The development and validation of a microneutralization assay for the detection and quantification of anti-yellow fever virus antibodies in human serum

With increased globalization and shifting climate patterns, yellow fever (YF) is re-emerging as a global threat. At present, vaccination remains the most effective prevention strategy. This study describes the development and validation of a new YF microneutralization (MN) assay for the detection and quantification of YF virus-neutralizing antibodies in human serum that offers increased throughput compared with the current standard assay. Overall, the YF MN assay demonstrated acceptable intra-assay precision (repeatability), intermediate precision, dilutional accuracy, linearity, and specificity and is suitable for the detection of YF virus-neutralizing antibodies. Further, the Center for Biologics Evaluation and Research (CBER) supports the use of the YF MN assay in the licensure of candidate YF vaccines.