Virus reduction neutralization test and LI-COR microneutralization assay bridging and WHO international standard calibration studies for respiratory syncytial virus
Dengyun Sun , Ying X Homan, Joseph M Antonello, et al. | Bioanalysis, 14(15), 1067-1079, (2022)
Keywords: • bridging study • calibration study • microneutralization assay • respiratory syncytial virus • virus reduction neutralization test • WHO international standard
Background: Respiratory syncytial virus (RSV) vaccine is an unmet medical need. The virus reduction neutralization test (VRNT) was developed to replace the LI-COR microneutralization assay to measure RSV neutralization titers. Methods: A bridging study using selected V171 phase I samples and calibration studies using the WHO international standard antiserum to RSV were performed to compare VRNT and LI-COR. Results: From the bridging study, we showed good concordance between VRNT and LI-COR titers, and similar post-/prevaccination titer ratios. From the calibration studies, we can convert VRNT and LI-COR titers into similar IU/ml. Conclusion: The VRNT and LI-COR microneutralization assay correlate well and the titers can be standardized as similar IU/ml, enabling direct comparison of titers from different assays.
