SARS-CoV-2 Virus-like Particles (VLPs) Specifically Detect Humoral Immune Reactions in an ELISA-Based Platform
Stefan Hirschberg,
Hannes Bauer,
Julian Kamhieh-Milz,
Frauke Ringel,
Christoph Harms,
Omar Kamal Eddin,
Axel Pruß,
Katja Hanack,
Kai Schulze-Forster
Affiliations
Stefan Hirschberg
Charité-Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Institute of Transfusion Medicine, 10117 Berlin, Germany
Hannes Bauer
CellTrend GmbH, 14943 Luckenwalde, Germany
Julian Kamhieh-Milz
Charité-Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Institute of Transfusion Medicine, 10117 Berlin, Germany
Frauke Ringel
Wimedko GmbH, 12101 Berlin, Germany
Christoph Harms
Charité-Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Center for Stroke Research Berlin, Department of Experimental Neurology, 10117 Berlin, Germany
Omar Kamal Eddin
Wimedko GmbH, 12101 Berlin, Germany
Axel Pruß
Charité-Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Institute of Transfusion Medicine, 10117 Berlin, Germany
Katja Hanack
Department of Biochemistry and Biology, University of Potsdam, 14476 Potsdam, Germany
A key in controlling the SARS-CoV-2 pandemic is the assessment of the immune status of the population. We explored the utility of SARS-CoV-2 virus-like particles (VLPs) as antigens to detect specific humoral immune reactions in an enzyme-linked immunosorbent assay (ELISA). For this purpose, SARS-CoV-2 VLPs were produced from an engineered cell line and characterized by Western blot, ELISA, and nanoparticle tracking analysis. Subsequently, we collected 42 serum samples from before the pandemic (2014), 89 samples from healthy subjects, and 38 samples from vaccinated subjects. Seventeen samples were collected less than three weeks after infection, and forty-four samples more than three weeks after infection. All serum samples were characterized for their reactivity with VLPs and the SARS-CoV-2 N- and S-protein. Finally, we compared the performance of the VLP-based ELISA with a certified in vitro diagnostic device (IVD). In the applied set of samples, we determined a sensitivity of 95.5% and a specificity of 100% for the certified IVD. There were seven samples with an uncertain outcome. Our VLP-ELISA demonstrated a superior performance, with a sensitivity of 97.5%, a specificity of 100%, and only three uncertain outcomes. This result warrants further research to develop a certified IVD based on SARS-CoV-2 VLPs as an antigen.
