Heparin-induced Thrombocytopenia Diagnosis: A Retrospective Study Comparing Heparin-induced Platelet Activation Test to 14 C-serotonin Release Assay

Marie-Caroline Gonthier; Nicolas Gendron; Philippine Eloy; Marie-Charlotte Bourrienne; Martine Alhenc-Gelas; Claire Pouplard; Bernard Tardy; Jean Szymezak; Charles Burdet; Vasiliki Gkalea; Dorothée Faille; Nadine Ajzenberg

doi:10.1055/a-1653-5065

Heparin-induced Thrombocytopenia Diagnosis: A Retrospective Study Comparing Heparin-induced Platelet Activation Test to ¹⁴ C-serotonin Release Assay

TH Open. 2021 Sep 24;5(4):e507-e512. doi: 10.1055/a-1653-5065. eCollection 2021 Oct.

Authors

Affiliations

¹ Laboratory of Vascular Translational Science, Université de Paris, INSERM, et Laboratoire d'Hématologie, AH-HP, Bichat-Claude Bernard Hospital, Paris, France.
² Hematology Department and Biosurgical Research Lab (Carpentier Foundation), Assistance Publique Hôpitaux de Paris.Centre-Université de Paris (APHP-CUP), Paris, France.
³ Département d'Epidémiologie, Biostatistique et Recherche Clinique, AH-HP, Bichat-Claude Bernard Hospital, Paris, France.
⁴ CHRU Tours, Service d'hématologie-hémostase, Université de Tours, Tours, France.
⁵ Inserm CIC 1408 CHU Saint Etienne, Saint-Etienne, France.
⁶ Laboratoire d'hématologie, CHU Robert Debré, Reims, France.
⁷ Université de Paris, IAME, INSERM, Paris, France.

Abstract

Laboratory confirmation of heparin-induced thrombocytopenia (HIT) is of crucial importance and remains challenging and relies on platelet functional assays highlighting the presence of heparin-dependent platelet-activating antibodies in patient serum or plasma. Platelet functional assays using washed platelets include the ¹⁴ C-serotonin release assay (SRA), usually described as the gold standard, and the heparin-induced platelet activation assay (HIPA). Since its first comparison with SRA there has been no additional published study regarding HIPA diagnostic performances compared with SRA. Aim of our retrospective study was to compare the concordance between HIPA and SRA in HIT suspected-patients with positive anti-PF4/heparin antibodies between October 2010 and October 2015. Fifty-five HIT-suspected patients who beneficiated from both HIPA and SRA were included. Positive and negative percent agreements were 83.8% (95% CI 68.0-93.8%) and 66.7% (95% CI 41.0-86.7%), respectively. Overall percent agreement was 78.2% (95% CI 65.0-92.2%). Agreement was higher in patients who underwent cardiopulmonary bypass with extracorporeal circulation circuit for cardiac surgery. We also confirm that the use of a minimum of 2 platelet donors to establish positive HIT diagnosis and 4 platelet donors to exclude HIT diagnosis allows obtaining a good agreement with SRA. Although HIPA and SRA were performed with different platelet donors and in different laboratories, HIPA had a good positive agreement with SRA for HIT diagnosis, showing that HIPA is a useful functional assay that does not require radioactivity and could be developed worldwide to improve HIT diagnosis.

Keywords: 14 C-serotonin release assay; PF4/heparin antibodies; heparin induced platelet activation test; heparin-induced thrombocytopenia; laboratory diagnosis.

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