Instrumentation Laboratory (IL) recently released its 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 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.

HemosIL AcuStar HIT assays are not currently 510(k) cleared.

Source: Instrumentation Laboratory