Technical Information - Bayer HealthCare Contour TS User Manual

Technical Information

Accuracy
The C ® TS blood glucose monitoring system
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was tested in 100 capillary blood samples using 600
C ® TS test strips. Two replicates were tested with
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each of 3 lots of C TS test strips for a total of 600
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readings. Results were compared to the YSI
which is traceable to the CDC hexokinase method. The tables
below compare the performance of the 2 methods.
Table 1 – System accuracy results for glucose
concentration < 5.55 mmol/L
Difference range
in values between
Within ±
YSI laboratory
0.28 mmol/L
reference method and
C TS meter
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Number (and percent)
77 of 180
of samples within
(42.8%)
specifi ed range
Table 2 – System accuracy results for glucose
concentration ≥ 5.55 mmol/L
Difference range in values
Within ±
between YSI laboratory
reference method and
C TS meter
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Number (and percent) of
297 of 420
samples within specifi ed
(70.7%)
range
34
C ® TS meter C
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®
glucose analyzer,
Within ± Within ±
0.56 mmol/L 0.83 mmol/L
145 of 180 170 of 180
(80.6%) (94.4%)
Within ± Within ±
5% 10% 15%
399 of 420 416 of 420
(95.0%) (99.0%)
® TS test strips
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Table 3 – System accuracy results for glucose
concentrations between 2.0 and 24.6 mmol/L
Within ±0.83 mmol/L or ±15%
Acceptance criteria in ISO 15197: 2013 are that 95% of
all differences in glucose values (i.e., between reference
method and meter) should be within ±0.83 mmol/L for
glucose values less than 5.55 mmol/L, and within ±15% for
glucose values greater than or equal to 5.55 mmol/L.
User Accuracy
A study evaluating glucose values from fingertip capillary
blood samples obtained by 132 lay persons showed
the following results: 100% within ± 0.83 mmol/L of the
medical laboratory values at glucose concentrations below
5.55 mmol/L and 95.6% within ±15% of the medical
laboratory glucose concentrations at or above 5.55 mmol/L.
Precision
A repeatability study was conducted with the C
blood glucose monitoring system using 5 venous
whole blood specimens with glucose levels from 2.2 to
18.3 mmol/L. Multiple replicates (n=300) were tested using
multiple C TS blood glucose meters and 3 lots
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of C ® TS blood glucose test strips. The following
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precision results were obtained.
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586 of 600 (97.7%)
®
TS
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35