Sensitivity and performance of three novel quantitative assays of SARS-CoV-2 nucleoprotein in blood
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 me...
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Published in | Scientific reports Vol. 13; no. 1; p. 2868 |
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Main Authors | , , , , , , , , , |
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17.02.2023
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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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AbstractList | 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. 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. |
ArticleNumber | 2868 |
Author | Olsen, Dorte A. Brasen, Claus L. Jensen, Claus A. Hansen, Young B. L. Friis-Hansen, Lennart Madsen, Jonna S. Brandslund, Ivan Hillig, Thore Davidsen, Camilla Kristensen, Josephine R. |
Author_xml | – sequence: 1 givenname: Thore surname: Hillig fullname: Hillig, Thore email: thore.hillig@regionh.dk organization: Department of Clinical Biochemistry, Nordsjællands Hospital – sequence: 2 givenname: Josephine R. surname: Kristensen fullname: Kristensen, Josephine R. organization: Department of Clinical Biochemistry, Bispebjerg and Frederiksberg Hospitals – sequence: 3 givenname: Claus L. surname: Brasen fullname: Brasen, Claus L. organization: Biochemistry and Immunology, University Hospital of Southern Denmark, Department of Regional Health Research, Faculty of Health Sciences, University of Southern Denmark – sequence: 4 givenname: Ivan surname: Brandslund fullname: Brandslund, Ivan organization: Biochemistry and Immunology, University Hospital of Southern Denmark, Department of Regional Health Research, Faculty of Health Sciences, University of Southern Denmark – sequence: 5 givenname: Dorte A. surname: Olsen fullname: Olsen, Dorte A. organization: Biochemistry and Immunology, University Hospital of Southern Denmark – sequence: 6 givenname: Camilla surname: Davidsen fullname: Davidsen, Camilla organization: Biochemistry and Immunology, University Hospital of Southern Denmark – sequence: 7 givenname: Jonna S. surname: Madsen fullname: Madsen, Jonna S. organization: Biochemistry and Immunology, University Hospital of Southern Denmark, Department of Regional Health Research, Faculty of Health Sciences, University of Southern Denmark – sequence: 8 givenname: Claus A. surname: Jensen fullname: Jensen, Claus A. organization: Department of Clinical Biochemistry, Nordsjællands Hospital – sequence: 9 givenname: Young B. L. surname: Hansen fullname: Hansen, Young B. L. organization: Department of Clinical Biochemistry, Nordsjællands Hospital – sequence: 10 givenname: Lennart surname: Friis-Hansen fullname: Friis-Hansen, Lennart organization: Department of Clinical Biochemistry, Bispebjerg and Frederiksberg Hospitals, Department of Clinical Medicine, University of Copenhagen |
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Cites_doi | 10.1038/s41467-020-19883-7 10.1093/infdis/jiac073 10.1038/s41598-021-99807-7 10.3390/v13061115 10.1136/bmj.h5527 10.1093/clinchem/hvab216 10.1128/JCM.01001-21 10.7326/M22-0924 10.1515/cclm-2021-0694 10.1177/2211068215589580 10.1128/JCM.42.11.5309-5314.2004 10.1002/jmv.27300 10.7326/M21-3507 10.1186/s13054-022-04153-3 10.1038/nbt.1641 10.1002/jmv.26855 10.1126/sciadv.abd5393 10.1093/clinchem/hvab148 10.1515/9783110616576-044 |
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References | Veyrenche (CR20) 2021; 93 He (CR2) 2004; 42 Rissin (CR14) 2010; 28 (CR9) 2022; 175 Armbruster, Pry (CR17) 2008; 29 Alexandersen, Chamings, Bhatta (CR19) 2020; 11 Olsen (CR4) 2021; 11 CR18 Bai, Cao, Liu, Li (CR1) 2021; 13 (CR6) 2022; 175 Olea (CR11) 2022; 94 Larremore (CR5) 2021; 7 Wick (CR10) 2022; 26 Brasen (CR3) 2021; 59 Wang (CR8) 2021; 68 Wilson (CR15) 2016; 21 Bossuyt (CR16) 2015; 351 Veyrenche (CR21) 2022; 226 Peacock (CR12) 2022; 3 Zhang (CR7) 2021; 68 Thudium (CR13) 2021; 59 DB Larremore (29973_CR5) 2021; 7 Z Bai (29973_CR1) 2021; 13 DA Olsen (29973_CR4) 2021; 11 CL Brasen (29973_CR3) 2021; 59 Y Zhang (29973_CR7) 2021; 68 RF Thudium (29973_CR13) 2021; 59 N Veyrenche (29973_CR20) 2021; 93 H Wang (29973_CR8) 2021; 68 ACTIV-3/TICO Study Group (29973_CR9) 2022; 175 DH Wilson (29973_CR15) 2016; 21 PM Bossuyt (29973_CR16) 2015; 351 29973_CR18 B Olea (29973_CR11) 2022; 94 DM Rissin (29973_CR14) 2010; 28 Y He (29973_CR2) 2004; 42 KD Wick (29973_CR10) 2022; 26 DA Armbruster (29973_CR17) 2008; 29 N Veyrenche (29973_CR21) 2022; 226 ACTIV-3/TICO Bamlanivimab Study Group (29973_CR6) 2022; 175 WF Peacock (29973_CR12) 2022; 3 S Alexandersen (29973_CR19) 2020; 11 |
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Snippet | To assess if SARS-CoV-2 (COVID-19) systemic disease can be determined by available nucleoprotein assays, we compared the performance of three commercial... Abstract To assess if SARS-CoV-2 (COVID-19) systemic disease can be determined by available nucleoprotein assays, we compared the performance of three... |
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SubjectTerms | 692/1807 692/308 692/420 692/53 692/700 Antigens Biological Assay Coronaviruses COVID-19 COVID-19 - diagnosis Enzyme-linked immunosorbent assay Humanities and Social Sciences Humans Immunosorbents multidisciplinary N protein Nucleoproteins Plasma SARS-CoV-2 Science Science (multidisciplinary) Severe acute respiratory syndrome coronavirus 2 Viruses |
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Title | Sensitivity and performance of three novel quantitative assays of SARS-CoV-2 nucleoprotein in blood |
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