High Definition Signal Transmission (HDST) and Autocoding for reliable accuracy and precision
Autocoding stands for the automatic calibration of the meter, meaning modern blood glucose measuring systems correct the measurement automatically. The measurement of mylife Unio Cara is adjusted by a specific correction value stored in the Autocoding module of the meter, correcting the measured blood glucose value as close as possible to the reference device. The patient does not have to calibrate the meter manually by inserting a code or key.
Signal transmission from the test strip to the device is crucial for the quality of measurement results. mylife Unio Cara 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 help to minimise interference and thus ensure very good signal transmission. Gold is one of the most corrosion-resistant of all established conductive materials, ensuring optimal signal transmission from test strip to measurement device.1
In the context of the requirements of ISO 15197:20132, mylife Unio Cara’s advanced measuring technique leads to convincing results:
ISO 15197:2013 demands ≥ 95 % of measurements within ± 15 mg/dL (± 0.83 mmol/L) at a glucose concentration < 100 mg/dL (< 5.55 mmol/L) and within ± 15 % at a glucose concentration ≥ 100 mg/dL (≥ 5.55 mmol/L). All three reagent system lots achieved 100 % within ± 15 mg/dL (± 0.83 mmol/L) and ± 15 %. 100 % of mylife Unio Cara 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 Unio Cara shows very good results when tested for measurement repeatability (ten meters, three test strip lots at five glucose ranges): SD ≤ 2.3 mg/dL (≤ 0.13 mmol/L) (TNO5 acceptance criteria: SD ≤ 10 mg/dL (≤ 0.56 mmol/L) at glucose concentrations < 100 mg/dL (< 5.55 mmol/L) and CV ≤ 2.6 % (TNO criteria: CV ≤ 5 % at a glucose concentration ≥ 100 mg/dL (≥ 5.55 mmol/L)).
1 Hsu C. et al.: Fabrication of a Glucose Biosensor Based on Inserted Barrel Plating Gold Electrodes. Anal Chem 2009, 81(1): 515–518. DOI: 10.1021/ac8019619.
2 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.
3 Bionime Corporation: Test Report for the System Accuracy Evaluation Blood Glucose Monitoring System GM722, Chung Shan Medical University Hospital, Taiwan, 09.2017. Declaration Letter of Study Report Equivalence of GM722 and mylife Unio Cara, 03.2018, available on request.
4 Bionime Corporation: Test Report for the Evaluation of Precision (ISO 15197:2013), Model GM722 and Strip GS720 (mylife Unio), Taichung, Taiwan, 08.2017. Declaration Letter of Study Report Equivalence of GM722 and mylife Unio Cara, 03.2018, available on request.
5 Post H. et al.: Portable In-Vitro Blood Monitor System for (Self)-Monitoring-Blood Glucose Monitors – Particular Requirements and Test Methods. TNO Quality Guideline PG/TG/2001 045 2001. Delft: TNO, 2001.