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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
+=56356D
No.:
$0F)"+$#$.&
Recipient:
Dr. Leibersperger, R. Heyer
Date:
Page
EGE H86I8519J5'84>93;8D8=5
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Form 011/03
!"#$%&'(")$*$+,-$.&
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 2 of 6
E' $4>93;8D8=5
The imprecision (within-run and day-to-day) of the HUMASED 20, consisting of the
HUMASED 20 ESR instrument, HUMASED Tubes an the EQUNINOX SEDRATE control. ,
was calculated from altogether 28 determinations for each level on 4 consecutive days (4
instruments, 1 tube lot) . The EQUINOX Sedrate control solutions has been employed as
sample material. The results are summarized in the following tables
EGE' H86I8519J5'84>93;8D8=5
Level 1, (1h Mode )
Mean, mm/h
11,9
!"#$%&
!'($%)*
Standard deviation, mm/h
0,9
Coefficient of variation, %
7,6
Level 1, (2h Mode )
Mean, mm/h
37,6
!"#$%++
!'($%,-
Standard deviation, mm/h
1,4
Coefficient of variation, %
3,7
Level 2, (1h Mode )
Mean, mm/h
92,6
!"#$%./
!'($%&0
Standard deviation, mm/h
1,6
Coefficient of variation, %
1,7
Level 2, (2h Mode )
Mean, mm/h
143,3
!"#$%)+&
!'($%),/
Standard deviation, mm/h
2,1
Coefficient of variation, %
1,4
Form 011/03
!"#$%&'(")$*$+,-$.&
9001/7.3 Design Development
/0'1'"2343567
-86327' !3D8S5'(398:8;<68=5')3DJ26D':=9'?@0,#"!'AB'
#CD634
Nr.:
7.3.2
Rev.: 001
valid from: 02.05.2003
Page 3 of 6
EGA' !<C16=1K<C'84>93;8D8=5
Level 1, (1h Mode )
Mean, mm/h
12,9
Standard deviation, mm/h
1,7
Coefficient of variation, %
13,1
Level 1, (2h Mode )
Mean, mm/h
38,9
Standard deviation, mm/h
2,5
Coefficient of variation, %
5,8
Level 2, (1h Mode )
Mean, mm/h
91,4
Standard deviation, mm/h
1,9
Coefficient of variation, %
2.07
Level 2, (2h Mode )
Mean, mm/h
142,1
Standard deviation, mm/h
1,8
Coefficient of variation, %
1,2
Conclusion: the above results confirm the good precision and reproducibility of the system.
Form 011/03
!"#$%&'(")$*$+,-$.&
9001/7.3 Design Development
/0'1'"2343567
-86327' !3D8S5'(398:8;<68=5')3DJ26D':=9'?@0,#"!'AB'
#CD634
Nr.:
7.3.2
Rev.: 001
valid from: 02.05.2003
Page 4 of 6
A' #35D868T86C'<5K'#>3;8:8;86C
The Sensitivity and Specificity was determined by comparison of the manual method with
The Humased 20 system. Figure 2 shows the Sensitivity:
Correct positive results [78] / correct positive results [78] + false negative results [1] = 98 %
Specifity:
Correct negative results [28] / correct negative results [28] + false positive results [0] = 100 %
+=5;=9K<5;3'DI336'7'?@0,#"!'#CD634
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Figure 2
28
correct positive: 78
false postive:0
24
20
16
correct negative: 28
12
8
4
false negative: 1
0
0
12
16
20
24
28
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Form 011/03
!"#$%&'(")$*$+,-$.&
9001/7.3 Design Development
/0'1'"2343567
-86327' !3D8S5'(398:8;<68=5')3DJ26D':=9'?@0,#"!'AB'
#CD634
Nr.:
7.3.2
Rev.: 001
valid from: 02.05.2003
Page 5 of 6
L' +=4><98D=5'=:'436I=KD
The datas obtained were compared with manually measurd results ( Westergren standard
method).
The comparison of measurements (n = 107) between the manual system and HUMASED 20
can be seen in figure 1. The statistical analysis shows a correlation coefficient of r = 0,985,
the regression line was Y = 1,02 + 0,08.
Figure 1
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120
100
80
60
40
20
0
0
20
40
60
80
100
120
140
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Form 011/03
!"#$%&'(")$*$+,-$.&
/0'1'"2343567
9001/7.3 Design Development
-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
N' -J_3'D6<_8286C
Under evaluation.
Form 011/03
