Brigger, D.; Horn, M. P.; Pennington, L. F.; Powell, A. E.; Siegrist, D.; Weber, B.; Engler, O.; Piezzi, V.; Damonti, L.; Iseli, P.; Hauser, C.; Froehlich, T. K.; Villiger, P. M.; Bachmann, Martin F.; Leib, S. L.; Bittel, P.; Fiedler, M.; Largiadèr, C.; Marschall, J.; Stalder, H.; ... (2021). Accuracy of serological testing for SARS-CoV-2 antibodies: first results of a large mixed-method evaluation study. Allergy, 76(3), pp. 853-865. Wiley 10.1111/all.14608
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Accuracy of serological testing for SARS-CoV-2.pdf - Accepted Version Available under License Creative Commons: Attribution-Noncommercial (CC-BY-NC). Download (17MB) | Preview |
BACKGROUND
Serological immunoassays that can identify protective immunity against SARS-CoV-2 are needed to adapt quarantine measures, assess vaccination responses, and evaluate donor plasma. To date, however, the utility of such immunoassays remains unclear. In a mixed-design evaluation study, we compared the diagnostic accuracy of serological immunoassays that are based on various SARS-CoV-2 proteins and assessed the neutralizing activity of antibodies in patient sera.
METHODS
Consecutive patients admitted with confirmed SARS-CoV-2 infection were prospectively followed alongside medical staff and biobank samples from winter 2018/2019. An in-house enzyme-linked immunosorbent assay utilizing recombinant receptor-binding domain (RBD) of the SARS-CoV-2 spike protein was developed and compared to three commercially available enzyme-linked immunosorbent assays (ELISAs) targeting the nucleoprotein (N), the S1 domain of the spike protein (S1) and a lateral flow immunoassay (LFI) based on full-length spike protein. Neutralization assays with live SARS-CoV-2 were performed.
RESULTS
One-thousand four-hundred and seventy-seven individuals were included comprising 112 SARS-CoV-2 positives (defined as a positive real-time PCR result; prevalence 7.6%). IgG seroconversion occurred between day 0 and day 21. While the ELISAs showed sensitivities of 88.4% for RBD, 89.3% for S1, and 72.9% for N protein, the specificity was above 94% for all tests. Out of 54 SARS-CoV-2 positive individuals, 96.3% showed full neutralization of live SARS-CoV-2 at serum dilutions ≥1:16, while none of the 6 SARS-CoV-2 negative sera revealed neutralizing activity.
CONCLUSIONS
ELISAs targeting RBD and S1 protein of SARS-CoV-2 are promising immunoassays which shall be further evaluated in studies verifying diagnostic accuracy and protective immunity against SARS-CoV-2.
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