34
Beurer GL50
The test is based on the measurement of an electric current that is generated by the chemical reaction
of the glucose with the enzyme glucose dehydrogenase (Aspergillus oryzae) on the strip.
During the reaction, a mediator transports electrons through the electrode surface and so generates
a current.
The monitor analyses this current. The current flow is proportional to the glucose content 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. 5 seconds. The test strip detects blood
glucose values from 20 to 630 mg/dL (1.1 to 35.0 mmol/L).
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
control solution is similar to a blood test. However, control solution is used instead of blood. The
measurement using control solution must be within the result range. This value range is printed on
every test strip box and/or on the information sheet included with the test strips in film packaging.
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 blood glucose monitor complies with the European standards: IVD (98/79/EC) and
MDD (93/42/EC).
10 c
omparison
of
measured
values
with
laboratory
values
Precision
Three lots of the GL50 blood glucose test strips have been tested to assess the precision of the
GL50 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 46.1 to 433.5 mg/dL (2.6 to 24.1 mmol/L) and control material
from three concentrations is used.
