Large-scale performance evaluation of Accu-Chek inform II point-of-care glucose meters

Area of Science:

• Clinical Chemistry
• Medical Device Evaluation
• Point-of-Care Testing

Background:

• Large-scale performance evaluation of 238 Accu-Chek Inform II point-of-care (POC) glucose meters was conducted in a single medical setting.
• Assessing the reliability and accuracy of POC devices is crucial for effective patient management.

Purpose of the Study:

• To evaluate the performance of Accu-Chek Inform II POC glucose meters.
• To assess precision, linearity, and correlation with central laboratory results.

Main Methods:

• Repeatability and within-site imprecision of 238 and 12 POC devices, respectively, were assessed using glucose control solutions.
• Linearity of 49 devices was evaluated, and glucose results from 24 POC devices were compared against a central laboratory using patient samples.

Main Results:

• Pooled repeatability coefficient of variation (CV) was 2.0% (Level 1) and 1.6% (Level 2).
• Pooled within-site imprecision and reproducibility CVs were 2.7% and 1.9% for Level 1 and Level 2, respectively.
• Devices demonstrated linearity from 1.55-31.02 mmol/L with high correlation coefficients (0.9967-0.9985 for individual devices, 0.998 for total correlation).

Conclusions:

• Accu-Chek Inform II POC blood glucose meters exhibit excellent performance in precision, linearity, and correlation.
• There is a need for consensus guidelines for large-scale performance evaluations of POC devices.