15/01/2017

We are very pleased to announce the UK launch of the PIFA^® Heparin/PFA rapid test from Akersbio

The PIFA^® Heparin/Platelet Factor 4 Rapid Assay is a qualitative in vitro diagnostic device designed for the detection of antibodies to Platelet Factor 4 (PF4) that are found in some patients undergoing heparin therapy.

The risk of heparin induced thrombocytopenia (HIT) is greatly increased in patients with recent exposure to heparin. HIT is often caused by platelet activating antibodies that recognize complexes of Heparin/PF4. HIT is caused by heparin-dependent antibodies formed to the heparin/platelet factor 4 complex, and 1-5% of adults exposed to heparin develop these antibodies. These antibodies are initially formed when a patient has been on heparin therapy for five or more days. An immune response to a heparin may be observed sooner (1-2 days) if the patient has had previous exposure to heparin. The classic symptoms of HIT are a drastic fall in platelet count and thrombosis.

There are two categories of laboratory methods used to identify HIT antibodies: Functional/ActivationAssays andAntigenAssays/Immunoassays. Functional Assays include the C-14 Serotonin Release Assay (SRA) and the Platelet Aggregation Test (PAT). The Antigen Assay class consists of the Enzyme-Linked Immunoassay (ELISA) and the Particle ImmunoFiltration Assay (PIFA®).

The SRAs, PATs and ELISAs take many hours to perform, and are used primarily as a confirmation of HIT after the symptoms are seen in a patient. In contrast, the new PIFA® Heparin/PF4 Rapid Assay can easily be performed in minutes.

The PIFA® Heparin/PF4 Rapid Assay is based upon principles of the Particle ImmunoFiltration Assay (PIFA®). Dyed microparticles coated with purified Platelet Factor 4 (PF4) protein derived from platelet-rich plasma provide the visual signal for the results of the assay. The ability of matrixed or non-matrixed particles to move through a filter medium is the measure of the reactivity/non-reactivity of the test sample. The assay consists of a MiniReactor device that contains a membrane filtration system, a REAGENT Window, TEST Result Window, CONTROL Window, and a push button reagent dispensing system, referred to as the Tower, that contains microparticle based reaction reagents.

The new test provides a quick method of screening for HIT in 7 simple steps and takes just 10 minutes to complte with results in under 1 hour. The PIFA® Heparin/PF4 Rapid Assay is ideal for ruling out PF4 Antibodies with a > 98% Negative Predictive Value (NPV).

The test is a CE marked and FDA cleared device.