Sensitivity and performance of three novel quantitative assays of SARS-CoV-2 nucleoprotein in blood

Abstract To assess if SARS-CoV-2 (COVID-19) systemic disease can be determined by available nucleoprotein assays, we compared the performance of three commercial SARS-CoV-2 nucleoprotein (N) assays in plasma. A total of 272 plasma samples collected in the period November–December 2021 were analyzed...

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Main Authors: Thore Hillig, Josephine R. Kristensen, Claus L. Brasen, Ivan Brandslund, Dorte A. Olsen, Camilla Davidsen, Jonna S. Madsen, Claus A. Jensen, Young B. L. Hansen, Lennart Friis-Hansen
Format: Article
Language:English
Published: Nature Portfolio 2023-02-01
Series:Scientific Reports
Online Access:https://doi.org/10.1038/s41598-023-29973-3
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author Thore Hillig
Josephine R. Kristensen
Claus L. Brasen
Ivan Brandslund
Dorte A. Olsen
Camilla Davidsen
Jonna S. Madsen
Claus A. Jensen
Young B. L. Hansen
Lennart Friis-Hansen
author_facet Thore Hillig
Josephine R. Kristensen
Claus L. Brasen
Ivan Brandslund
Dorte A. Olsen
Camilla Davidsen
Jonna S. Madsen
Claus A. Jensen
Young B. L. Hansen
Lennart Friis-Hansen
author_sort Thore Hillig
collection DOAJ
description Abstract To assess if SARS-CoV-2 (COVID-19) systemic disease can be determined by available nucleoprotein assays, we compared the performance of three commercial SARS-CoV-2 nucleoprotein (N) assays in plasma. A total of 272 plasma samples collected in the period November–December 2021 were analyzed by the methods Simoa SARS CoV‐2 N Protein Advantage Kit [Quanterix Simoa], Solsten SARS-CoV-2 Antigen enzyme immunosorbent assay (ELISA) [Solsten ELISA], and Elecsys SARS‐CoV‐2 Antigen electrochemiluminescence immunoassay [Elecsys ECLIA]. Additionally, a dilution series of inactivated virus culture was analyzed by the three assays. The SARS CoV-2 PCR-status was not known for the patients. Linear correlation in the pairwise correlation between assays as well as linearity of dilution series of inactivated virus culture was estimated by Spearman score. Sensitivity and specificity were estimated by pairwise comparison. The three assays showed poor agreement on patient samples with regards to concentration. Performance on virus culture was excellent but with different level of detection (LOD). Positive vs negative results show comparable sensitivity and specificity of Quanterix Simoa and Solsten ELISA, with a higher LOD in Elecsys ECLIA and thus lower sensitivity and high specificity. N by all tested assays can be used as a marker for systemic COVID-19 disease.
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spelling doaj.art-00195815aae2461c9c0b3ec6194139e82023-03-22T11:08:38ZengNature PortfolioScientific Reports2045-23222023-02-011311810.1038/s41598-023-29973-3Sensitivity and performance of three novel quantitative assays of SARS-CoV-2 nucleoprotein in bloodThore Hillig0Josephine R. Kristensen1Claus L. Brasen2Ivan Brandslund3Dorte A. Olsen4Camilla Davidsen5Jonna S. Madsen6Claus A. Jensen7Young B. L. Hansen8Lennart Friis-Hansen9Department of Clinical Biochemistry, Nordsjællands HospitalDepartment of Clinical Biochemistry, Bispebjerg and Frederiksberg HospitalsBiochemistry and Immunology, University Hospital of Southern DenmarkBiochemistry and Immunology, University Hospital of Southern DenmarkBiochemistry and Immunology, University Hospital of Southern DenmarkBiochemistry and Immunology, University Hospital of Southern DenmarkBiochemistry and Immunology, University Hospital of Southern DenmarkDepartment of Clinical Biochemistry, Nordsjællands HospitalDepartment of Clinical Biochemistry, Nordsjællands HospitalDepartment of Clinical Biochemistry, Bispebjerg and Frederiksberg HospitalsAbstract To assess if SARS-CoV-2 (COVID-19) systemic disease can be determined by available nucleoprotein assays, we compared the performance of three commercial SARS-CoV-2 nucleoprotein (N) assays in plasma. A total of 272 plasma samples collected in the period November–December 2021 were analyzed by the methods Simoa SARS CoV‐2 N Protein Advantage Kit [Quanterix Simoa], Solsten SARS-CoV-2 Antigen enzyme immunosorbent assay (ELISA) [Solsten ELISA], and Elecsys SARS‐CoV‐2 Antigen electrochemiluminescence immunoassay [Elecsys ECLIA]. Additionally, a dilution series of inactivated virus culture was analyzed by the three assays. The SARS CoV-2 PCR-status was not known for the patients. Linear correlation in the pairwise correlation between assays as well as linearity of dilution series of inactivated virus culture was estimated by Spearman score. Sensitivity and specificity were estimated by pairwise comparison. The three assays showed poor agreement on patient samples with regards to concentration. Performance on virus culture was excellent but with different level of detection (LOD). Positive vs negative results show comparable sensitivity and specificity of Quanterix Simoa and Solsten ELISA, with a higher LOD in Elecsys ECLIA and thus lower sensitivity and high specificity. N by all tested assays can be used as a marker for systemic COVID-19 disease.https://doi.org/10.1038/s41598-023-29973-3
spellingShingle Thore Hillig
Josephine R. Kristensen
Claus L. Brasen
Ivan Brandslund
Dorte A. Olsen
Camilla Davidsen
Jonna S. Madsen
Claus A. Jensen
Young B. L. Hansen
Lennart Friis-Hansen
Sensitivity and performance of three novel quantitative assays of SARS-CoV-2 nucleoprotein in blood
Scientific Reports
title Sensitivity and performance of three novel quantitative assays of SARS-CoV-2 nucleoprotein in blood
title_full Sensitivity and performance of three novel quantitative assays of SARS-CoV-2 nucleoprotein in blood
title_fullStr Sensitivity and performance of three novel quantitative assays of SARS-CoV-2 nucleoprotein in blood
title_full_unstemmed Sensitivity and performance of three novel quantitative assays of SARS-CoV-2 nucleoprotein in blood
title_short Sensitivity and performance of three novel quantitative assays of SARS-CoV-2 nucleoprotein in blood
title_sort sensitivity and performance of three novel quantitative assays of sars cov 2 nucleoprotein in blood
url https://doi.org/10.1038/s41598-023-29973-3
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