Key result
Point-of-care bSens.INR device matches laboratory reference standards in ~99% of determinations.
Why the study?
Vitamin K antagonist therapy requires periodic PT/INR monitoring, and point-of-care devices may improve monitoring accessibility and frequency, motivating the clinical validation of the bSens.INR system against a laboratory reference method.
Does the bSens.INR point-of-care system provide accurate and precise prothrombin time and INR determinations compared to a laboratory reference method in participants undergoing anticoagulation monitoring?
Observational (n=77)
Does the bSens.INR point-of-care system provide accurate and precise prothrombin time and INR determinations compared to a laboratory reference method in participants undergoing anticoagulation monitoring?
The bSens.INR point-of-care device demonstrated 98,5% agreement with laboratory reference methods and <10% repeatability variability for PT/INR monitoring, supporting its regulatory evaluation in Brazil.
Supports PT/INR method validation; leaves open whether it can safely guide warfarin dosing before larger trials.
Background Anticoagulant therapy with vitamin K antagonists, particularly warfarin, requires periodic monitoring of prothrombin time (PT) and the International Normalized Ratio (INR) to maintain patients within the therapeutic range and reduce thromboembolic and hemorrhagic risks. Point-of-care (POC) devices may improve the accessibility and frequency of anticoagulation monitoring. Objectives To evaluate the clinical performance of bSens.INR, a POC system for quantitative PT/INR determination, by comparison with a laboratory reference method and assessment of precision and usability. Patients/Methods Clinical validation included 77 participants and 200 capillary blood determinations performed in duplicate (400 bSens.INR tests), with corresponding venous samples analyzed by laboratory reference methods. Accuracy, repeatability, intermediate precision, and usability were assessed. Potential interfering factors were evaluated descriptively and exploratorily. Results Overall, 98,5% of results met the predefined accuracy acceptance criteria, demonstrating adequate agreement with the laboratory reference method. Accuracy decreased at INR values above 3.7. All duplicate measurements met the repeatability acceptance criteria, with variability below 10%. Intermediate precision and usability assessments further supported system performance under the evaluated conditions. Exploratory assessment of potential interfering factors did not establish causal relationships but identified factors warranting further investigation. Conclusions bSens.INR demonstrated adequate clinical performance for PT/INR determination under the evaluated conditions. These findings provide clinical evidence supporting its regulatory evaluation by the Brazilian Health Regulatory Agency (ANVISA). Further studies should investigate higher INR ranges, potential interfering factors, and real-world performance, including self-monitoring.
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Moreira et al. (2026) conducted an observational in Anticoagulant therapy monitoring (prothrombin time and INR) (n=77). bSens.INR point-of-care system vs. Laboratory reference method (venous blood) was evaluated on Clinical accuracy agreement with the laboratory reference method. The bSens.INR point-of-care device met predefined accuracy criteria in 98.5% of determinations compared with the laboratory reference method, with duplicate repeatability variability <10%.
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