34
Beurer GL49
Results of the intermediate precision measurement
Sam-
ple
Control material
Grand mean value Pooled standard
deviation
Pooled coefficient
of variation (%)
mg/dL
mmol/L mg/dL
mmol/L mg/dL
mmol/L
1
40
2.2
41.5
2.3
1.6
0.1
2
120
6.7
131.3
7.3
3.5
0.2
2.7
3
350
19.4
320.9
17.8
7.9
0.4
2.5
System accuracy
The
GL48/GL49
blood glucose monitor compared to the Cobas hexokinase method.
Three lots of
GL48/GL49
blood glucose test strips have been tested to assess the system accuracy of the
GL48/
GL49
blood glucose measuring system and to compare it with the reference method in which capillary
whole blood concentrations of 36.3 mg/dL (2.0 mmol/L) to 597.0 mg/dL (33.1 mmol/L) have been used.
Results of the system accuracy for glucose concentrations <100 mg/dL (<5.55 mmol/L)
Within ±5 mg/dL
(Within ±0.28 mmol/L)
Within ±10mg/dL
(Within ±0.56 mmol/L)
Within ±15mg/dL
(Within ±0.83 mmol/L)
218/306 (71.2%)
298/306 (97.4%)
305/306 (99.7%)
Results of the system accuracy for glucose concentrations ≥100 mg/dL (≥5.55 mmol/L)
Within ±5%
Within ±10%
Within ±15%
344/654 (52.6%)
568/654 (86.9%)
644/654 (98.5%)
Results of the system accuracy for combined glucose concentrations between 36.3 mg/dL
(2.0 mmol/L) and 597.0 mg/dL (33.1 mmol/L).
Within ±15 mg/dL or ±15%
(Within ±0.83 mmol/L or ±15%)
949/960 (98.9%)
In comparison to the Cobas, the
GL48/GL49
met the EN ISO 15197:2015 standard, whereby 95%
of the blood glucose values measured have to fall within the following zones: either ±15 mg/dL (±
0.83 mmol/L) of the measured average value when using the reference measuring procedure for
blood glucose concentrations <100 mg/dL (<5.55 mmol/L) or ±15% for blood glucose
concentrations of ≥100 mg/dL (≥5.55 mmol/L). 99 % of the individual measured blood glucose
values must fall within zones A and B of the Consensus Error Grid (CEG) for diabetes type 1.
Performance evaluation by the user
A study to assess the glucose values of blood samples of capillary blood from the fingertips, which
were obtained from 160 individuals that had no special training, produced the following results:
100% within ±15 mg/dL (±0.83 mmol/L) with glucose concentrations <100 mg/dL (<5.55 mmol/L)
and 100% within ±15% of the values obtained in the medical laboratory with glucose concentrations
of at least 100 mg/dL (5.55 mmol/L).
