Sex difference in the discordance between Abbott Architect and EuroImmun serological assays

Abstract

Background This study evaluated the discordance between Abbott Architect SARS-CoV-2 IgG and EUROIMMUN SARS-COV-2 ELISA in a seroprevalence study. Methods From June 10 to August 15, 2020, 8,246 specimens were dually evaluated by the Abbott Architect SARS-CoV-2 IgG (Abbott) and the EUROIMMUN SARS-CoV-2 ELISA (EI) assays. Sex-stratified phi correlation coefficients were calculated to evaluate the concordance between Abbott and EI assay’s quantitative results. Multivariable mixed-effect logistic models were implemented to evaluate the association between assay positivity and sex on a low prevalence sample while controlling for age, race, ethnicity, diabetes, cardiovascular disease, hypertension, immunosuppressive therapy, and autoimmune disease. Results EI positivity among males was 2.1-fold that of females; however, no significant differences in Abbott positivity were observed between sexes. At the manufacturer-recommended threshold, the phi correlation coefficient for the Abbott and EI qualitative results among females (Φ = 0.47) was 34% greater than males (Φ = 0.35). The unadjusted and fully adjusted models yielded a strong association between sex and positive EI result for the low prevalence subgroup (unadjusted OR: 2.24, CI: 1.63, 3.11, adjusted OR: 3.40, CI: 2.15, 5.39). A similar analysis of Abbott positivity in the low prevalence subgroup did not find an association with any of the covariates examined. Significant quantitative and qualitative discordance was observed between Abbott and EI throughout the seroprevalence study. Our results suggest the presence of sex-associated specificity limitations with the EI assay. As these findings may extend to other anti-S assays utilized for SARS-CoV-2 seroprevalence investigations, further investigation is needed to evaluate the generalizability of these findings.