Clinical and laboratoristic performance evaluation of three point-of-care devices for INR determination (Coagucheck, ProTime, Harmony)

Abstract number: P1966

Accardo^* P., Ghirarduzzi^* A., Silingardi^* M., Franzoni^* C., Iorio† A.

^*Azienda Ospedaliera S. Maria Nuova, Reggio Emilia, Italy; †Sezione di Medicina Interna e Cardiovascolare, Italy

Normalized ratio on patient plasma. Recently, several point-of-care (POC) devices for INR determination on capillary whole blood have been introduced for clinical use.

Objective  

To compare the accuracy of three POC devices (CoaguCheck S, Roche; ProTme, IL; Harmony, LifeScan) as compared to standard plasma PT-INR for INR determination in a routine clinical setting.

Materials and methods  

INR was simultaneously measured in patients on stabilized long-term anti-coagulation both from venous blood drawn from the antecubital vein (PT Diagnostica Stago on STA automated coagulometer, Roche) and from capillary blood by the three POC devices under study. The results from the POC devices were used in a blinded simulation study to evaluate the impact on drug dosage assignment and time to the following visit, as compared with real data produced from PT-INR. The accuracy of the POC devices vs. plasma PT-INR was evaluated by measuring the standard correlation coefficient and by the Bland and Altman procedure.

Results  

One hundred and twenty patients were enrolled and analyzed. Main results are shown in the Table.

Conclusions  

All the three POC devices showed a good correlation with plasma PT-INR, and are likely to be efficiently and safely used in clinical practice. Marginal differences concerning clinical and laboratory agreement as compared to plasma PT exist and could be used, besides economic considerations, in the choice between the devices.

Table 1