BloodCenter of Wisconsin’s Diagnostic Laboratories announced the availability of new and enhanced tests for Heparin-Induced Thrombocytopenia (HIT). Thrombocytopenia is characterized by a low level of platelets in the blood, a condition that that can lead to serious and potentially life-threatening bleeding.  Yet when patients develop thrombocytopenia due to the administration of the anticoagulant heparin, their platelets become activated, putting them at significant risk of thrombosis, the formation of blood clots that can cause severe complications, including death. Up to five percent of patients treated with heparin develop HIT, with cardiac and orthopedic surgery patients at greatest risk.

BloodCenter’s new PF4 ELISA-IgG test, the latest addition to its suite of assays used to detect HIT, replaces the PF4 ELISA-IgGAM assay.  The PF4 ELISA-IgG provides greater specificity for detecting clinically significant HIT antibodies, with the same degree of sensitivity as the previous test. A “strong positive” result in the new PF4 ELISA-IgG correlates with the clinical likelihood of HIT. BloodCenter staff will use the PF4 ELISA-IgG assay as the first-line test on all samples submitted for heparin-dependent platelet antibody-PF4 testing.

“Prompt and accurate diagnosis of HIT is of extreme importance due to a patient’s significant risk of a life-threatening thrombosis,” said Majed Abuhajir, M.D., Director of Clinical Trials at Columbia St. Mary’s Cancer Center in Milwaukee, Wis.  “The diagnosis needs to be made with complete confidence, not only because alternative therapy to heparin must be started immediately, but also because there are lifelong consequences to the patient that affect future decisions about medical and post-operative care.  BloodCenter of Wisconsin’s new assay raises my confidence of an accurate HIT diagnosis.”

BloodCenter provides a gold-standard serotonin release assay (SRA) used to confirm less definitive results from other tests.  The SRA offers the highest specificity and sensitivity among all laboratory tests for HIT. Today BloodCenter is also introducing PF4-IgM and IgG assays to detect rare antibodies that would be missed by both the SRA and the new PF4 ELISA-IgG. BloodCenter’s expanded and enhanced suite of tests enables clinicians to diagnose HIT, or confirm a preliminary diagnosis, at a level of accuracy that is unsurpassed by any other laboratory in the world.

According to Dr. Richard Aster, who established BloodCenter’s Platelet & Neutrophil Immunology Laboratory (PNIL), previously served as BloodCenter’s president and CEO and currently works as a full-time researcher, the new tests are a direct response to requests from the medical community.  “The desire for more specific assays for HIT has been expressed repeatedly in research papers and in discussions at scientific meetings,” said Dr. Aster.  “Our new assays fill that unmet medical need. We are proud to build off of our legacy of being one of the few laboratories in the world that can combine specialized testing and clinical expertise to help hospital staff provide state-of-the-art care to their patients.”

Source: BloodCenter of Wisconsin