Abstract
Background: In Korea, there were issues regarding the use of immunoassays for anti-severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) antibodies to detect infection. So, we compared antibody results of eight kinds of commercial immunoassays using clinical remnant specimens.
Methods: We compared the results of several immunoassay kits tested on 40 serum samples from 15 confirmed patients and 86 remnant serum samples from clinical laboratory. Eight kinds of IVD kits-four enzyme-linked immunosorbent assay, two lateral flow rapid immunochromatographic assays, and two chemiluminescent immunoassays with one RUO kit were tested.
Results: Among 40 serum samples from 15 coronavirus disease 2019 (COVID-19) patients, 35 yielded at least one positive result for detecting antibodies in the combined assessment. There were inconsistent results in 12 (28%) samples by single immunoassay. Forty samples collected in 2019 before the first COVID-19 Korean case showed negative results except for one equivocal result.
Conclusion: The discrepant results obtained with different immunoassay kits in this study show that serological assessment of SARS-CoV-2 by a single immunoassay requires caution not only in detecting infection but also in assessing immunologic status.
Keywords: Antibodies; COVID-19; ELISA; Immunoassay; Korea; SARS-CoV-2.
【저자키워드】 COVID-19, antibodies, SARS-CoV-2, Korea, ELISA, immunoassay, 【초록키워드】 coronavirus disease, SARS-CoV-2, Coronavirus disease 2019, coronavirus, antibody, Infection, ELISA, Laboratory, lateral flow, immunoassays, immunoassay, enzyme-linked immunosorbent assay, Patient, chemiluminescent immunoassay, respiratory, immunochromatographic, specimens, patients, Korean, clinical laboratory, except for, acute respiratory syndrome, acute respiratory syndrome coronavirus, serum samples, caution, positive result, serological assessment, serum sample, discrepant results, IVD, commercial immunoassay, enzyme-linked immunosorbent, tested, detect, collected, assays, eight, discrepant result, 【제목키워드】 serologic, response,