28 May 2013 A novel microfluidic anti-factor Xa assay device for monitoring anticoagulant therapy at the point-of-care
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Millions of patients worldwide are receiving anticoagulant therapy to treat hypercoagulable diseases. While standard testing is still performed in the central laboratory, point-of-care (POC) diagnostics are being developed due to the increasing number of patients requiring long-term anticoagulation and with a need for more personalized and targeted therapy. Many POC devices on the market focus on clot measurement, a technique which is limited in terms of variability, highlighting the need for more reliable assays of anticoagulant status. The anti-Xa assay, a factor specific optical assay, was developed to measure the extent to which exogenous factor Xa (FXa) is inhibited by heparinantithrombin complexes. We have developed a novel microfluidic device and assay for monitoring the effect of heparin anticoagulant therapy at the point-of-care. The assay which was also developed in our institute is based on the anti-Xa assay principle but uses fluorescence as the method of detection. Our device is a disposable laminate microfluidic strip, fabricated from the cyclic polyolefin (COP), Zeonor®, which is extremely suitable for application to fluorescent device platforms. We present data on the execution of the anti-Xa assay in this microfluidic format, demonstrating that the assay can be used to measure heparin in human plasma samples from 0 to 0.8 U/ml, with average assay reproducibility of 8% and a rapid result obtained within 60 seconds. Results indicate that with further development, the fluorogenic anti-Xa assay and device could become a successful method for monitoring anticoagulant therapy.
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Leanne F. Harris, Leanne F. Harris, Paul Rainey, Paul Rainey, Vanessa Castro-López, Vanessa Castro-López, James S. O'Donnell, James S. O'Donnell, Anthony J. Killard, Anthony J. Killard, } "A novel microfluidic anti-factor Xa assay device for monitoring anticoagulant therapy at the point-of-care", Proc. SPIE 8765, Bio-MEMS and Medical Microdevices, 876509 (28 May 2013); doi: 10.1117/12.2016872; https://doi.org/10.1117/12.2016872

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