Rapid Quantitative Point-Of-Care Diagnostic Test for Post COVID-19 Vaccination Antibody Monitoring

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Point-of-care (POC) quantification of antibody responses against SARS-CoV-2 spike protein can enable decentralized monitoring of immune responses after infection or vaccination. We evaluated a novel POC microfluidic cartridge-based device (ViroTrack Sero COVID-19 Total Ab) for quantitative detection of total antibodies against SARS-CoV-2 spike trimeric spike protein compared to standard laboratory chemiluminescence (CLIA)-based tests. Antibody responses of 101 individuals were measured on capillary blood, venous whole blood, plasma, and diluted plasma samples directly on the POC. Results were available within 7 min. As the reference, plasma samples were analyzed on DiaSorin LIAISON XL CLIA analyzer using LIAISON SARS-CoV-2 IgM, LIAISON SARS-CoV-2 S1/S2 IgG, and LIAISON SARS-CoV-2 TrimericS IgG assays. The Spearman rank’s correlation coefficient between ViroTrack Sero COVID-19 Total Ab and LIAISON SARS-CoV-2 S1/S2 IgG and LIAISON SARS-CoV-2 TrimericS IgG assays was found to be 0.83 and 0.89, respectively. ViroTrack Sero COVID-19 Total Ab showed high correlation between the different matrixes. Agreement for determination of samples of .230 binding antibody units (BAU)/ mL on POC and CLIA methods is estimated to be around 90%. ViroTrack Sero Covid Total Ab is a rapid and simple-to-use POC test with high sensitivity and correlation of numerical results expressed in BAU/mL compared to those of a commercial CLIA assay.

OriginalsprogEngelsk
Artikelnummer00396
TidsskriftMicrobiology Spectrum
Vol/bind10
Udgave nummer2
ISSN2165-0497
DOI
StatusUdgivet - 2022

Bibliografisk note

Funding Information:
Editor Tulip A. Jhaveri, University of Mississippi Medical Center Copyright © 2022 Moeller et al. This is an open-access article distributed under the terms of the Creative Commons Attribution 4.0 International license. Address correspondence to Maria E. Moeller, maria.elizabeth.engel.moeller@regionh.dk. The authors declare a conflict of interest. P. Pah, M. Bade, J. Fock, and M. Donolato are employed at Blusense Diagnostics APS and have been part of the developing of ViroTrack Sero COVID-19 Total Ab. This work was supported by BluSense Diagnostics who provided the test kits for the study. Received 31 January 2022 Accepted 1 March 2022 Published 31 March 2022

Funding Information:
We thank Heike Ebermann from the Department of Microbiology, Copenhagen University Hospital - Amager and Hospital for excellent technical assistance and Laura Catalina Bohorquez for her help in drafting the paper introduction. P. Pah, M. Bade, J. Fock, and M. Donolato are employed at Blusense Diagnostics APS and have been part of the development of ViroTrack Sero COVID-19 Total Ab. This work was supported by BluSense Diagnostics, who provided the test kits for the study.

Publisher Copyright:
Copyright © 2022 Moeller et al.

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