Performance evaluation of novel fluorescent-based lateral flow immunoassay (LFIA) for rapid detection and quantification of total anti-SARS-CoV-2 S-RBD binding antibodies in infected individuals
<h3>Background</h3><p dir="ltr">A vast majority of the commercially available lateral flow immunoassay (LFIA) is used to detect SARS-CoV-2 antibodies qualitatively. Recently, a novel fluorescence-based lateral flow immunoassay (LFIA) test was developed for quantitative me...
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2022
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| Summary: | <h3>Background</h3><p dir="ltr">A vast majority of the commercially available lateral flow immunoassay (LFIA) is used to detect SARS-CoV-2 antibodies qualitatively. Recently, a novel fluorescence-based lateral flow immunoassay (LFIA) test was developed for quantitative measurement of the total binding antibody units (BAUs) (BAU/mL) against SARS-CoV-2 spike protein receptor-binding domain (S-RBD).</p><h3>Aim</h3><p dir="ltr">This study aimed to evaluate the performance of the fluorescence LFIA Finecare<sup>TM</sup> 2019-nCoV S-RBD test along with its reader (Model No.: FS-113).</p><h3>Methods</h3><p dir="ltr">Plasma from 150 reverse trancriptase–PCR (RT-PCR)-confirmed positive individuals and 100 prepandemic samples were tested by Fincare<sup>TM</sup> to access sensitivity and specificity. For qualitative and quantitative validation of the FinCare<sup>TM</sup> measurements, BAU/mL results of FinCare<sup>TM</sup> were compared with results of 2 reference assays: the surrogate virus-neutralizing test (sVNT, GenScript Biotech, USA) and the VIDAS®3 automated assay (BioMérieux, France).</p><h3>Results</h3><p dir="ltr">Finecare<sup>TM</sup> showed 92% sensitivity and 100% specificity compared with PCR. Cohen's Kappa statistic denoted moderate and excellent agreement with sVNT and VIDAS®3, with values being 0.557 (95% CI: 0.32–0.78) and 0.731 (95% CI: 0.51–0.95), respectively. A strong correlation was observed between Finecare<sup>TM</sup>/sVNT (r = 0.7, p < 0.0001) and Finecare<sup>TM/</sup>VIDAS®3 (r = 0.8, p < 0.0001).</p><h3>Conclusion</h3><p dir="ltr">Finecare<sup>TM</sup> is a reliable assay and can be used as a surrogate to assess binding and neutralizing antibody response after infection or vaccination, particularly in none or small laboratory settings.</p><h2>Other Information</h2><p dir="ltr">Published in: International Journal of Infectious Diseases<br>License: <a href="http://creativecommons.org/licenses/by/4.0/" target="_blank">http://creativecommons.org/licenses/by/4.0/</a><br>See article on publisher's website: <a href="https://dx.doi.org/10.1016/j.ijid.2022.02.052" target="_blank">https://dx.doi.org/10.1016/j.ijid.2022.02.052</a></p> |
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