AKR8 Apr 2011 08:07
Conclusion of First Heparin-induced Thrombocytopenia Study
Akers Biosciences, Inc. (AIM:AKR), a leading designer and manufacturer of rapid diagnostic screening and testing products, announces the results of a study recently concluded at the University of Miami/Jackson Memorial Hospital, which included an analysis of ABI's PIFA Heparin/PF-4 Rapid Assay ("PIFA test"), as well as several different laboratory methods in the screening for heparin-induced thrombocytopenia ("HIT") in critically ill patients.
The Company is pleased to announce that not only did its PIFA test correctly identify every positive patient but, more importantly, it produced no "false negative" results, unlike the alternative ELISA test. The study concluded that ABI's unique, patented PIFA assay can serve as a quick "rule out" test for HIT, thus assisting the physician in the rapid diagnosis of the patient's potentially serious condition.
In the US and EU, approximately 25 million patients are exposed to Heparin annually and 1 to 5% of those patients receive a HIT diagnosis. The largest at-risk populations are patients undergoing major cardiac or orthopedic surgical procedures. It is estimated that up to 50% of cardiac surgery patients develop HIT-antibodies, while these antibodies may be detected in close to 15% of orthopedic surgery patients. Patients with HIT are at risk of developing limb- and life-threatening complications, so the timely test result provided by ABI's PIFA test, is paramount to effective, clinical decision making.
Daniel Kett, M.D, one of the principal investigators of the ABI-funded study, was invited to present the conclusions at the 31st International Symposium of Intensive Care and Emergency Medicine last week in Brussels. Significantly, Dr. Kett and his colleagues proposed a new algorithm in the diagnosis of HIT that uses ABI's PIFA test, which could have an impact on how HIT patients are detected and managed.
The Company's new point-of care testing platform for HIT antibodies, PIFA POC, was also introduced as, with the benefit of its patented integrated blood cell separator, it will further reduce the time to diagnosis to approximately 2 minutes.
Dr. Kett's presentation was entitled "Heparin induced thrombocytopenia in the critically ill: How to interpret anti-PF4 antibody test results".