Development and Validation of the Elecsys Anti-SARS-CoV-2 Immunoassay as a Highly Specific Tool for Determining Past Exposure to SARS-CoV-2.
SARS-CoV-2
cross-reactivity
diagnosis
immunoassay
neutralization testing
sensitivity
specificity
Journal
Journal of clinical microbiology
ISSN: 1098-660X
Titre abrégé: J Clin Microbiol
Pays: United States
ID NLM: 7505564
Informations de publication
Date de publication:
22 09 2020
22 09 2020
Historique:
received:
03
07
2020
accepted:
30
07
2020
pubmed:
5
8
2020
medline:
6
10
2020
entrez:
5
8
2020
Statut:
epublish
Résumé
The Elecsys Anti-SARS-CoV-2 immunoassay (Roche Diagnostics) was developed to provide accurate, reliable detection of antibodies to severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). We evaluated sensitivity, specificity, cross-reactivity, and agreement with a vesicular stomatitis virus-based pseudoneutralization assay for the Elecsys Anti-SARS-CoV-2 immunoassay. Sensitivity and agreement between Elecsys Anti-SARS-CoV-2 immunoassay and pseudoneutralization assay measurements were evaluated using samples from patients with PCR-confirmed SARS-CoV-2 infection, a majority of whom were hospitalized. Specificity was evaluated using samples from routine diagnostic testing/blood donors collected before December 2019 and thus deemed negative for SARS-CoV-2-specific antibodies. Cross-reactivity was evaluated using samples containing a wide range of potentially cross-reacting analytes, purchased from commercial vendors. For sensitivity and specificity, point estimates and 95% confidence intervals (CIs) were calculated. Agreement between the Elecsys Anti-SARS-CoV-2 immunoassay and the pseudoneutralization assay was calculated. The sensitivity of the Elecsys Anti-SARS-CoV-2 immunoassay in patients with prior PCR-confirmed SARS-CoV-2 infection was 99.5% (95% CI, 97.0 to 100.0%) at ≥14 days post-PCR confirmation. Overall specificity (
Identifiants
pubmed: 32747400
pii: JCM.01694-20
doi: 10.1128/JCM.01694-20
pmc: PMC7512151
pii:
doi:
Substances chimiques
Antibodies, Viral
0
Types de publication
Journal Article
Research Support, Non-U.S. Gov't
Validation Study
Langues
eng
Sous-ensembles de citation
IM
Informations de copyright
Copyright © 2020 Muench et al.
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