Comparison of SARS-CoV-2 Antibody Responses and Seroconversion in COVID-19 Patients Using Twelve Commercial Immunoassays
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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.
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.
참고문헌 (28)
- Wu Z, "Characteristics of and important lessons from the coronavirus Disease 2019 (COVID-19) outbreak in China: summary of a report of 72 314 cases from the Chinese Center for Disease Control and Prevention", JAMA, 323, pp.1239~1242 (2020)
- Fong CH, "Improved detection of antibodies against SARS-CoV-2 by microsphere-based antibody assay", Int J Mol Sci, 21, pp.6595~ (2020)
- Tu YF, "A review of SARS-CoV-2 and the ongoing clinical trials", Int J Mol Sci, 21, pp.2657~ (2020)
- Trabaud MA, "Comparison of eight commercial, high-throughput, automated or ELISA assays detecting SARS-CoV-2 IgG or total antibody", J Clin Virol, 132, pp.104613~ (2020)
- Charlton CL, "Evaluation of six commercial mid- to high-volume antibody and six point-of-care lateral flow assays for detection of SARS-CoV-2 antibodies", J Clin Microbiol, 58, pp.e01361-20~ (2020)
- Kohmer N, "Brief clinical evaluation of six high-throughput SARS-CoV-2 IgG antibody assays", J Clin Virol, 129, pp.104480~ (2020)
- Tan CW, "A SARS-CoV-2 surrogate virus neutralization test based on antibody-mediated blockage of ACE2-spike protein–protein interaction", Nat Biotechnol, 38, pp.1073~1078 (2020)
- To KK, "Temporal profiles of viral load in posterior oropharyngeal saliva samples and serum antibody responses during infection by SARS-CoV-2: an observational cohort study", Lancet Infect Dis, 20, pp.565~574 (2020)
- Klimstra WB, "SARS-CoV-2 growth, furin-cleavage-site adaptation and neutralization using serum from acutely infected hospitalized COVID-19 patients", J Gen Virol, 101, pp.1156~1169 (2020)
- Landis JR, "The measurement of observer agreement for categorical data", Biometrics, 33, pp.159~174 (1977)
- Mukaka MM, "Statistics corner: A guide to appropriate use of correlation coefficient in medical research", Malawi Med J, 24, pp.69~71 (2012)
- 김영진, "COVID-19 Testing in South Korea: Current Status and the Need for Faster Diagnostics", Annals of Laboratory Medicine, 40(5), pp.349~350 (2020), 대한진단검사의학회[DOI]
- Ki Ho Hong, "Guidelines for Laboratory Diagnosis of Coronavirus Disease 2019 (COVID-19) in Korea", Annals of Laboratory Medicine, 40(5), pp.351~360 (2020), 대한진단검사의학회[DOI]
- Huh Hee Jae, "Surveillance of Coronavirus Disease 2019 (COVID-19) Testing in Clinical Laboratories in Korea", Annals of Laboratory Medicine, 41(2), pp.225~229 (2021), 대한진단검사의학회[DOI]
- Choudhary Sarita, "Role of Genetic Variants and Gene Expression in the Susceptibility and Severity of COVID-19", Annals of Laboratory Medicine, 41(2), pp.129~138 (2021), 대한진단검사의학회[DOI]
- Cota G, "Diagnostic performance of commercially available COVID-19 serology tests in Brazil", Int J Infect Dis, 101, pp.382~390 (2020)
- Liu X, "Patterns of IgG and IgM antibody response in COVID-19 patients", Emerg Microbes Infect, 9, pp.1269~1274 (2020)
- Lee CY-P, "Serological approaches for COVID-19: epidemiologic perspective on surveillance and control", Front Immunol, 11, pp.879~ (2020)
- Plebani M, "Diagnostic performances and thresholds: the key to harmonization in serological SARS-CoV-2 assays?", Clin Chim Acta, 509, pp.1~7 (2020)
- Zilla M, "Variable performance in 6 commercial SARS-CoV-2 antibody assays may affect convalescent plasma and seroprevalence screening", Am J Clin Pathol, 155, pp.343~353 (2021)
- Zhao J, "Antibody responses to SARS-CoV-2 in patients with novel coronavirus disease 2019", Clin Infect Dis, 71, pp.2027~2034 (2020)
- Okba NMA, "Severe acute respiratory syndrome coronavirus 2-specific antibody responses in coronavirus disease patients", Emerg Infect Dis, 26, pp.1478~1488 (2020)
- GeurtsvanKessel CH, "An evaluation of COVID-19 serological assays informs future diagnostics and exposure assessment", Nat Commun, 11, pp.3436~ (2020)
- Bošnjak B, "Low serum neutralizing anti-SARS-CoV-2 S antibody levels in mildly affected COVID-19 convalescent patients revealed by two different detection methods", Cell Mol Immunol, 18, pp.936~944 (2021)
- Tang MS, "Association between SARS-CoV-2 neutralizing antibodies and commercial serological assays", Clin Chem, 66, pp.1538~1547 (2020)
- Brouwer PJM, "Potent neutralizing antibodies from COVID-19 patients define multiple targets of vulnerability", Science, 369, pp.643~650 (2020)
- Seow J, "Longitudinal observation and decline of neutralizing antibody responses in the three months following SARS-CoV-2 infection in humans", Nat Microbiol, 5, pp.1598~1607 (2020)
- Luchsinger LL, "Serological assays estimate highly variable SARS-CoV-2 neutralizing antibody activity in recovered COVID-19 patients", J Clin Microbiol, 58, pp.e02005~e02020 (2020)