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Article

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

1
Biosystems and Biomaterials Division, National Institute of Standards and Technology (NIST), Gaithersburg, MD 20899, USA
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Applied and Computational Mathematics Division, NIST, Gaithersburg, MD 20899, USA
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Frederick National Laboratory for Cancer Research (FNLCR), Frederick, MD 21702, USA
*
Author to whom correspondence should be addressed.
Academic Editor: Anatoly V Zherdev
Int. J. Mol. Sci. 2021, 22(5), 2723; https://doi.org/10.3390/ijms22052723
Received: 20 February 2021 / Revised: 4 March 2021 / Accepted: 5 March 2021 / Published: 8 March 2021
(This article belongs to the Special Issue New Receptor Molecules: Design, Obtaining and Analytical Use)
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. View Full-Text
Keywords: SARS-CoV-2 virus; quantitative serology assays; IgG; IgM; spike; RBD; monoclonal antibody reference standard; neutralization assay; cross reactivity; sensitivity and specificity SARS-CoV-2 virus; quantitative serology assays; IgG; IgM; spike; RBD; monoclonal antibody reference standard; neutralization assay; cross reactivity; sensitivity and specificity
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MDPI and ACS Style

Tian, L.; Elsheikh, E.B.; Patrone, P.N.; Kearsley, A.J.; Gaigalas, A.K.; Inwood, S.; Lin-Gibson, S.; Esposito, D.; Wang, L. Towards Quantitative and Standardized Serological and Neutralization Assays for COVID-19. Int. J. Mol. Sci. 2021, 22, 2723. https://doi.org/10.3390/ijms22052723

AMA Style

Tian L, Elsheikh EB, Patrone PN, Kearsley AJ, Gaigalas AK, Inwood S, Lin-Gibson S, Esposito D, Wang L. Towards Quantitative and Standardized Serological and Neutralization Assays for COVID-19. International Journal of Molecular Sciences. 2021; 22(5):2723. https://doi.org/10.3390/ijms22052723

Chicago/Turabian Style

Tian, Linhua, Elzafir B. Elsheikh, Paul N. Patrone, Anthony J. Kearsley, Adolfas K. Gaigalas, Sarah Inwood, Sheng Lin-Gibson, Dominic Esposito, and Lili Wang. 2021. "Towards Quantitative and Standardized Serological and Neutralization Assays for COVID-19" International Journal of Molecular Sciences 22, no. 5: 2723. https://doi.org/10.3390/ijms22052723

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