Journal
JOURNAL OF IMMUNOLOGICAL METHODS
Volume 490, Issue -, Pages -Publisher
ELSEVIER
DOI: 10.1016/j.jim.2021.112958
Keywords
SARS-CoV-2; COVID-19; ELISA; Spike protein; Clinical diagnostic
Categories
Funding
- German Center for Infection Research (DZIF), section Emergency Vaccines [FKZ 8033801805]
- LOEWE Center DRUID (project A1)
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The study developed an ELISA assay for detecting SARS-CoV-2 specific antibodies with high specificity, reproducibility, and sensitivity, showing good performance in monitoring antibody responses to the virus, including seroconversion and the presence of neutralizing antibodies. Comparisons with a commercial assay demonstrated the in-house ELISA's superior sensitivity, highlighting its potential in detecting SARS-CoV-2 infections.
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.
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