Beurer GL 50 - Value Comparison and Accuracy; Test Strip Precision

Beurer GL50 evo mg/dL 35
During the reaction, a mediator transports electrons through the electrode surface and so gener-
ates a current.
The blood glucose monitor analyses this current. The current flow is proportional to the glucose con-
tent in the blood sample. The results are shown on the blood glucose monitor display.
Only a small amount of blood is required (0.6 microlitres) and measurement takes approx. five sec-
onds. The test strip detects blood glucose values from 20 to 630 mg/dL.
Chemical components of the test strip sensor
• FAD glucose dehydrogenase 6%
• Potassium ferricyanide 56%
• Non-reactive components 38%
Control solution functionality
The control solution contains a fixed amount of glucose that reacts with the test strip. A test with con-
trol solution is similar to a blood test. However, control solution is used instead of blood. The measured
result using control solution must be within the result range. This range is printed on each test strip box.
Chemical composition of the control solution
The control solution is a red solution with the following D-glucose level (in percentage shares):
Ingredients Control solution LEVEL 3 Control solution LEVEL 4
D-glucose 0.14% 0.37%
Non-reactive components 99.86% 99.63%
Standards
The Beurer GL50 evo blood glucose monitor complies with the European standards: IVD (98/79/EC)
and MDD (93/42/EC).
10 comparison of measured values with laboratory value
Precision
Three lots of the GL50 evo blood glucose test strips have been tested to assess the precision of the
GL50 evo blood glucose measuring system. This includes a repeat assessment using venous blood
and a laboratory precision assessment using the control material. The blood glucose content of the
venous blood samples ranges from 42.7 to 418.0 mg/dL and control material from three concent
-
rations is used.
Results of the repeat precision measurements
Sample Venous blood
(mg/dL)
Grand mean
value (mg/dL)
Pooled standard de-
viation
Pooled coecient
ofvariation (%)
1 42,7 36,0 2,0 5,6
2 62,0 59,2 3,5 5,9
3 120,5 127,1 4,1 3,2