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9001/7.3 Design development
/0'1'"2343567
-86327''''''(398:8;<68=5')3>=96':=9'?@0,#"!'AB'#CD634
For authorized persons only:
Retention time: 5 years
yes
Author:Roland Heyer,
Produkt Manager
Checked by:
Dr. Dreher
Dr. Hanno Leibersperger, PM
Date of Release
Documentation
no
7.3.3
Rev.: 001
valid of:
replaced Rev.: n/a
File:
16020.DOC
from: n/a
Page 1 of 6
Date:
17.7.2003
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No.:
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Recipient:
Dr. Leibersperger, R. Heyer
Date:
Page
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Form 011/03
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9001/7.3 Design Development
/0'1'"2343567
-86327' !3D8S5'(398:8;<68=5')3DJ26D':=9'?@0,#"!'AB'
#CD634
Nr.:
7.3.2
Rev.: 001
valid from: 02.05.2003
Page 2 of 6
E' $4>93;8D8=5
The imprecision (within-run and day-to-day) of the HUMASED 20, consisting of the
HUMASED 20 ESR instrument, HUMASED Tubes an the EQUNINOX SEDRATE control. ,
was calculated from altogether 28 determinations for each level on 4 consecutive days (4
instruments, 1 tube lot) . The EQUINOX Sedrate control solutions has been employed as
sample material. The results are summarized in the following tables
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Level 1, (1h Mode )
Mean, mm/h
11,9
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Coefficient of variation, %
7,6
Coefficient of variation, %
3,7
Coefficient of variation, %
1,7
Coefficient of variation, %
1,4
Form 011/03
!"#$%&'(")$*$+,-$.&
9001/7.3 Design Development
/0'1'"2343567
-86327' !3D8S5'(398:8;<68=5')3DJ26D':=9'?@0,#"!'AB'
#CD634
Nr.:
7.3.2
Rev.: 001
valid from: 02.05.2003
Page 3 of 6
EGA' !<C16=1K<C'84>93;8D8=5
Level 1, (1h Mode )
Mean, mm/h
12,9
Coefficient of variation, %
13,1
Coefficient of variation, %
5,8
Coefficient of variation, %
2.07
Coefficient of variation, %
1,2
Conclusion: the above results confirm the good precision and reproducibility of the system.
Form 011/03
!"#$%&'(")$*$+,-$.&
9001/7.3 Design Development
/0'1'"2343567
-86327' !3D8S5'(398:8;<68=5')3DJ26D':=9'?@0,#"!'AB'
#CD634
Nr.:
7.3.2
Rev.: 001
valid from: 02.05.2003
Page 4 of 6
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The Sensitivity and Specificity was determined by comparison of the manual method with
The Humased 20 system. Figure 2 shows the Sensitivity:
Correct positive results [78] / correct positive results [78] + false negative results [1] = 98 %
Specifity:
Correct negative results [28] / correct negative results [28] + false positive results [0] = 100 %
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Figure 2
28
correct positive: 78
false postive:0
24
20
16
correct negative: 28
12
8
4
false negative: 1
0
0
12
16
20
24
28
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Form 011/03
!"#$%&'(")$*$+,-$.&
9001/7.3 Design Development
/0'1'"2343567
-86327' !3D8S5'(398:8;<68=5')3DJ26D':=9'?@0,#"!'AB'
#CD634
Nr.:
7.3.2
Rev.: 001
valid from: 02.05.2003
Page 5 of 6
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The datas obtained were compared with manually measurd results ( Westergren standard
method).
The comparison of measurements (n = 107) between the manual system and HUMASED 20
can be seen in figure 1. The statistical analysis shows a correlation coefficient of r = 0,985,
the regression line was Y = 1,02 + 0,08.
Figure 1
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Form 011/03
!"#$%&'(")$*$+,-$.&
/0'1'"2343567
-86327' !3D8S5'(398:8;<68=5')3DJ26D':=9'?@0,#"!'AB'
#CD634
Nr.:
7.3.2
Rev.: 001
valid from: 02.05.2003
Page 6 of 6
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Under evaluation.
Form 011/03