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KMID : 1100720210410060577
Annals of Laboratory Medicine
2021 Volume.41 No. 6 p.577 ~ p.587
Comparison of SARS-CoV-2 Antibody Responses and Seroconversion in COVID-19 Patients Using Twelve Commercial Immunoassays
Yun So-Jeong

Ryu Ji-Hyeong
Jang Joo-Hee
Bae Hyun-Joo
Yoo Seung-Hyo
Choi Ae-Ran
Jo Sung-Jin
Lim Ji-Hyang
Lee Je-Hoon
Ryu Hye-Jin
Cho Sung-Yeon
Lee Dong-Gun
Lee Jong-Min
Kim Seok-Chan
Park Yeon-Joon
Lee Hye-Young
Oh Eun-Jee
Abstract
Background: Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) antibody assays have high clinical utility in managing the pandemic. We compared antibody responses and seroconversion of coronavirus disease 2019 (COVID-19) patients using different immunoassays.

Methods: We evaluated 12 commercial immunoassays, including three automated chemiluminescent immunoassays (Abbott, Roche, and Siemens), three enzyme immunoassays (Bio-Rad, Euroimmun, and Vircell), five lateral flow immunoassays (Boditech Med, SD biosensor, PCL, Sugentech, and Rapigen), and one surrogate neutralizing antibody assay (GenScript) in sequential samples from 49 COVID-19 patients and 10 seroconversion panels.

Results: The positive percent agreement (PPA) of assays for a COVID-19 diagnosis ranged from 84.0% to 98.5% for all samples (>14 days after symptom onset), with IgM or IgA assays showing higher PPAs. Seroconversion responses varied across the assay type and disease severity. Assays targeting the spike or receptor-binding domain protein showed a tendency for early seroconversion detection and higher index values in patients with severe disease. Index values from SARS-CoV-2 binding antibody assays (three automated assays, one LFIA, and three EIAs) showed moderate to strong correlations with the neutralizing antibody percentage (r=0.517?0.874), and stronger correlations in patients with severe disease and in assays targeting spike protein. Agreement among the 12 assays was good (74.3%?96.4%) for detecting IgG or total antibodies.

Conclusions: Positivity rates and seroconversion of SARS-CoV-2 antibodies vary depending on the assay kits, disease severity, and antigen target. This study contributes to a better understanding of antibody response in symptomatic COVID-19 patients using currently available assays.
KEYWORD
SARS-CoV-2 antibody, Immunoassays, Neutralizing antibody, Seroconversion, Correlation, Disease severity, Positive percent agreement
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