2021 Volume 70 Issue 2 Pages 330-335
The anti-SARS-CoV-2 antibody test is recognized as reliable for the diagnosis of the novel coronavirus infectious disease (COVID-19). Various measurement reagents have been developed, but the characteristics of these reagents have not been sufficiently compared. The aim of this study was to evaluate the characteristics of four reagents used to analyze serum anti-SARS-CoV-2 antibody. The 37 employees of our hospital who had underwent SARS-CoV-2 PCR tests with suspicion of COVID-19 or for having close contacts with confirmed COVID-19 cases were included in this study. Serum samples were obtained and the anti-SARS-CoV-2 antibody was analyzed using the four reagents: Elecsys Anti-SARS-CoV-2 (RUO) (Roche Diagnostics Co., Ltd), ARCHITECT SARS-CoV-2 IgG (Abbott Japan GK), and the two commercial lateral flow immunoassay (LFIA) kits to analyze IgM and IgG, manufactured by Kurabo Co., Ltd. and Artron Laboratories Inc., respectively. The within-run and between-day reproducibilities of all four reagents were excellent. Regarding the dilution test, Elecsys Anti-SARS-CoV-2 (RUO), which measured the total amount of IgM and IgG, had the highest detection sensitivity among the four reagents. However, freezing and thawing of the samples caused unstable results of tests using the LFIA kits. Thus, it is necessary to understand the characterists of a reagent before choosing and using it for the anti-SARS-CoV-2 antibody test.