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Heparin-Induced Thrombocytopenia (HIT) and PF4 Antibodies

PIFA Heparin/PF4 Rapid Assay

Take Control with the Clinical and Cost Saving Advantages of PIFA® Rapid Assays for HIT / 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!

Specifications

Put PF4 antibody screening control back in YOUR HANDS

PIFA® PF4 Advantages vs. other PF4 antibody screening tests:

  PIFA PlussPF4™ Rapid Assay ELISA
Complexity (CLIA): Moderate High
Capital Equipment: None Yes
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%

Other specifications:

  • Specificity = 98.1%
  • Sensitivity = 91.3%
  • Results interpreted as easy-to-read color change
  • Internal Control on each device

Training Videos

PIFA PlussPF4 training video:

PIFA® Heparin/PF4 training video:

References

  1. Warkentin TE, Greinacher A, eds. Heparin-induced Thrombocytopenia, 3rd ed. New York: Marcel Dekker, Inc. 2004, 53, 205, 271, 295.
  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. 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.
  6. 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.

How to Order

PIFA® Heparin/PF4™ and PIFA® PlussPF4™ Rapid Assays are available through multiple distributors in the U.S. (Cardinal Health, Fisher HealthCare, Typenex Medical) and internationally. Contact a distributor representative, or contact Akers Bio directly.

Tri-Cholesterol

PIFA Heparin/PF4™ Rapid Assay

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PIFA Heparin/PF4™ Rapid Assay

Tri-Cholesterol

PIFA PlussPF4™ Rapid Assay

seraSTAT® Rapid Blood Cell Separator

Calculate Potential Savings for YOUR Organization!

Calculate cost savings now

when switching from ELISA to PIFA® PF4 antibody testing

The Importance of Rapid PF4 Antibody Rule Out

Rapid PF4 Antibody assay – PIFA

  • 1% to 5% of patients treated with unfractionated heparin develop Heparin-Induced Thrombocytopenia (HIT Type II)1
  • Diagnosis of HIT typically occurs between 5 and 10 days after initiation of Heparin Therapy
  • Risk of Thrombosis in HIT patients is at least 33-50% 4,5 – leading to 30% mortality risk and 20% risk of limb amputation3,4