Accurate detection of HIT antibodies just got easier... and faster!

Heparin is one of the most widely prescribed medications in the United States, with an estimated 12 million patients receiving the drug annually.¹ Although the most common adverse event associated with heparin is bleeding, a significant number of patients develop a prothrombotic state known as Heparin-Induced Thrombocytopenia (HIT), the clinical course of which can be as severe and potentially devastating as a thromboembolic complication (HIT Type II).

The major determinant in the pathogenesis of HIT Type II appears to be antibodies to the heparin/platelet factor4 complex.^2,3,4 These antibodies are most frequently induced by Unfractionated Heparin (UFH) use following Cardiopulmonary Bypass Surgery (50%) and major Orthopedic Surgery (15%).⁵

Until recently, testing methods for identifying patients with HIT antibodies were limited CLIA-classified high complexity tests that require special instrumentation, take hours to perform, and are not conducive to cost-effectively or efficiently processing single patient samples. These tests include the Serotonin Release Assay (SRA), Platelet Aggregation Studies, and the Enzyme-Linked Immunoassay (ELISA).

In 2004, Akers Biosciences introduced the PAIFA^® Heparin/PF4 Rapid Assay in response to an unmet medical need to determine a patient's HIT antibody status in minutes versus hours. This information could then be could be integrated into time-sensitive, therapeutic decisions. The PAIFA^® Heparin/PF4 Rapid Assay is a single-use, single patient test that can easily be performed in approximately 10 minutes and is CLIA-classified as moderate complexity.

References:

1. Amiral, J., F. Bridey, M. Dreyfus, A. M. Vissoc, E. Fressinaud, M. Wolf, and D. Meyer. 1992.
Platelet factor 4 complexed to heparin is the target for antibodies generated in heparin-induced thrombocytopenia. Thromb. Haemost. 68:95-96.
2. Brieger DB, Mak K-H, Kottke-Marchant K, Topol EJ. Heparin-induced thrombocytopenia.
J Am Coll Cardiol. 1998;31:1449-1459.
3. Warkentin TE, Kelton JG. A 14-year study of heparin-induced thrombocytopenia. Am J Med. 1996;101:502-507.
4. King DJ, Kelton JG. Heparin-associated thrombocytopenia. Ann Intern Med. 1984;100:535-540.
5. McGarry L, Thompson D, Weinstein M, and Goldhaber S. 2004. Cost Effectiveness of
Thromboprophylaxis With a Low-Molecular-Weight Heparin Versus Unfractioned Heparin in
Acutely Ill Medical Inpatients. Am J Manag Care. 10:632-642.