Multiplexed, microscale, microarray-based serological assay for antibodies against all human-relevant coronaviruses.
J Virol Methods
; 291: 114111, 2021 05.
Article
in En
| MEDLINE
| ID: mdl-33640374
ABSTRACT
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 2â¯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 2.0â¯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.
Key words
Full text:
1
Collection:
01-internacional
Database:
MEDLINE
Main subject:
Serologic Tests
/
Coronavirus Infections
/
Coronavirus
/
Microarray Analysis
/
Antibodies, Viral
Type of study:
Diagnostic_studies
Limits:
Humans
Language:
En
Journal:
J Virol Methods
Year:
2021
Document type:
Article