J Korean Med Sci.  2021 Mar;36(9):e64. 10.3346/jkms.2021.36.e64.

Comparison of Serologic Response of Hospitalized COVID-19 Patients Using 8 Immunoassays

Affiliations
  • 1Department of Laboratory Medicine, Pusan National University Yangsan Hospital, Pusan National University School of Medicine, Yangsan, Korea
  • 2Research Institute for Convergence of Biomedical Science and Technology, Pusan National University Yangsan Hospital, Yangsan, Korea
  • 3Department of Laboratory Medicine, Pusan National University School of Medicine, Yangsan, Korea
  • 4Division of Infection, Department of Internal Medicine, Pusan National University Yangsan Hospital, Yangsan, Korea
  • 5Department of Laboratory Medicine, Pusan National University Hospital, Busan, Korea
  • 6Department of Laboratory Medicine, Seoul Medical Center, Seoul, Korea

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.

Keyword

SARS-CoV-2; COVID-19; ELISA; Immunoassay; Korea; Antibodies
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