Results of a European-Wide External Quality Assessment (EQA) Scheme for Serological Detection of Anti-SARS-CoV-2 (CoVimm)-Pitfalls of Routine Application.
COVID-19
EQA
SARS-CoV-2
anti-SARS-CoV-2 antibodies
external quality assessment scheme
external quality control
immunoassays
proficiency testing
serological testing
test performance
Journal
Viruses
ISSN: 1999-4915
Titre abrégé: Viruses
Pays: Switzerland
ID NLM: 101509722
Informations de publication
Date de publication:
28 07 2022
28 07 2022
Historique:
received:
30
06
2022
revised:
15
07
2022
accepted:
19
07
2022
entrez:
26
8
2022
pubmed:
27
8
2022
medline:
30
8
2022
Statut:
epublish
Résumé
During the last two years, a variety of assays for the serological detection of antibodies to the new SARS-CoV-2 virus have been launched and used as part of standard care in many laboratories. The pace with which these tests have been introduced into routine care emphasizes the importance of quality measures for analytical methods, particularly with regard to the implications of results for clinical and epidemiologic decisions. Accuracy, reliability and comparability of analytical test results are thus essential, and here external quality assessment (EQA) is the most important quality assurance tool. It allows us to achieve harmonization of test methods as a prerequisite for a high standard of performance for laboratory and analytical techniques and their interpretation. This EQA scheme consisted of pre-characterized clinical biospecimens dedicated to the analysis of anti-SARS-CoV-2 IgG total antibodies and differentiation into spike protein-specific IgG antibodies against SARS-CoV-2 (anti-S-SARS-CoV-2) and nucleocapsid-specific IgG antibodies against SARS-CoV-2 (anti-N-SARS-CoV-2). A total of 239 laboratories across Europe participated in this scheme, called CoVimm. In detail, 536 results for anti-SARS-CoV-2 IgG, 431 results for anti-S-SARS-CoV-2 IgG, and 200 results for anti-N-SARS-CoV-2 IgG were reported. Based on the pre-defined thresholds, the success rates for the determination of anti-S-SARS-CoV-2 IgG and anti-N-SARS-CoV-2 IgG were 96% and 90%, respectively. Interestingly, only 64% of the participating laboratories successfully passed the EQA scheme for the determination of total anti-SARS-CoV-2 IgG. This EQA revealed serious concerns regarding the reliability and appropriate use of anti-SARS-CoV-2 antibody assays in routine care. In addition to the wide heterogeneity of different assays used by participating laboratories, a lack of standardization and harmonization is also evident. This is of particular importance for reliable and clinically meaningful interpretation of test results.
Sections du résumé
BACKGROUND
During the last two years, a variety of assays for the serological detection of antibodies to the new SARS-CoV-2 virus have been launched and used as part of standard care in many laboratories. The pace with which these tests have been introduced into routine care emphasizes the importance of quality measures for analytical methods, particularly with regard to the implications of results for clinical and epidemiologic decisions. Accuracy, reliability and comparability of analytical test results are thus essential, and here external quality assessment (EQA) is the most important quality assurance tool. It allows us to achieve harmonization of test methods as a prerequisite for a high standard of performance for laboratory and analytical techniques and their interpretation.
METHODS
This EQA scheme consisted of pre-characterized clinical biospecimens dedicated to the analysis of anti-SARS-CoV-2 IgG total antibodies and differentiation into spike protein-specific IgG antibodies against SARS-CoV-2 (anti-S-SARS-CoV-2) and nucleocapsid-specific IgG antibodies against SARS-CoV-2 (anti-N-SARS-CoV-2).
