A cell-based ELISA as surrogate of virus neutralization assay for RBD SARS-CoV-2 specific antibodies

基于细胞的 ELISA 作为 RBD SARS-CoV-2 特异性抗体病毒中和试验的替代方法

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作者:Franciscary Pi-Estopiñan, María Teresa Pérez, Anitza Fraga, Gretchen Bergado, Geidy D Díaz, Ivette Orosa, Marianniz Díaz, Joaquín Antonio Solozábal, Laura Marta Rodríguez, Dagmar Garcia-Rivera, Consuelo Macías, Yanet Jerez, Ana V Casadesús, Briandy Fernández-Marrero, Ernesto Bermúdez, Claudia A Plas

Abstract

SARS-CoV-2, the cause of the COVID-19 pandemic, has provoked a global crisis and death of millions of people. Several serological assays to determine the quality of the immune response against SARS-CoV-2 and the efficacy of vaccines have been developed, among them the gold standard conventional virus neutralization assays. However, these tests are time consuming, require biosafety level 3 (BSL3), and are low throughput and expensive. This has motivated the development of alternative methods, including molecular inhibition assays. Herein, we present a safe cell-based ELISA-virus neutralization test (cbE-VNT) as a surrogate for the conventional viral neutralization assays that detects the inhibition of SARS-CoV-2 RBD binding to ACE2-bearing cells independently of species. Our test shows a very good correlation with the conventional and molecular neutralization assays and achieves 100% specificity and 95% sensitivity. cbE-VNT is cost-effective, fast and enables a large-scale serological evaluation that can be performed in a BSL2 laboratory, allowing its use in pre-clinical and clinical investigations.

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