THB/SO2-4
Operator’s Manual – OPTI CCA-TS2
tHb/SO
2
ANALYTES
Reproducibility
Controls
Within run precision (S
wr
) and Total Precision (S
T
), were determined from 2 runs per day with 2 replicates
per run over a period of 20 days following the CLSI guideline EP5-A2. Typical results for 3 different
control levels are shown below:
tHb (g/dL)
OPTI Check Level 1
OPTI Check Level 2
OPTI Check Level 3
Days Run
20
20
20
Total Average
20.7
14.0
8.9
Within Run St. Dev. (S
wr
)
0.1
0.1
0.1
Within Run % CV
0.3%
0.4%
1.2%
Total Precision St. Dev. (S
T
)
0.2
0.1
0.2
Total % CV
0.9%
0.8%
2.5%
SO
2
(%)
OPTI Check Level 1
OPTI Check Level 2
OPTI Check Level 3
Days Run
20
20
20
Total Average
81.2
89.8
96.4
Within Run St. Dev. (S
wr
)
0.1
0.3
0.4
Within Run % CV
0.2%
0.3%
0.4%
Total Precision St. Dev. (S
T
)
0.5
0.5
0.7
Total % CV
0.6%
0.6%
0.8%
Whole Blood
Within-run precision in whole blood samples was evaluated at 3 different concentrations on the OPTI
CCA-TS2. The table below shows the Averages, Standard Deviations and % CV calculated from 10
samples for each level.
tHb (g/dL)
Whole Blood
Level 1
Level 2
Level 3
Average
7.5
17.7
12.1
St. Dev
0.2
0.2
0.2
%CV
2.59%
1.34%
1.86%
n
10
10
10
SO
2
(%)
Whole Blood
Level 1
Level 2
Level 3
Average
79.5
96.8
99.9
St. Dev
0.2
0.1
0.0
%CV
0.21%
0.05%
0.00%
n
10
10
10
Содержание CCA-TS2
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