Image: ACL Acustar Hemostasis Testing System (Photo courtesy of Instrumentation Laboratories).
A fully automated von Willebrand Factor assay has been released in Europe and international territories as a European CE in vitro diagnostic (IVD) Mark product under the European Directive on in vitro Diagnostic Medical Devices but not currently 510(k)-cleared.
A product of Instrumentation Laboratories (Bedford, MA, USA), the fully automated HemosIL AcuStar VWF assay panel, designed exclusively for use on the ACL AcuStar Hemostasis Testing System, includes HemosIL AcuStar VWF Antigen (VWF:Ag) and HemosIL AcuStar VWF Ristocetin Cofactor (VWF:RCo) Activity assays.
HemosIL AcuStar VWF:RCo is the first fully automated, chemiluminescent assay to use recombinant technology, allowing full automation and greater precision than platelet-based tests. It meets guidelines on VDF investigation and enhances accuracy versus manual methods. Chemiluminescence offers an enhanced linearity range to quantify extremely low levels of VWF concentrations.
Like all reagents on the ACL AcuStar System, HemosIL AcuStar VWF assays are ready-to-use, cartridge-based and offer results in 30 minutes—on-demand, 24/7. This is the third specialty assay panel commercialized on the ACL AcuStar system. Previously introduced panels include Antiphospholipid Syndrome and Heparin-Induced Thrombocytopenia.
"With the ACL AcuStar Hemostasis Testing System, our goal is to automate complex assays and offer enhanced efficiency and sensitivity where it matters most," said Remo Tazzi, Director of Hemostasis Marketing at IL. "Our new HemosIL AcuStar VWF assays achieve this, allowing clinicians to make quicker and more effective patient care decisions."
VDF is an acquired or inherited bleeding disorder, caused by a qualitative or quantitative defect of the VWF protein. Whereas hemophilia mainly affects males, VDF is not gender-specific. The disease affects over 1% of the worldwide population and occurs in 1/100–100,000 people with hemophilia. Acquired VDF can be associated with serious autoimmune problems (e.g., rheumatoid arthritis, systemic lupus erythematosus, and specific types of kidney failure or cancers) and may develop with no underlying conditions. Certain kinds of VDF may remain undiagnosed because symptoms can be mild. Prompt diagnosis and classification are necessary for optimal therapeutic management.