Comparison of PF4/heparin ELISA assay with the 14C-serotonin release assay in the diagnosis of heparin-induced thrombocytopenia

Am J Clin Pathol. 1995 Dec;104(6):648-54. doi: 10.1093/ajcp/104.6.648.


The diagnosis of heparin-induced thrombocytopenia (HIT) may be affirmed by demonstrating heparin-dependent anti-platelet antibodies using the 14C-serotonin release assay (SRA). In this study, results of the SRA was compared with the recently described platelet factor 4 (PF4)/heparin enzyme-linked immunosorbent assay (ELISA). Compared with the SRA, the sensitivity and specificity of a PF4/heparin ELISA was 87% and 92%, respectively, using an assay developed in our laboratory; and 90% and 98%, respectively, using a commercially developed kit (Diagnostica Stago, Asnieres, France). However, antibodies to PF4/heparin were also detected in up to 8% of patients whose plasma was negative by SRA, and 23% of patients receiving heparin who were not thrombocytopenic. These data indicate that results obtained with the PF4/heparin ELISA and the SRA are generally in accord in patients with a clinical diagnosis of HIT. However, discrepant results occur in approximately 20% of cases because of the greater sensitivity of ELISA and the possible involvement of other heparin-binding proteins. The fact that each assay contributes independent information in some cases must be considered in the sequence of test performance and in providing consultation to the practicing hematologist.

Publication types

  • Comparative Study
  • Research Support, Non-U.S. Gov't
  • Research Support, U.S. Gov't, P.H.S.

MeSH terms

  • Adult
  • Antibodies / blood*
  • Biological Assay / methods*
  • Carbon Radioisotopes
  • Enzyme-Linked Immunosorbent Assay
  • Heparin / adverse effects*
  • Heparin / immunology*
  • Humans
  • Platelet Factor 4 / immunology
  • Sensitivity and Specificity
  • Serotonin
  • Thrombocytopenia / diagnosis*
  • Thrombocytopenia / etiology
  • Thrombocytopenia / immunology


  • Antibodies
  • Carbon Radioisotopes
  • Serotonin
  • Platelet Factor 4
  • Heparin