BEDFORD, Mass., Feb. 14, 2012 /PRNewswire/ -- Instrumentation Laboratory (IL) today announced the release of their new HemosIL AcuStar HIT Assay Panel assay as a European CE IVD Mark product under the European Directive on in vitro Diagnostic Medical Devices. This fully automated panel includes HemosIL AcuStar HIT-IgG(PF4-H) and HemosIL AcuStar HIT-Ab(PF4-H) assays.
HemosIL AcuStar HIT assays are the first on-demand, fully automated, chemiluminescent reagents on a hemostasis testing system for the detection of antibodies associated with Heparin-Induced Thrombocytopenia (HIT). They provide enhanced detection of HIT antibodies in specialty and hospital hemostasis laboratories. Unlike existing manual processes, the ready-to-use, cartridge-based assays offer results in approximately 30 minutes -- on-demand, 24/7 -- allowing clinicians to make timely, well-informed therapeutic decisions. In addition, pre-calibrated reagent cartridges offer significant time- and cost- efficiencies. Chemiluminescent technology provides analytical excellence through an expansive working range for high sensitivity and precision.
"We are proud to be at the forefront of HIT testing solutions," said Remo Tazzi, Director of Hemostasis Marketing at IL. "Arming healthcare providers with better diagnostic tools is our mission, and this test panel is an excellent example of that. Now, management decisions for patients at risk for HIT can be made faster and more effectively than ever before, leading to significant time- and cost-efficiencies, as well as enhanced patient care."
This is the second panel of assays that has been commercialized on the ACL AcuStar system. The first is the highly sensitive, fully automated Antiphospholipid Syndrome (APS) panel. The assays in this panel provide a full clinical picture to distinguish APS and other thrombotic disorders efficiently and effectively, 24/7. APS is one of the most common autoimmune diseases, occurring in 1-5% of the general population. Clinical manifestations include vascular thrombosis and related sequelae (eg, stroke, pulmonary embolism, myocardial infarction) and pregnancy complications. While approximately 10-15% of these events result from APS, there are many other conditions to consider when determining root cause. Therefore, accurate and rapid diagnosis is essential when managing these critically ill patients.
HIT is a severe immunologic adverse reaction to Heparin, paradoxically resulting in venous and/or arterial thrombosis. It is one of the most common of all adverse drug effects, due to the sheer volume of patients receiving heparin therapy. Approximately 0.2–2.0% of patients treated with heparin (over 12 million patients/year in the US, alone) develop HIT. If HIT is untreated, risk for serious sequelae (eg, stroke, pulmonary embolism, death) increases significantly. Positive outcomes depend on early and accurate diagnosis and prompt initiation of alternative anticoagulants.
HemosIL AcuStar HIT assays are 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 complementary products GEM PCL Plus, a portable coagulation analyzer, GEM OPL CO-Oximeter, and GEMdraw arterial blood samplers. 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, ACL TOP 700 CTS, and ACL TOP 500 CTS. IL also offers the new ACL AcuStar®, ACL ELITE®, 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.