Harmonizing platelet function analyzer testing and reporting in a large laboratory network

Int J Lab Hematol. 2022 Oct;44(5):934-944. doi: 10.1111/ijlh.13907. Epub 2022 Jun 26.

Abstract

Introduction: The platelet function analyzer (PFA) is a popular platelet function screening instrument, highly sensitive to von Willebrand disease (VWD) and to aspirin therapy, with moderate sensitivity to defects in platelet function and/or deficiencies in platelet number. There are two models, the original PFA-100 and the contemporary PFA-200. Normal reference ranges (NRRs) provided by the manufacturer are the same for both models, instead being based on the type of test cartridge, for which there are two main ones: collagen/epinephrine (C/Epi) and collagen/adenosine diphosphate (C/ADP).

Methods: Comparative evaluations of PFA testing and reporting in six different sites of a large pathology network, aiming to harmonize NRRs and test reporting across all network sites. A separate comparative study of testing a range of samples (n > 150) on a PFA-100 versus that on a PFA-200. Review of contemporary literature.

Results: Each site was identified to have a different reporting NRR, which after consolidating data permitted establishment of an agreed harmonized NRR for use across the network (C/Epi: 90-160; C/ADP: 70-124; based on n > 180). Similarly, each site reported and interpreted results in different ways, and after discussion and consolidation, a harmonized approach to interpretation and reporting was achieved. The separate comparative study of PFA-100 versus PFA-200 testing confirmed instrument equivalence.

Conclusion: We achieved harmonized NRRs and reporting for PFA testing across a large pathology network. Our approach may be useful for other laboratory networks wishing to harmonize PFA testing.

Keywords: PFA-100; PFA-200; harmonization; platelet function analyzer.

MeSH terms

  • Adenosine Diphosphate
  • Blood Platelets
  • Collagen
  • Epinephrine
  • Humans
  • Platelet Function Tests*
  • Sensitivity and Specificity
  • von Willebrand Diseases* / diagnosis

Substances

  • Adenosine Diphosphate
  • Collagen
  • Epinephrine

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