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

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

*Corresponding author for this work

Research output: Contribution to journalJournal articleResearchpeer-review

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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.

Original languageEnglish
Article number2868
JournalScientific Reports
Volume13
Number of pages8
ISSN2045-2322
DOIs
Publication statusPublished - 17. Feb 2023

Bibliographical note

Publisher Copyright:
© 2023, The Author(s).

Keywords

  • Biological Assay
  • COVID-19/diagnosis
  • Humans
  • Immunosorbents
  • Nucleoproteins
  • Plasma
  • SARS-CoV-2

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