Establishment and validation of a High-throughput Micro-Neutralization assay for Respiratory Syncytial Virus (subtypes A and B)

The validation of a bioanalytical method allows us to determine its validity for a designated purpose and to guarantee the reliability of its analytical results. The virus neutralization assay has proved to be suitable for the detection and quantization of specific serum neutralizing antibodies against respiratory syncytial virus subtypes A and B. Respiratory syncytial virus is a negative-sense RNA virus and is responsible for the majority of acute lower respiratory tract infections in infants and older adults worldwide. Owing to its widespread infection, the WHO considers it a target for the development of preventive vaccines. Despite the high impact of its infections, however, no vaccine candidate is currently available. The aim of this paper is to provide a detailed validation process for the micro-neutralization assay and to demonstrate that this method can effectively support the efficacy assessment of candidate vaccines and the definition of correlates of protection. ### Competing Interest Statement CB, IB, SL, SLE, CS, PP and AM are employed by VisMederi srl. LB and ML are employed by VisMederi Research srl. EM is founder and Chief Scientific Officer of VisMederi srl and VisMederi Research srl. CMT is an external consultant of VisMederi Research srl.