title: Virus assay methods: accuracy and validation.
abstract: Assay validation is the characterization of assay performance that allows the significance of the values obtained in an assay to be evaluated. Biological assays have several inherent sources of variation and this has been used as an excuse for years to explain unexpected or unanticipated results. However, with careful control of reagents and strictly controlled procedures, biological assays can be successfully validated to allow accurate quantitation and interpretation of the result obtained.
authors.affiliation: MA BioServices Inc., 9900 Blackwell Road, Rockville, MD 20850, USA.
authors.forename: A J
authors.initials: AJ
authors.lastname: Darling
authors.forename: J A
authors.initials: JA
authors.lastname: Boose
authors.forename: J
authors.initials: J
authors.lastname: Spaltro
mesh_terms: D000818:Animals; D001681:Biological Assay / Q000379:methods* / Q000592:standards / Q000706:statistics & numerical data; D006801:Humans; D011786:Quality Control; D015203:Reproducibility of Results; D014481:United States; D014486:United States Food and Drug Administration; D014773:Virology / Q000379:methods* / Q000592:standards / Q000706:statistics & numerical data; D014780:Viruses / Q000302:isolation & purification*