Clinical validation of SARS-CoV-2 electrochemical immunosensor based on the spike-ACE2 complex

Viviana Vásquez; Jahir Orozco

doi:10.1016/j.jviromet.2024.114940

Clinical validation of SARS-CoV-2 electrochemical immunosensor based on the spike-ACE2 complex

J Virol Methods. 2024 Apr 10:327:114940. doi: 10.1016/j.jviromet.2024.114940. Online ahead of print.

Authors

Viviana Vásquez¹, Jahir Orozco²

Affiliations

¹ Max Planck Tandem Group in Nanobioengineering. Institute of Chemistry, Faculty of Natural and Exact Sciences, University of Antioquia, Complejo Ruta N, Calle 67 Nº 52-20, Medellín 050010, Colombia.
² Max Planck Tandem Group in Nanobioengineering. Institute of Chemistry, Faculty of Natural and Exact Sciences, University of Antioquia, Complejo Ruta N, Calle 67 Nº 52-20, Medellín 050010, Colombia. Electronic address: grupotandem.nanobioe@udea.edu.co.

PMID: 38608761
DOI: 10.1016/j.jviromet.2024.114940

Abstract

Background and aims: Advances in health, especially in prevention, diagnosis, and treatment, have significantly impacted the way of facing emerging infectious diseases. Yet, events such as the COVID-19 pandemic have shown that there is still a long way to go. Therefore, an urgent need exists for portable and easily deployable point-of-care (POC) detection tools. Biosensors at the POC remain in the laboratory in an analytical characterization step and are not yet mature enough to reach the market massively. In this context, it is necessary to progress in validating these devices to demonstrate their relevance in detecting different disease biomarkers. This work reports on the clinical validation of an electrochemical immunosensor for detecting SARS-CoV-2.

Methods: A monocentric retrospective cohort study was conducted with 150 random nasopharyngeal swabs or tracheal aspiration samples tested by RT-PCR. The immunosensor based on magnetic beads and chronoamperometry detected SARS-CoV-2 through the spike-angiotensin-converting protein (ACE2) immunocomplex.

Results: This biosensor demonstrated 96.04 % clinical sensitivity and 87.75 % clinical specificity in detecting SARS-CoV-2 in the samples, highly correlated with the RT-PCR gold standard.

Conclusions: It demonstrates the potential of electrochemical biosensors to be implemented as highly sensitive and easily deployable detection strategies even in remote locations.

Keywords: Clinical validation; Electrochemical biosensor; Immunosensor; Magnetic bead; SARS-CoV-2; Spike protein.