Performance evaluation of coaguchek pro II in comparison with coaguchek XS plus and sta‐r Max using a sta‐neoplastine CI plus.

Introduction: We evaluated the analytical performance of CoaguChek Pro II (Roche Diagnostics GmbH, Mannheim, Germany), a new point‐of‐care device measuring the international normalized ratio (INR) values, in comparison with CoaguChek XS Plus (Roche Diagnostics GmbH) and STA‐R Max using STA‐Neoplastine CI Plus (Diagnostica Stago SAS, Asnières‐sur‐Seine, France). Methods: The precision of Pro II was analyzed, according to the Clinical and Laboratory Standards Institute guidelines (CLSI POCT14‐A2 and EP15‐A3). In 105 clinical samples, the Pro II INR values were compared with those of XS Plus and STA‐R Max using STA‐Neoplastine CI Plus (CLSI EP09‐A3 and EP35). We also compared the Pro II INR values between capillary blood (CB) and venous blood (VB; CLSI EP35). Results: The precision of Pro II was acceptable (within‐run and between‐run CV%: 2.71% and 3.28% at normal level; 1.52% and 4.47% at abnormal level, respectively). The Pro II INR values showed very high correlation and almost perfect agreement with those of XS Plus and STA‐R Max using STA‐Neoplastine CI Plus (r =.97 and κ =.94; r =.95 and κ =.91). The mean difference between Pro II and STA‐R Max using STA‐Neoplastine CI Plus increased as INR values increased, with 60% of samples showing differences >0.5 in the supratherapeutic range. The Pro II INR values showed very high correlation between CB and VB (r =.98). Conclusion: Pro II INR values are accurate and reliable using both CB and VB; however, they should be confirmed by laboratory analyzers in the supratherapeutic range. [ABSTRACT FROM AUTHOR]