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Anal Chem . Label-Free Plasmonic Biosensor for Rapid, Quantitative, and Highly Sensitive COVID-19 Serology: Implementation and Clinical Validation

tetano

Editor, Senior Moderator
Anal Chem


. 2021 Dec 31.
doi: 10.1021/acs.analchem.1c03850. Online ahead of print.
Label-Free Plasmonic Biosensor for Rapid, Quantitative, and Highly Sensitive COVID-19 Serology: Implementation and Clinical Validation


Olalla Calvo-Lozano[SUP] 1 [/SUP], Miquel Sierra[SUP] 1 [/SUP], Maria Soler[SUP] 1 [/SUP], Maria Carmen Estévez[SUP] 1 [/SUP], Luis Chiscano-Camón[SUP] 2 3 [/SUP], Adolfo Ruiz-Sanmartin[SUP] 2 3 [/SUP], Juan Carlos Ruiz-Rodriguez[SUP] 2 3 [/SUP], Ricard Ferrer[SUP] 2 3 [/SUP], Juan José González-López[SUP] 4 5 6 [/SUP], Juliana Esperalba[SUP] 4 5 [/SUP], Candela Fernández-Naval[SUP] 4 5 [/SUP], Leticia Bueno[SUP] 7 8 9 [/SUP], Ruben López-Aladid[SUP] 7 8 9 [/SUP], Antoni Torres[SUP] 7 8 9 [/SUP], Laia Fernández-Barat[SUP] 7 8 9 [/SUP], Sarah Attoumani[SUP] 10 [/SUP], Rémi Charrel[SUP] 10 [/SUP], Bruno Coutard[SUP] 10 [/SUP], Laura M Lechuga[SUP] 1 [/SUP]



Affiliations

Abstract

Serological tests are essential for the control and management of COVID-19 pandemic (diagnostics and surveillance, and epidemiological and immunity studies). We introduce a direct serological biosensor assay employing proprietary technology based on plasmonics, which offers rapid (<15 min) identification and quantification of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) antibodies in clinical samples, without signal amplification. The portable plasmonic device employs a custom-designed multiantigen (RBD peptide and N protein) sensor biochip and reaches detection limits in the low ng mL[SUP]-1[/SUP] range employing polyclonal antibodies. It has also been implemented employing the WHO-approved anti-SARS-CoV-2 immunoglobulin standard. A clinical validation with COVID-19 positive and negative samples (n = 120) demonstrates its excellent diagnostic sensitivity (99%) and specificity (100%). This positions our biosensor as an accurate and easy-to-use diagnostics tool for rapid and reliable COVID-19 serology to be employed both at laboratory and decentralized settings for the disease management and for the evaluation of immunological status during vaccination or treatment.
 
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