DEVELOPMENT OF A BIODIAGNOSTIC DEVICE ASSAY FOR COAGULATION MONITORING

Magdalena M. Dudek, Anthony J. Killard

2010

Abstract

There is an urgent need for the development of reliable point-of-care devices capable of anticoagulant dose monitoring due to the increasing number of patients being treated with clotting control therapy. Millions of patients suffering from cardiovascular-related disorders rely on the anticoagulant therapy. One of the commonly administered drugs is warfarin. It is effective for primary and secondary prevention of venous thromboembolism, for prevention of cardioembolic events in patients with atrial fibrillation or prosthetic heart valves, for prevention of stroke, recurrent infarction or mortality in patients with acute myocardial infarction and for the primary prevention of acute myocardial infarction in high-risk men. Regular monitoring of warfarin effect is of paramount importance and therefore affords are made to develop novel, reliable point-of-care devices for drug level determination. Miniaturized microfluidic systems made of polymers have gained great interest of the diagnostics industry in recent years. Due to the low cost of manufacturing and processing, they have been employed in the development of several disposable diagnostic systems. Among the wide selection of different synthetic polymers, thermoplastics have gained significant popularity. Cyclic polyolefins (COPs) are a relatively new class of thermoplastics with an excellent combination of optical and electronic properties and are dimensionally stable while being subject to a range of operational temperatures and pressures. One such COP is marketed by Zeon Corp. under the brand name Zeonor®. This material has been used as the base for the developed assay. The technology developed by Åmic B.V. (Sweden) allowed the formation of an ordered array of micropillars which introduce controlled and highly reproducible capillary filling forces when liquid samples are introduced to the substrate. Capillary forces play an important role in most of these systems. Assays based on the flow of a fluid in a device with some form of immobilized reagents are considered as the most commonly used tool in many detection systems, including diagnostics. Herein, the concept of monitoring blood clotting properties by measuring a sample distance traveled in a lateral flow system was shown. Substances known to be strong coagulation activators were employed in the monitoring system. All necessary components were incorporated into a test strip, so that no pre-treatment steps were required. These were capable of inducing rapid clot formation and thus arrest of sample flow. The device was shown to be a viable tool for measuring the clotting status of samples containing different quantities of an anticoagulant. This idea of a simple assay device could be employed in a point-of-care determination of a drug level.

References

  1. Ansell, J., Hirsh, J., Poller, L., Bussey, H., Jacobson, A., Hylek, E., 2004. The pharmacology and management of the vitamin K antagonists. In Chest, 126, 3, 204S233S.
  2. Baigent, C., Collins, R., Appleby, P., 1998. ISIS-2: 10 year survival among patients with suspected acute myocardial infarction in randomised comparison of intravenous streptokinase, oral aspirin, both, or neither. In British Medical Journal, 316, 1337-1343.
  3. Hart, R. G., Pearce, L. A., Aguilar, M. I., 2007. Metaanalysis: Antithrombotic therapy to prevent stroke in patients who have nonvalvular atrial fibrillation. In Annals of Internal Medicine, 146, 857-867.
  4. Hirsh, J., Fuster, V., Ansell, J., 2003. American Heart Association American College of Cardiology - Foundation guide to warfarin therapy. In Journal of the American College of Cardiology, 41, 1633-1652.
  5. Levine, M. N., Raskob, G., Landefeld, S., Hirsh, J., 1995. Hemorrhagic complications of anticoagulant treatment. In Chest, 108, 276S-90S.
  6. Sick, P. B., Schuler, G., Hauptmann, K. E., 2007. Initial worldwide experience with the Watchman left atrial appendage system for stroke prevention in atrial fibrillation. In Journal of the American College of Cardiology, 49, 1490-1495.
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Paper Citation


in Harvard Style

Dudek M. and J. Killard A. (2010). DEVELOPMENT OF A BIODIAGNOSTIC DEVICE ASSAY FOR COAGULATION MONITORING . In Proceedings of the Third International Conference on Biomedical Electronics and Devices - Volume 1: BIODEVICES, (BIOSTEC 2010) ISBN 978-989-674-017-7, pages 183-186. DOI: 10.5220/0002743001830186


in Bibtex Style

@conference{biodevices10,
author={Magdalena M. Dudek and Anthony J. Killard},
title={DEVELOPMENT OF A BIODIAGNOSTIC DEVICE ASSAY FOR COAGULATION MONITORING},
booktitle={Proceedings of the Third International Conference on Biomedical Electronics and Devices - Volume 1: BIODEVICES, (BIOSTEC 2010)},
year={2010},
pages={183-186},
publisher={SciTePress},
organization={INSTICC},
doi={10.5220/0002743001830186},
isbn={978-989-674-017-7},
}


in EndNote Style

TY - CONF
JO - Proceedings of the Third International Conference on Biomedical Electronics and Devices - Volume 1: BIODEVICES, (BIOSTEC 2010)
TI - DEVELOPMENT OF A BIODIAGNOSTIC DEVICE ASSAY FOR COAGULATION MONITORING
SN - 978-989-674-017-7
AU - Dudek M.
AU - J. Killard A.
PY - 2010
SP - 183
EP - 186
DO - 10.5220/0002743001830186