Assessment of the performances of AcuStar HIT and the combination with heparin-induced multiple electrode aggregometry: A retrospective study |
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Authors: | V Minet N Bailly J Douxfils JC Osselaer J Laloy C Chatelain I Elalamy B Chatelain JM Dogné F Mullier |
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Institution: | 1. Department of Pharmacy, Namur Research Institute for LIfe Sciences (NARILIS), Namur Thrombosis and Hemostasis Center (NTHC), University of Namur, Namur, Belgium;2. Hematology Laboratory, Namur Research Institute for LIfe Sciences (NARILIS), CHU UCL Mont-Godinne, Dinant, Université Catholique de Louvain (UCL), Yvoir, Belgium;3. Blood Transfusion Center, CHU UCL Mont-Godinne, Dinant, Université Catholique de Louvain UCL, Yvoir, Belgium;4. Hematology Department, Namur Research Institute for LIfe Sciences (NARILIS), CHU UCL Mont-Godinne, Dinant, Université Catholique de Louvain (UCL), Yvoir, Belgium;5. Hematology Department, Hôpital Tenon, Paris, France |
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Abstract: | BackgroundEarly diagnosis of immune heparin-induced thrombocytopenia (HIT) is challenging. HemosIL® AcuStar HIT and heparin-induced multiple electrode aggregometry (HIMEA) were recently proposed as rapid diagnostic methods.ObjectivesWe conducted a study to assess performances of AcuStar HIT-IgG (PF4-H) and AcuStar HIT-Ab (PF4-H). The secondary objective was to compare the performances of the combination of Acustar HIT and HIMEA with standardised clinical diagnosis.MethodsSera of 104 suspected HIT patients were retrospectively tested with AcuStar HIT. HIMEA was performed on available sera (n = 81). The clinical diagnosis was established by analysing in a standardized manner the patient’s medical records. These tests were also compared with PF4-Enhanced®, LTA, and SRA in subsets of patients. Thresholds were determined using ROC curve analysis with clinical outcome as reference.ResultsUsing the recommended thresholds (1.00 AU), the negative predictive value (NPV) of HIT-IgG and HIT-Ab were 100.0% (95% CI: 95.9%-100.0% and 95.7%-100.0%). The positive predictive value (PPV) were 64.3% (95% CI: 35.1%-87.2.2%) and 45.0% (95% CI: 23.2%-68.6%), respectively. Using our thresholds (HIT-IgG: 2.89 AU, HIT-Ab: 9.41 AU), NPV of HIT-IgG and HIT-Ab were 100.0% (95% CI: 96.0%-100.0% and 96.1%-100.0%). PPV were 75.0% (95% CI: 42.7%-94.5%) and 81.8% (95% CI: 48.3%-97.7%), respectively. Of the 79 patients with a medium-high pretest probability score, 67 were negative using HIT-IgG (PF4-H) test at our thresholds. HIMEA was performed on HIT-IgG positive patients. Using this combination, only one patient on 79 was incorrectly diagnosed.ConclusionAcustar HIT showed good performances to exclude the diagnosis of HIT. Combination with HIMEA improves PPV. |
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Keywords: | Immunoassay Heparin-induced thrombocytopenia Platelets |
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