Biodata has announced the launch of VW Select, an all-in-one Ristocetin Cofactor Assay that measures the functional activity of the von Willebrand Factor.
The assay system includes all the reagents, control plasma, reference plasma and diluents required to construct a standard reference curve and determine the Ristocetin Cofactor Activity in patient samples.
Assay components are formulated, optimised and performance-tested as a system to ensure that linear standard reference curves are easy to achieve and test results are consistent, reliable and available quickly.
VW Select is manufactured, validated and performance-tested under USFDA Quality System Regulations as well as the ISO 13485:2003 (Medical Device) Quality Management System Standard.
This simplifies test implementation and CLIA compliance, while eliminating the onerous regulatory mandates for homebrew or lab-developed tests.
The analytical variability of existing Ristocetin Cofactor test systems is high at 30 per cent, and inter-laboratory variability is about the same.
Random combinations of Ristocetin reagents, general-purpose control and reference plasmas, buffers and diluents are primary contributors to this variability.
The matched components in each VW Select kit have been selected, tested and optimised to meet published guidelines by improving overall assay system performance and reducing analytical variability.
VW Select addresses the clinical laboratory's need for a complete, accurate and cost-effective test system for the detection, diagnosis and management of von Willebrand disease.
For a limited time, Biodata is offering free samples of VW Select to qualified laboratories.
Submit an online request for a free sample and please mention Laboratorytalk.
