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.
Blood av
4.1mmol
/
L
CV
=
4.9%
Blood
av
6.7mmol
/
L
CV
=
3.0%
Blood
av
10.3mmol
/
L
CV
=
3.1%
Blood
av
18.2mmol
/
L
CV
=
3.0%
Precision:
Control Solution av 2.6mmol/L SD=0.16mmol/L
Intermediate
Precision
Control Solution av 18.9mmol
/
L
CV
=
3.8%
Blood
av
2.5mmol
/
L
SD
=
0.14mmol
/
L
Repeatability
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.
599/600(99.8%)
Within ± 0.83 mmol/L or Within ±15%
Control Solution av 6.9mmol
/
L
CV
=
3.5%
