Version 1
: Received: 1 December 2023 / Approved: 4 December 2023 / Online: 4 December 2023 (03:43:14 CET)
How to cite:
Hamilton, S.; Zhu, M.; Clark, S.C.; Mayes, P.; Fenner, J.; Cui, L.; Cai, R.; Kalkeri, R.; Fries, L.F.; Pryor, M.; Plested, J. Validation of a Severe Acute Respiratory Syndrome Coronavirus 2 Microneutralization Assay for Evaluation of Vaccine Immunogenicity. Preprints2023, 2023120120. https://doi.org/10.20944/preprints202312.0120.v1
Hamilton, S.; Zhu, M.; Clark, S.C.; Mayes, P.; Fenner, J.; Cui, L.; Cai, R.; Kalkeri, R.; Fries, L.F.; Pryor, M.; Plested, J. Validation of a Severe Acute Respiratory Syndrome Coronavirus 2 Microneutralization Assay for Evaluation of Vaccine Immunogenicity. Preprints 2023, 2023120120. https://doi.org/10.20944/preprints202312.0120.v1
Hamilton, S.; Zhu, M.; Clark, S.C.; Mayes, P.; Fenner, J.; Cui, L.; Cai, R.; Kalkeri, R.; Fries, L.F.; Pryor, M.; Plested, J. Validation of a Severe Acute Respiratory Syndrome Coronavirus 2 Microneutralization Assay for Evaluation of Vaccine Immunogenicity. Preprints2023, 2023120120. https://doi.org/10.20944/preprints202312.0120.v1
APA Style
Hamilton, S., Zhu, M., Clark, S.C., Mayes, P., Fenner, J., Cui, L., Cai, R., Kalkeri, R., Fries, L.F., Pryor, M., & Plested, J. (2023). Validation of a Severe Acute Respiratory Syndrome Coronavirus 2 Microneutralization Assay for Evaluation of Vaccine Immunogenicity. Preprints. https://doi.org/10.20944/preprints202312.0120.v1
Chicago/Turabian Style
Hamilton, S., Melinda Pryor and Joyce Plested. 2023 "Validation of a Severe Acute Respiratory Syndrome Coronavirus 2 Microneutralization Assay for Evaluation of Vaccine Immunogenicity" Preprints. https://doi.org/10.20944/preprints202312.0120.v1
Abstract
As variants of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) continue to emerge, assessment of vaccine immunogenicity remains a critical factor to support continued vaccination. To this end, an in vitro microneutralization (MN50) assay was validated to quantitate SARS-CoV-2 neutralizing antibodies against ancestral and variant strains (Beta, Delta, Omicron BA.1, Omicron BA.5 and XBB.1.5) in human serum. For ancestral strain, the MN50 assay met acceptance criteria for inter-/intra-assay precision, specificity, linearity, and selectivity. The assay was robust against changes to virus/serum incubation time, cell seeding density, virus content per well, cell passage number, and serum interference. Analyte in serum samples was stable up to 5 freeze/thaw cycles and for up to 12 months of storage at –80 ± 10 °C. Similar results were observed for the variant-adapted MN50 assays. The conversion factor to convert assay result units to WHO international standard units (IU/mL) was determined to be 0.62 for the ancestral prototype strain. This MN50 assay will be useful for vaccine immunogenicity analyses in clinical trial samples, enabling assessment of vaccine immunogenicity for ancestral and variant strains as variant-adapted vaccines are developed.
Keywords
microneutralization; COVID-19; Omicron variant; wildtype; Live virus,; XBB.1.5; MN50; SARS CoV-2; variants of concern; BSL-3
Subject
Biology and Life Sciences, Virology
Copyright:
This is an open access article distributed under the Creative Commons Attribution License which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.
