Performance comparison between Elecsys Anti-SARS-CoV-2 and Anti-SARS-CoV-2 S and Atellica IM SARS-CoV-2 Total and SARS-CoV-2 IgG assays / 고신대학교의과대학학술지

ABSTRACT

Background@#Although serological severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) tests from several manufacturers have been introduced in South Korea and some are commercially available, the performance of these test kits has not yet been sufficiently validated. Therefore, we compared the performance of Elecsys Anti-SARS-CoV-2 (ACOV2) and Anti-SARS-CoV-2 S (ACOV2S) and Atellica IM SARS-CoV-2 Total (COV2T) and SARS-CoV-2 IgG (sCOVG) serological tests in this study. @*Methods@#A total of 186 patient samples were used. For each test, we analyzed the positive rate of serological antibody tests, precision, linearity, and agreement among the four assays. @*Results@#The positive rates of COV2T, sCOVG, and ACOV2S were high (81.7%–89.2%) in total, with those for ACOV2S being the highest, while those of ACOV2 were as low as 44.6%. This may be related to the high completion rate of vaccination in Korea. The repeatability and within-laboratory coefficients of variation were within the claimed allowable imprecision; however, further research is needed to establish an allowable imprecision at low concentrations. COV2T showed a linear fit, whereas sCOVG and ACOV2S were appropriately modeled with a nonlinear fit. Good agreement was found among COV2T, sCOVG, and ACOV2S; however, the agreement between ACOV2 and any one of the other methods was poor. @*Conclusions@#Considering the different antigens used in serological SARS-CoV-2 antibody assays, the performance of the tested assays is thought to show no significant difference for the qualitative detection of antibodies to SARS-CoV-2.