Clinical Evaluation of SD CHECK GOLD as Point-of-care Glucose Meter / 임상검사와정도관리

ABSTRACT

BACKGROUND: Self-monitoring devices for blood glucose are widely used as a point-of-care testing (POCT) in the management of diabetic patients. In the present study, we evaluated the performance of SD CHECK GOLD Blood Glucose Testing System (SD diagnostic, Korea) using electrochemical detection technique. METHODS: SD CHECK GOLD was tested for linearity, precision and comparison of method. Other glucometers including ACCU CHEK ACTIVE (Roche Diagnostics Ltd., Germany) and ONE TOUCH ULTRA (Lifescan Inc., USA) were compared for the same categories according to the Clinical and Laboratory Standards Institute (CLSI) guidelines. RESULTS: SD CHECK GOLD revealed good linearity in glucose concentration ranging from 50 mg/dL to 550 mg/dL (r(2)=0.9931). In the precision study, within-run precision and total-run precision (CV)s were within 10%. Excellent correlation was found between SD CHECK GOLD and Toshiba 200FR (Toshiba, Japan) (y=0.9212x, r=0.9756). CONCLUSIONS: SD CHECK GOLD showed good linearity, precision, and correlation with the reference method. No significant effect of testing procedure or operator was found. SD CHECK GOLD provided rapid and reliable results for blood glucose and seemed to be appropriate for the clinical useful in the management of diabetic patients.