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.