Performance Evaluation of BAROZEN H, a Networking Blood Glucose Monitoring System for Medical Institutions
Laboratory Medicine Online
;
: 69-76, 2015.
Artigo
em Coreano
| WPRIM
| ID: wpr-143279
ABSTRACT
BACKGROUND:
We evaluated the analytical performance of Barozen H (i-SENS Inc., Korea), a new glucometer equipped with networking function for medical institutions, according to the ISO 151972003 and ISO/DIS 151972011 guidelines.METHODS:
We measured the precision of 10 Barozen H glucometers, in terms of repeatability and intermediate precision, and determined their accuracy relative to that of automatic chemistry analyzer AU5421 (Beckman Coulter, USA). Three other glucometers-Precision PCx (Abbott, USA), Glucocard Sigma (Arkray, Japan), and SureStep Flexx (Johnson & Johnson, USA) were also evaluated, and their accuracies and hematocrit interferences were compared.RESULTS:
The standard deviation and coefficient of variation of Barozen H for repeatability and intermediate precision were 0.11-0.15 mmol/L and 2.3-3.6%, respectively. With respect to accuracy, in accordance with ISO 151972003 criteria, Barozen H yielded 98.0% of results within +/-0.83 mmol/L or +/-20%. Further, per the ISO/DIS 151972011 criteria, 95.2% of results were within +/-0.83 mmol/L or +/-15%; Barozen H was the only glucometer satisfying the more stringent ISO/DIS 151972011 criteria. Error grid analysis showed that all results from Barozen H were in zone A, indicating its excellent clinical accuracy. Hematocrit, ranging from 20% to 60% did not cause any significant interference.CONCLUSIONS:
Barozen H showed excellent analytical performance, and it was the most clinically accurate glucometer tested. It can be expected to provide reliable results satisfying ISO/DIS 151972011 as well as ISO 151972003 criteria.
Texto completo:
DisponíveL
Índice:
WPRIM (Pacífico Ocidental)
Assunto principal:
Glicemia
/
Automonitorização da Glicemia
/
Química
/
Sistemas Automatizados de Assistência Junto ao Leito
/
Diabetes Mellitus
/
Glucose Oxidase
/
Hematócrito
Tipo de estudo:
Guia de Prática Clínica
Idioma:
Coreano
Revista:
Laboratory Medicine Online
Ano de publicação:
2015
Tipo de documento:
Artigo
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