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Diagn Microbiol Infect Dis. 2022 Feb;102(2):115561. doi: 10.1016/j.diagmicrobio.2021.115561. Epub 2021 Oct 11.

Importance of anti-SARS-CoV-2 assay antigenic composition as revealed by the results of the Belgian external quality assessment (EQA) scheme.

Diagnostic microbiology and infectious disease

Alena Moerman, Kris Vernelen, Bernard China, Arnaud Capron, Dorien Van Den Bossche, Joachim Mariën, Kevin K Ariën, Jos Van Acker, Marie-Luce Delforge, Marijke Reynders, An Boel, Melissa Depypere, Natasja Van Gasse, Sara Vijgen, Jonathan Brauner, Barbara Dujardin, Elizaveta Padalko

Affiliations

  1. Laboratory of Medical Microbiology, Ghent University Hospital, Ghent, Belgium. Electronic address: [email protected].
  2. Experts Committee EQA Infectious serology, Quality of Laboratories, Sciensano, Brussels, Belgium; Quality of Laboratories, Sciensano, Brussels, Belgium.
  3. Experts Committee EQA Infectious serology, Quality of Laboratories, Sciensano, Brussels, Belgium; Institute of Tropical Medicine, Antwerp, Belgium.
  4. Institute of Tropical Medicine, Antwerp, Belgium.
  5. Institute of Tropical Medicine, Antwerp, Belgium; University of Antwerp, Antwerp, Belgium.
  6. Experts Committee EQA Infectious serology, Quality of Laboratories, Sciensano, Brussels, Belgium; Laboratory of Clinical Microbiology, AZ Sint-Lucas, Ghent, Belgium.
  7. Experts Committee EQA Infectious serology, Quality of Laboratories, Sciensano, Brussels, Belgium; CUB-Hôpital Erasme, ULB, Brussels, Belgium.
  8. Experts Committee EQA Infectious serology, Quality of Laboratories, Sciensano, Brussels, Belgium; AZ St. Jan, Bruges-Ostend, Belgium.
  9. Experts Committee EQA Infectious serology, Quality of Laboratories, Sciensano, Brussels, Belgium; Department of Medical Microbiology, OLVZ Aalst, Aalst, Belgium.
  10. Experts Committee EQA Infectious serology, Quality of Laboratories, Sciensano, Brussels, Belgium; Department of Laboratory Medicine, University Hospitals Leuven, Leuven, Belgium.
  11. Experts Committee EQA Infectious serology, Quality of Laboratories, Sciensano, Brussels, Belgium; Hospital Network Antwerp, Antwerp, Belgium.
  12. Experts Committee EQA Infectious serology, Quality of Laboratories, Sciensano, Brussels, Belgium; Department of Laboratory Medicine, Jessa Hospital, Hasselt, Belgium.
  13. Experts Committee EQA Infectious serology, Quality of Laboratories, Sciensano, Brussels, Belgium; University Centre Tivoli, La Louvière, Belgium.
  14. Laboratory of Medical Microbiology, Ghent University Hospital, Ghent, Belgium; Experts Committee EQA Infectious serology, Quality of Laboratories, Sciensano, Brussels, Belgium.

PMID: 34773801 PMCID: PMC8503966 DOI: 10.1016/j.diagmicrobio.2021.115561

Abstract

We report on sample IS/17575 since it generated highly divergent results in the Belgian SARS-CoV-2 serology external quality assessment scheme. Sample IS/17575 was serum originating from a 30 years old male patient. 124 diagnostic laboratories analysed this sample. A total of 168 results was returned (including 5 doubles). Overall, 38 were positive. All tests against S1 were positive except the Euroimmun IgG ELISA and the Ortho clinical Diagnostics VITROS IgG CLIA. All tests against S1/S2 (Liaison, Diasorin) resulted in a signal above cutoff. Assays against RBD, mostly generate a negative result. An exception are the Wantai SARS-CoV-2 ELISA's. All tests targeting N protein were negative. The survey shows, when >6 months post-infection, assays targeting at least S1, and preferably S1 combined with S2, are the most sensitive. This finding accentuates the necessity of external quality assessment schedules and importance of antigenic composition of serologic SARS-CoV-2 assays.

Copyright © 2021 Elsevier Inc. All rights reserved.

Keywords: Nucleocapsid protein; SARS-CoV-2; Spike protein; external quality assessment scheme; receptor-binding domain; serology

Conflict of interest statement

Declaration of competing interest The author stated that there are no conflicts of interest regarding the publication of this article.

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