부산대학교 도서관

Background: Coronavirus disease 2019 (COVID-19) is a serious infectious disease caused by the highly contagious severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). In this study, three types of kits for the lateral flow assay (LFA) and two types of reagents used in the chemiluminescent immunoassay (CLIA) for serological testing of COVID-19 were evaluated and compared to investigate the current status of antibody testing. Methods: From January 2020 to February 2021, 193 positive and 94 negative samples were tested. For these samples, WonMed COVID-19 immunoglobulin M (IgM)/immunoglobulin G (IgG) (Wonmed, Korea), careUS COVID-19 IgM/IgG (WELLS BIO, Korea), and STANDARD Q COVID-19 IgM/IgG Plus test (SD Biosensors, Korea) kits were used for the LFA, and Anti-SARS-CoV2 Elecsys nucleocapsid (N) and spike (S) (Roche, Switzerland) and ACCESS SARSCoV- 2 IgM and IgG (Beckman Coulter, USA) for the CLIA were compared and evaluated. Results: All kits and reagents except Elecsys showed variable sensitivities of 46.1%–72.0% for IgM, and 85.0%–88.1% for IgG. Elecsys showed a sensitivity of 86.0% for the N antibody and 85.5% for the S antibody. All reagents showed higher sensitivity in samples 14 days after symptom onset than within 14 days (P =0.007). The specificity of LFA and CLIA was 97.9%–100.0%. Conclusions: Most kits and reagents showed low clinical sensitivity at 7–14 days, that is before the antibody was sufficiently produced. When performing a serological test, IgM and IgG should be checked together to obtain sufficient clinical sensitivity, and the test timing should also be applied carefully.