Development and characterization of an indirect ELISA to detect SARS-CoV - 2 spike protein-specific antibodies
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Development and characterization of an indirect ELISA to detect SARS-CoV - 2 spike protein-specific antibodies. / Krähling, Verena; Halwe, Sandro; Rohde, Cornelius; Becker, Dirk; Berghöfer, Susanne; Dahlke, Christine; Eickmann, Markus; Ercanoglu, Meryem S; Gieselmann, Lutz; Herwig, Astrid; Kupke, Alexandra; Müller, Helena; Neubauer-Rädel, Petra; Klein, Florian; Keller, Christian; Becker, Stephan.
in: J IMMUNOL METHODS, Jahrgang 490, 112958, 03.2021.Publikationen: SCORING: Beitrag in Fachzeitschrift/Zeitung › SCORING: Zeitschriftenaufsatz › Forschung › Begutachtung
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TY - JOUR
T1 - Development and characterization of an indirect ELISA to detect SARS-CoV - 2 spike protein-specific antibodies
AU - Krähling, Verena
AU - Halwe, Sandro
AU - Rohde, Cornelius
AU - Becker, Dirk
AU - Berghöfer, Susanne
AU - Dahlke, Christine
AU - Eickmann, Markus
AU - Ercanoglu, Meryem S
AU - Gieselmann, Lutz
AU - Herwig, Astrid
AU - Kupke, Alexandra
AU - Müller, Helena
AU - Neubauer-Rädel, Petra
AU - Klein, Florian
AU - Keller, Christian
AU - Becker, Stephan
N1 - Copyright © 2019. Published by Elsevier B.V.
PY - 2021/3
Y1 - 2021/3
N2 - The current Severe acute respiratory syndrome-related coronavirus 2 (SARS-CoV-2) pandemic is a public health emergency of international concern. Sensitive and precise diagnostic tools are urgently needed. In this study, we developed a SARS-CoV-2 spike (S1) protein enzyme-linked immunosorbent assay (ELISA) to detect SARS-CoV-2-specific antibodies. The SARS-CoV-2 S1 ELISA was found to be specific [97.8% (95% CI, 96.7% - 98.5%)], reproducible and precise (intra-assay coefficient of variability (CV) 5.3%, inter-assay CV 7.9%). A standard curve and the interpolation of arbitrary ELISA units per milliliter served to reduce the variability between different tests and operators. Cross-reactivity to other human coronaviruses was addressed by using sera positive for MERS-CoV- and hCoV HKU1-specific antibodies. Monitoring antibody development in various samples of twenty-three and single samples of twenty-nine coronavirus disease 2019 (COVID-19) patients revealed seroconversion and neutralizing antibodies against authentic SARS-CoV-2 in all cases. The comparison of the SARS-CoV-2 (S1) ELISA with a commercially available assay showed a better sensitivity for the in-house ELISA. The results demonstrate a high reproducibility, specificity and sensitivity of the newly developed ELISA, which is suitable for the detection of SARS-CoV-2 S1 protein-specific antibody responses.
AB - The current Severe acute respiratory syndrome-related coronavirus 2 (SARS-CoV-2) pandemic is a public health emergency of international concern. Sensitive and precise diagnostic tools are urgently needed. In this study, we developed a SARS-CoV-2 spike (S1) protein enzyme-linked immunosorbent assay (ELISA) to detect SARS-CoV-2-specific antibodies. The SARS-CoV-2 S1 ELISA was found to be specific [97.8% (95% CI, 96.7% - 98.5%)], reproducible and precise (intra-assay coefficient of variability (CV) 5.3%, inter-assay CV 7.9%). A standard curve and the interpolation of arbitrary ELISA units per milliliter served to reduce the variability between different tests and operators. Cross-reactivity to other human coronaviruses was addressed by using sera positive for MERS-CoV- and hCoV HKU1-specific antibodies. Monitoring antibody development in various samples of twenty-three and single samples of twenty-nine coronavirus disease 2019 (COVID-19) patients revealed seroconversion and neutralizing antibodies against authentic SARS-CoV-2 in all cases. The comparison of the SARS-CoV-2 (S1) ELISA with a commercially available assay showed a better sensitivity for the in-house ELISA. The results demonstrate a high reproducibility, specificity and sensitivity of the newly developed ELISA, which is suitable for the detection of SARS-CoV-2 S1 protein-specific antibody responses.
U2 - 10.1016/j.jim.2021.112958
DO - 10.1016/j.jim.2021.112958
M3 - SCORING: Journal article
C2 - 33412174
VL - 490
JO - J IMMUNOL METHODS
JF - J IMMUNOL METHODS
SN - 0022-1759
M1 - 112958
ER -