Performance Evaluation of CareSens PRO Glucose Monitoring System

Kim, Borahm; Seo, Ji Young; Woo, Hye In; Lee, Soo Youn; Park, Hyung Doo

Abstract

BACKGROUND
Point-of-care testing (POCT) glucometers are widely used for the management of diabetic patients. We evaluated the analytical performance of the recently developed glucometer CareSens PRO (i-SENS Inc., Korea).
METHODS
Linearity, precision, and correlation were evaluated according to the Clinical and Laboratory Standards Institute guidelines. Five levels of glucose obtained from patient samples were used to determine the linearity of the device response. Control materials with low, medium, and high levels of glucose were evaluated with two different CareSens PRO glucometers to determine their precision. Correlations were evaluated between venous plasma analyzed with Synchron CX3 Delta (Beckman Coulter Inc., USA) and capillary whole blood analyzed with CareSens PRO, and between venous whole blood analyzed with ADAMS GA-1171 (Arkray, Inc., Japan) and venous whole blood analyzed with CareSens PRO, respectively. The effect of hematocrit was assessed.
RESULTS
The linearity in the glucose range of 25.5 to 535.0 mg/dL was R2=0.9988. The coefficients of variations (CVs) of within-run precision were 2.06 to 3.47% and the CVs of total precision were 2.99 to 5.38%. The correlations were as follows: r=0.9660 in the range of 68.0 to 404.0 mg/dL with Synchron CX3 Delta and r=0.9886 in the range of 20.5 to 511.0 mg/dL with ADAMS GA-1171. In the specimens containing glucose above 75 mg/dL, 91.2% and 98.9% of CareSens PRO results were within +/- 20% of the results by Synchron CX3 Delta and ADAMS GA-1171, respectively. Hematocrit influenced the glucose concentration.
CONCLUSIONS
CareSens PRO displayed acceptable linearity and precision. For clinical application, it is necessary for the improvement of comparable analytical performance and careful interpretation according to hematocrit concentration.