Orphee mythic 22 - Page 37

REF : M22/UM/EN/014
3. INSTRUMENT SET UP
MYTHIC 22
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Precision (Reproductibility)*
The Mythic 22 was initially calibrated with Myt-CAL calibrator (lot PLUS065, expiry date 14-05-2015).
Three levels of Myt-5D control material (lot MYT 506, expiry date 05-08-2015) were run in duplicate twice
daily for 20 days. The results were used to quantify within run precision, SD of the run means, SD of the
daily means and the total imprecision with the NCCLS EP-05 A2 guidelines.
Parameter
Myt-5D control
Within run
SD
SD of run
means
SD of daily
means
Total
imprecision SD
WBC
MYT506 High
MYT506 Normal
MYT506 LOW
0.06
0.16
0.44
0.06
0.05
0.31
0.04
0.08
0.25
0.1
0.18
0.59
RBC
MYT506 High
MYT506 Normal
MYT506 LOW
0.02
0.03
0.04
0.01
0.02
0.01
0.01
0.02
0.03
0.03
0.04
0.05
HGB
MYT506 High
MYT506 Normal
MYT506 LOW
0.05
0.07
0.06
0.13
0.09
0.09
0.04
0.07
0.08
0.15
0.13
0.15
HCT
MYT506 High
MYT506 Normal
MYT506 LOW
0,17
0,21
0,33
0.09
0.73
0.15
0.04
1.90
0.22
0.19
2.05
0.42
PLT
MYT506 High
MYT506 Normal
MYT506 LOW
4,8
7,04
12,01
0.97
8.29
16.31
3.06
5.26
8.83
5.78
12.08
22.09
Parameter
Myt-5D control
Within run
CV%
CV% of run
means
CV% of daily
means
Total
imprecision
CV%
WBC
MYT506 High
MYT506 Normal
MYT506 LOW
2,2
2,0
2,2
2,2
0,7
1,5
1,5
1,0
1,2
3,5
2,4
2,9
RBC
MYT506 High
MYT506 Normal
MYT506 LOW
1,0
0,7
0,8
0,7
0,4
0,3
0,5
0,5
0,7
1,3
0,9
1,1
HGB
MYT506 High
MYT506 Normal
MYT506 LOW
1,0
0,5
0,6
2,3
0,7
0,5
0,7
0,5
0,5
2,6
1,0
0,9
HCT
MYT506 High
MYT506 Normal
MYT506 LOW
1,1
0,6
0,7
0,6
2,1
0,3
0,3
5,4
0,5
1,2
5,8
1,0
PLT
MYT506 High
MYT506 Normal
MYT506 LOW
7,9
2,8
2,4
1,6
3,2
3,3
5,0
2,1
1,8
9,5
4,7
4,5
* Source 510K submission # K030799