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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

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Date:
17.7.2003

+=56356D

No.:

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Recipient:
Dr. Leibersperger, R. Heyer

Date:

Page

EGE H86I8519J5'84>93;8D8=5

EGA !<C16=1K<C'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
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Standard deviation, mm/h


0,9

Coefficient of variation, %
7,6

Level 1, (2h Mode )


Mean, mm/h
37,6
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!'($%,-

Standard deviation, mm/h


1,4

Coefficient of variation, %
3,7

Level 2, (1h Mode )


Mean, mm/h
92,6
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!'($%&0

Standard deviation, mm/h


1,6

Coefficient of variation, %
1,7

Level 2, (2h Mode )


Mean, mm/h
143,3
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!'($%),/

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 %

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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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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.

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