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Jae Hyeon Park, Ji-Eun Kim, Hyun Ju Yoo, Ja-Yoon Gu, Kyou Sup Han, and Hyun Kyung Kim Department of Laboratory Medicine, Seoul National University College of Medicine, Seoul, Korea Background: Heparin-induced thrombocytopenia (HIT) is a significant complication of heparin therapy induced by antibodies to heparin/platelet factor 4 (PF4) complexes. We investigated the diagnostic performance of four commercial immunoassays that detect the anti-heparin/PF4 antibody. Methods: Four different anti-heparin/PF4 antibody assays were performed in 39 patients with suspected HIT: HemosIL AcuStar HIT-IgG, HemosIL AcuStar HIT-total antibody (Ab) (Instrumentation Laboratory, USA), STic Expert HIT (Diagnostica Stago, France), and PF4 Enhanced (Immucor GTI Diagnostics, USA). Patients were diagnosed with HIT when the Chong score was ≥5. Results: Th e estimated sensitivity and specifi city for diagnosis of HIT were 33.3% and 80.0% for AcuStar HIT-IgG, 55.6% and 53.3% for AcuStar HIT-total Ab, 100.0% and 37.9% for STic Expert HIT, and 33.3% and 66.7% for PF4 Enhanced. All specifi cities signifi cantly increased when 4Ts scores were included in the diagnosis. Th e areas under the curves (AUCs) for predicting thrombosis in the AcuStar HIT-IgG, AcuStar HIT-total Ab, and PF4 Enhanced assays were 0.639, 0.522, and 0.681, respectively. When the results of each assay were analysed along with 4Ts scores, the AUC increased to 0.927 in the AcuStar HIT-IgG assay and 0.944 in the AcuStar HIT-total Ab and PF4 Enhanced assays. Conclusions: Th e STic Expert HIT assay had high sensitivity but low specifi city for diagnosis of HIT. Th e performances of the three other immunoassays were comparable to each other. Specificity significantly increased when assay data were combined with 4Ts scores. Differences in the diagnostic performance of the four immunoassays were not evident, and simultaneous consideration of clinical scoring systems improved performance. (J Lab Med Qual Assur 2015;37:84-91)

Performance of Four Anti-Heparin/Platelet Factor 4 Immunoassays for the Diagnosis of Heparin-Induced Th rombocytopenia