Performance Evaluations; Precision - Bayer HealthCare Ascensia Contour Blood Glucose Monitoring System User Manual

Performance Evaluations

(for Healthcare Professionals)

Precision

1. Laboratory Precision: To assess the repeatability (within-
run precision) of the Ascensia
Monitoring System, 100 blood glucose readings (10
readings on each of 10 instruments) were obtained with
venous blood specimens at five glucose concentrations. The
following table summarizes the mean and pooled within-
Meter %CV at each level.
Mean 2.6 mmol/L
%CV 2.4%
2. Control Testing Precision: Precision results were obtained
from duplicate assays of Control Solutions at two diabetes
clinics with the Ascensia C
performed over 63 days. People with diabetes and
healthcare professionals (HCP) at each clinic evaluated two
reagent lots. One lot was evaluated at both clinics. The
tables below show the combined results for the lay users
and HCPs. The overall standard deviations (SD) and
coefficients of variation (CV) include the within run and
between run / day variations.
Low Control Solution
Reagent
Lot
22B HCP
Lay User
22C HCP
Lay User
23B HCP
Lay User
5.1 mmol/L
2.5%
ONTOUR
Operator
(n = 1)
(n = 51)
(n = 4)
(n = 53)
(n = 5)
(n = 104)
C
™
ONTOUR
8.0 mmol/L 13.1 mmol/L
2.8%
System. Testing was
Duplicate
Assays Mean
(n = ) (mmol/L)
35 2.34
76 2.35
39 2.39
78 2.39
74 2.36
154 2.32
Blood Glucose
™
20.9 mmol/L
3.1% 2.4%
Overall
SD
(mmol/L)
0.074
0.102
0.063
0.093
0.063
0.112
Overall
CV
(%)
3.2
4.3
2.6
3.9
2.7
4.8
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