Heparin-Induced Thrombocytopenia (HIT) and PF4 Antibodies
FAST: Quicker Clinical Decisions
- 7 simple steps
- Ability to use fresh, whole blood with PIFA PlussPF4™ device
- 10 minute procedure / Results in < 1 hour
ACCURATE: Confidently Rule Out PF4 Antibodies
- > 98% Negative Predictive Value (NPV)
- FDA cleared device
- Manufactured in an ISO 13485 certified facility
LAB-FRIENDLY: Empowers Your Hospital Lab
- No capital equipment required
- Moderately-complex CLIA test; easy to cross-train lab staff
COST-SAVINGS: Dramatic VALUE for Your Hospital
- Potential to save typical organizations $500K to $1 million or more in testing, pharmacy, and clinical monitoring costs!
- See what your organization can save at www.pifasavings.akersbio.com!
Put PF4 antibody screening control back in YOUR HANDS
PIFA® PF4 Advantages vs. other PF4 antibody screening tests:
|PIFA PlussPF4™ Rapid Assay||ELISA|
|Stat Testing:||Yes (Single-unit device)||Typically batched 48/96 well plate may make single-patient testing prohibitive|
|Turnaround Time (TAT):||< 1 Hour||Minimum 2-3 hour assay commonly batched or sent to reference lab with 2 to 4 day TAT|
|Negative Predictive Value: 6||> 98 %||99%|
- Specificity = 98.1%
- Sensitivity = 91.3%
- Results interpreted as easy-to-read color change
- Internal Control on each device
Safety Data Sheets (SDS):
Quality Control Information: As of January 1, 2016, hospital labs should either follow CLIA ’88 or their Individual Quality Control Plan for PIFA® Heparin/PF4 or PIFA PlussPF4™. Akers Bio is proud to provide manufacturer support for the development of your IQCP.
Frequently Asked Questions (FAQs):
PIFA PlussPF4™ training video:
PIFA® Heparin/PF4 training video:
- Warkentin TE, Greinacher A, eds. Heparin-induced Thrombocytopenia, 3rd ed. New York: Marcel Dekker, Inc. 2004, 53, 205, 271, 295.
- Brieger DB, Mak K-H, Kottke-Marchant K, Topol EJ.Heparin-induced thrombocytopenia. J Am Coll Cardiol. 1998;31:1449-1459.
- Warkentin TE, Kelton JG.A 14-year study of heparin-induced thrombocytopenia.Am J Med. 1996;101:502-507.
- King DJ, Kelton JG.Heparin-associated thrombocytopenia.Ann Intern Med. 1984;100:535-540.
- Amiral J, Bridey F, Wolf M, Boyer-Neumann C, et al, 1995.Antibodies to macromolecular platelet factor 4-hepain complexes in heparin-induced thrombocytopenia: a study of 44 cases.Thromb. Haemost. 73:21-28.
- The Negative Predictive Value of a PF4 antibody diagnostic tool refers to its ability to correctly rule-out the presence of PF4 antibodies, which are associated with HIT Type II.Negative Predictive Value = True Negatives / (True Negatives + False Negatives).Data from PIFA PLUSS PF4 package insert dated October 2012; Immucor PF4 Enhanced® assay package insert dated March 2, 2015.