Information for experts
Autocoding for reliable accuracy and precision
Autocoding stands for the automatic calibration of the meter. Modern blood glucose monitoring systems correct each measurement automatically to compensate production tolerances of the test strip lots regarding chemistry and physics. Each individual test strip gets a lot-specific electronic code during production, which is read by the meter to correct the measured blood glucose value as close as possible to the reference device. The patient does not have to calibrate the meter manually in any way.
In the context of the requirements of ISO 15197:20131, mylife Aveo measuring technique leads to convincing results:
ISO 15197:2013 demands ≥ 95 % of measurements within ± 15 mg/dL at a glucose concentration < 100 mg/dL and within ± 15 % at a glucose concentration ≥ 100 mg/dL. All three reagent system lots achieved 99.7 % within ± 15 mg/dL and ± 15 %. 100 % of mylife Aveo test results (600 of 600 pooled measurements) cover zone A in the Consensus Error Grid (CEG) (A and B zones must be ≥ 99 %).
Definition of the error grid zones
Zone A No effect on clinical action
Zone B Altered clinical action – little or no effect on clinical outcome
Zone C Altered clinical action – likely to affect clinical outcome
Zone D Altered clinical action – could have significant medical risk
Zone E Altered clinical action – could habe dangerous consequences
mylife Aveo shows very good results when tested for measurement repeatability (ten meters, three test strip lots at five glucose ranges): SD ≤ 2.8 mg/dL (TNO4 acceptance criteria: SD ≤ 10 mg/dL at glucose concentrations < 100 mg/dL) and CV ≤ 3.7 % (TNO criteria: CV ≤ 5 % at a glucose concentration ≥ 100 mg/dL).
1 ISO 15197:2013; In vitro diagnostic test systems – Requirements for blood-glucose monitoring systems for self-testing in managing diabetes mellitus. International Organisation for Standardization, Geneva.
2 i-SENS: Test Report for the System Accuracy Evaluation Blood Glucose Monitoring System mylife Aveo, Yangjae Choi’s Hospital, Korea, 10.2019.
3 i-SENS: Test Report for the Evaluation of Precision (ISO 15197:2013) of the mylife Aveo Blood Glucose Monitoring System, Sensor laboratory (B1F) Seocho, i-SENS, Inc., Korea, 10.2019.
4 Post H. et al.: Portable In-Vitro Blood Monitor Systems for (Self)-Monitoring-Blood Glucose Monitors – Particular Requirements and Test Methods. TNO Quality Guideline PG/TG/2001 045 2001. Delft: TNO, 2001.