Multiplexed, microscale, microarray-based serological assay for antibodies against all human-relevant coronaviruses

Copyright © 2021 The Author(s). Published by Elsevier B.V. All rights reserved..

Rapid, sensitive, and precise multiplexed assays for serological analysis during candidate COVID-19 vaccine development would streamline clinical trials. The VaxArray Coronavirus (CoV) SeroAssay quantifies IgG antibody binding to 9 pandemic, potentially pandemic, and endemic human CoV spike antigens in 2 h with automated results analysis. IgG antibodies in serum bind to the CoV spike protein capture antigens printed in a microarray format and are labeled with a fluorescent anti-species IgG secondary label. The assay demonstrated excellent lower limits of quantification ranging from 0.3 to 2.0 ng/mL and linear dynamic ranges of 76 to 911-fold. Average precision of 11 % CV and accuracy (% recovery) of 92.5 % over all capture antigens were achieved over 216 replicates representing 3 days and 3 microarray lots. Clinical performance on 263 human serum samples (132 SARS-CoV-2 negatives and 131 positives based on donor-matched RT-PCR and/or date of collection) produced 98.5 % PPA and 100 % NPA.

Medienart:

E-Artikel

Erscheinungsjahr:

2021

Erschienen:

2021

Enthalten in:

Zur Gesamtaufnahme - volume:291

Enthalten in:

Journal of virological methods - 291(2021) vom: 15. Mai, Seite 114111

Sprache:

Englisch

Beteiligte Personen:

Dawson, Erica D [VerfasserIn]
Kuck, Laura R [VerfasserIn]
Blair, Rebecca H [VerfasserIn]
Taylor, Amber W [VerfasserIn]
Toth, Evan [VerfasserIn]
Knight, Vijaya [VerfasserIn]
Rowlen, Kathy L [VerfasserIn]

Links:

Volltext

Themen:

Antibodies, Viral
Antigens, Viral
COVID-19
Human coronavirus
Immunoassay
Immunoglobulin G
Journal Article
Research Support, Non-U.S. Gov't
SARS-CoV-2
Serology
Spike Glycoprotein, Coronavirus
VaxArray

Anmerkungen:

Date Completed 12.04.2021

Date Revised 21.12.2022

published: Print-Electronic

Citation Status MEDLINE

doi:

10.1016/j.jviromet.2021.114111

funding:

Förderinstitution / Projekttitel:

PPN (Katalog-ID):

NLM321982746