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Comparison of Allplex™ SARS-CoV-2 Assay, Easy SARS-CoV-2 WE and Lumipulse quantitative SARS-CoV-2 antigen test performance using automated systems for the diagnosis of COVID-19

Diagnostic methods based on SARS-CoV-2 antigen detection are a promising alternative to SARS-CoV-2 RNA amplification. We evaluated the automated chemiluminescence-based Lumipulse® G SARS-CoV-2 Ag assay as compared to real time assays (combined results from RT-PCR Allplex™ SARS-CoV-2 assay and Easy S...

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Autores principales: Sberna, Giuseppe, Basile, Flavia, Guarino, Maria Luisa, Capobianchi, Maria Rosaria, Bordi, Licia, Parisi, Gabriella
Formato: Online Artículo Texto
Lenguaje:English
Publicado: The Authors. Published by Elsevier Ltd on behalf of International Society for Infectious Diseases. 2021
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8479447/
https://www.ncbi.nlm.nih.gov/pubmed/34597768
http://dx.doi.org/10.1016/j.ijid.2021.09.069
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author Sberna, Giuseppe
Basile, Flavia
Guarino, Maria Luisa
Capobianchi, Maria Rosaria
Bordi, Licia
Parisi, Gabriella
author_facet Sberna, Giuseppe
Basile, Flavia
Guarino, Maria Luisa
Capobianchi, Maria Rosaria
Bordi, Licia
Parisi, Gabriella
author_sort Sberna, Giuseppe
collection PubMed
description Diagnostic methods based on SARS-CoV-2 antigen detection are a promising alternative to SARS-CoV-2 RNA amplification. We evaluated the automated chemiluminescence-based Lumipulse® G SARS-CoV-2 Ag assay as compared to real time assays (combined results from RT-PCR Allplex™ SARS-CoV-2 assay and Easy SARS-CoV-2 WE kit) on 513 nasopharyngeal swabs (NPS). Among these, 53.6% resulted positive to RT-PCR, considered as the reference test. Compared to the reference test, overall sensitivity and specificity of Lumipulse® G SARS-CoV-2 Ag assay were 84.0%, and 89.1%, respectively, and overall agreement between the antigen and molecular assays was substantial (κ = 0.727). When stratifying samples into groups based on ranges of RT-PCR cycle threshold (Ct), the antigen test sensitivity was >95% for samples with Ct <30. Linear regression analysis showed strong and highly significant correlation between the Lumipulse Ag concentrations and the RT-PCR Ct values (RdRp gene), irrespective of whether the Ct values from molecular test were combined in a unique regression analysis or analysed separately. Overall, chemiluminescence-based antigen assay may be reliably applied to NPS samples to identify individuals with high viral loads, more likely to transmit the virus.
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spelling pubmed-84794472021-09-29 Comparison of Allplex™ SARS-CoV-2 Assay, Easy SARS-CoV-2 WE and Lumipulse quantitative SARS-CoV-2 antigen test performance using automated systems for the diagnosis of COVID-19 Sberna, Giuseppe Basile, Flavia Guarino, Maria Luisa Capobianchi, Maria Rosaria Bordi, Licia Parisi, Gabriella Int J Infect Dis Article Diagnostic methods based on SARS-CoV-2 antigen detection are a promising alternative to SARS-CoV-2 RNA amplification. We evaluated the automated chemiluminescence-based Lumipulse® G SARS-CoV-2 Ag assay as compared to real time assays (combined results from RT-PCR Allplex™ SARS-CoV-2 assay and Easy SARS-CoV-2 WE kit) on 513 nasopharyngeal swabs (NPS). Among these, 53.6% resulted positive to RT-PCR, considered as the reference test. Compared to the reference test, overall sensitivity and specificity of Lumipulse® G SARS-CoV-2 Ag assay were 84.0%, and 89.1%, respectively, and overall agreement between the antigen and molecular assays was substantial (κ = 0.727). When stratifying samples into groups based on ranges of RT-PCR cycle threshold (Ct), the antigen test sensitivity was >95% for samples with Ct <30. Linear regression analysis showed strong and highly significant correlation between the Lumipulse Ag concentrations and the RT-PCR Ct values (RdRp gene), irrespective of whether the Ct values from molecular test were combined in a unique regression analysis or analysed separately. Overall, chemiluminescence-based antigen assay may be reliably applied to NPS samples to identify individuals with high viral loads, more likely to transmit the virus. The Authors. Published by Elsevier Ltd on behalf of International Society for Infectious Diseases. 2021-12 2021-09-29 /pmc/articles/PMC8479447/ /pubmed/34597768 http://dx.doi.org/10.1016/j.ijid.2021.09.069 Text en © 2021 The Authors Since January 2020 Elsevier has created a COVID-19 resource centre with free information in English and Mandarin on the novel coronavirus COVID-19. The COVID-19 resource centre is hosted on Elsevier Connect, the company's public news and information website. Elsevier hereby grants permission to make all its COVID-19-related research that is available on the COVID-19 resource centre - including this research content - immediately available in PubMed Central and other publicly funded repositories, such as the WHO COVID database with rights for unrestricted research re-use and analyses in any form or by any means with acknowledgement of the original source. These permissions are granted for free by Elsevier for as long as the COVID-19 resource centre remains active.
spellingShingle Article
Sberna, Giuseppe
Basile, Flavia
Guarino, Maria Luisa
Capobianchi, Maria Rosaria
Bordi, Licia
Parisi, Gabriella
Comparison of Allplex™ SARS-CoV-2 Assay, Easy SARS-CoV-2 WE and Lumipulse quantitative SARS-CoV-2 antigen test performance using automated systems for the diagnosis of COVID-19
title Comparison of Allplex™ SARS-CoV-2 Assay, Easy SARS-CoV-2 WE and Lumipulse quantitative SARS-CoV-2 antigen test performance using automated systems for the diagnosis of COVID-19
title_full Comparison of Allplex™ SARS-CoV-2 Assay, Easy SARS-CoV-2 WE and Lumipulse quantitative SARS-CoV-2 antigen test performance using automated systems for the diagnosis of COVID-19
title_fullStr Comparison of Allplex™ SARS-CoV-2 Assay, Easy SARS-CoV-2 WE and Lumipulse quantitative SARS-CoV-2 antigen test performance using automated systems for the diagnosis of COVID-19
title_full_unstemmed Comparison of Allplex™ SARS-CoV-2 Assay, Easy SARS-CoV-2 WE and Lumipulse quantitative SARS-CoV-2 antigen test performance using automated systems for the diagnosis of COVID-19
title_short Comparison of Allplex™ SARS-CoV-2 Assay, Easy SARS-CoV-2 WE and Lumipulse quantitative SARS-CoV-2 antigen test performance using automated systems for the diagnosis of COVID-19
title_sort comparison of allplex™ sars-cov-2 assay, easy sars-cov-2 we and lumipulse quantitative sars-cov-2 antigen test performance using automated systems for the diagnosis of covid-19
topic Article
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8479447/
https://www.ncbi.nlm.nih.gov/pubmed/34597768
http://dx.doi.org/10.1016/j.ijid.2021.09.069
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