1887
  1. Home
  2. Eurosurveillance
  3. Volume 27, Issue 42, 20/Oct/2022
  4. Article
Research Open Access
Like 0
Download

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.

© Creative Commons License
This work is licensed under a Creative Commons Attribution 4.0 International License.
Closure
A corrected article has been published for this content:
Erratum for Euro Surveill. 2021;27(42)
Loading

Article metrics loading...

/content/10.2807/1560-7917.ES.2022.27.42.2101057
2022-10-20
2024-04-26
http://instance.metastore.ingenta.com/content/10.2807/1560-7917.ES.2022.27.42.2101057
Loading
Loading full text...

Full text loading...

/deliver/fulltext/eurosurveillance/27/42/eurosurv-27-42-5.html?itemId=/content/10.2807/1560-7917.ES.2022.27.42.2101057&mimeType=html&fmt=ahah

References

  1. World Health Organization (WHO). WHO Coronavirus (COVID-19) dashboard. Geneva: WHO. [Accessed: 27 Jun 2021]. Available from: https://covid19.who.int
  2. Hellewell J, Abbott S, Gimma A, Bosse NI, Jarvis CI, Russell TW, et al. Feasibility of controlling COVID-19 outbreaks by isolation of cases and contacts. Lancet Glob Health. 2020;8(4):e488-96.  https://doi.org/10.1016/S2214-109X(20)30074-7  PMID: 32119825 
  3. World Health Organization (WHO). Serology and early investigation protocols. Geneva: WHO. [Accessed: 29 Nov 2021]. Available from: https://www.who.int/emergencies/diseases/novel-coronavirus-2019/serology-in-the-context-of-covid-19
  4. FIND. Test directory. Geneva: FIND. [Accessed: 27 Jun 2021]. Available from: https://www.finddx.org/test-directory/?_type_of_technology=immunoassay
  5. Stone M, Grebe E, Sulaeman H, Di Germanio C, Dave H, Kelly K, et al. Evaluation of commercially available high-throughput SARS-CoV-2 serologic assays for serosurveillance and related applications. Emerg Infect Dis. 2022;28(3):672-83.  https://doi.org/10.3201/eid2803.211885  PMID: 35202525 
  6. Fischer C, Pedroso C, Mendrone A Jr, Bispo de Filippis AM, Vallinoto ACR, Ribeiro BM, et al. External quality assessment for Zika virus molecular diagnostic testing, Brazil. Emerg Infect Dis. 2018;24(5):888-92.  https://doi.org/10.3201/eid2405.171747  PMID: 29470164 
  7. Reusken CB, Mögling R, Smit PW, Grunow R, Ippolito G, Di Caro A, et al. Status, quality and specific needs of Ebola virus diagnostic capacity and capability in laboratories of the two European preparedness laboratory networks EMERGE and EVD-LabNet. Euro Surveill. 2018;23(19):17-00404.  https://doi.org/10.2807/1560-7917.ES.2018.23.19.17-00404  PMID: 29766839 
  8. Matheeussen V, Corman VM, Donoso Mantke O, McCulloch E, Lammens C, Goossens H, et al. International external quality assessment for SARS-CoV-2 molecular detection and survey on clinical laboratory preparedness during the COVID-19 pandemic, April/May 2020. Euro Surveill. 2020;25(27):2001223.  https://doi.org/10.2807/1560-7917.ES.2020.25.27.2001223  PMID: 32672149 
  9. Sung H, Han MG, Yoo CK, Lee SW, Chung YS, Park JS, et al. Nationwide external quality assessment of SARS-CoV-2 molecular testing, South Korea. Emerg Infect Dis. 2020;26(10):2353-60.  https://doi.org/10.3201/eid2610.202551  PMID: 32723432 
  10. Kohmer N, Rabenau HF, Hoehl S, Kortenbusch M, Ciesek S, Berger A. Comparative analysis of point-of-care, high-throughput and laboratory-developed SARS-CoV-2 nucleic acid amplification tests (NATs). J Virol Methods. 2021;291:114102.  https://doi.org/10.1016/j.jviromet.2021.114102  PMID: 33607117 
  11. Joint Research Council (JRC). EURM-017 HUMAN SERUM (antibodies against SARS-CoV-2). Geel: JRC. [Accessed: 27 Jun 2021]. Available from: https://crm.jrc.ec.europa.eu/p/40456/40491/By-analyte-group/Protein-content/EURM-017-HUMAN-SERUM-antibodies-against-SARS-CoV-2/EURM-017
  12. Joint Research Council (JRC). EURM-018 HUMAN SERUM (antibodies against SARS-CoV-2). Geel: JRC. [Accessed: 27 Jun 2021]. Available from: https://crm.jrc.ec.europa.eu/p/EURM-018
  13. van Tol S, Mögling R, Li W, Godeke GJ, Swart A, Bergmans B, et al. Accurate serology for SARS-CoV-2 and common human coronaviruses using a multiplex approach. Emerg Microbes Infect. 2020;9(1):1965-73.  https://doi.org/10.1080/22221751.2020.1813636  PMID: 32819220 
