PERFORMANCE EVALUATIONS:
Precision
1. Laboratory Precision: To assess the repeatability (within-run
precision) of Ascensia
®
B
REEZE
™, 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.
2. Control Testing Precision: An imprecision study of the
Ascensia
®
B
REEZE
™ System was conducted at two diabetes
clinics. In each location, 50 lay persons with diabetes tested
the low, normal and high control solutions in duplicate
using the meter system. A different lot of test strips was
used in each of the two locations. The table below shows
the total standard deviations (SD) and coefficients of
variation (CV), which include the within run and between
run / day variations.
Low Control Solution
32
Mean
2.9 mmol/L 7.4 mmol/L 9.1 mmol/L 14.7 mmol/L 23.7 mmol/L
%CV
8.9%
4.1%
4.4%
3.8%
2.9%
Total
Total
Strip No.
of
Mean
SD
CV
Lot
Operator
Assays
(mmol/L) (mmol/L)
(%)
A
Lay User (n=50)
100
4.272
0.267
6.2
B
Lay User (n=50)
100
4.100
0.244
6.0
