PF4 ENHANCED assay for the diagnosis of heparin-induced thrombocytopenia in complex medical and surgical patients.

To evaluate the sensitivity and specificity of the PF4 ENHANCED (GTI Diagnostics, Waukesha, WI) enzyme-linked immunosorbent assay for heparin-induced thrombocytopenia using the carbon-14 serotonin-release assay as the reference method.
A total of 34 patients were prospectively enrolled with a variety of diagnoses and suspected heparin-induced thrombocytopenia. They were clinically scored and underwent testing with the (14)C-serotonin-release assay. Enzyme-linked immunosorbent assay and (14)C-serotonin-release assay results were also available from 21 medical and surgical patients who had previously been tested.
With the (14)C-serotonin-release assay as the reference method, the sensitivity and specificity of the enzyme-linked immunosorbent assay were 93% and 65%, respectively. There was only one false-negative enzyme-linked immunosorbent assay. The clinical scores were frequently misleading, largely because of difficulty excluding other causes of thrombocytopenia.
Because of its high sensitivity, we believe the PF4 ENHANCED enzyme-linked immunosorbent assay should be used to identify heparin-induced thrombocytopenia in patients with multiple potential causes of thrombocytopenia, although false-positive results will not be uncommon.
AuthorsGurvinder Shaheed, Vera Malkovska, Jose Mendoza, Mehool Patel, John Rees, Robert Wesley, Paula Merryman, McDonald Horne
JournalCritical care medicine (Crit Care Med) Vol. 35 Issue 7 Pg. 1691-5 (Jul 2007) ISSN: 0090-3493 [Print] United States
PMID17507826 (Publication Type: Evaluation Studies, Journal Article, Research Support, N.I.H., Intramural, Research Support, Non-U.S. Gov't)
Chemical References
  • Anticoagulants
  • Carbon Radioisotopes
  • Serotonin
  • Platelet Factor 4
  • Heparin
  • Adult
  • Aged
  • Aged, 80 and over
  • Anticoagulants (adverse effects)
  • Carbon Radioisotopes
  • Enzyme-Linked Immunosorbent Assay (methods)
  • Female
  • Heparin (adverse effects)
  • Humans
  • Male
  • Middle Aged
  • Platelet Factor 4 (analysis)
  • Prospective Studies
  • Sensitivity and Specificity
  • Serotonin (analysis)
  • Thrombocytopenia (chemically induced, diagnosis)

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