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

Serological testing is an important diagnostic support tool in the fight against COVID-19. So far, serological testing has been performed on either lateral flow assays, which perform only qualitatively and can be difficult for the individual to read, or standard laboratory assays, which are time- an...

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Veröffentlicht in:Microbiology spectrum Jg. 10; H. 2; S. e0039622
Hauptverfasser: Moeller, Maria E., Engsig, Frederik N., Bade, Melanie, Fock, Jeppe, Pah, Pearlyn, Soerensen, Anna Louise, Bang, Didi, Donolato, Marco, Benfield, Thomas
Format: Journal Article
Sprache:Englisch
Veröffentlicht: United States American Society for Microbiology 27.04.2022
Schlagworte:
Antibodies, Viral
COVID-19 - diagnosis
COVID-19 Vaccines
Humans
Immunoassay - methods
Immunoglobulin G
immunomagnetic agglutination assay
Pandemics
point-of-care
Point-of-Care Testing
rapid IgG-IgM-IgA combined test
Research Article
S protein trimer
SARS-CoV-2
Sensitivity and Specificity
Spike Glycoprotein, Coronavirus
Vaccination
Vaccines
SARS-CoV-2
rapid IgG-IgM-IgA combined test
point-of-care
S protein trimer
immunomagnetic agglutination assay
vaccination
ISSN:2165-0497, 2165-0497
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Zusammenfassung:Serological testing is an important diagnostic support tool in the fight against COVID-19. So far, serological testing has been performed on either lateral flow assays, which perform only qualitatively and can be difficult for the individual to read, or standard laboratory assays, which are time- and resource-consuming. 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. IMPORTANCE Serological testing is an important diagnostic support tool in the fight against COVID-19. So far, serological testing has been performed on either lateral flow assays, which perform only qualitatively and can be difficult for the individual to read, or standard laboratory assays, which are time- and resource-consuming. The purpose of the study was to evaluate the performance of a new POC microfluidic cartridge-based device based on immunomagnetic agglutination assay that can provide an accurate numerical quantification of the total antibodies within only 7 min from a single drop of capillary blood. We demonstrated a high level of correlation between the POC and the two CLIA laboratory-based immunoassays from Diasorin, thus allowing a potentially wider use of quantitative serology tests in the COVID-19 pandemic.
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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.
ISSN:2165-0497
2165-0497
DOI:10.1128/spectrum.00396-22