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

被引:69
作者
Fung, Becky [1 ]
Gopez, Allan [1 ,2 ]
Servellita, Venice [1 ,2 ]
Arevalo, Shaun [1 ,2 ]
Ho, Coral [1 ]
Deucher, Anne [1 ]
Thornborrow, Ed [1 ]
Chiu, Charles [1 ,2 ]
Miller, Steve [1 ,2 ]
机构
[1] Univ Calif San Francisco, Dept Lab Med, San Francisco, CA 94143 USA
[2] UCSF Abbott Viral Diagnost & Discovery Ctr, San Francisco, CA 94143 USA
关键词
SARS-CoV-2; limit of detection;
D O I
10.1128/JCM.01535-20
中图分类号
Q93 [微生物学];
学科分类号
071005 ; 100705 ;
摘要
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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页数:4
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