Clinical validation of the Siemens quantitative SARS-CoV-2 spike IgG assay (sCOVG) reveals improved sensitivity and a good correlation with virus neutralization titers.
Adult
Aged
Aged, 80 and over
Antibodies, Neutralizing
/ blood
Antibodies, Viral
/ blood
COVID-19
/ diagnosis
Female
Humans
Immunoglobulin G
/ blood
Male
Middle Aged
Neutralization Tests
Protein Subunits
/ immunology
Reagent Kits, Diagnostic
SARS-CoV-2
/ isolation & purification
Sensitivity and Specificity
Severity of Illness Index
Spike Glycoprotein, Coronavirus
/ immunology
Young Adult
COVID-19
SARS-CoV-2
neutralization assay
sensitivity
serology
specificity
Journal
Clinical chemistry and laboratory medicine
ISSN: 1437-4331
Titre abrégé: Clin Chem Lab Med
Pays: Germany
ID NLM: 9806306
Informations de publication
Date de publication:
27 07 2021
27 07 2021
Historique:
received:
17
02
2021
accepted:
24
03
2021
pubmed:
11
4
2021
medline:
8
7
2021
entrez:
10
4
2021
Statut:
epublish
Résumé
Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infections cause coronavirus disease 2019 (COVID-19) and induce a specific antibody response. Serological assays detecting IgG against the receptor binding domain (RBD) of the spike (S) protein are useful to monitor the immune response after infection or vaccination. The objective of our study was to evaluate the clinical performance of the Siemens SARS-CoV-2 IgG (sCOVG) assay. Sensitivity and specificity of the Siemens sCOVG test were evaluated on 178 patients with SARS-CoV-2-infection and 160 pre-pandemic samples in comparison with its predecessor test COV2G. Furthermore, correlation with virus neutralization titers was investigated on 134 samples of convalescent COVID-19 patients. Specificity of the sCOVG test was 99.4% and sensitivity was 90.5% (COV2G assay 78.7%; p<0.0001). S1-RBD antibody levels showed a good correlation with virus neutralization titers (r=0.843; p<0.0001) and an overall qualitative agreement of 98.5%. Finally, median S1-RBD IgG levels increase with age and were significantly higher in hospitalized COVID-19 patients (median levels general ward: 25.7 U/mL; intensive care: 59.5 U/mL) than in outpatients (3.8 U/mL; p<0.0001). Performance characteristics of the sCOVG assay have been improved compared to the predecessor test COV2G. Quantitative SARS-CoV-2 S1-RBD IgG levels could be used as a surrogate for virus neutralization capacity. Further harmonization of antibody quantification might assist to monitor the humoral immune response after COVID-19 disease or vaccination.
Identifiants
pubmed: 33837679
pii: cclm-2021-0214
doi: 10.1515/cclm-2021-0214
doi:
Substances chimiques
Antibodies, Neutralizing
0
Antibodies, Viral
0
Immunoglobulin G
0
Protein Subunits
0
Reagent Kits, Diagnostic
0
Spike Glycoprotein, Coronavirus
0
spike protein, SARS-CoV-2
0
Types de publication
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Pagination
1453-1462Informations de copyright
© 2021 Walter de Gruyter GmbH, Berlin/Boston.
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