Practical Laboratory Medicine
From laboratory to point of care: Clinical performance and validation of bSens.INR for prothrombin time and INR monitoring
By Julia Konzen Moreira, Gabriela Victória de Mello Jantzch, Duane da Silva Moraes and 6 others.
Abstract
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.