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Comparison of Serologic Response of Hospitalized COVID-19 Patients Using 8 Immunoassays
Sun Min Lee1,2,3, In Suk Kim1,2,4, Seungjin Lim2,5
1Department of Laboratory Medicine, Pusan National University Yangsan Hospital, Pusan National University School of Medicine, Yangsan, Korea.
Insights
Commercial immunoassays for detecting severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) antibodies show inconsistent results. Caution is advised when using a single immunoassay for infection detection or assessing immunologic status.
Area of Science:
- Clinical diagnostics
- Immunology
- Infectious diseases
Background:
- Immunoassays for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) antibody detection faced challenges in Korea.
- Clinical remnant specimens were utilized to evaluate commercial antibody tests.
Purpose of the Study:
- To compare the performance of eight different commercial immunoassays for SARS-CoV-2 antibody detection.
- To assess the reliability of these kits in a real-world clinical setting.
Main Methods:
- Eight in vitro diagnostic (IVD) kits were tested: four enzyme-linked immunosorbent assays (ELISAs), two lateral flow rapid immunochromatographic assays, and two chemiluminescent immunoassays.
- Tests were performed on 40 serum samples from 15 confirmed coronavirus disease 2019 (COVID-19) patients and 86 clinical remnant serum samples.
Main Results:
- Out of 40 samples from COVID-19 patients, 35 showed at least one positive antibody result.
- Significant inconsistencies were observed, with 12 (28%) samples yielding discrepant results across single immunoassay kits.
- Serum samples collected in 2019, prior to the first reported COVID-19 case in Korea, tested negative, with one equivocal result.
Conclusions:
- Discrepant results highlight the need for caution when relying on a single immunoassay for SARS-CoV-2 serological assessment.
- The findings underscore the importance of careful interpretation for both infection detection and evaluation of immune status.
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.
