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PIFA^® Heparin/PF4 Rapid Assay - Overview

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

The Second Generation is Here!

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 Factor 4 (PF4) 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 PIFA^® 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 PIFA^® 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.

Heparin/PF4 Antibody Serum Panels, intended for use as serum QC controls to monitor and evaluate the precision and accuracy of the PIFA® Heparin/PF4 Rapid Assay, are also available. Included are both confirmed positive and negative control panel members. FDA 510(k) Cleared

FDA 510(k) Cleared

Second Generation

In July 2008, the Second Generation of the assay became available. Modifications made to ABI’s proprietary reagent and filtration system have resulted in the following user benefits:

Improved Readability: The BLUE that appears in the TEST Window to denote a NEGATIVE result is a much deeper, easier-to-read BLUE.

More Rapid Time to Result: The CONTROL Window generally turns RED within 2 minutes of completing the Test Procedure, prompting the Technician to read the Result.

See Package Insert - Please note a slight increase in the Sample Volume required.

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.