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The Ultegra rapid platelet-function assay: comparison to standard platelet function assays in patients undergoing
Guy L Wheeler1, Gregory A Braden, Steven R Steinhubl
1Wake Forest University School of Medicine, Winston-Salem, NC 27157-1045, USA.
Insights
The Ultegra rapid platelet-function assay (RPFA) accurately and precisely monitors antiplatelet response during percutaneous coronary intervention. This assay is reliable across different operators and patient factors, ensuring consistent monitoring of platelet function.
Area of Science:
- Cardiology
- Hematology
- Clinical Chemistry
Background:
- Glycoprotein IIb/IIIa inhibitors are beneficial during percutaneous coronary intervention (PCI).
- Interpatient variability in antiplatelet response to these inhibitors exists.
- Diminished platelet inhibition predicts adverse cardiac events, necessitating precise monitoring.
Purpose of the Study:
- To evaluate the accuracy and precision of the Ultegra rapid platelet-function assay (RPFA).
- To compare Ultegra RPFA with conventional platelet aggregometry and a receptor binding assay.
- To assess operator variability and influencing factors on Ultegra RPFA measurements.
Main Methods:
- 192 patients undergoing elective PCI were enrolled.
- Ultegra RPFA, conventional aggregometry, and [125I]-abciximab binding assay were compared at baseline, during, and post-abciximab administration.
- Operator variability was assessed by point-of-care vs. laboratory performance.
Main Results:
- Ultegra RPFA showed strong correlation with both aggregometry (r=0.89) and the receptor binding assay (r=0.89).
- Good agreement (r=0.80) was observed between intended users and laboratory scientists.
- Ultegra RPFA demonstrated equivalent precision to standard assays.
Conclusions:
- Ultegra RPFA offers equivalent accuracy and precision compared to reference assays.
- Ultegra RPFA measurements are not influenced by operator, concomitant medications, hematologic parameters, or demographics.
- The assay provides reliable monitoring of platelet function in PCI patients.
Background:
Despite the proven benefit of glycoprotein IIb/IIIa inhibitors during percutaneous coronary intervention, significant interpatient variability exists in antiplatelet response. Furthermore, a diminished degree of platelet inhibition is an independent predictor of adverse cardiac events, highlighting the need for accurate and precise monitoring of platelet function.
Methods:
Patients (n = 192) who underwent elective percutaneous coronary intervention at 4 centers were enrolled. The following 3 time points were studied: 1, baseline, before abciximab bolus administration; 2, during, within 1 hour of abciximab bolus administration; and 3, post, 24 hours after abciximab bolus administration or at the time of patient discharge, whichever occurred first. The following 3 assays were compared at all time points: Ultegra rapid platelet-function assay (Ultegra RPFA), conventional turbidometric platelet aggregometry, and receptor binding assay with [125I]-abciximab. Variability in Ultegra RPFA measurements between operators was determined with performance of the assays at the point of care and in the laboratory. A sub-study of 22 patients at 1 center was performed in which the laboratory scientist performed all 3 assays in duplicate at each time point.
Results:
Comparison with the receptor binding assay and conventional platelet aggregometry in 120 patients showed that the Ultegra RPFA correlated with aggregometry (r = 0.89) and with the receptor binding assay (r = 0.89). There was good agreement (r = 0.80) between values obtained by intended users and those obtained by laboratory scientists. Furthermore, Ultegra RPFA values had equivalent precision to the standard assays.
Conclusion:
The Ultegra RPFA has equivalent accuracy and precision when compared with the 2 reference assays studied. Ultegra RPFA measurements are not operator-dependent and are not influenced by concomitant medications, hematologic parameters, or demographics.