • Author(s): Fung, Becky
  • Gopez, Allan
  • Servellita, Venice
  • Arevalo, Shaun
  • Ho, Coral
  • Deucher, Anne
  • Thornborrow, Ed
  • Chiu, Charles
  • Miller, Steve
  • et al.
Abstract

Analytical sensitivity for SARS-CoV-2 detection is a key performance metric for the evaluation of viral detection assays. We determined analytical limits of detection for seven SARS-CoV-2 assays using serial dilutions of pooled patient material quantified with droplet digital PCR. Limits of detection ranged from ≤10 to 74 copies/ml for commercial high-throughput laboratory analyzers (Roche Cobas, Abbott m2000, and Hologic Panther Fusion) and 167 to 511 copies/ml for sample-to-answer (DiaSorin Simplexa, GenMark ePlex) and point-of-care instruments (Abbott ID NOW). The CDC assay yielded limits of detection ranging from 85 to 499 copies/ml, depending on the extraction method and thermocycler used. These results can help to inform the assay choice for testing approaches to manage the current COVID-19 outbreak.

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