Verification of a Blood Glucose Monitoring System Based on Standard Guidelines: Evaluating Performance Characteristics

Abstract

The Health Impact Blood Glucose Monitoring System Model No. BG-709 and Health Impact Blood Glucose Test Strip were verified for assessing the performance characteristics, including precision, linearity, interferences, and system accuracy, in accordance with the Clinical and Laboratory Standards Institute documents, i.e. EP15-A3, EP06-Ed2, and POCT12-A3, and ISO 15197:2013 guidelines. The measurement precision was assessed by calculating the standard deviation (SD) and coefficient of variation (%CV) for each glucose concentration interval. The repeatability and within-laboratory precision were acceptable across the target blood glucose ranges (< 100 mg/dL and ≥ 100 mg/dL) for all devices and strip lots with the SDs between 0.95–1.29 and 1.69–2.18, respectively, and with the CVs in the range of 0.60–1.63% and 1.29–2.68%, respectively. Moreover, the results of meter-to-meter comparison showed no significant differences between the groups (p-value = 0.160, 0.486 and 0.941). To determine the linearity verification, the allowable deviation from linearity (ADL) criterion was set to be 5%. Indeed, the results demonstrated that the proposed system met this criterion. Regression analysis was also performed to calculate the correlation coefficient (r), which was found to be within the range of 0.9984–0.9998. The acceptable recoveries ranged from 96.67% to 108.33%, with linearity observed in the range of 30 to 550 mg/dL. Additionally, the interferences, i.e. galactose (15 mg/dL), maltose (1,250 mg/dL), icodextrin (1,094.4 mg/dL), triglyceride (1,850 mg/dL), and packed cell volume (0–70%), did not interfere with the measurement results. In summary, the system accuracy of Health Impact Blood Glucose Monitoring System met the acceptance criteria of CLSI POCT12-A3 and ISO 15197:2013 requirements for evaluating blood glucose level.