RESULTS
A total of 239 laboratories across Europe participated in this scheme, called CoVimm. In detail, 536 results for anti-SARS-CoV-2 IgG, 431 results for anti-S-SARS-CoV-2 IgG, and 200 results for anti-N-SARS-CoV-2 IgG were reported. Based on the pre-defined thresholds, the success rates for the determination of anti-S-SARS-CoV-2 IgG and anti-N-SARS-CoV-2 IgG were 96% and 90%, respectively. Interestingly, only 64% of the participating laboratories successfully passed the EQA scheme for the determination of total anti-SARS-CoV-2 IgG.
CONCLUSIONS
This EQA revealed serious concerns regarding the reliability and appropriate use of anti-SARS-CoV-2 antibody assays in routine care. In addition to the wide heterogeneity of different assays used by participating laboratories, a lack of standardization and harmonization is also evident. This is of particular importance for reliable and clinically meaningful interpretation of test results.
Identifiants
pubmed: 36016287
pii: v14081662
doi: 10.3390/v14081662
pmc: PMC9412523
pii:
doi:
Substances chimiques
Antibodies, Viral
0
Immunoglobulin G
0
Types de publication
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Références
Lancet Reg Health Eur. 2021 May 21;5:100119
pubmed: 34557824
Clin Chem Lab Med. 2020 Dec 04;59(5):e175-e177
pubmed: 33554559
J Clin Microbiol. 2021 Aug 18;59(9):e0055921
pubmed: 34190575
J Clin Microbiol. 2002 Jun;40(6):1938-46
pubmed: 12037046
Clin Infect Dis. 2021 Nov 2;73(9):e3042-e3046
pubmed: 33532847
Clin Chem Lab Med. 2018 Jan 26;56(2):220-228
pubmed: 28841569
J Clin Microbiol. 2022 Mar 16;60(3):e0239021
pubmed: 35044204
J Clin Microbiol. 2021 Apr 20;59(5):
pubmed: 33574119
J Med Virol. 2021 Feb;93(2):803-811
pubmed: 32667733
Front Immunol. 2021 Apr 15;12:633184
pubmed: 33936045
Cochrane Database Syst Rev. 2020 Jun 25;6:CD013652
pubmed: 32584464
MMWR Morb Mortal Wkly Rep. 2020 Feb 07;69(5):140-146
pubmed: 32027631
ACS Sens. 2021 Mar 26;6(3):593-612
pubmed: 33544999
Microbiol Spectr. 2021 Sep 3;9(1):e0024721
pubmed: 34190591
Clin Chem Lab Med. 2021 Aug 05;59(11):1878-1884
pubmed: 34348424
Nat Rev Microbiol. 2021 Mar;19(3):171-183
pubmed: 33057203
J Public Health Res. 2020 Jun 04;9(1):1786
pubmed: 32550223
J Clin Microbiol. 2020 Jul 23;58(8):
pubmed: 32350047
Immunol Cell Biol. 2021 Jan;99(1):21-33
pubmed: 32864735
Clin Infect Dis. 2020 Dec 31;71(11):2996-3001
pubmed: 32511679
Int J Infect Dis. 2021 Feb;103:590-596
pubmed: 33310108
Pract Lab Med. 2021 May;25:e00227
pubmed: 33898690
Clin Chem Lab Med. 2020 Aug 27;58(12):2121-2130
pubmed: 32853163
Clin Chem Lab Med. 2016 Oct 1;54(10):1589-98
pubmed: 27092652
Clin Chim Acta. 2004 Aug 2;346(1):87-97
pubmed: 15234640
Lancet Microbe. 2022 Mar;3(3):e235-e240
pubmed: 34723229
Euro Surveill. 2020 Jul;25(27):
pubmed: 32672149
PLoS One. 2020 Oct 21;15(10):e0240775
pubmed: 33085693
Clin Chem Lab Med. 2020 Oct 7;58(12):2001-2008
pubmed: 33027043
Sci Rep. 2021 Mar 9;11(1):5491
pubmed: 33750810
EBioMedicine. 2020 Dec;62:103101
pubmed: 33160207
Clin Chem. 2011 Dec;57(12):1670-80
pubmed: 21965556