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Exploring SARS-CoV-2 Neutralization Assays in Clinical Trials: A Comprehensive Narrative Review

Abstract

Ziyao Zhao

The emergence of SARS-CoV-2 has spurred global efforts to develop effective vaccines and therapeutics to combat COVID-19. Critical to this endeavor is the evaluation of interventions' ability to neutralize the virus, a task accomplished through neutralization assays. This narrative review examines the diverse neutralization assays utilized in clinical trials targeting SARS-CoV-2. These assays, ranging from plaque reduction to pseudovirus and live virus assays, offer distinct advantages and considerations in terms of safety, sensitivity, and scalability. Employed in trials assessing vaccines, monoclonal antibodies, convalescent plasma, and antiviral drugs, neutralization assays provide crucial data on interventions' ability to induce neutralizing immunity, guide dose selection, assess treatment efficacy, and inform regulatory decisions. Despite their utility, challenges such as assay variability, standardization, and the emergence of viral variants persist, necessitating collaborative efforts to address these issues. Overall, neutralization assays play an indispensable role in advancing our understanding of COVID-19 interventions and guiding strategies to combat the pandemic. Continued research and standardization endeavors are imperative to optimize their performance and utility in the fight against SARS-CoV-2 and future viral threats.

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