54
55
Precision
Within-run
Level
No. of test
Mean (mg/dL)
Within-Run C.V. (%)
40.6
93.3
120
213
336
532
100
100
100
100
100
100
41.5
99.5
124.0
216.4
340.7
531.7
4.5
4.2
3.1
3.8
3.5
3.3
Between-run
Level
No. of test
Mean (mg/dL)
Within-Run C.V. (%)
50
100
300
100
100
100
61.5
123.9
346.8
4.7
4.2
3.9
Performance Evaluations
Accuracy
Glucose concentration < 75 mg/dL
Within ± 5 mg/dL
Within ± 10 mg/dL
Within ± 15 mg/dL
6/13 (46%)
11/13 (85%)
13/13 (100%)
Glucose concentration ≥ 75 mg/dL
Within ± 5 %
Within ± 10 %
Within ± 15 % Within ± 20 %
35/87 (40%)
67/87 (77%)
78/87 (90%)
85/87 (98%)
Tests were conducted by trained technicians in
the laboratory setting. The venous whole blood
from one subject was adjusted to 6 different
levels. Strips out of a single lot were tested. The
results are shown in the following table.
Tests were performed at hospital by healthcare
professionals and diabetic patients. Fresh capillary
finger whole blood samples were tested with the
GoodLife System; venous blood samples from the
subjects were tested with YSI Model 2300 Glucose
Analyzer as reference. The results are shown in the
following table.
