Platelet factor 4/heparin antibody (IgG/M/A) in healthy subjects: a literature analysis of commercial immunoassay results

J Thromb Thrombolysis. 2008 Aug;26(1):55-61. doi: 10.1007/s11239-008-0217-y. Epub 2008 Mar 28.

Abstract

Purpose: We determined the seroprevalence of platelet factor 4 (PF4)/heparin antibodies in healthy subjects.

Methods: A literature search identified studies in which healthy subjects were evaluated using commercial immunoassays for PF4/heparin antibody (IgG/M/A). Proportions of test-positive subjects were calculated, by assay.

Results: Across 11 eligible studies, 860 healthy subjects were tested using the Stago enzyme-linked immunosorbent assay (ELISA) (nine studies), GTI ELISA (three studies), and/or DiaMed particle gel immunoassay (PGIA) (three studies). Seropositivity occurred in 17 of 790 (2.2%, 95% CI, 1.1-3.2%) subjects by Stago ELISA, one of 100 (1.0%, 95% CI, 0-3.0%) subjects by GTI ELISA, and three of 70 (4.3%, 95% CI, 0-9.0%) subjects by PGIA (P > 0.20). Of seven seropositive subjects tested further, none had platelet-activating antibodies.

Conclusion: Commercial immunoassays detect PF4/heparin antibody in 1.0-4.3% of healthy subjects. Because this "background" prevalence overlaps seropositivity rates in heparin-treated patients in various clinical settings, normality cut-offs may require refinement.

Publication types

  • Research Support, N.I.H., Extramural
  • Review

MeSH terms

  • Antibodies / blood*
  • Anticoagulants / immunology*
  • Enzyme-Linked Immunosorbent Assay
  • Heparin / immunology*
  • Humans
  • Immunoassay* / methods
  • Immunoglobulin A / blood
  • Immunoglobulin G / blood
  • Immunoglobulin M / blood
  • Platelet Factor 4 / immunology*
  • Reagent Kits, Diagnostic*
  • Reference Values
  • Reproducibility of Results
  • Seroepidemiologic Studies

Substances

  • Antibodies
  • Anticoagulants
  • Immunoglobulin A
  • Immunoglobulin G
  • Immunoglobulin M
  • Reagent Kits, Diagnostic
  • Platelet Factor 4
  • Heparin