56 57
TECHNICAL INFORMATION
C
ONTOUR
®
NEXT ONE blood glucose monitoring system
Technical Information: Accuracy
The CONTOUR NEXT ONE blood glucose monitoring system was tested
with capillary blood samples from 100 subjects. Two replicates were
tested with each of 3 lots of
C
ONTOUR NEXT test strips for a total of
600 readings. Results were compared to the YSI glucose analyzer,
which is traceable to the CDC hexokinase method. The following
accuracy results were obtained.
Table 1: System accuracy results for glucose concentration
< 5.55 mmol/L
Difference range in values
between YSI laboratory
reference method and
CONTOUR NEXT ONE meter
Within
± 0.28
mmol/L
Within
± 0.56
mmol/L
Within
± 0.83
mmol/L
Number (and percent) of samples
within specified range
191 of 210
(91.0%)
210 of 210
(100%)
210 of 210
(100%)
Table 2: System accuracy results for glucose concentration
≥ 5.55 mmol/L
Difference range in values
between YSI laboratory
reference method and
CONTOUR NEXT ONE meter
Within
± 5%
Within
± 10%
Within
± 15%
Number (and percent) of samples
within specified range
257 of 390
(65.9%)
380 of 390
(97.4%)
390 of 390
(100%)
Table 3: System accuracy results for glucose concentrations
between 2.0 mmol/L and 35.7 mmol/L
Within ± 0.83 mmol/L or ± 15%
600 of 600 (100%)
Acceptance criterion in ISO 15197:2013 is that 95% of the measured
glucose values shall fall within either ± 0.83 mmol/L of the average
measured values of the reference measurement procedure at
glucose concentrations < 5.55 mmol/L or within ± 15% at glucose
concentrations ≥ 5.55 mmol/L.
User Accuracy
A study evaluating glucose values from fingertip capillary blood
samples obtained by 329 lay persons showed the following results:
98.6% within ± 0.83 mmol/L of the medical laboratory values at
glucose concentrations below 5.55 mmol/L and 99.6% within
± 15% of the medical laboratory glucose concentrations at or above
5.55 mmol/L.
85096877_CntrNxtONE_UG_EN.indd 56-57 9/21/16 3:47 AM
To Next Page
Loading...
