Instrumentation Laboratory (IL), Bedford, MA, announced the release of their new HemosIL AcuStar HIT Panel assay that is also now a European CE IVD Marked product.The ACL AcuStar is a fully automated device for chemiluminescent testing in the hemostasis laboratory. Ready to use cartridges with reagents can be kept stable up to six weeks refrigerated at 4°C onboard. One test takes around 30 minutes and one rack accommodates 30 samples, so 60 results can be produced per hour.
The system comes with an easy to use touchscreen and runs on a Windows interface. Several hemostasis assays are already available on the ACL AcuStar like D-Dimer testing and an Anti-phospholipids panel for diagnosis of Antiphospohlipid syndrome (APS).
The new approved assay detects antibodies associated with Heparin-Induced Thrombocytopenia (HIT), a severe immunologic adverse reaction to Heparin, paradoxically resulting in venous and/or arterial thrombosis.
Remo Tazzi, Director of Hemostasis Marketing at IL commented in the press release:
We are proud to be at the forefront of HIT testing solutions. 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.
HemosIL AcuStar HIT assays are not currently 510(k) cleared.