Abstract Number: PB0573
Meeting: ISTH 2020 Congress
Background: The T-TAS01 PL assay is a novel in vitro diagnostic system that passes whole blood through a collagen-coated microcapillary bed at arterial shear stress to measure the platelet thrombus formation process. The test is used to assess overall primary hemostatic function. Results are reported as the area under the pressure-time curve (AUC).
Aims: To validate the analytical performance of the T-TAS01 PL assay by evaluating precision, reproducibility, limit of quantification (LoQ), and analytical specificity.
Methods: Blood samples were collected from apparently healthy volunteers with and without taking antiplatelet therapy to produce a wide range of results, and measured with the T-TAS01 PL assay. Reproducibility testing was performed at three locations; all other testing was performed at one location.
Results: Precision and reproducibility testing demonstrated that the repeatability and reproducibility has less than 15% CV or less than 39 SD across the analytical measurement range, which was determined to be 10.4-467.7 AUC. The primary sources of error from highest to lowest were within-run > between-lot > between-operator > between-instrument. The PL assay is not significantly influenced by common potentially interfering substances and is not affected by dabigatran or rivaroxaban, which specifically cause secondary hemostasis defects. A dose-response effect was observed for cilostazol, tirofiban, ibuprofen, and dipyridamole, which are known to affect primary hemostatic function. Taken together, the results indicate that the test is highly specific for primary hemostatic function and is not significantly influenced by secondary hemostatic function.
Conclusions: The T-TAS01 PL assay is highly specific for the measurement of primary hemostatic function, with acceptable precision and reproducibility and a sufficiently wide analytical measurement range. T-TAS01 PL assay measurements may be useful for the assessment of overall primary hemostatic function in patients with bleeding tendencies, defects in primary hemostatic function, or prior to clinical procedures involving bleeding risk.
To cite this abstract in AMA style:Dahlen J, Dobashi K, Yuan W, Ishikawa S, Hosokawa K. Analytical Performance Validation of the T-TAS 01 PL Assay [abstract]. Res Pract Thromb Haemost. 2020; 4 (Suppl 1). https://abstracts.isth.org/abstract/analytical-performance-validation-of-the-t-tas-01-pl-assay/. Accessed November 26, 2020.
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