Haematologica 2004;89: supplement no. 8 - Supplements ...

XVIII Congress of the Italian Society for Hemostasis and Thrombosis Research, Rome, Sept. 30-Oct. 3, 2004181methods. Seven outpatient peripheral units from theINHS were identified. Three hundred unselectedpatients referring to the Thrombosis Centre (TC) ofPerugia were enrolled on a first come basis afterobtaining informed consent. As a control group, westudied a series of matched patients of the TC. ThePoint-of-care (POC) device for the capillary determinationof INR was the Protime Microcoagulation System(IL, Milan), while the software used to manageOAT was P.A.R.M.A. 5 (IL, Milan, Italy). The project wasplanned and conducted with a research grant given byRegion Umbria. Results. Patients recruitment startedon October 2002 and fifty patients were assigned toeach unit. Five patients asked to withdraw. The meannumber of monthly accesses was 1.5 per patient. Theanalysis of the INR values showed that 62.1% of controlswere in the therapeutic range and that 72.0% oftime was spent within the therapeutic range. Neithermajor bleedings nor thromboembolic complicationswere documented. Interpretation and conclusions.These figures were not different from those measuredin the control group and in the historical analysis ofthe study group confirming the feasibility of this typeof management of OAT.PO-170QUALITY CONTROL PROGRAMS FOR POC DEVICES TOMEASURE INR. RESULTS OF A PILOT EXERCISEFerrante F, Paccamiccio E, Servettini I, Iorio ASezione di Medicina Interna e Cardiovascolare –Università di Perugia, ItalyBackground. INR testing is usually performed onvenous plasma with automated coagulometers, andmany external and internal quality controls programare available. To date, several studies have demonstratedthat Point-Of-Care (POC) coagulation monitorsrepresent an attractive and efficient option forOAT monitoring, but specific quality controls programsare to be validated. Aim of the study: Set up,run and evaluate a quality control program for INR-POC measurements. Materials and Methods. Ten POCdevices (ProTime, IL, Milan) are routinarily used forINR determination in 350 patients over seven outpatientsservices. Four time a year, five randomlyselected patients from each service gave their consentto undergo both fingerstick and venipuncture.The device was then recalled in the coordinating laboratory,checked with control material (Direct-check,IL, Milan) by a skilled technician, and rotated toanother service following a randomized scheme.Venous PT-INR was performed in duplicate in twodifferent laboratories (using one MLA – Recombiplastinand the other Futura – Recombiplastin, allfrom IL, Milan). Correlation coefficients, Bland andAltman comparison, and ANOVA were used toanalyse the data. Results. Sixty two couples of datawere available at the end of April. No effect of service,instrument and sample was found. Main resultsare shown in the table.Mean Mean SD Agreement Range R 2of means of means limitsProtime vs lab1 2.54±0.91 0.49±0.66 -0.8 to + 1.78 -0.3 to +3.6 0.70Protime vs lab2 2.70±1.03 0.129±0.38 -0.624 to +0.882 -0.9 to +1.9 0.88Lab1 vs lab2 2.47±0.84 0.33±0.56 -0.77 to + 1.42 -0.2 to +2.7 071Mean SD 95%CI Range CV %Control low 1.631 .2496 1.08 to 2.18 1.3 to 1.9 15Control high 3.32 .606 2.12 to 4.51 3.0 to 4.0 18Conclusions. POC results are comparable to thoseof a clinical laboratory. Direct-check showed a CVsuitable for its use as control materials.PO-171DETERMINATION OF THE TECHNIQUE- AND SPECIMEN-SPECIFIC INTERNATIONAL SENSITIVITY INDEX FOR THETHROMBOTESTTM REAGENTChantarangkul V, 1 Frontoni R, 2 Gresele P, 3 Oca G, 4Paniccia R, 5 Pellegrini L, 6 Tripodi A 11A Bianchi Bonomi Hemophilia and ThrombosisCenter, University and IRCCS Maggiore Hospital,Milano; 2 Laboratorio di Coagulazione, Dipartimentodi Patologia Clinica, Ospedale di Macerata; 3 Dipartimentodi Medicina Interna, Sezione di MedicinaInterna e Cardiovascolare, Universita’ di Perugia;4U.O. Angiologia e Malattie della Coagulazione,Policlinico S. Orsola - Malpighi, Bologna; 5 CentroTrombosi, Azienda Ospedaliera Universitaria Careggi,Florence; 6 Servizio Trasfusionale, ASL1-Umbra,Citta’ di Castello, ItalyISI values for 3 different lots of ThrombotestTM,(Axis-Shield PoC, Oslo, Norway) were estimated usingboth the manual (tilt-tube) technique and the Thrombotrackselect 2 (Axis-Shield PoC, Oslo, Norway)coagulometer. The calibration has been divided into2 steps. First, Thrombotest Lot1 was calibratedagainst the WHO-International Standard codedOBT/79 using citrated plasma in 2 expert laboratoriesthat used both the manual technique and Thrombotrack.Second, Thrombotest Lot 2 and 3 were calibratedagainst Thrombotest Lot 1 in other 4 laboratoriesthat used only Thrombotrack. In this secondstep, testing was performed using both citrated plas-haematologica vol. 89(suppl. n. 8):september 2004