title: Biological diagnosis of von Willebrand disease: analytical characteristics of Innovance vWF:Ac assay kit on STA-R Evolution Expert series analyzer (Stago).
abstract: The Innovance VWF:Ac test (Siemens) has the particularity to assess the binding capacity of von Willebrand factor (VWF) to recombinant platelet GPIb mutated in the absence of ristocetin. Our study aimed to evaluate and validate according to standard NF EN ISO 15189 the original protocol adaptation on STA-R Evolution series analyser (Diagnostica Stago). We evaluated the performance in terms of imprecision and we validate additional parameters necessary in range B as recommended by the SH GTA 04 (Cofrac). We compared the new assay with the reference assay: ristocetin cofactor activity (VWF:RCo) performed on the BCS-XP analyser by testing retrospectively samples from 82 healthy normal subjects and 61 patients with von Willebrand disease (VWD). This new assay is consistent with objectives set in terms of imprecision with CV around 4%. Excepted limit of quantification higher, additional parameters evaluated in range B have been validated. The Innovance VWF: Ac assay allowed the detection of all deficits of VWF already detected by the VWF:RCo test on the BCS-XP. This adjustment on STA-R analyser therefore has satisfactory analytical performance criteria. Apart from the limit of quantification, this reagent can be used according to the recommendations specified in the original protocol adaptation. Its performance and compatibility with the spot measurement allow the diagnosis and therapeutic monitoring of VWD according to current requirements and guidelines.
authors.affiliation: Laboratoire d'hématologie, CHU de Saint-Étienne, France.
authors.forename: Cécile
authors.initials: C
authors.lastname: Florin
authors.affiliation: EFS Loire-Auvergne, CHU de Saint-Étienne, France.
authors.forename: Olivier
authors.initials: O
authors.lastname: Garraud
authors.affiliation: Département d'anesthésie, CHU de Saint-Étienne, France.
authors.forename: Serge
authors.initials: S
authors.lastname: Molliex
authors.affiliation: Laboratoire d'hématologie, CHU de Saint-Étienne, France.
authors.forename: Brigitte
authors.initials: B
authors.lastname: Tardy
authors.affiliation: Laboratoire d'hématologie, CHU de Saint-Étienne, France.
authors.forename: Lydia
authors.initials: L
authors.lastname: Campos
authors.affiliation: Laboratoire d'hématologie, CHU de Saint-Étienne, France.
authors.forename: Carine
authors.initials: C
authors.lastname: Scherrer
mesh_terms: D057205:Automation, Laboratory; D001681:Biological Assay / Q000295:instrumentation / Q000379:methods / Q000592:standards; D001774:Blood Chemical Analysis / Q000295:instrumentation / Q000379:methods / Q000592:standards; D016022:Case-Control Studies; D004866:Equipment Contamination; D006801:Humans; D057230:Limit of Detection; D015203:Reproducibility of Results; D012189:Retrospective Studies; D012680:Sensitivity and Specificity; D014842:von Willebrand Diseases / Q000175:diagnosis*; D014841:von Willebrand Factor / Q000032:analysis*
chemical_list: D014841:von Willebrand Factor
keywords: NF EN 15189; Willebrand activity assay; analytical validation; ristocetin cofactor activity; von Willebrand disease