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© 2023 by the authors. Licensee MDPI, Basel, Switzerland. This article is an open access article distributed under the terms and conditions of the Creative Commons Attribution (CC BY) license (https://creativecommons.org/licenses/by/4.0/). Notwithstanding the ProQuest Terms and Conditions, you may use this content in accordance with the terms of the License.

Abstract

COVID-19 has highlighted challenges in the measurement quality and comparability of serological binding and neutralization assays. Due to many different assay formats and reagents, these measurements are known to be highly variable with large uncertainties. The development of the WHO international standard (WHO IS) and other pool standards have facilitated assay comparability through normalization to a common material but does not provide assay harmonization nor uncertainty quantification. In this paper, we present the results from an interlaboratory study that led to the development of (1) a novel hierarchy of data analyses based on the thermodynamics of antibody binding and (2) a modeling framework that quantifies the probability of neutralization potential for a given binding measurement. Importantly, we introduced a precise, mathematical definition of harmonization that separates the sources of quantitative uncertainties, some of which can be corrected to enable, for the first time, assay comparability. Both the theory and experimental data confirmed that mAbs and WHO IS performed identically as a primary standard for establishing traceability and bridging across different assay platforms. The metrological anchoring of complex serological binding and neuralization assays and fast turn-around production of an mAb reference control can enable the unprecedented comparability and traceability of serological binding assay results for new variants of SARS-CoV-2 and immune responses to other viruses.

Details

Title
Monoclonal Antibodies as SARS-CoV-2 Serology Standards: Experimental Validation and Broader Implications for Correlates of Protection
Author
Wang, Lili 1   VIAFID ORCID Logo  ; Patrone, Paul N 2 ; Kearsley, Anthony J 2 ; Izac, Jerilyn R 1   VIAFID ORCID Logo  ; Gaigalas, Adolfas K 1 ; Prostko, John C 3 ; Kwon, Hyung Joon 4 ; Tang, Weichun 4 ; Kosikova, Martina 4 ; Xie, Hang 4   VIAFID ORCID Logo  ; Tian, Linhua 1   VIAFID ORCID Logo  ; Elsheikh, Elzafir B 1 ; Kwee, Edward J 1   VIAFID ORCID Logo  ; Kemp, Troy 5 ; Jochum, Simon 6 ; Thornburg, Natalie 7   VIAFID ORCID Logo  ; McDonald, L Clifford 7   VIAFID ORCID Logo  ; Gundlapalli, Adi V 7 ; Lin-Gibson, Sheng 1 

 Biosystems and Biomaterials Division, National Institute of Standards and Technology (NIST), Gaithersburg, MD 20899, USA; [email protected] (J.R.I.); [email protected] (A.K.G.); [email protected] (L.T.); [email protected] (E.B.E.); [email protected] (E.J.K.) 
 Applied and Computational Mathematics Division, National Institute of Standards and Technology (NIST), Gaithersburg, MD 20899, USA; [email protected] (P.N.P.); [email protected] (A.J.K.) 
 Abbott Laboratories, Abbott Park, IL 60064, USA; [email protected] 
 Laboratory of Pediatric and Respiratory Viral Diseases, Office of Vaccines Research and Review, Center for Biologics Evaluation, Food and Drug Administration (FDA), Silver Spring, MD 20993, USA; [email protected] (H.J.K.); [email protected] (W.T.); [email protected] (M.K.); [email protected] (H.X.) 
 Vaccine, Immunity and Cancer Directorate, Frederick National Laboratory for Cancer Research (FNLCR), Frederick, MD 21702, USA; [email protected] 
 Roche Diagnostics GmbH, 82377 Penzberg, Germany; [email protected] 
 Centers for Disease Control and Prevention (CDC), Atlanta, GA 30329, USA; [email protected] (N.T.); [email protected] (L.C.M.); [email protected] (A.V.G.) 
First page
15705
Publication year
2023
Publication date
2023
Publisher
MDPI AG
ISSN
16616596
e-ISSN
14220067
Source type
Scholarly Journal
Language of publication
English
ProQuest document ID
2888205758
Copyright
© 2023 by the authors. Licensee MDPI, Basel, Switzerland. This article is an open access article distributed under the terms and conditions of the Creative Commons Attribution (CC BY) license (https://creativecommons.org/licenses/by/4.0/). Notwithstanding the ProQuest Terms and Conditions, you may use this content in accordance with the terms of the License.