[Point-of-Care Blood Glucose Testing: Post-Market Performance Assessment of the Accu-Chek Inform II Hospital-Use...

Area of Science:

• Clinical Chemistry
• Medical Diagnostics
• Point-of-Care Testing

Background:

• Conventional glucose meters in Russian medical facilities present accuracy issues and lack laboratory information system integration.
• Home-use glucose meters can lead to medical errors due to measurement bias and manual data entry.
• Specialized point-of-care glucose meters offer improved accuracy and system integration for clinical settings.

Purpose of the Study:

• To evaluate the performance characteristics of the Accu-Chek Inform II point-of-care glucose testing meter.
• Assessed parameters include accuracy, linearity, repeatability, and mean absolute relative difference (MARD).

Main Methods:

• Compared Accu-Chek Inform II results with a reference laboratory analyzer using capillary blood samples.
• Conducted 99 parallel glucose measurements across 45 samples.
• Evaluated accuracy against ISO 15197-2013 and POCT12-A3 criteria.

Main Results:

• The Accu-Chek Inform II meter satisfied ISO 15197-2013 and POCT12-A3 accuracy requirements.
• Demonstrated high linearity with a correlation coefficient (r) of 1.0.
• Exhibited good repeatability (mean coefficient of variation, CV = 1.38%) and acceptable MARD (4.9%).

Conclusions:

• The Accu-Chek Inform II point-of-care glucose meter is suitable for safe and efficient use in medical facilities.
• Recommended for both inpatient and outpatient settings, especially within pediatric clinics.
• Facilitates reliable glucose monitoring and data management in clinical environments.