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KMID : 0985420210430040199
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Laboratory Medicine and Quality Assurance
2021 Volume.43 No. 4 p.199 ~ p.207
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Clinical Evaluation of Five Commercial Serological SARS-CoV-2 Immunoassays for COVID-19
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Shin Woo-Yong
Bang Hae-In
Yu Geun-Young
Kim Mi-Young
Jang Eui-Young
Kim Jung-Ah
Kim Ji-Eun
Park Ro-Jin
Shin Jeong-Won
Choi Tae-Youn
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Abstract
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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 SARS-CoV-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.
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KEYWORD
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COVID-19, SARS-COV-2, COVID-19 serological testing, Immunoassay, Antibodies
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