Clinical Evaluation of Five Commercial Serological SARS-CoV-2 Immunoassays for COVID-19

Wooyong Shin; Hae In Bang; Geun Young Yu; Mi-Young Kim; Eui Young Jang; Jung-Ah Kim; Jieun Kim; Rojin Park; Jeong Won Shin; Tae Youn Choi

doi:10.15263/jlmqa.2021.43.4.199

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자료유형: 학술저널

저자정보: Wooyong Shin (Soonchunhyang University Seoul Hospital) Hae In Bang (Soonchunhyang University Seoul Hospital) Geun Young Yu (Soonchunhyang University Seoul Hospital) Mi-Young Kim (Soonchunhyang University Seoul Hospital) Eui Young Jang (Soonchunhyang University Seoul Hospital) Jung-Ah Kim (Soonchunhyang University Seoul Hospital) Jieun Kim (Soonchunhyang University Seoul Hospital) Rojin Park (Soonchunhyang University Seoul Hospital) Jeong Won Shin (Soonchunhyang University Seoul Hospital) Tae Youn Choi (Soonchunhyang University Seoul Hospital)

저널정보: 대한임상검사정도관리협회 Journal of Laboratory Medicine And Quality Assurance Laboratory Medicine and Quality Assurance 제43권 제4호

발행연도: 2021.12

수록면: 199 - 207 (9page)

DOI: 10.15263/jlmqa.2021.43.4.199

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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 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.

#COVID-19 #SARS-COV-2 #COVID-19 serological testing #Immunoassay #Antibodies

참고문헌 (26)

참고문헌 신청

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Weiss P / 2020 / Clinical course and mortality risk of severe COVID-19 / Lancet 395:1014~1015

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