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

被引：71

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

来源：

JOURNAL OF CLINICAL MICROBIOLOGY | 2020年 / 58卷 / 09期

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.

引用

页数：4

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