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 hours 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 (sensitivity) and 100% NPA (specificity).
Competing Interest Statement
E. Dawson, K. Rowlen, and L. Kuck are employed by and hold stock in InDevR, Inc. R. Blair, A. Taylor, and E. Toth are employees of InDevR.
No external funding was received for the work described herein.
I confirm all relevant ethical guidelines have been followed, and any necessary IRB and/or ethics committee approvals have been obtained.
The details of the IRB/oversight body that provided approval or exemption for the research described are given below:
All specimens were tested at InDevR, and were received completely deidentified. Specimens from Colorado Childrens Hospital (Denver, CO) were collected under a Colorado Multiple IRB (COMIRB) approved protocol. Specimens obtained from Lankenau Institute for Medical Research (LIMR, Wynnewood, PA) were collected under a Main Line Hospitals IRB approved protocol. Deidentified specimens from Veritas, PA (Belton, TX) were obtained under an AspireIRB approved protocol. Deidentified specimens from Mount Sinai Icanh School of Medicine (New York, NY) were obtained under a license agreement which indicates appropriate IRB approval and informed consent was obtained for the specimens provided.
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All data described in the study is available from the corresponding author.