Key result
Point-of-care CoaguChek XS shows ~84% clinical agreement with laboratory INR testing.
Why the study?
The accuracy and precision of the CoaguChek XS INR meter for monitoring INR in patients on warfarin therapy had not been validated in the Namibian setting.
Does the CoaguChek XS point-of-care INR meter provide reliable clinical agreement compared to standard laboratory automated coagulometers in outpatients on warfarin?
Cohort (n=89)
No
Does the CoaguChek XS point-of-care INR meter provide reliable clinical agreement compared to standard laboratory automated coagulometers in outpatients on warfarin?
Mean Difference: -0.15
p-value: p=<0.001
The CoaguChek XS point-of-care INR meter provides reliable and accurate results compared to laboratory testing, supporting its use for expanding anticoagulation monitoring services.
May support POC INR monitoring in warfarin outpatients; extends validation data but leaves open need for randomized outcome trials.
Background: The use of point-of-care INR (international normalised ratio) testing is on the rise because of its ability to facilitate quick clinical decisions as it allows for rapid turnaround time of INR results. Ensuring the quality of these tests is crucial when implementing them in new settings. Objective: This study aimed to assess the sensitivity, specificity, and clinical agreement between the CoaguChek® XS INR meter and the Beckman Coulter ACL 7000 automated coagulometer in outpatients undergoing warfarin therapy. Methods: A prospective cohort design was employed for this comparison. The analysis included Spearman’s correlation, a Bland-Altman plot, and a Cohen’s Kappa analysis of paired INR values. Key outcome measures included the percentage sensitivity, specificity, and clinical agreement of the two methods. A p-value < 0.05 was considered statistically significant. Results: The study involved 89 patients, predominantly female (59.4%), with a mean age of 46 years. Deep vein thrombosis was the most common indication for warfarin therapy (51.9%). The mean difference between INR values determined by the two methods was –0.15 (± 0.27, N = 89), and the Spearman rank correlation coefficient was 0.97 (p < 0.001, N = 89). A clinical agreement of 83.8% (p < 0.05) was obtained. The sensitivity was 94.4%, with specificities of 82.5% for subtherapeutic and 100% for supratherapeutic INRs. Conclusion: The CoaguChek® XS INR meter was proven to be a reliable alternative to the Beckman Coulter ACL 7000 automated coagulometer for monitoring INR results and adjusting warfarin therapy in well-trained patients with stable INR values. What this study adds: The CoaguChek® XS INR meter was proven to be a reliable alternative to the Beckman Coulter ACL 7000 automated coagulometer for monitoring INR results.
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Thikukutu et al. (2026) conducted a cohort in Patients on warfarin therapy (n=89). CoaguChek XS point-of-care INR meter vs. Beckman Coulter ACL 7000 automated coagulometer was evaluated on Mean difference in INR values between methods (Mean difference -0.15, p=<0.001). The CoaguChek XS point-of-care INR meter demonstrated high clinical agreement (83.8%) with laboratory testing, showing a mean difference of -0.15 and a correlation of 0.97.
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