Validation of a novel fluorescent lateral flow assay for rapid qualitative and quantitative assessment of total anti-SARS-CoV-2 S-RBD binding antibody units (BAU) from plasma or fingerstick whole-blood of COVID-19 vaccinees
Abstract
Background
Limited commercial LFA assays are available to provide a reliable quantitative measurement of the total binding antibody units (BAU/mL) against the receptor-binding domain of the SARS-CoV-2 spike protein (S-RBD).
Aim
To evaluate the performance of FinecareTM2019-nCoV S-RBD LFA and its fluorescent reader (FinecareTM-FIA Meter) against the following reference methods (i) The FDA-approved Genscript surrogate virus-neutralizing assay (sVNT), and (ii) three highly performing automated immunoassays: BioMérieux VIDAS®3, Ortho VITROS®, and Mindray CL-900i®.
Methods
Plasma from 488 vaccinees were tested by all aforementioned assays. Fingerstick whole-blood samples from 156 vaccinees were also tested by FinecareTM.
Results and conclusions
FinecareTM showed 100% specificity as none of the pre-pandemic samples tested positive. Equivalent FinecareTM results were observed among the samples taken from fingerstick or plasma (Pearson correlation r =0.9, p<0.0001), suggesting that fingerstick samples are sufficient to quantitate the S-RBD BAU/mL. A moderate correlation was observed between FinecareTM and sVNT ( r= 0.5, p<0.0001), indicating that FinecareTM can be used for rapid prediction of the neutralization antibody post-vaccination. FinecareTM BAU results showed strong correlation with VIDAS®3 ( r= 0.6, p<0.0001), and moderate correlation with VITROS® ( r =0.5, p<0.0001), and CL-900i® ( r =0.4, p<0.0001), suggesting that FinecareTM be used as a surrogate for the advanced automated assays to measure S-RBD BAU/mL.
Related articles
Related articles are currently not available for this article.