Evaluation of a Broad Panel of SARS-CoV-2 Serological Tests for Diagnostic Use

Serological testing is crucial in detection of previous infection and in monitoring convalescent and vaccine-induced immunity. During the Severe Acute Respiratory Syndrome Corona Virus 2 (SARS-CoV-2) pandemic, numerous assay platforms have been developed and marketed for clinical use. Several studies recently compared clinical performance of a limited number of serological tests, but broad comparative evaluation is currently missing. Within this study, a panel of 161 sera from SARS-CoV-2 infected, seasonal CoV-infected and SARS-CoV-2 naive subjects was enrolled to evaluate 16 ELISA/ECLIA-based and 16 LFA-based tests. Specificities of all ELISA/ECLIA-based assays were acceptable and generally in agreement with the providers' specifications, but sensitivities were lower as specified. Results of the LFAs were less accurate as compared to the ELISAs, albeit with some exceptions. We found a sporadic unequal immune response for different antigens and thus recommend the use of a nucleocapsid protein (N)- and spike protein (S)-based test combination when maximal sensitivity is necessary. Finally, the quality of the immune response in terms of neutralization should be tested using S-based IgG tests.

Automated summary

Serological testing is important for detecting previous infection and monitoring immunity. This study evaluated 16 ELISA/ECLIA and 16 LFA tests using 161 sera samples. Specificities of ELISA/ECLIA tests were acceptable, but sensitivities were lower; LFAs were less accurate than ELISAs. A combination of nucleocapsid and spike protein-based tests is recommended for maximal sensitivity.