BEDFORD, Mass., Nov. 29, 2011 /PRNewswire/ -- Instrumentation Laboratory (IL) today announced the release of the new HemosIL von Willebrand Factor Ristocetin Cofactor Activity (VWF: RCo) assay as a European CE IVD Mark product under the European Directive on in vitro Diagnostic Medical Devices. It will be commercialized in Europe and other international regions. This new, fully automated VWF: RCo assay is for use on the ACL TOP® Family of Hemostasis Testing Systems. Together with other HemosIL reagents (HemosIL VWF Antigen, HemosIL VWF Activity, and HemosIL FVIII), it aids in the diagnosis and monitoring of von Willebrand Disease (VWD).
Based on new proprietary technology, the assay represents an innovative approach to VWD testing. Demonstrating excellent agreement with existing ristocetin-platelet-based tests, the HemosIL VWF: RCo assay eliminates platelet-associated variability. The result is superior precision. Additionally, variability associated with human interpretation, common with manual testing methods, is eliminated. Moreover, because the assay is automated, liquid and ready-to-use, results are available in minutes and on-demand, 24/7.
"This important new addition to our portfolio of VWF assays will help ensure early diagnosis and proper treatment for patients," said Remo Tazzi, Director, Hemostasis Marketing at IL. "By simplifying and automating a complex procedure, the HemosIL VWF: RCo assay marks a significant improvement in not only the turnaround time for results, but also in accuracy and precision. It is a perfect example of our commitment to providing specialized solutions for disease-state management."
About von Willebrand Disease
VWD is the most common inherited blood disorder, occurring in approximately 1% of the general population. It disrupts the blood's ability to clot properly. Unlike hemophilia, it affects both genders and is caused by a quantitative defect (i.e., VWF level is abnormally low) or a qualitative defect (i.e., VWF has abnormal physical characteristics) of the VWF. A large protein involved in primary hemostasis, VWF helps platelets stick to damaged vessel walls and carries the clotting protein, Factor VIII, in the blood. Excessive or prolonged bleeding can be a sign of VWD. For those with a moderate-to -severe form of the disease, proper diagnosis and treatment is essential. Acquired von Willebrand Syndrome (AVWS) can also occur as a direct consequence of other medical disorders. Laboratory findings in AVWS are similar to those in VWD and may include decreased values for VWF:Ag, VWF:RCo, or FVIII.
Principle of the HemosIL VWF:RCo Assay
HemosIL VWF:RCo assay detects quantitative and qualitative VWF defects (VWD Type 1, 2 and 3). It is based on the principle that a recombinant fragment of the platelet receptor, glycoprotein-Ib alpha contains the VWF-binding site. The VWF:RCo reagent consists of a latex particle, coated with glycoprotein-Ib alpha, through a highly specific monoclonal antibody. If VWF is present in the sample, it will bind to the glycoprotein-Ib alpha fragment, in the presence of ristocetin. The degree of agglutination is directly proportional to the activity of VWF in the sample, and is determined by measuring the decrease of transmitted light caused by the aggregates.
HemosIL VWF:RCo Assay is not currently 510(k) cleared.
Instrumentation Laboratory (www.ilus.com), founded in 1959, is a worldwide developer, manufacturer and distributor of in vitro diagnostic instruments, related reagents and controls for use primarily in hospitals and independent clinical laboratories. The company's product lines include critical care systems, hemostasis systems and information management systems. IL's GEM® product offerings, part of the critical care line, include the GEM Premier™ 4000 analyzer with Intelligent Quality Management (iQM®), GEM Premier 3500, GEMweb® Plus Custom Connectivity, and the GEM PCL Plus, a portable coagulation analyzer. IL's hemostasis portfolio includes the ACL TOP® Family of Hemostasis Testing Systems, fully automated, high-productivity analyzers, including the ACL TOP 700, ACL TOP 700 LAS and ACL TOP 500 CTS. IL also offers the new ACL AcuStar®, ACL ELITE® and ELITE PRO, other hemostasis analyzers and the HemosIL® line of reagents. IL is based in Bedford, Massachusetts.
The Instrumentation Laboratory logo, GEM, iQM, HemosIL, ACL TOP, ACL ELITE, ACL AcuStar and Premier are trademarks of Instrumentation Laboratory Company and/or one of its subsidiaries or parent companies, and may be registered in the United States Patent and Trademark Office and in other jurisdictions. All other product names, company names, marks, logos, and symbols are trademarks of their respective owners.
|SOURCE Instrumentation Laboratory|
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