Evaluation of CareSens(R) N Glucometer Glucose Monitoring System / 임상검사와정도관리

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.