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 through biochemical substances into electrons 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 generated current for 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 distance 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
1 Signal path 2 Gold contacts
Short signal paths permit interference-free transmission of the signal. Gold is one of the most corrosion-resistant of all established conductive materials, ensuring optimal signal transmission from test strip to measurement device.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.
100 % of the test results fall within the accuracy requirements according to ISO 15197:2013
With the IVD standard ISO 15197:20132 the minimum requirements for
- measurement precision
- system accuracy and
- interference quantities (especially haematocrit range)
have been tightened to become more demanding. Using these tighter measurement requirements, mylife Pura X’s advanced measuring technique leads to the following results3,4:
ISO 15197:2013 requires ≥ 95 % of measurements within ± 0.83 mmol/L at glucose concentration < 5.55 mmol/L and ± 15 % at glucose concentration ≥ 5.55 mmol/L. 100 % of mylife Pura test results (636 of 636 pooled measurements) fall within the specified boundaries, and 100 % fall within zone A of 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 ≤ 0.08 mmol/L (TNO5 acceptance criteria: SD ≤ 0.56 mmol/L at glucose concentration < 5.55 mmol/L) and CV ≤ 2.0 % (TNO criteria: CV ≤ 5% at glucose concentration ≥ 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.
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 – Particular Requirements and Test Methods. TNO Quality Guideline PG / TG / 2001 045 2001. Delft: TNO, 2001.