Characterization of a Pan-Immunoglobulin Assay Quantifying Antibodies Directed against the Receptor Binding Domain of the SARS-CoV-2 S1-Subunit of the Spike Protein: A Population-Based Study

Autor: Harald Renz, Stefanie Aeschbacher, Corina Risch, Martin Risch, Kirsten Grossmann, Thomas Bodmer, Michael Pichler, David Conen, Lorenz Risch, Raphael Twerenbold, Dorothea Hillmann, Pietro Vernazza, Mauro Imperiali, Anna Schaffner, Nadia Wohlwend, Susanna Bigler, Katharina Jüngert, Philipp Kohler, Matthias Paprotny, Myriam Weber, Thomas Lung, Christian R Kahlert, Sarah Thiel
Rok vydání: 2020
Předmět:
Zdroj: Journal of Clinical Medicine
Volume 9
Issue 12
Schaffner, Anna; Risch, Lorenz; Aeschbacher, Stefanie; Risch, Corina; Weber, Myriam C; Thiel, Sarah L; Jüngert, Katharina; Pichler, Michael; Grossmann, Kirsten; Wohlwend, Nadia; Lung, Thomas; Hillmann, Dorothea; Bigler, Susanna; Bodmer, Thomas; Imperiali, Mauro; Renz, Harald; Kohler, Philipp; Vernazza, Pietro; Kahlert, Christian R; Twerenbold, Raphael; ... (2020). Characterization of a Pan-Immunoglobulin Assay Quantifying Antibodies Directed against the Receptor Binding Domain of the SARS-CoV-2 S1-Subunit of the Spike Protein: A Population-Based Study. Journal of clinical medicine, 9(12) MDPI 10.3390/jcm9123989
Journal of Clinical Medicine, Vol 9, Iss 3989, p 3989 (2020)
ISSN: 2077-0383
DOI: 10.3390/jcm9123989
Popis: Pan-immunoglobulin assays can simultaneously detect IgG, IgM and IgA directed against the receptor binding domain (RBD) of the S1 subunit of the spike protein (S) of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2 S1-RBD Ig). In this work, we aim to evaluate a quantitative SARS-CoV-2 S1-RBD Ig electrochemiluminescence immunoassay (ECLIA) regarding analytical, diagnostic, operational and clinical characteristics. Our work takes the form of a population-based study in the principality of Liechtenstein, including 125 cases with clinically well-described and laboratory confirmed SARS-CoV-2 infection and 1159 individuals without evidence of coronavirus disease 2019 (COVID-19). SARS-CoV-2 cases were tested for antibodies in sera taken with a median of 48 days (interquartile range, IQR, 43&ndash
52) and 139 days (IQR, 129&ndash
144) after symptom onset. Sera were also tested with other assays targeting antibodies against non-RBD-S1 and -S1/S2 epitopes. Sensitivity was 97.6% (95% confidence interval, CI, 93.2&ndash
99.1), whereas specificity was 99.8% (95% CI, 99.4&ndash
99.9). Antibody levels linearly decreased from hospitalized patients to symptomatic outpatients and SARS-CoV-2 infection without symptoms (p <
0.001). Among cases with SARS-CoV-2 infection, smokers had lower antibody levels than non-smokers (p = 0.04), and patients with fever had higher antibody levels than patients without fever (p = 0.001). Pan-SARS-CoV-2 S1-RBD Ig in SARS-CoV-2 infection cases significantly increased from first to second follow-up (p <
0.001). A substantial proportion of individuals without evidence of past SARS-CoV-2 infection displayed non-S1-RBD antibody reactivities (248/1159, i.e., 21.4%, 95% CI, 19.1&ndash
23.4). In conclusion, a quantitative SARS-CoV-2 S1-RBD Ig assay offers favorable and sustained assay characteristics allowing the determination of quantitative associations between clinical characteristics (e.g., disease severity, smoking or fever) and antibody levels. The assay could also help to identify individuals with antibodies of non-S1-RBD specificity with potential clinical cross-reactivity to SARS-CoV-2.
Databáze: OpenAIRE
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