Harmonization of Multiple SARS-CoV-2 Reference Materials Using the WHO IS (NIBSC 20/136): Results and Implications

作者：William Windsor, Yannik Roell, Heidi R. Tucker, Chi‐An Cheng, Sara Suliman, Laura J. Peek, Gary A. Pestano, William T. Lee, Heinz Zeichhardt, Molly M. Lamb, Martin Kammel, Hui Wang, Ross M. Kedl, Cody Rester, Thomas E. Morrison, Bennet J. Davenport, Kyle Carson, Jennifer L. Yates, Kelly M. Howard, Karen E. Kulas, David R. Walt, Aner Dafni, Daniel Taylor, May Chu · 发表于：Frontiers in Microbiology · 年份：2022 · DOI：10.3389/fmicb.2022.893801 · 被引用次数：15 · 研究领域：SARS-CoV-2 detection and testing、SARS-CoV-2 and COVID-19 Research、COVID-19 Clinical Research Studies

Background: There is an urgent need for harmonization between severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) serology platforms and assays prior to defining appropriate correlates of protection and as well inform the development of new rapid diagnostic tests that can be used for serosurveillance as new variants of concern (VOC) emerge. We compared multiple SARS-CoV-2 serology reference materials to the WHO International Standard (WHO IS) to determine their utility as secondary standards, using an international network of laboratories with high-throughput quantitative serology assays. This enabled the comparison of quantitative results between multiple serology platforms. Methods: Between April and December 2020, 13 well-characterized and validated SARS-CoV-2 serology reference materials were recruited from six different providers to qualify as secondary standards to the WHO IS. All the samples were tested in parallel with the National Institute for Biological Standards and Control (NIBSC) 20/136 and parallel-line assays were used to calculate the relevant potency and binding antibody units. Results: All the samples saw varying levels of concordance between diagnostic methods at specific antigen-antibody combinations. Seven of the 12 candidate materials had high concordance for the spike-immunoglobulin G (IgG) analyte [percent coefficient of variation (%CV) between 5 and 44%]. Conclusion: Despite some concordance between laboratories, qualification of secondary m...