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Egger, M; Bundschuh, C; Wiesinger, K; Gabriel, C; Clodi, M; Mueller, T; Dieplinger, B.
Comparison of the Elecsys® Anti-SARS-CoV-2 immunoassay with the EDI™ enzyme linked immunosorbent assays for the detection of SARS-CoV-2 antibodies in human plasma.
Clin Chim Acta. 2020; 509(4):18-21
Doi: 10.1016/j.cca.2020.05.049
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PubMed
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- Co-authors Med Uni Graz
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GABRIEL Christian
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- Abstract:
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Here, we report on a head-to-head comparison of the fully-automated Elecsys® Anti-SARS-CoV-2 immunoassay with the EDITM enzyme linked immunosorbent assays (ELISA) for the detection of SARS-CoV-2 antibodies in human plasma.
SARS-CoV-2 antibodies were measured with the Elecsys® assay and the EDITM ELISAs (IgM and IgG) in 64 SARS-CoV-2 RT-PCR confirmed COVID-19 patients with serial blood samples (n = 104) collected at different time points from symptom onset. Blood samples from 200 healthy blood donors and 256 intensive care unit (ICU) patients collected before the COVID-19 outbreak were also used.
In COVID-19 patients, the percentage of positive results rose with time from symptom onset, peaking to positivity rates after 15-22 days of 100% for the Elecsys® assay, of 94% for the EDITM IgM-ELISA and of 100% for the EDITM IgG ELISA. In the 104 blood samples, the agreement between positive/negative classifications of the Elecsys® assay and the EDITM ELISAs (IgM or IgG) was 90%. The false positivity rates in the healthy blood donors and the ICU patients were < 1% for the Elecsys® assay and < 3% for the EDITM ELISAs.
Our results indicate a high sensitivity and specificity for the Elecsys® assay and an acceptable agreement with the EDITM ELISAs.
Copyright © 2020 Elsevier B.V. All rights reserved.
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Antibodies, Viral - blood
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Betacoronavirus - isolation & purification
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COVID-19 -
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Clinical Laboratory Techniques - methods
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Clinical Laboratory Techniques - standards
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Coronavirus Infections - blood
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Coronavirus Infections - diagnosis
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Enzyme-Linked Immunosorbent Assay - methods
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Enzyme-Linked Immunosorbent Assay - standards
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Female -
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Humans -
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Immunoassay - methods
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Immunoassay - standards
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Male -
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Pandemics -
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Serologic Tests - methods
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COVID-19
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SARS-CoV-2
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ECLIA
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Antibody testing
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Serological test