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

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 detectio...

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Autores principales: Fung, Becky, Gopez, Allan, Servellita, Venice, Arevalo, Shaun, Ho, Coral, Deucher, Anne, Thornborrow, Ed, Chiu, Charles, Miller, Steve
Formato: Online Artículo Texto
Lenguaje:English
Publicado: American Society for Microbiology 2020
Materias:
Virology
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7448668/
https://www.ncbi.nlm.nih.gov/pubmed/32651238
http://dx.doi.org/10.1128/JCM.01535-20
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author Fung, Becky
Gopez, Allan
Servellita, Venice
Arevalo, Shaun
Ho, Coral
Deucher, Anne
Thornborrow, Ed
Chiu, Charles
Miller, Steve
author_facet Fung, Becky
Gopez, Allan
Servellita, Venice
Arevalo, Shaun
Ho, Coral
Deucher, Anne
Thornborrow, Ed
Chiu, Charles
Miller, Steve
author_sort Fung, Becky
collection PubMed
description 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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spelling pubmed-74486682020-09-09 Direct Comparison of SARS-CoV-2 Analytical Limits of Detection across Seven Molecular Assays Fung, Becky Gopez, Allan Servellita, Venice Arevalo, Shaun Ho, Coral Deucher, Anne Thornborrow, Ed Chiu, Charles Miller, Steve J Clin Microbiol Virology 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. American Society for Microbiology 2020-08-24 /pmc/articles/PMC7448668/ /pubmed/32651238 http://dx.doi.org/10.1128/JCM.01535-20 Text en Copyright © 2020 American Society for Microbiology. All Rights Reserved (https://doi.org/10.1128/ASMCopyrightv2) . https://doi.org/10.1128/ASMCopyrightv2 This article is made available via the PMC Open Access Subset for unrestricted noncommercial re-use and secondary analysis in any form or by any means with acknowledgement of the original source. These permissions are granted for the duration of the World Health Organization (WHO) declaration of COVID-19 as a global pandemic.
spellingShingle Virology
Fung, Becky
Gopez, Allan
Servellita, Venice
Arevalo, Shaun
Ho, Coral
Deucher, Anne
Thornborrow, Ed
Chiu, Charles
Miller, Steve
Direct Comparison of SARS-CoV-2 Analytical Limits of Detection across Seven Molecular Assays
title Direct Comparison of SARS-CoV-2 Analytical Limits of Detection across Seven Molecular Assays
title_full Direct Comparison of SARS-CoV-2 Analytical Limits of Detection across Seven Molecular Assays
title_fullStr Direct Comparison of SARS-CoV-2 Analytical Limits of Detection across Seven Molecular Assays
title_full_unstemmed Direct Comparison of SARS-CoV-2 Analytical Limits of Detection across Seven Molecular Assays
title_short Direct Comparison of SARS-CoV-2 Analytical Limits of Detection across Seven Molecular Assays
title_sort direct comparison of sars-cov-2 analytical limits of detection across seven molecular assays
topic Virology
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7448668/
https://www.ncbi.nlm.nih.gov/pubmed/32651238
http://dx.doi.org/10.1128/JCM.01535-20
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