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

Author:

Fung Becky1,Gopez Allan12,Servellita Venice12,Arevalo Shaun12,Ho Coral1,Deucher Anne1,Thornborrow Ed1,Chiu Charles12ORCID,Miller Steve12ORCID

Affiliation:

1. Department of Laboratory Medicine, University of California San Francisco, San Francisco, California, USA

2. UCSF-Abbott Viral Diagnostics and Discovery Center, San Francisco, California, USA

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).

Funder

UCSF Medical Center

Publisher

American Society for Microbiology

Subject

Microbiology (medical)

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