SARS-CoV-2 antibody characterization in emergency department, hospitalized and convalescent patients by two semi-quantitative immunoassays.
Adult
Aged
Aged, 80 and over
Antibodies, Viral
/ blood
Betacoronavirus
/ isolation & purification
COVID-19
Clinical Laboratory Techniques
/ methods
Cohort Studies
Convalescence
Coronavirus Infections
/ blood
Emergency Service, Hospital
/ trends
Female
Hospitalization
/ trends
Humans
Immunoassay
/ methods
Longitudinal Studies
Male
Middle Aged
Pandemics
Pneumonia, Viral
/ blood
SARS-CoV-2
Coronavirus disease 19 (COVID-19)
Immunoassay
Serology
Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2)
Journal
Clinica chimica acta; international journal of clinical chemistry
ISSN: 1873-3492
Titre abrégé: Clin Chim Acta
Pays: Netherlands
ID NLM: 1302422
Informations de publication
Date de publication:
Oct 2020
Oct 2020
Historique:
received:
12
05
2020
revised:
28
05
2020
accepted:
03
06
2020
pubmed:
9
6
2020
medline:
1
9
2020
entrez:
8
6
2020
Statut:
ppublish
Résumé
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. 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. 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. 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.
Sections du résumé
BACKGROUND
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
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
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
CONCLUSIONS
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.
Identifiants
pubmed: 32505774
pii: S0009-8981(20)30268-0
doi: 10.1016/j.cca.2020.06.004
pmc: PMC7272145
pii:
doi:
Substances chimiques
Antibodies, Viral
0
Types de publication
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Pagination
117-125Informations de copyright
Copyright © 2020 The Author(s). Published by Elsevier B.V. All rights reserved.
Déclaration de conflit d'intérêts
Declaration of Competing Interest ZZ received seed instruments and sponsored travel from ET Healthcare. The manufacturers did not review the article and had no input on data analysis prior to the manuscript submission.
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