Introduction: Heparin-induced thrombocytopenia (HIT) remains a very challenging diagnosis. The first objective of this study was to compare the performance of the ID-H/PF4 PaGIA with the Asserachrom HPIA ELISA. The main purpose was to evaluate the diagnostic utility of the combination of the H/PF4 PaGIA with the clinical "4T's" score as a screening strategy.
Materials and methods: 102 patients with clinical suspicion of HIT were classified into risk groups using the 4T's score. The presence of HIT antibodies was assessed by two immunoassays and confirmed by a functional flow cytometric assay.
Results: Comparison of the ID-H/PF4 PaGIA with the Asserachrom HPIA ELISA demonstrated a comparable technical performance, being an excellent screening test to rule out HIT (negative predictive value or NPV=100%). According to the 4T's score, HIT was excluded in all low risk patients (NPV=100%). ELISA optical density levels were significantly different between all risk groups (P-values<0.01). In contrast, due to the low positive predictive value (22%) and weak positive likelihood ratio (2.6), a positive ID-H/PF4 PaGIA result did not considerably increase the probability of HIT.
Conclusion: Our study confirms the combination of the 4T's score with the ID-H/PF4 PaGIA as a reliable strategy to rule out HIT. Yet, confirming positive ID-H/PF4 PaGIA results by flow cytometry within 1-2 h after blood sampling remains necessary. This novel clinical-laboratory approach can contribute in a rapid and reliable way to the definite diagnosis of HIT.