Instrumentation Laboratory (IL) today announced the release of the new HemosIL HIT-Ab(PF4-H) assay as a European CE IVD Mark product under the European Directive on In Vitro Diagnostic Medical Devices. Delivering results in minutes, the HemosIL HIT-Ab(PF4-H) assay detects total immunoglobulin against Platelet Factor 4-Heparin complexes, the antibodies associated with the pathology of HIT.
HemosIL HIT-Ab(PF4-H) is the first, on-demand, fully automated assay for HIT antibody detection on hemostasis testing systems. Unlike existing manual processes, HemosIL HIT-Ab(PF4-H) assay is liquid and ready-to-use, provides results in minutes and is available 24 hours/day, 7 days/week. Moreover, the assay is designed exclusively for the ACL TOP® Family of Hemostasis Testing Systems—ensuring ultimate simplicity and efficiency throughout the testing process.
"Rapid detection of HIT antibodies is critical in the management of Heparin-treated patients suspected of HIT. HemosIL HIT-Ab(PF4-H) assay provides fast and accurate HIT antibody detection to inform therapeutic decisions when time is critical, " said Giovanni Russi, Director of Worldwide Marketing, Hemostasis Reagents at IL. "This assay provides significant new efficiencies for our ACL TOP customers in Europe, where, until now, HIT antibody testing has been prohibitively labor-intensive and costly; and, most importantly, it will contribute to enhanced patient care."
HIT is a severe immune reaction to Heparin that can result in the paradoxical development of a thrombotic event. One of the most common of all adverse drug effects, due to the sheer volume of patients receiving Heparin therapy (over 12 million patients annually in the US alone), it has a significant impact on anticoagulant management in hospitals worldwide. If left untreated, patients with HIT may develop serious sequelae, including pulmonary embolism, myocardial infarction, or death.
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