vW Select Significantly Reduces Laboratory Variability and Provides Clinicians with More Reliable Test Results
HORSHAM, Pa., June 30 /PRNewswire/ -- Today, Bio/Data Corporation announced the launch of vW Select(TM), the world's first all-in-one Ristocetin CoFactor Assay. vW Select is the first and only complete assay that measures the functional activity of the von Willebrand Factor. A deficiency of von Willebrand Factor causes von Willebrand Disease -- the world's most common bleeding disorder.
This new 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, optimized and performance tested as a system to assure 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 -- 30%, 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 these variabilities. The matched components in each vW Select kit have been selected, tested and optimized to meet current 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
|SOURCE Bio/Data Corporation|
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