User Manual
56 57
TECHNICAL INFORMATION
C
ONTOUR
®
NEXT ONE blood glucose monitoring system
Technical Information: User Accuracy
The CONTOUR NEXT ONE blood glucose monitoring system was
tested by 372 lay users using capillary blood samples and three
C
ONTOUR NEXT test strip lots. The results were compared to the YSI
Glucose Analyzer laboratory reference method, traceable to the CDC
hexokinase method. The following accuracy results were obtained.
Table 1: System accuracy results for glucose concentration
< 75 mg/dL
Difference range in values
between YSI laboratory
reference method and
CONTOUR NEXT ONE meter
Within
± 5
mg/dL
Within
± 10
mg/dL
Within
± 15
mg/dL
Number (and percent) of samples
within specified range
14 of 17
(82.4%)
16 of 17
(94.1%)
16 of 17
(94.1%)
Table 2: System accuracy results for glucose concentration
≥ 75 mg/dL
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
288 of 355
(81.1%)
342 of 355
(96.3%)
354 of 355
(99.7%)
Table 3: System accuracy results for glucose concentrations
between 32.2 mg/dL and 458 mg/dL
Within ± 15 mg/dL or ± 15%
370 of 372 (99.5%)
Technical Information: Precision
A measurement repeatability study was conducted with the
C
ONTOUR NEXT ONE blood glucose monitoring system using
5 venous whole blood specimens with glucose levels from
43 mg/dL to 333 mg/dL. With each blood specimen, each of 3 lots
of
CONTOUR NEXT test strips was tested 10 times on each of
10 instruments for a total of 300 readings. The following precision
results were obtained.
Table 1: System repeatability results for
C
ONTOUR NEXT ONE
meter using C
ONTOUR NEXT test strips
Mean,
mg/dL
Pooled
Standard
Deviation,
mg/dL
95% CI of SD,
mg/dL
Coefficient of
Variation, %
43.7 0.9 0.83–0.98 2.1
77.6 1.2 1.14–1.35 1.6
129.3 1.8 1.62–1.92 1.4
205.3 2.9 2.65 – 3.13 1.4
331.7 3.9 3.63–4.29 1.2
Intermediate measurement precision (which includes variability across
multiple days) was evaluated using control solutions at 3 glucose
levels. With each control solution, each of 3 lots of
C
ONTOUR NEXT
test strips was tested once on each of 10 instruments on 10 separate
days for a total of 300 readings. The following precision results were
obtained.
85025015_CntrNxtONE_UG_EN.indd 56-57 8/18/16 10:06 AM