Direct comparison of SARS-CoV-2 analytical limits of detection across seven molecular assays

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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-toanswer (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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Fung, B., Gopez, A., Servellita, V., Arevalo, S., Ho, C., Deucher, A., … Miller, S. (2020). Direct comparison of SARS-CoV-2 analytical limits of detection across seven molecular assays. Journal of Clinical Microbiology, 58(9). https://doi.org/10.1128/JCM.01535-20

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