![]() Furthermore, to better understand the development of the current pandemic especially the approximate total number of COVID-19 cases, well characterized serological assays are needed. Therefore, rapid diagnosis of COVID-19 cases was mandatory to contain the pandemic. In summer 2020, neither specific drugs nor vaccines for the treatment or prevention of COVID-19, the disease caused by SARS-CoV-2, were available. ![]() The current Severe acute respiratory syndrome-related coronavirus 2 (SARS-CoV-2) outbreak was declared a public health emergency of international concern on 30th January 2020 ( World Health Organization (WHO), 2020a) and classified as a pandemic on 12th of March 2020 ( World Health Organization (WHO), 2020b). 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. The comparison of the SARS-CoV-2 (S1) ELISA with a commercially available assay showed a better sensitivity for the in-house ELISA. 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. Cross-reactivity to other human coronaviruses was addressed by using sera positive for MERS-CoV- and hCoV HKU1-specific antibodies. A standard curve and the interpolation of arbitrary ELISA units per milliliter served to reduce the variability between different tests and operators. The SARS-CoV-2 S1 ELISA was found to be specific, reproducible and precise (intra-assay coefficient of variability (CV) 5.3%, inter-assay CV 7.9%). In this study, we developed a SARS-CoV-2 spike (S1) protein enzyme-linked immunosorbent assay (ELISA) to detect SARS-CoV-2-specific antibodies. Sensitive and precise diagnostic tools are urgently needed. The current Severe acute respiratory syndrome-related coronavirus 2 (SARS-CoV-2) pandemic is a public health emergency of international concern.
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