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

Minet, V.;Bailly, N.;Douxfils, J.;Osselaer, Jean-Claude;Mullier, François;et.al.
(2013) Thrombosis Research : vascular obstruction, hemorrhage and hemostasis — Vol. 132, n° 3, p. 352-359 (2013)

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Authors
  • Minet, V.
    Author
  • Bailly, N.
    Author
  • Douxfils, J.
    Author
  • Osselaer, Jean-ClaudeUCLouvain
    Author
  • Chatelain, ChristianUCLouvain
    Author
  • Chatelain, BernardUCLouvain
    Author
  • Mullier, FrançoisUCLouvain
    Author
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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. © 2013 Elsevier Ltd. All rights reserved.
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Minet, V., Bailly, N., Douxfils, J., Osselaer, J.-C., Laloy, J., Chatelain, C., Elalamy, I., Chatelain, B., Dogné, J. M., & Mullier, F. (2013). Assessment of the performances of AcuStar HIT and the combination with heparin-induced multiple electrode aggregometry: A retrospective study. Thrombosis Research : vascular obstruction, hemorrhage and hemostasis, 132(3), 352-359. https://doi.org/10.1016/j.thromres.2013.06.004 (Original work published 2013)