Abstract Number: PB0055
Meeting: ISTH 2021 Congress
Background: The HemosIL Liquid Anti-Xa Assay, when used with HemosIL Apixaban Calibrators and Controls, is an automated, one-stage anti-Xa chromogenic assay for in vitro diagnostic use by laboratory professionals in clinical laboratories for the quantitative determination of apixaban in human citrated plasma on ACL TOP Family and ACL TOP Family 50 Series models.
Aims: The method comparison study was conducted to demonstrate the performance of the HemosIL Liquid Anti-Xa Assay for apixaban measurement on ACL TOP Family analyzers in a clinical setting, with liquid chromatography tandem mass spectrometry (LC-MS/MS) used as the reference method.
Methods: 367 samples, including 301 from patients requiring emergency surgery or at high risk for major bleeding, were tested at 3 clinical sites with HemosIL Liquid Anti-Xa assay on ACL TOP Family analyzers and at an external site for LC-MS/MS measurement. Weighted Deming regression analysis was performed for the method comparison study using LC-MS/MS as the reference method.
Results: As shown in Figure 1 and Table 1 the regression analysis for the pooled sites showed a correlation coefficient of 0.995, a slope of 1.10 and a mean bias of 6.8%. The bias at medical decision levels was 1.9% (at 30 ng/mL apixaban) and 9.4% (at 350 ng/mL apixaban), respectively.
Conclusions: Method comparison demonstrates performance equivalency of the HemosIL Liquid Anti-Xa Assay, when used with HemosIL Apixaban Calibrators and Controls, to the LC-MS/MS method in a patient population requiring emergency surgery or at high risk for major bleeding.
To cite this abstract in AMA style:Hammelburger J, Cao Z, Kung C. HemosIL Liquid Anti-Xa Apixaban Measurement in Patients with High Risk of Major Bleeding [abstract]. Res Pract Thromb Haemost. 2021; 5 (Suppl 2). https://abstracts.isth.org/abstract/hemosil-liquid-anti-xa-apixaban-measurement-in-patients-with-high-risk-of-major-bleeding/. Accessed November 29, 2021.
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