Abstract
Oral anticoagulant (OA) treatment is saving lives by reducing mortality and morbid1. Materials and Methods ity associated with thrombosis-related clinical events [1]. The number of patients treated 1.1. Patients is rapidly increasing, and monitoring OA treatment is an emerging health/social problem [2]. During 15 working days, 150 patients referred to Near-patient testing devices are increasingly our Center for a periodic checkup of OA treatment proposed, and home-monitoring offers an attracwere evaluated. They were in stable OA therapy, tive alternative to testing in the clinic. However, with at least three preceding international normalstudies designed to validate the adequacy of such ized ratios (INRs) in the therapeutic range. Both devices are mandatory prior to their general applivenous and capillary blood samples were drawn cation. by qualified personnel. Each session included two The adequacy of self-testing devices was first plasma samples from healthy subjects. reported by Lucas et al. [3]. Subsequently, many The Pro Timet Microcoagulation System is a studies reported the reliability of various devices hand-held portable device that can be used by eiin comparison to standard prothrombin time (PT) ther battery or electrical power supply. This instrudeterminations [4–8]. ment gives PT determinations on capillary blood In this study we have compared the reliability samples obtained by using a disposable device of Pro Timet, a new microcoagulation device (In(Tenderlettt Plus) for fingerstick incision, blood ternational Technidyne Corporation, Edison, NJ, collection, and application of the sample to a test USA), with the PT determination system routinely cuvette. Each test cuvette has five reaction channels containing lyophilized human recombinant thromboplastin with an international sensitivity Abbreviations: OA, oral anticoagulant; PT, prothrombin time; index (ISI) of around 1.0. INR, international normalized ratio. When the blood sample is applied and the quality Corresponding author: Vittorio Pengo, Department of Clinical and Experimental Medicine, University of Padova School of Medcontrol results are within the expected ranges, the icine, Thrombosis Centre, “Ex Busonera” Hospital, via Gattamelinstrument displays the PT result in INR and secata, 64, I-35128 Padova, Italy. Tel.: 139 (49) 821 5658. Fax: 139 (49) 875 4179. E-mail: ,pengo@ux1.unipd.it.. onds. If the test has not been performed correctly,
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