Because premature rupture of fetal membranes (PROM) is a serious pregnancy complication that causes approximately one third of premature deliveries.
Prematurity increases the risk of perinatal morbidity and mortality. Additionally, PROM increases the risk of maternal and fetal infections. Although an accurate diagnosis is vital, traditional methods are highly insufficient. They frequently give wrong results, and they are sensitive to contaminating substances, such as blood, semen, and cervical mucus.
A decade ago, Medix Biochemica was the first in the world to create a reliable method to detect PROM. Since then, hundreds of thousands of women have benefited from the test’s superior performance. Actim PROM is a fast immunochromatographic dipstick test that reacts to the presence of amniotic fluid in vaginal secretions. Based on monoclonal antibodies, it detects IGFBP-1 (insulin-like growth factor binding protein-1) in a vaginal sample. Since the concentration of IGFBP-1 is substantially high in amniotic fluid, finding IGFBP-1 in the vaginal sample indicates a membrane rupture (PROM).
Superior performance
Compared to other methods commonly used for detecting PROM, Actim PROM clearly surpasses them in performance. Neither the specificity nor sensitivity of other methods comes even close to the reliability of Actim PROM.
Comparison of methods to detect PROM Kubota & Takeuchi 1998
Actim PROM
pH
Ferning
Sensitivity
94.7
73.3
42.1
Specificity
93.1
72.4
75.9
Actim PROM is the most reliable test for detecting premature rupture of fetal membranes.
Reliable results regardless of contaminating substances
The concentration of IGFBP-1 in amniotic fluid is 100–1000 times higher than in maternal serum, so its presence in a sample is a very clear indication of ruptured fetal membranes. The detection limit of the test is so low that it even detects micro ruptures. Semen and urine contain insignificant quantities of IGFBP-1. Since amniotic fluid can only be present in the vagina if fetal membranes are no longer intact, the presence of IGFBP-1 in the sample is a reliable indication of a membrane rupture. Blood contamination is extremely unlikely to affect the test results, since the 95th percentile of normal IGFBP-1 levels in maternal serum falls below the test’s detection limit.
IGFBP-1 concentraction in various body fluids Rutanen et at.1993
Sample
Concentration of IGFBP-1
Normal adult serum
0.5 - 03 µg/l
Serum (Pregnancy)
58 - 600 µg/l
Urine
Undetectable
Semen
Undetectable
Amniotic fluid
10000 - 400000 µg/l
Actim PROM is the most reliable test for detecting premature rupture of fetal membranes.
Actim Prom Technical Data Brochure Premature rupture of fetal membranes
(PROM) is a serious pregnancy complication
that causes approximately one third of
premature deliveries. Prematurity increases
the risk of perinatal morbidity and mortality.