title: International sensitivity index calibration of the near-patient testing prothrombin time monitor, ProTime.
abstract: Near-patient testing devices (monitors) capable of measuring prothrombin time on an unmeasured drop of blood would be suitable alternatives to centralized laboratory monitoring of patients receiving oral anticoagulants. The essential prerequisite for the use of these monitors is their conformity to the international sensitivity index (ISI) calibration model recommended by the World Health Organization. We report on the ISI calibration of the ProTime monitor (International Technidyne, Edison, NJ) designed and approved for patient self-testing. According to our results, this monitor can be calibrated by adopting the model already used for other monitors. The apparent ISI was close to unity. Overall, the international normalized ratio values displayed by the monitor agreed with those measured with the international reference preparation for thromboplastin. Confirmation of these results in a large multicenter study is warranted.
authors.affiliation: Angelo Bianchi Bonomi Hemophilia and Thrombosis Center, Department of Internal Medicine, University and Istituto Ricovero e Cura a Carattere Scientifico Maggiore Hospital, Milano, Italy.
authors.forename: Armando
authors.initials: A
authors.lastname: Tripodi
authors.forename: Veena
authors.initials: V
authors.lastname: Chantarangkul
authors.forename: Caterina
authors.initials: C
authors.lastname: Bressi
authors.forename: Pier Mannuccio
authors.initials: PM
authors.lastname: Mannucci
mesh_terms: D000284:Administration, Oral; D000925:Anticoagulants / Q000008:administration & dosage / Q000627:therapeutic use*; D002138:Calibration; D016903:Drug Monitoring / Q000295:instrumentation / Q000379:methods / Q000592:standards*; D006801:Humans; D007391:International Cooperation; D019934:International Normalized Ratio; D019095:Point-of-Care Systems / Q000592:standards*; D011517:Prothrombin Time; D012015:Reference Standards
chemical_list: D000925:Anticoagulants