Performance Characteristics
43
To maximize your chances of an accurate comparison between meter
and laboratory results, follow a few basic guidelines:
Before going to the lab
·
Perform a control solution test to make sure the meter is working properly.
·
Do Not eat for at least eight hours before you test your blood.
·
Take your meter with you to the lab.
While at the lab
·
Conduct your meter test within 15 minutes of the lab test.
·
Use fresh capillary blood obtained from the fingertip.
·
Follow all instructions in this Owners Booklet for performing a blood
glucose test with your meter.
Precision:
Table3. System accuracy results for glucose between 2.2 mmol/L (40 mg/dL)
and 33.3 mmol/L (600 mg/dL)
This study shows that the system compares well with a laboratory method
and meets the minimum acceptable performance criteria defined in EN ISO
15197 : 2015.
Control Solution av 2.5mmol/L SD=0.16mmol/L
Intermediate
Precision
Control Solution av 7.2mmol
/
L
CV
=
3.5%
Control Solution av 19.2mmol
/
L
CV
=
3.3%
Blood av 2.5mmol/L SD=0.15mmol/L
Blood av 4.5mmol/L CV=4.3%
Blood av 6.9mmol/L CV=3.8%
Blood av 11.1mmol/L CV=3.2%
Blood av 18.7mmol/L CV=2.5%
Repeatability
600/600(100.0%)
Within ± 0.83 mmol/L or Within ±15%
