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.