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Technology for high measurement accuracy and precision High Definition Signal Transmission and Autocoding
High Definition Signal Transmission
Accuracy and precision of blood glucose measurements result from a combination of various elements. In principle, the glucose molecules in a blood sample are translated into electrons through biochemical substances which can be measured by creating an electric current (other technologies are also common in the market, e. g. photometry). The higher the measured current, the higher the blood glucose value.
However, the current generated from the measurement is extremely low and therefore sensitive to interference. The signal transmission is crucial for the quality of the measurement.1
The concept of the shortest possible signal path has been consistently applied. All unnecessary amounts of conductive distances were eliminated on the test strips, and gold electrodes in the device as well as in every individual test strip ensure optimal signal transmission. Furthermore, gold-plated battery contacts guarantee a stable operating voltage at all times.1
The meter automatically identifies a specific test strip lot code after the insertion of a mylife test strip into mylife Pura X (Autocoding). This Autocoding feature allows the meter to cope with variations in test strip productions in order to ensure a high level of accuracy and precision.
Latest study results of mylife Pura X
100 % of the test results fall within the accuracy requirements according to ISO 15197:2013
With the IVD standard ISO 15197:20132 the minimal requirements for measurement precision and system accuracy have been defined more demanding. In this more selective context, mylife Pura X’s advanced measuring technique leads to the following results3,4:
ISO 15197:2013 demands ≥ 95 % of measurements within ± 15 mg/dL at glucose concentration < 100 mg/dL and ± 15 % at glucose concentration ≥ 100 mg/dL. 100 % of mylife Pura X test results (636 of 636 pooled measurements) fall in both areas together and A-coverage of 100 % in the Consensus Error Grid (CEG) (AB 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 Pura X shows strong results when tested for measurement repeatability (ten meters, three test strip lots and five glucose concentrations): SD ≤ 1.5 mg/dL (TNO5 acceptance criteria: SD ≤ 10 mg/dL) at glucose concentration < 100 mg/dL and CV ≤ 2.0 % (TNO criteria: CV ≤ 5 % at glucose concentration ≥ 100 mg/dL).
1 Hsu C. et al.: Fabrication of a Glucose Biosensor Based on Inserted Barrel Plating Gold Electrodes. Anal Chem 2009, 81(1): 515-518.
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 of Rightest Blood Glucose Monitoring System GM550 (mylife Pura X), Min-Sheng General Hospital, Taiwan, 05.2015.
4 Bionime Corporation: Test Report for the Evaluation of Precision (ISO 15197:2013), Model GM550 (mylife Pura X) and Strip GS550 (mylife Pura), Taichung, Taiwan, 04.2015.
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.