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2020 ; 509
(ä): 117-125
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SARS-CoV-2 antibody characterization in emergency department, hospitalized and
convalescent patients by two semi-quantitative immunoassays
#MMPMID32505774
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
Clin Chim Acta
2020[Oct]; 509
(ä): 117-125
PMID32505774
show ga
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.