TY - JOUR
T1 - SARS-CoV-2 antibody characterization in emergency department, hospitalized and convalescent patients by two semi-quantitative immunoassays
AU - Yang, He S.
AU - Racine-Brzostek, Sabrina E.
AU - Lee, William T.
AU - Hunt, Danielle
AU - Yee, Jim
AU - Chen, Zhengming
AU - Kubiak, Jeffrey
AU - Cantu, Miguel
AU - Hatem, Layla
AU - Zhong, Elaine
AU - D'Ambrosio, Danielle
AU - Chadburn, Amy
AU - Westblade, Lars
AU - Glesby, Marshall
AU - Loda, Massimo
AU - Cushing, Melissa M.
AU - Zhao, Zhen
N1 - Funding Information:
The authors thank the contribution of the following scientists from Wadsworth Center, Diagnostic Immunology Laboratory New York State Department of Health: K. McDonough, K. Kulas, R. Bievenue, S. Bush, K. Carson, V. Demarest, A. Furuya, K. Howard, M. Marchewka, R. Stone. We thank Dr. Fred Apple from University of Minnesota and Dr Alan Wu from University of California San Francisco for their help with manuscript review.
Publisher Copyright:
© 2020 The Author(s)
PY - 2020/10
Y1 - 2020/10
N2 - Background: In the ongoing COVID-19 pandemic, there is an urgent need for comprehensive performance evaluation and clinical utility assessment of serological assays to understand the immune response to SARS-CoV-2. Methods: IgM/IgG and total antibodies against SARS-CoV-2 were measured by a cyclic enhanced fluorescence assay (CEFA) and a microsphere immunoassay (MIA), respectively. Independent performance evaluation included imprecision, reproducibility, specificity and cross-reactivity (CEFA n = 320, MIA n = 364). Clinical utility was evaluated by both methods in 87 patients at initial emergency department visit, 28 during subsequent hospitalizations (106 serial samples), and 145 convalescent patients. Totally 916 patients and 994 samples were evaluated. Results: Agreement of CEFA and MIA was 90.4%-94.5% (Kappa: 0.81–0.89) in 302 samples. CEFA and MIA detected SARS-CoV-2 antibodies in 26.2% and 26.3%, respectively, of ED patients. Detection rates increased over time reaching 100% after 21 days post-symptom onset. Longitudinal antibody kinetic changes by CEFA and MIA measurements correlated well and exhibited three types of seroconversion. Convalescent sera showed a wide range of antibody levels. Conclusion: Rigorously validated CEFA and MIA assays are reliable for detecting antibodies to SARS-CoV-2 and show promising clinical utility when evaluating immune response in hospitalized and convalescent patients, but are not useful for early screening at patient's initial ED visit.
AB - Background: In the ongoing COVID-19 pandemic, there is an urgent need for comprehensive performance evaluation and clinical utility assessment of serological assays to understand the immune response to SARS-CoV-2. Methods: IgM/IgG and total antibodies against SARS-CoV-2 were measured by a cyclic enhanced fluorescence assay (CEFA) and a microsphere immunoassay (MIA), respectively. Independent performance evaluation included imprecision, reproducibility, specificity and cross-reactivity (CEFA n = 320, MIA n = 364). Clinical utility was evaluated by both methods in 87 patients at initial emergency department visit, 28 during subsequent hospitalizations (106 serial samples), and 145 convalescent patients. Totally 916 patients and 994 samples were evaluated. Results: Agreement of CEFA and MIA was 90.4%-94.5% (Kappa: 0.81–0.89) in 302 samples. CEFA and MIA detected SARS-CoV-2 antibodies in 26.2% and 26.3%, respectively, of ED patients. Detection rates increased over time reaching 100% after 21 days post-symptom onset. Longitudinal antibody kinetic changes by CEFA and MIA measurements correlated well and exhibited three types of seroconversion. Convalescent sera showed a wide range of antibody levels. Conclusion: Rigorously validated CEFA and MIA assays are reliable for detecting antibodies to SARS-CoV-2 and show promising clinical utility when evaluating immune response in hospitalized and convalescent patients, but are not useful for early screening at patient's initial ED visit.
KW - Coronavirus disease 19 (COVID-19)
KW - Immunoassay
KW - Serology
KW - Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2)
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U2 - 10.1016/j.cca.2020.06.004
DO - 10.1016/j.cca.2020.06.004
M3 - Article
C2 - 32505774
AN - SCOPUS:85086372961
SN - 0009-8981
VL - 509
SP - 117
EP - 125
JO - Clinica Chimica Acta
JF - Clinica Chimica Acta
ER -