Accuracy and Precision of Point-of-Care International Normalized Ratio in Patients with Liver Disease.

OBJECTIVE: To determine if the CoaguChek® XS-Pro Point-of-Care (POC) device can accurately and precisely measure the international normalized ratio (INR) compared with the gold standard laboratory INR in pediatric and adult patients with liver disease.

METHODS: This prospective cohort study included 15 pediatric patients without liver disease, 13 pediatric patients with liver disease, and 17 adult patients with liver disease. The accuracy of the POC INR values was determined using the correlation and Bland-Altman limits of agreement. The accuracy of the coagulometer INR was assessed by calculating the proportion of POC INR measurements that were ≤15% of their corresponding laboratory INR.

RESULTS: A comparison of INR measurements showed an excellent correlation in pediatric patients without liver disease (r=0.82), pediatric patients with liver disease (r=0.89), and adult patients with liver disease (r=0.96). 14 (93%) POC INR values were ≤15% in pediatric patients without liver disease from its paired laboratory INR. All 13 paired measurements were ≤15% in pediatric patients with liver disease. In adult patients with liver disease, 12 (71%) POC INR values were ≤15% of their paired laboratory INR.

CONCLUSIONS: In patients with liver disease, the CoaguChek® XS-Pro provides an accurate measure of the INR compared to laboratory INR measurements.