RESUMO
BackgroundLimited commercial LFA assays are available to provide a reliable quantitative measurement of the total binding antibody units (BAU/mL) against the receptor-binding domain of the SARS-CoV-2 spike protein (S-RBD). AimTo evaluate the performance of FinecareTM2019-nCoV S-RBD LFA and its fluorescent reader (FinecareTM-FIA Meter) against the following reference methods (i) The FDA-approved Genscript surrogate virus-neutralizing assay (sVNT), and (ii) three highly performing automated immunoassays: BioMerieux VIDAS(R)3, Ortho VITROS(R), and Mindray CL-900i(R). MethodsPlasma from 488 vaccinees were tested by all aforementioned assays. Fingerstick whole-blood samples from 156 vaccinees were also tested by FinecareTM. Results and conclusionsFinecareTM showed 100% specificity as none of the pre-pandemic samples tested positive. Equivalent FinecareTM results were observed among the samples taken from fingerstick or plasma (Pearson correlation r=0.9, p<0.0001), suggesting that fingerstick samples are sufficient to quantitate the S-RBD BAU/mL. A moderate correlation was observed between FinecareTM and sVNT (r=0.5, p<0.0001), indicating that FinecareTM can be used for rapid prediction of the neutralization antibody post-vaccination. FinecareTM BAU results showed strong correlation with VIDAS(R)3 (r=0.6, p<0.0001), and moderate correlation with VITROS(R) (r=0.5, p<0.0001), and CL-900i(R) (r=0.4, p<0.0001), suggesting that FinecareTM be used as a surrogate for the advanced automated assays to measure S-RBD BAU/mL.
RESUMO
Two mRNA vaccines, Pfizer-BNT162b2 and Moderna-mRNA-1273, were granted the US Food and Drug Administration Emergency Use Authorization for preventing COVID-19. However, little is known about the difference in antibody responses induced by the two mRNA vaccines in naive and individuals with a previous history of infections (PI group). Therefore, we investigated the levels of anti-S-RBD total antibodies (IgM, IgA, and IgG), anti-S-RBD IgG, and anti-S-RBD IgA in these two groups 1-13 (median=6) weeks following administration of two doses of mRNA-1273 or BNT162b2 vaccines. Results showed that in naive-vaccinated group, the mRNA-1327 vaccine induces significantly higher levels of S-RBD total antibodies (3.5-fold; p<0.001), S-RBD IgG (2-fold-p<0.01), and S-IgA (2.1-fold, p<0.001) than the BNT162b2 vaccine. In the PI-vaccinated group, both vaccines produce significantly higher S-RBD total antibodies level than those of the naive-vaccinated group. The PI group produced a higher level of S-RBD IgG than the naive-BNT162b2 (p=0.05) but not more than the naive-mRNA-1273 (p=0.9) group. Interestingly, the PI-vaccinated group produced a comparable level of IgA ratio to the naive-mRNA-1273 group but significantly higher than the naive-BNT162b2 group (1.6-fold, p<0.001). Our results showed that the mRNA-1327 vaccine is more immunogenic and induces a greater antibody response than the BNT162b2 vaccine.
