SARS-CoV-2 antibody characterization in emergency department, hospitalized and convalescent patients by two semi-quantitative immunoassays

He S. Yang; Sabrina E. Racine-Brzostek; William T. Lee; Danielle Hunt; Jim Yee; Zhengming Chen; Jeffrey Kubiak; Miguel Cantu; Layla Hatem; Elaine Zhong; Danielle D'Ambrosio; Amy Chadburn; Lars Westblade; Marshall Glesby; Massimo Loda; Melissa M. Cushing; Zhen Zhao

doi:10.1016/j.cca.2020.06.004

SARS-CoV-2 antibody characterization in emergency department, hospitalized and convalescent patients by two semi-quantitative immunoassays

He S. Yang, Sabrina E. Racine-Brzostek, William T. Lee, Danielle Hunt, Jim Yee, Zhengming Chen, Jeffrey Kubiak, Miguel Cantu, Layla Hatem, Elaine Zhong, Danielle D'Ambrosio, Amy Chadburn, Lars Westblade, Marshall Glesby, Massimo Loda, Melissa M. Cushing, Zhen Zhao

Research output: Contribution to journal › Article › peer-review

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Abstract

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.

Original language	English (US)
Pages (from-to)	117-125
Number of pages	9
Journal	Clinica Chimica Acta
Volume	509
DOIs	https://doi.org/10.1016/j.cca.2020.06.004
State	Published - Oct 2020
Externally published	Yes

Bibliographical note

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)

Keywords

Coronavirus disease 19 (COVID-19)
Immunoassay
Serology
Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2)

UN SDGs

This output contributes to the following UN Sustainable Development Goals (SDGs)

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10.1016/j.cca.2020.06.004

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Yang, H. S., Racine-Brzostek, S. E., Lee, W. T., Hunt, D., Yee, J., Chen, Z., Kubiak, J., Cantu, M., Hatem, L., Zhong, E., D'Ambrosio, D., Chadburn, A., Westblade, L., Glesby, M., Loda, M., Cushing, M. M., & Zhao, Z. (2020). SARS-CoV-2 antibody characterization in emergency department, hospitalized and convalescent patients by two semi-quantitative immunoassays. Clinica Chimica Acta, 509, 117-125. https://doi.org/10.1016/j.cca.2020.06.004

Yang, HS, Racine-Brzostek, SE, Lee, WT, Hunt, D, Yee, J, Chen, Z, Kubiak, J, Cantu, M, Hatem, L, Zhong, E, D'Ambrosio, D, Chadburn, A, Westblade, L, Glesby, M, Loda, M, Cushing, MM & Zhao, Z 2020, 'SARS-CoV-2 antibody characterization in emergency department, hospitalized and convalescent patients by two semi-quantitative immunoassays', Clinica Chimica Acta, vol. 509, pp. 117-125. https://doi.org/10.1016/j.cca.2020.06.004

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title = "SARS-CoV-2 antibody characterization in emergency department, hospitalized and convalescent patients by two semi-quantitative immunoassays",

abstract = "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.",

keywords = "Coronavirus disease 19 (COVID-19), Immunoassay, Serology, Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2)",

author = "Yang, {He S.} and Racine-Brzostek, {Sabrina E.} and Lee, {William T.} and Danielle Hunt and Jim Yee and Zhengming Chen and Jeffrey Kubiak and Miguel Cantu and Layla Hatem and Elaine Zhong and Danielle D'Ambrosio and Amy Chadburn and Lars Westblade and Marshall Glesby and Massimo Loda and Cushing, {Melissa M.} and Zhen Zhao",

note = "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: {\textcopyright} 2020 The Author(s)",

year = "2020",

month = oct,

doi = "10.1016/j.cca.2020.06.004",

language = "English (US)",

volume = "509",

pages = "117--125",

journal = "Clinica Chimica Acta",

issn = "0009-8981",

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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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ER -

SARS-CoV-2 antibody characterization in emergency department, hospitalized and convalescent patients by two semi-quantitative immunoassays

Abstract

Bibliographical note

Keywords

UN SDGs

Publisher link

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