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

Olalla Calvo-LozanoMiquel SierraMaria SolerMaria Carmen EstevezLuis Chiscano-CamónAdolfo Ruiz-SanmartinJuan Carlos Ruiz-RodriguezRicard FerrerJuan José González-LópezJuliana EsperalbaCandela Fernández-NavalLeticia BuenoRuben López-AladidAntoni TorresLaia Fernández-BaratSarah AttoumaniRémi CharrelBruno CoutardLaura M Lechuga
Published in: Analytical chemistry (2021)
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 -1 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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