From laboratory to point of care: Clinical performance and validation of bSens.INR for prothrombin time and INR monitoring.
8 affiliations
- 1Postgraduate Program in Chemistry, Federal University of Rio Grande do Sul, 91501-970, Brazil.
- 2Biosens Biosensor Development and Manufacturing Ltda., 93022-715, Brazil.
- 3Postgraduate Program in Environmental Quality, Feevale University, 93525-075, Brazil.
- 4Postgraduate Program in Mining, Metallurgical and Materials Engineering, Federal University of Rio Grande do Sul, 91501-970, Brazil.
- 5Postgraduate Program of Collective Health, University of Vale do Rio dos Sinos, 93022-750, Brazil.
- 6Undergraduate Program in Systems Analysis and Development, University of Vale do Rio dos Sinos, 93022-750, Brazil.
- 7Postgraduate Program in Materials Engineering and Technology, Pontifical Catholic University of Rio Grande do Sul, 90619-900, Brazil.
- 8Postgraduate Program in Bioengineering and Biotechnology, Swiss Federal Institute of Technology Lausanne, AI 1206 CH-1015, Switzerland.
Abstract
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. 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. 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. 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. 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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BibTeX
@article{moreira2026from,
title = {{From laboratory to point of care: Clinical performance and validation of bSens.INR for prothrombin time and INR monitoring.}},
author = {Julia Konzen Moreira and Gabriela Victória de Mello Jantzch and Duane da Silva Moraes and Bruna Ferri Serafini and Milleny Germann Souza and Marcele Arais Hocevar and Rodrigo Ritzel Bernasconi and Fernanda Santos Dos Santos and Willyan Hasenkamp Carreira},
journal = {Practical laboratory medicine},
year = {2026},
month = oct,
doi = {10.1016/j.plabm.2026.e00564},
url = {https://europepmc.org/article/MED/42997056},
note = {CC BY},
}
RIS
TY - JOUR
TI - From laboratory to point of care: Clinical performance and validation of bSens.INR for prothrombin time and INR monitoring.
AU - Julia Konzen Moreira
AU - Gabriela Victória de Mello Jantzch
AU - Duane da Silva Moraes
AU - Bruna Ferri Serafini
AU - Milleny Germann Souza
AU - Marcele Arais Hocevar
AU - Rodrigo Ritzel Bernasconi
AU - Fernanda Santos Dos Santos
AU - Willyan Hasenkamp Carreira
PY - 2026
DA - 2026/10/27
JO - Practical laboratory medicine
DO - 10.1016/j.plabm.2026.e00564
UR - https://europepmc.org/article/MED/42997056
AB - 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. 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. 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. 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. 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.
SN - 2352-5517
ER -