Actim Partus 1ngeni Gebrauchsanweisung Seite 68

Table 5.
RELATIVE RISK OF SPONTANEOUS PRETERM DELIVERY ACCORDING TO
QUANTITATIVE ACTIM PARTUS 1NGENI CATEGORIES
phIGFPB-1 Delivery Delivery
category (ng/ml) ≤ 7 days ≤ 14 days
≤2 - -
2.1-9.9 5.9 0.8
10.0-49.9 10.0 2.1
50.0-249.9 15.8* 4.5*
≥ 250 22.8** 8.1***
Relative risk compared to phIGFBP-1 ≤2 ng/ml.
z-statistics significance: *P<0.05, **P<0.01, ***P < 0.001
Table 7.
RESULTS FROM THE REPRODUCIBILITY STUDY.
Sample Mean value, µg/l N
1 3.5 75
2 15 75
3 40 75
4 157 75
5 341 75
6 778 75
* One run per day performed
Delivery Delivery Delivery
< 30 wks < 34 wks < 37 wks
- - -
0.6 1.5 1.5
5.0 2.5 2.0**
11.8** 4.9** 2.4**
17.1** 7.1*** 3.1***
Repeatability Between-Run*
SD, µg/l %CV SD, µg/l %CV
0.61 17.4 NA NA
2.16 14.4 NA NA
7.21 18.0 NA NA
22.29 14.2 NA NA
57.52 16.9 NA NA
139.0 17.9 NA NA
** A negative variance
Table 6.
RESULTS FROM THE REPEATABILITY STUDY.
Sample Mean value, Repeatability
µg/l
SD, µg/l
1 3.5 0.46
2 14 1.50
3 43 4.87
Between-Day Between-Instrument
SD, µg/l %CV SD, µg/l
0.85 24.3 0.36
2.25 15.0 1.97
4.41 11.0 4.16
25.91 16.5 13.00
78.48 23.0 13.59
262.5 33.7 NA
Within-Laboratory
Precision (overall)
%CV SD, µg/l %CV
13.1 0.69 19.7
10.7 2.33 16.6
11.3 6.01 14.0
Reproducibility
%CV SD, µg/l %CV
10.3 1.10 31.4
13.1 3.69 24.6
10.4 9.42 23.6
8.3 36.57 23.3
4.0 98.25 28.8
NA** 297.0 38.2