Evaluation of ACCU-CHEK(R) Inform II Blood Glucose Meter and ACCU-CHEK(R) Performa Strip

Seo, Youkyung; Won, Youngcheol; Kim, Hyo Sik; Kwon, Oh Hun; Lee, Woonhyoung

Abstract

BACKGROUND
Self-monitoring of blood glucose levels is recommended for all diabetic patients who receive insulin treatment, because such monitoring of glucose levels may aid in achieving better control in type II diabetes. Further, the use of point-of-care (POC) blood glucose testing in hospitals has increased substantially. In the present study, we validated the performance of ACCU-CHEK(R) Inform II Blood Glucose Meter and ACCU-CHEK(R) Performa Strip (Roche Diagnostics, Germany).
METHODS
We evaluated the precision, accuracy, and maltose interference of the ACCU-CHEK(R) Inform II Blood Glucose Meter and ACCU-CHEK(R) Performa Strip. Further, precision was evaluated using dedicated quality control (QC) and Bio-Rad Whole Blood (WB) QC materials (Meter Trax(TM) Control; Bio-Rad, USA). Forty samples were used to compare the results obtained using the ACCU-CHEK(R) Inform II Blood Glucose Meter and ACCU-CHEK(R) Performa Strip with those obtained using the clinical chemistry analyzer Hitachi 7600 (Hitachi, Japan). Maltose interference was assessed at 2 glucose concentration levels at 3 maltose concentration levels.
RESULTS
For each concentration level of control materials, within-run coefficient of variation (CV) and total CV obtained were less than 5%. Good correlation was obtained using the Hitachi 7600 (y = 1.02x - 0.18; r 2 = 0.996; N = 40). Effects of maltose interference were less than 10%.
CONCLUSIONS
Thus, the ACCU-CHEK(R) systems show good precision and correlation with the routine clinical chemistry analyzer and allow only minimal effects of maltose interference.