title: Analytic variability due to change of deficient plasma vials: application to one-stage clotting factor VIII assay.
abstract: The statistical process control required under International Organization for Standardization 15189 as well as economic considerations necessitates having robust methods that do not need systematic recalibration for each series of analyses. Using the concrete example of one-stage clotting factor VIII assay, we assessed the analytic variability specifically linked to changing factor VIII deficient plasma vials. The study used freeze-dried (Instrumentation Laboratory, Siemens, Stago and T-Coag) and frozen (Affinity Biologicals and Precision Biologic) factor VIII deficient plasmas. On the most widely recognized acceptability criteria and methods (i.e. those of Kallner et al. and Kasper et al.), the Stago and Instrumentation Laboratory plasmas require systematic recalibration at each vial changeover.
authors.affiliation: Hemostasis Laboratory, Edouard Herriot Hospital, Lyon, France.
authors.forename: Christophe
authors.initials: C
authors.lastname: Nougier
authors.forename: Frédéric
authors.initials: F
authors.lastname: Sobas
authors.forename: Thi K
authors.initials: TK
authors.lastname: Nguyen
authors.forename: Marie L
authors.initials: ML
authors.lastname: Carage
authors.forename: Anne
authors.initials: A
authors.lastname: Lienhart
authors.forename: Claude
authors.initials: C
authors.lastname: Négrier
mesh_terms: D001681:Biological Assay / Q000592:standards*; D001777:Blood Coagulation; D001780:Blood Coagulation Tests / Q000592:standards*; D002138:Calibration; D005069:Evaluation Studies as Topic; D005169:Factor VIII / Q000032:analysis / Q000592:standards*; D005612:Freeze Drying; D017408:Guidelines as Topic; D006467:Hemophilia A / Q000097:blood; D006801:Humans; D010949:Plasma / Q000737:chemistry; D015203:Reproducibility of Results
chemical_list: D005169:Factor VIII