title: Validation of Single Radial Haemolysis assay: A reliable method to measure antibodies against influenza viruses.
abstract: The Single Radial Haemolysis (SRH) assay is a serological method widely used for measuring antibodies against influenza viruses. Despite the broad application and recommendation by licensing authorities, the SRH assay has not been standardized. The aim of this study is to demonstrate how the SRH assay satisfies validation parameters of regulatory agencies in terms of specificity, precision, repeatability, intermediate precision, linearity, accuracy and robustness. This study shows that the SRH is a rapid, simple, reliable and reproducible assay, which requires only small volumes of serum samples and can be easily standardized.
authors.affiliation: Department of Molecular and Developmental Medicine, University of Siena, Via Aldo Moro, 53100 Siena, Italy.
authors.forename: Claudia Maria
authors.initials: CM
authors.lastname: Trombetta
authors.affiliation: VisMederi srl, Enterprise in Life Science, Via Fiorentina 1, 53100 Siena, Italy.
authors.forename: Daniele
authors.initials: D
authors.lastname: Perini
authors.affiliation: VisMederi srl, Enterprise in Life Science, Via Fiorentina 1, 53100 Siena, Italy.
authors.forename: Licia
authors.initials: L
authors.lastname: Vitale
authors.affiliation: The Influenza Centre, Department of Clinical Sciences, University of Bergen, Bergen, Norway; Jebsen Centre for Influenza Vaccine Research, University of Bergen, Bergen, Norway; Department of Research and Development, Haukeland University Hospital, Bergen, Norway.
authors.forename: Rebecca Jane
authors.initials: RJ
authors.lastname: Cox
authors.affiliation: VisMederi srl, Enterprise in Life Science, Via Fiorentina 1, 53100 Siena, Italy.
authors.forename: Valerio
authors.initials: V
authors.lastname: Stanzani
authors.affiliation: VisMederi srl, Enterprise in Life Science, Via Fiorentina 1, 53100 Siena, Italy.
authors.forename: Simona
authors.initials: S
authors.lastname: Piccirella
authors.affiliation: Department of Molecular and Developmental Medicine, University of Siena, Via Aldo Moro, 53100 Siena, Italy; VisMederi srl, Enterprise in Life Science, Via Fiorentina 1, 53100 Siena, Italy. Electronic address: emanuele.montomoli@unisi.it.
authors.forename: Emanuele
authors.initials: E
authors.lastname: Montomoli
mesh_terms: D000293:Adolescent; D000328:Adult; D000914:Antibodies, Viral / Q000097:blood* / Q000276:immunology; D006462:Hemolytic Plaque Technique / Q000379:methods; D006801:Humans; D007074:Immunoglobulin G / Q000097:blood / Q000276:immunology; D053118:Influenza A Virus, H1N1 Subtype / Q000276:immunology*; D053122:Influenza A Virus, H3N2 Subtype / Q000276:immunology*; D053124:Influenza A Virus, H5N1 Subtype / Q000276:immunology*; D009981:Influenza B virus / Q000276:immunology*; D008875:Middle Aged; D012680:Sensitivity and Specificity; D055815:Young Adult
chemical_list: D000914:Antibodies, Viral; D007074:Immunoglobulin G
keywords: SRH assay; Validation parameters.