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Heparin-induced thrombocytopenia (HIT) is a prothrombotic condition characterized by a platelet decrease of 50% or thrombosis with a temporal relationship of 1 to 2 weeks after the initiation of heparin. These surrogate markers are useful for the clinical assessment but are hardly applicable in multimorbid patients with clinical conditions that mimic HIT. Platelet activation assays (heparin-induced platelet activation [HIPA] and serotonin release assay) and platelet factor 4 (PF4)/polyanion enzyme-linked immunosorbent assay (ELISA) confirm HIT. HIPA and serotonin release assay are highly specific, but they are laborious and require selected donor platelets and extended experience. High titer immunoglobulin (Ig)G antibodies correlate with clinical HIT, but ELISA is also time-consuming. The alternative heparin/PF4-antigen particle gel immunoassay (PaGIA) is easy, provides results within 1 hour, and detects mainly IgG but also IgA/M antibodies. We evaluated the specificity and sensitivity of PaGIA in relation to HIPA and ELISA in 285 patients with an undetermined likelihood for HIT with the intention to validate it as a rapid assay to exclude HIT.

The particle gel immunoassay as a rapid test to rule out heparin-induced thrombocytopenia?