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Abstract

Background

Countries worldwide are focusing to mitigate the ongoing SARS-CoV-2 pandemic by employing public health measures. Laboratories have a key role in the control of SARS-CoV-2 transmission. Serology for SARS-CoV-2 is of critical importance to support diagnosis, define the epidemiological framework and evaluate immune responses to natural infection and vaccine administration.

Aim

The aim of this study was the assessment of the actual capability among laboratories involved in sero-epidemiological studies on COVID-19 in EU/EEA and EU enlargement countries to detect SARS-CoV-2 antibodies through an external quality assessment (EQA) based on proficiency testing.

Methods

The EQA panels were composed of eight different, pooled human serum samples (all collected in 2020 before the vaccine roll-out), addressing sensitivity and specificity of detection. The panels and two EU human SARS-CoV-2 serological standards were sent to 56 laboratories in 30 countries.

Results

The overall performance of laboratories within this EQA indicated a robust ability to establish past SARS-CoV-2 infections via detection of anti-SARS-CoV-2 antibodies, with 53 of 55 laboratories using at least one test that characterised all EQA samples correctly. IgM-specific test methods provided most incorrect sample characterisations (24/208), while test methods detecting total immunoglobulin (0/119) and neutralising antibodies (2/230) performed the best. The semiquantitative assays used by the EQA participants also showed a robust performance in relation to the standards.

Conclusion

Our EQA showed a high capability across European reference laboratories for reliable diagnostics for SARS-CoV-2 antibody responses. Serological tests that provide robust and reliable detection of anti-SARS-CoV-2 antibodies are available.

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This work is licensed under a Creative Commons Attribution 4.0 International License.
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A corrected article has been published for this content:
Erratum for Euro Surveill. 2021;27(42)
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2022-10-20
2024-12-22
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External quality assessment of SARS-CoV-2 serology in European expert laboratories, April 2021
<p class="citation"> <span>Citation style for this article:</span> <span class="meta-value authors"> <a href="/search?value1=Ramona+M%C3%B6gling&option1=author&noRedirect=true" class="nonDisambigAuthorLink">Mögling Ramona</a>, <a href="/search?value1=Francesca+Colavita&option1=author&noRedirect=true" class="nonDisambigAuthorLink">Colavita Francesca</a>, <a href="/search?value1=Johan+Reimerink&option1=author&noRedirect=true" class="nonDisambigAuthorLink">Reimerink Johan</a>, <a href="/search?value1=Angeliki+Melidou&option1=author&noRedirect=true" class="nonDisambigAuthorLink">Melidou Angeliki</a>, <a href="/search?value1=Katrin+Leitmeyer&option1=author&noRedirect=true" class="nonDisambigAuthorLink">Leitmeyer Katrin</a>, <a href="/search?value1=Maria+Keramarou&option1=author&noRedirect=true" class="nonDisambigAuthorLink">Keramarou Maria</a>, <a href="/search?value1=Daniele+Lapa&option1=author&noRedirect=true" class="nonDisambigAuthorLink">Lapa Daniele</a>, <a href="/search?value1=Massimo+Francalancia&option1=author&noRedirect=true" class="nonDisambigAuthorLink">Francalancia Massimo</a>, <a href="/search?value1=Jean-Luc+Murk&option1=author&noRedirect=true" class="nonDisambigAuthorLink">Murk Jean-Luc</a>, <a href="/search?value1=Ann+Vossen&option1=author&noRedirect=true" class="nonDisambigAuthorLink">Vossen Ann</a>, <a href="/search?value1=Fabrizio+Carletti&option1=author&noRedirect=true" class="nonDisambigAuthorLink">Carletti Fabrizio</a>, <a href="/search?value1=Boris+Hogema&option1=author&noRedirect=true" class="nonDisambigAuthorLink">Hogema Boris</a>, <a href="/search?value1=Adam+Meijer&option1=author&noRedirect=true" class="nonDisambigAuthorLink">Meijer Adam</a>, <a href="/search?value1=Liesbet+Deprez&option1=author&noRedirect=true" class="nonDisambigAuthorLink">Deprez Liesbet</a>, <a href="/search?value1=Antonino+di+Caro&option1=author&noRedirect=true" class="nonDisambigAuthorLink">di Caro Antonino</a>, <a href="/search?value1=Concetta+Castilletti&option1=author&noRedirect=true" class="nonDisambigAuthorLink">Castilletti Concetta</a>, <a href="/search?value1=Chantal+BEM+Reusken&option1=author&noRedirect=true" class="nonDisambigAuthorLink">Reusken Chantal BEM</a></span>. External quality assessment of SARS-CoV-2 serology in European expert laboratories, April 2021. <a href="/content/ecdc">Euro Surveill.</a> 2022;27(42):pii=2101057. <a href="https://doi.org/10.2807/1560-7917.ES.2022.27.42.2101057" title="doi link" target="_blank">https://doi.org/10.2807/1560-7917.ES.2022.27.42.2101057</a> <span class="ES_Article_citation"> <span class="generated">Received</span>: 11 Nov 2021;&nbsp;&nbsp; <span class="generated">Accepted</span>: 09 Aug 2022 </span> </p>
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