Performance evaluation of serological assays to determine the immunoglobulin status in SARS-CoV-2 infected patients.

ABSTRACT

BACKGROUND: Serological assays for the determination of the immune status of patients that have tested positive for infection with SARS-CoV-2 by RT-PCR are required for, e.g., contact tracing and epidemiological studies. However, data concerning the performance parameters of commercially available high-throughput ELISA tests are still not available on a large scale. STUDY DESIGN: In our study, we have evaluated an in-house developed ELISA for the detection of the immunoglobulin classes A, G and M directed against the full-length spike glycoprotein from SARS-CoV-2. For this analysis, we have included 110 sera from patients presenting with COVID-19 symptoms or blood donors without symptoms collected at the Austrian Red Cross, Blood Transfusion Service for Upper Austria, Linz. In addition, we have selected four commercially available IgG-based ELISAs as well as one IgA/IgG-based ELISA for the detection of SARS-CoV-2 antigens as well as a multiplexed IgG-based micro-ELISA assay developed for rapid Point of Care testing applications. CONCLUSIONS: All assays evaluated in the course of this study demonstrated suitable sensitivity and specificity values for the identification of patients that have experienced a past infection with SARS-CoV-2. However, testing for the presence of additional immunoglobulins (IgA and IgM) as well as using combinations of different viral antigens is highly advised to improve the predictive values of serological assays.