Towards Quantitative and Standardized Serological and Neutralization Assays for COVID-19

迈向新冠病毒定量和标准化血清学及中和试验

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作者:Linhua Tian ,Elzafir B Elsheikh ,Paul N Patrone ,Anthony J Kearsley ,Adolfas K Gaigalas ,Sarah Inwood ,Sheng Lin-Gibson ,Dominic Esposito ,Lili Wang

Abstract

Quantitative and robust serology assays are critical measurements underpinning global COVID-19 response to diagnostic, surveillance, and vaccine development. Here, we report a proof-of-concept approach for the development of quantitative, multiplexed flow cytometry-based serological and neutralization assays. The serology assays test the IgG and IgM against both the full-length spike antigens and the receptor binding domain (RBD) of the spike antigen. Benchmarking against an RBD-specific SARS-CoV IgG reference standard, the anti-SARS-CoV-2 RBD antibody titer was quantified in the range of 37.6 µg/mL to 31.0 ng/mL. The quantitative assays are highly specific with no correlative cross-reactivity with the spike proteins of MERS, SARS1, OC43 and HKU1 viruses. We further demonstrated good correlation between anti-RBD antibody titers and neutralizing antibody titers. The suite of serology and neutralization assays help to improve measurement confidence and are complementary and foundational for clinical and epidemiologic studies.

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