The objective is to demonstrate the performances of STA® - Apixaban Calibrator \& STA® - Apixaban Control used in combination with STA® - Liquid Anti-Xa to measure apixaban concentration in plasma. Anti-Xa results will be compared to LCMS (liquid chromatography - mass spectrometry) for validation of the assay. For this study, the anti-Xa assay will be performed on fresh samples only. The results will be used to complete results obtained previously on frozen samples.
About 60 samples from patients on apixaban meeting inclusion/exclusion criteria will be included in this study. Two sites will be in charge of sample recruitment and anti-Xa testing. A third site will be in charge of LCMS testing.
Study Type
OBSERVATIONAL
Enrollment
109
Measurement of apixaban level will be done using anti-Xa assay (IVD).
Moses Cone Memorial Hospital
Greensboro, North Carolina, United States
Lehigh Valley Health Nrwork
Allentown, Pennsylvania, United States
Method comparison between Anti-Xa method and LCMS to measure apixaban in plasma
Compare results from anti-Xa assay and LCMS to measure apixaban in plasma samples. Regression and difference charts will be used to compare the methods.
Time frame: The anti-Xa assay will be tested within 6h after sample collection and LCMS will be performed on frozen samples, at maximum 2 months after collection.
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