Efficiently rules out risk of imminent delivery
It has previously been shown that 94% of women with a cervical phIGFBP-1 concentration less than 10 ìg/l did not deliver preterm or within two weeks of the sampling. None of these women delivered before week 35. Among the women admitted to the hospital with preterm contractions and who delivered preterm, 88% had phIGFBP-1 higher than 10 ìg/l. Recent studies have confirmed these findings. Actim Partus helps you identify the patients with an elevated risk of delivering preterm. And more specifically, a negative test result is a safe indication that imminent delivery or delivery within two weeks is highly unlikely.
Actim Partus test in prediction of preterm delivery
Study
Patients
n
Gestational age (weeks)
End Point
Sensitivity
Specificity
PPV
NPV
Lembet et al
Symptomatic and controls
54
20-36
Delivery<37 weeks
89.50%
94.10%
94.40%
88.90%
Delivery<7days
93.80%
85%
83.30%
94.41%
Delivery<48hours
93.30%
81%
77.80%
94.40%
Kavek et al
Symptomatic
47
23-33
Delivery<36weeks
73.70%
82.60%
77.80%
94.40%
Elizur et al
Symptomatic
64
24-35
Delivery<37 weeks
69.60%
70.70%
57.10%
80.50%
Delivery <35 weeks
81.80%
64.10%
32.10%
94.40%
A negative result rules out the risk of imminenet or preterm delivery. Patients with a positive result have an elevated risk to deliver preterm.
Semen and urine have no effect on test results
Most bodily fluids potentially contaminating a cervical sample, such as semen and urine, contain only trace quantities of phosphorylated IGFBP-1. Therefore a recent intercourse has no effect on the results of the Actim Partus test. Since preterm contractions may be induced by the prostaglandins in seminal fluid, several symptomatic women may recently have had intercourse. These patients do not need to be excluded when using the Actim Partus test.
Gestational age at delivery according to Actim Partus test results
Study
Patients
n
Actim partus result
n
Mean gestational age at sample collection
Mean gestational age at delivery
Lembet et al
Symptomatic
36
negative
18
29.8
37.9
positive
18
32.4
34.4
Controls
18
negative
18
29.4
39.4
positive
0
29.4
39.4
Kavek et al
Symptomatic
47
negative
29
31
37
positive
18
31.5
33
Elizur et al
Symptomatic
64
negative
36
31.2
38
positive
28
29.6
36.2
Most patients with a negative result didn"t deliver prematurely. They gave birth much later than those with a positive result, who in general delivered preterm, The interval between a positive . Result and delivery was shorter than for patients with a negative result