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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
To order the PIFA® Heparin/PF4 Rapid Assay or for Technical Assistance, please call 1.800.451.8378 or +1.856.848.2116.
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FDA 510(k) Cleared
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Second Generation
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.
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