Comparison of CLEIA and ELISA for SARS-CoV-2 Virus Antibodies after First and Second Dose Vaccinations with the BNT162b2 mRNA Vaccine.

The global severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) pandemic has required rapid action to control its spread and vaccines are a fundamental solution to this pandemic. The development of rapid and reliable serological tests to monitor the antibody response to coronavirus disease vaccines is necessary for post-vaccination immune responses. Therefore, in this study, anti-SARS-CoV-2 antibody titers after the first and second doses were monitored using two different measurement systems, a highly sensitive analytical platform of chemiluminescent enzyme immunoassay (CLEIA) and an enzyme-linked immunosorbent assay (ELISA). Our study included 121 participants who received two doses of the BNT162b2 vaccine. Both methods show significant increase in anti-spike protein IgG antibody levels one week after the first vaccination, and then reached at a plateau at week five (week two after the second dose), with a 3.8 × 103-fold rise in CLEIA and a 22-fold rise in ELISA. CLEIA and ELISA showed a good correlation in the high titer range, >10 binding antibody unit (BAU)/mL. Both methods detected higher IgG antibody levels in females compared with male participants after the second vaccination, while CLEIA exhibits the sex difference after the first dose. Thus, our study showed better performance of CLEIA over ELISA in sensitivity, especially in the low concentration range, however ELISA was also useful in the high titer range (>10 BAU/mL) corresponding to the level seen several weeks after the first vaccination.