Establishment and validation of a high‐throughput micro‐neutralization assay for respiratory syncytial virus (subtypes A and B)

Author:

Bonifazi Carolina12,Trombetta Claudia Maria13ORCID,Barneschi Irene2,Latanza Simona2,Leopoldi Sara2,Benincasa Linda3,Leonardi Margherita23,Semplici Claudia2,Piu Pietro2,Marchi Serena1ORCID,Montomoli Emanuele123ORCID,Manenti Alessandro2

Affiliation:

1. Department of Molecular and Developmental Medicine University of Siena Siena Italy

2. VisMederi S.r.l. Siena Italy

3. VisMederi Research S.r.l. Siena Italy

Abstract

AbstractThe 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 quantification 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, only one vaccine has been recently approved. The aim of this paper is to provide a detailed validation process for the microneutralization assay and to demonstrate that this method can effectively support the efficacy assessment of candidate vaccines and the definition of correlates of protection.

Publisher

Wiley

Subject

Infectious Diseases,Virology

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