Rule out Heparin/PF4 antibodies that are associated with HIT

Rapid results (< 1 hour)

Dramatic cost savings potential

For your patients with suspected Heparin-Induced Thrombocytopenia (HIT)

See YOUR

potential c

ost savings of

switching fr

om ELISA to PIFA

® PF4 antibody

testing at h

ttp://pifa

savings.akersbio.com

Discover the advantages of

HIT

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% 1, 2 – leading to 30% mortality risk and

20% risk of limb amputation 3, 4

PF4 antibody screening tests can effectively rule out

HIT in some patients

Heparin/PF4 complexes appear to be major

determinant of HIT 5, 6

Diagnosis of HIT Type II should be based on two criteria:

Clinical symptoms of thrombocytopenia (the 4Ts)

in patients with current or recent heparin therapy

Detection of PF4 antibodies

Ruling out PF4 antibodies rapidly enables clinicians to avoid unnecessary

heparin discontinuation and use of alternative anticoagulant therapies,

such as Direct Thrombin Inhibitors (DTIs) that can result in:

Clinical monitoring

requirements and

associated costs

Increased length

of stay (LOS)

Potential

side effects

High drug

therapy costs

RAPID Heparin/PF4 antibody detection is crucial

Why are rapid PF4 antibody diagnostic results advantageous?

Advantages vs. other PF4 screening tests

Faster and easier than ELISA tests for PF4 antibodiesProviding > 98% Negative

Predictive Value (NPV)

PIFA™ Heparin/PF4 Rapid Assay puts PF4 antibody screening control back in your hands

PIFA™ Heparin/PF4

Rapid AssayELISA

Moderate Complexity (CLIA) High

None Capital Equipment Yes

Yes

(Single-unit device)STAT Testing

Typically batched 48/96 well

plate may make single-patient

testing prohibitive

< 1 Hour Turnaround Time (TAT)

Minimum 2-3 hour assay

commonly batched or sent to

reference lab with 2 to 4 day TAT

> 98%Negative

Predictive Value 799%

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., 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.

6. Amiral, J., F. Bridey, M. Wolf, C. Boyer-Neumann, E. Fressinaud, A. M. Vissac, E. Peynaud-Debayle, M. Dreyfus, and D. Meyer. 1995. Antibodies to

macromolecular platelet factor 4-heparin complexes in heparin-induced thrombocytopenia: a study of 44 cases. Thromb. Haemost. 73:21-28.

7. 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™ Heparin/PF4

package insert dated June 2013; Immucor PF4 Enhanced® assay package insert dated March 2, 2015.

y

Negative

Predictive Value 799%

bocytopenia, 3rd ed.

-induced thrombocytopenia. a.

thrombocytopenia. Am J MJ Med.

Ann Intern Med. 1984;100:53:535-55-540.40.

M. Wolf, and D. Meyer. 1992. Platelet factor 4 complexed to heparin

rombocytopenia. Thromb. Haemost. 68:95-96.

aud, A. M. Vissac, E. Peynaud-Debayle, M. Dreyfus, and D. Meyer. 1995. Antibodies to

arin-induced thrombocytopenia: a study of 44 cases. Thromb. Haemost. 73:21-28.

© 2015 Akers Biosciences, Inc.

Take control with the clinical and cost saving advantages

of PIFA™ Heparin/PF4 Rapid Assay

Potential to save typical organizations $500K - $1M+

in testing, pharmacy, and clinical monitoring costs

See what your organization can save at

www.pifasavings.akersbio.com

Dramatic Value for Your Hospital

COST-SAVINGS

No capital equipment required

Moderately-complex CLIA test; easy to cross-train

lab staff

Empowers Your Hospital

LAB-FRIENDLY

FDA cleared device

> 98% Negative Predictive Value (NPV)

ACCURATE

6 simple steps

10 minute procedure / results in < 1 hour

Quicker Clinical Decisions

FAST

Reference the following Akers Bio

catalog numbers when contacting

your sales representative for pricing.

Product Description Akers Cat #

PIFA™ Heparin/PF4 (serum) Devices (6 tests/pack) 4036025

PIFA™ Heparin/PF4 (serum) Devices (training - 3 tests/pack) 3330047

PIFA™ Heparin/PF4 (serum) - Controls, 6 Panel (5Pos / 1Neg) 4036028

PIFA™ Heparin/PF4 (serum) - Controls, 2 Panel (1Pos / 1Neg) 4036027

th li i l d t

PIFAPF4-1005XUS-BR-06/15