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Performance of a new, rapid, automated immunoassay for the detection of anti-platelet factor 4/heparin complex antibodies.

Publication ,  Journal Article
Davidson, SJ; Ortel, TL; Smith, LJ
Published in: Blood Coagul Fibrinolysis
June 2011

Heparin-induced thrombocytopenia (HIT) is a life-threatening adverse reaction to heparin that must be identified quickly to determine appropriate anticoagulant therapy strategies. The most common antibodies involved in HIT are directed against platelet factor 4/heparin (PF4/H) complexes. Many methods for anti-PF4/H detection exist such as enzyme immunoassays (EIAs), which have been shown to exhibit high-negative predictive value allowing for the exclusion of HIT in the majority of suspected patients; however, most EIAs are performed in a batch mode, thereby delaying results to the physician. HemosIL HIT-Ab(PF4-H) is a new, rapid method for the detection of total immunoglobulin against PF4/H complexes on ACL TOP Family systems. The assay was evaluated in a multicentre study at three sites with 414 HIT-suspected patients. Using a cut-off value of 1.0 U/ml for HemosIL HIT-Ab(PF4-H), the new test was compared with Asserachrom HPIA. Results showed a co-positivity of 60.2% [95% confidence interval (CI) 48.9-70.8], co-negativity of 94.6% (95% CI 91.5-96.7), and overall agreement of 87.7% (95% CI 84.1-90.7). These results are comparable to other PF4/H antibody assays available; with the added benefit of full automation and on-demand testing which provides results at the critical moment when physicians are required to make clinical decisions regarding anticoagulant therapy.

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Published In

Blood Coagul Fibrinolysis

DOI

EISSN

1473-5733

Publication Date

June 2011

Volume

22

Issue

4

Start / End Page

340 / 344

Location

England

Related Subject Headings

  • Thrombocytopenia
  • Sensitivity and Specificity
  • Reproducibility of Results
  • Platelet Factor 4
  • Immunoglobulin G
  • Immunoassay
  • Humans
  • High-Throughput Screening Assays
  • Heparin
  • Cardiovascular System & Hematology
 

Citation

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Davidson, S. J., Ortel, T. L., & Smith, L. J. (2011). Performance of a new, rapid, automated immunoassay for the detection of anti-platelet factor 4/heparin complex antibodies. Blood Coagul Fibrinolysis, 22(4), 340–344. https://doi.org/10.1097/MBC.0b013e328344f7e9
Davidson, Simon J., Thomas L. Ortel, and Larry J. Smith. “Performance of a new, rapid, automated immunoassay for the detection of anti-platelet factor 4/heparin complex antibodies.Blood Coagul Fibrinolysis 22, no. 4 (June 2011): 340–44. https://doi.org/10.1097/MBC.0b013e328344f7e9.
Davidson SJ, Ortel TL, Smith LJ. Performance of a new, rapid, automated immunoassay for the detection of anti-platelet factor 4/heparin complex antibodies. Blood Coagul Fibrinolysis. 2011 Jun;22(4):340–4.
Davidson, Simon J., et al. “Performance of a new, rapid, automated immunoassay for the detection of anti-platelet factor 4/heparin complex antibodies.Blood Coagul Fibrinolysis, vol. 22, no. 4, June 2011, pp. 340–44. Pubmed, doi:10.1097/MBC.0b013e328344f7e9.
Davidson SJ, Ortel TL, Smith LJ. Performance of a new, rapid, automated immunoassay for the detection of anti-platelet factor 4/heparin complex antibodies. Blood Coagul Fibrinolysis. 2011 Jun;22(4):340–344.

Published In

Blood Coagul Fibrinolysis

DOI

EISSN

1473-5733

Publication Date

June 2011

Volume

22

Issue

4

Start / End Page

340 / 344

Location

England

Related Subject Headings

  • Thrombocytopenia
  • Sensitivity and Specificity
  • Reproducibility of Results
  • Platelet Factor 4
  • Immunoglobulin G
  • Immunoassay
  • Humans
  • High-Throughput Screening Assays
  • Heparin
  • Cardiovascular System & Hematology