From Lynn Gingras, MT (ASCP), Rush-Copley Medical Center: Our institution is getting several complaints from the cardiologists as to the turnaround time of the heparin-induced platelet antibody (HIPA, heparin-induced thrombocytopenia with thrombosis, HIT, HITT) testing that we currently send out to a reference lab. Is there any value to bringing in the Akers Bioscience Particle ImmunoFiltration Assay (PIFA) heparin/PF4 rapid assay system as a quick qualitative answer for them? I do not know of any labs in my area using that technology. Please provide your input and/or suggestions.
Hello, Lynn, and thank you for your question. The Akers Bioscience rapid test is a lateral flow immunoassay method that uses a color indicator to identify the presence of anti-heparin-platelet factor 4 (PF4) antibodies, the agent that causes HIT. The assay requires a fresh 40 µL serum specimen and provides a qualitative result in 10 minutes. I’ve attached their package insert below. The presence of color is a negative result, no color followed by color change in the control well is a positive result.
Akers’ first-generation test, which has been available for several years, was criticized for its relatively weak color development that tended to yield equivocal results, however in 2011 the manufacturer released a newly formulated device that claims to provide better color development. The assay is FDA-cleared and is classified as a moderately complex assay by CLIA. I’ve checked with a couple of labs that reported they have not used the new kit, so I post this in the hopes that our participants will respond. I personally recommend that you try out the new kit by running a few comparisons to your current method, and continue to confirm positive results by sending to a lab that performs the serotonin release assay, which is the reference method for HIT.
We have used this kit for several years and feel it has good
We have used this kit for several years and feel it has good negative predictability. We send any positive screen out for confirmation.