Standardization of two SARS-CoV-2 serology assays to the WHO 20/136 human standard reference material

James Freeman; Justin Conklin

doi:10.1016/j.jviromet.2021.114430

Standardization of two SARS-CoV-2 serology assays to the WHO 20/136 human standard reference material

J Virol Methods. 2022 Feb:300:114430. doi: 10.1016/j.jviromet.2021.114430. Epub 2021 Dec 13.

Authors

James Freeman¹, Justin Conklin²

Affiliations

¹ Siemens Healthineers, Tarrytown, New York, United States. Electronic address: james.freeman@siemens-healthineers.com.
² Siemens Healthineers, Tarrytown, New York, United States.

Abstract

WHO 20/136 is standard reference material for SARS-COV-2 serology assays. Standardization of serology assays that target the same antigen and class of immunoglobulin will enable comparison of results between studies that use various lab-developed and commercial assays around the world. Standardization of assays will help better define immune correlates of protection and possibly immune correlates of vaccine efficacy. Two automated SARS-COV-2 anti-S1 RBD immunoglobulin serology assays on the Atellica IM Analyzer were calibrated to WHO 20/136 Standard Reference Material which was assigned 1000 binding antibody units (BAU/mL). The anti-S1 RBD IgG assay (sCOVG) cut-off Index of 1.00 corresponded to WHO 45.1 BAU/mL, and the anti-S1 RBD Ig Total assay (COV2T) cut-off Index of 1.00 corresponded to WHO 6.70 BAU/mL.

Keywords: Antibody; Atellica IM Analyzer; COVID-19; SARS-CoV-2; Serology reference material; WHO 20/136.

Publication types

Research Support, Non-U.S. Gov't

MeSH terms

Antibodies, Viral
COVID-19*
Humans
Immunoglobulin G
Reference Standards
SARS-CoV-2*
Vaccine Efficacy
World Health Organization

Substances

Antibodies, Viral
Immunoglobulin G