Assessment of the performances of AcuStar HIT and the combination with heparin-induced multiple electrode aggregometry: A retrospective study

V. Minet, N. Bailly, J. Douxfils, J. C. Osselaer, J. Laloy, C. Chatelain, I. Elalamy, B. Chatelain, J. M. Dogné, F. Mullier

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Abstract

Background Early 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. Objectives We 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. Methods Sera 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. Results Using 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. Conclusion Acustar HIT showed good performances to exclude the diagnosis of HIT. Combination with HIMEA improves PPV.

Original languageEnglish
Pages (from-to)352-359
Number of pages8
JournalThrombosis Research
Volume132
Issue number3
DOIs
Publication statusPublished - 1 Sep 2013

Keywords

  • Heparin-induced thrombocytopenia
  • Immunoassay
  • Platelets

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  • Student Theses

    Analytical and clinical validation of sensitive assays for the diagnosis of immune heparin-induced thrombocytopenia

    Author: Minet, V., 2017

    Supervisor: Dogne, J. (Supervisor), Mullier, F. (External person) (Co-Supervisor), Laloy, J. (Jury), Lucas, S. (Jury), Masereel, B. (Jury), Chatelain, M. (External person) (Jury), Hoylaerts, M. F. (External person) (Jury) & Tardy, B. (External person) (Jury)

    Student thesis: Doc typesDoctor of Biomedical and Pharmaceutical Sciences

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