  14. Haselmann V, Özçürümez MK, Klawonn F, Ast V, Gerhards C, Eichner R, et al. Results of the first pilot external quality assessment (EQA) scheme for anti-SARS-CoV2-antibody testing. Clin Chem Lab Med. 2020;58(12):2121-30.  https://doi.org/10.1515/cclm-2020-1183  PMID: 32853163 
  15. van den Beld MJC, Murk JL, Kluytmans J, Koopmans MPG, Reimerink J, van Loo IHM, et al. Increasing the efficiency of a national laboratory response to COVID-19; a nation-wide multicenter evaluation of 47 commercial SARS-CoV-2 immunoassays by 41 laboratories. J Clin Microbiol. 2021;59(9):e0076721.  https://doi.org/10.1128/JCM.00767-21  PMID: 34191578 
  16. Van Walle I, Leitmeyer K, Broberg EK, European COVID-19 microbiological laboratories group. Meta-analysis of the clinical performance of commercial SARS-CoV-2 nucleic acid and antibody tests up to 22 August 2020. Euro Surveill. 2021;26(45):2001675.  https://doi.org/10.2807/1560-7917.ES.2021.26.45.2001675  PMID: 34763752 
  17. Li K, Huang B, Wu M, Zhong A, Li L, Cai Y, et al. Dynamic changes in anti-SARS-CoV-2 antibodies during SARS-CoV-2 infection and recovery from COVID-19. Nat Commun. 2020;11(1):6044.  https://doi.org/10.1038/s41467-020-19943-y  PMID: 33247152 
  18. Long QX, Liu BZ, Deng HJ, Wu GC, Deng K, Chen YK, et al. Antibody responses to SARS-CoV-2 in patients with COVID-19. Nat Med. 2020;26(6):845-8.  https://doi.org/10.1038/s41591-020-0897-1  PMID: 32350462 
  19. Colavita F, Lapa D, Carletti F, Lalle E, Messina F, Rueca M, et al. Virological characterization of the first 2 COVID-19 patients diagnosed in Italy: phylogenetic analysis, virus shedding profile from different body sites, and antibody response kinetics. Open Forum Infect Dis. 2020;7(10):ofaa403.  https://doi.org/10.1093/ofid/ofaa403  PMID: 33527081 
  20. Sciacovelli L, Padoan A, Secchiero S, Plebani M. Serological diagnostic for SARS-CoV-2: an experimental External Quality Assessment Scheme. Clin Chem Lab Med. 2021;59(11):1878-84.  https://doi.org/10.1515/cclm-2021-0662  PMID: 34348424 
  21. Ast V, Costina V, Eichner R, Bode A, Aida S, Gerhards C, et al. Assessing the quality of serological testing in the COVID-19 pandemic: results of a European External Quality Assessment (EQA) scheme for Anti-SARS-CoV-2 antibody detection. J Clin Microbiol. 2021;59(9):e0055921.  https://doi.org/10.1128/JCM.00559-21  PMID: 34190575 
  22. Nguyen D, Simmonds P, Steenhuis M, Wouters E, Desmecht D, Garigliany M, et al. SARS-CoV-2 neutralising antibody testing in Europe: towards harmonisation of neutralising antibody titres for better use of convalescent plasma and comparability of trial data. Euro Surveill. 2021;26(27):2100568.  https://doi.org/10.2807/1560-7917.ES.2021.26.27.2100568  PMID: 34240697 
  23. Kristiansen PA, Page M, Bernasconi V, Mattiuzzo G, Dull P, Makar K, et al. WHO International Standard for anti-SARS-CoV-2 immunoglobulin. Lancet. 2021;397(10282):1347-8.  https://doi.org/10.1016/S0140-6736(21)00527-4  PMID: 33770519 
  24. National Institute for Biological Standards and Control (NIBSC). WHO International Standard. First WHO international standard for anti-SARS-CoV-2 immunoglobulin (human). NIBSC code: 20/136. Geneva: WHO;[Accessed: 23 Sep 2022]. 2020. Available from: https://www.nibsc.org/documents/ifu/20-136.pdf
  25. European Commission. Digital COVID certificate. Brussels; European Commission. [Accessed: 23 Sep 2022]. 2021. Available from: https://ec.europa.eu/info/live-work-travel-eu/coronavirus-response/safe-covid-19-vaccines-europeans/eu-digital-covid-certificate_en
  26. Federation of Dutch Medical Scientific Societies (Federa). Human tissue and medical research: Code of conduct for responsible use (2011). Rotterdam: Federa. [Accessed: 26 Sept 2022]. Available from: https://www.bbmri.nl/sites/bbmri/files/styles/Federa_code_of_conduct_english.pdf
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>
/content/10.2807/1560-7917.ES.2022.27.42.2101057
/content/10.2807/1560-7917.ES.2022.27.42.2101057
Loading

Data & Media loading...

Supplementary data

Submit comment
Close
Comment moderation successfully completed
This is a required field
Please enter a valid email address
Approval was a Success
Invalid data
An Error Occurred
Approval was partially successful, following selected items could not be processed due to error