Evaluation of CareSens(R) N Glucometer Glucose Monitoring System / 임상검사와정도관리
Journal of Laboratory Medicine and Quality Assurance
;
: 229-236, 2010.
Artigo
em Coreano
| WPRIM
| ID: wpr-22072
ABSTRACT
BACKGROUND:
Point-of-care testing (POCT) glucometers are widely being used for management of diabetes. We examined the analytical performance of the recently developed glucometer CareSens(R) N Glucometer (i-SENS Inc., Korea).METHODS:
CareSens N was evaluated for linearity, precision, and the effect of hematocrit. Method comparison using the laboratory reference method, hexokinase method by Hitachi 7600 (Hitachi Co., Japan) was also performed. Other glucometers, Accu-Chek(R) inform (Roche Diagnostics LTD., Germany) and Onetouch(R) ultra(TM) (Lifescan Inc., USA) were evaluated for the same categories according to CLSI guidelines.RESULTS:
CareSens N Glucometer showed a good linearity and precision. The linearity was r=0.9965. The coefficients of variations (CVs) of within-run precision were 0.73-1.98% and CVs of total precision were 1.65-2.71%. A high correlation (glucose by CareSens N = 0.9767 x glucose by Hitachi 7600 + 4.1734, r=0.9614) was also shown between the CareSens N glucometer and Hitachi 7600 in the central laboratory. Other glucometers showed a good linearity. The within-run and total-run CVs of other glucometers were within 10%. Although differences with the reference method were within allowable ranges, all glucometers showed variable bias compared with the reference method. Overestimation or underestimation of glucose values were observed by change of hematocrit in range of 31.1 to 51.2%.CONCLUSIONS:
CareSens N showed good linearity, precision, and correlation with reference method. CareSens N provided reliable result of blood glucose and seems appropriate for clinical use in the management of diabetic patients.
Texto completo:
DisponíveL
Índice:
WPRIM (Pacífico Ocidental)
Assunto principal:
Glicemia
/
Viés
/
Glucose
/
Hematócrito
/
Hexoquinase
/
Coreia (Geográfico)
Tipo de estudo:
Guia de Prática Clínica
Limite:
Humanos
País/Região como assunto:
Ásia
Idioma:
Coreano
Revista:
Journal of Laboratory Medicine and Quality Assurance
Ano de publicação:
2010
Tipo de documento:
Artigo
Similares
MEDLINE
...
LILACS
LIS