Information for experts
High Definition Signal Transmission (HDST) and Autocoding for reliable accuracy and precision1,2
Signal transmission from the test strip to the device is crucial for the quality of measurement results. mylife Unio uses the innovative High Definition Signal Transmission (HDST) technology, which enables precise and accurate signalling. The very short signal path of just 2.5 mm and gold contacts minimise interference and thus ensure the best possible signal transmission.3 The meter automatically identifies a specific test strip lot code after the insertion of a mylife test strip into mylife Unio (Autocoding). This Autocoding feature allows the meter to cope with test strip production variations in order to ensure a high level of accuracy and precision.
Latest study results of mylife Unio
ISO 15197:20134 demands ≥ 95 % of measurements within ± 15 mg/dL (± 0.83 mmol/L) at glucose concentration < 100 mg/dL (< 5.55 mmol/L) and ± 15 % at glucose concentration ≥ 100 mg/dL (≥ 5.55 mmol/L). The three reagent system lots achieved the following test results within ± 15 mg/dL (± 0.83 mmol/L) and ± 15 %: 99.5 %, 98.5 % and 99 %. 100 % of mylife Unio 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 have dangerous consequences
mylife Unio shows very good results when tested for measurement repeatability (ten meters, three test strip lots at five glucose ranges): SD ≤ 2.2 mg/dL (≤ 0.12 mmol/L) (TNO5 acceptance criteria: SD ≤ 10 mg/dL (≤ 0.56 mmol/L) at glucose concentration < 100 mg/dL (< 5.55 mmol/L) and CV ≤ 2.0 % (TNO criteria: CV ≤ 5 % at glucose concentration ≥ 100 mg/dL (≥ 5.55 mmol/L)).
1 IDT Ulm: System accuracy evaluation of mylife Unio blood glucose monitoring system based on ISO 15197:2013 versus Cobas Integra 400 plus. Institute for Diabetes-Technology Research and Development Corporation at the University of Ulm, Principal Investigator: N. Jendrike, 08.2016
2 Bionime Corporation: Test Report for the Evaluation of Precision (ISO 15197:2013), Model GM720 (mylife Unio) and Strip GS720 (mylife Unio), Taichung, Taiwan, 10.2015.
3 Hsu C. et al.: Fabrication of a Glucose Biosensor Based on Inserted Barrel Plating Gold Electrodes. Anal Chem 2009, 81(1): 515-518.
4 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.
5 Post H. et al.: Portable In-Vitro Blood Monitor Systems for (Self)-Monitoring-Blood Glucose Monitors – Perticular Requirements and Test Methods. TNO Quality Guideline PG / TG / 2001 045 2001. Delft: TNO, 2001.