A specific PROM test for all pregnancies – even those with vaginal bleeding.
Premature rupture of fetal membranes (PROM) is one of the most common identifiable causes of preterm births and a major cause of maternal and fetal morbidity. A timely and reliable PROM diagnosis is essential to minimize complications for both the birth-giver and the fetus.
Actim® PROM is a rapid diagnostic test used for reliably detecting premature rupture of fetal membranes (PROM), even in pregnancies with vaginal bleeding. In fact, about 20% of patients suspected with PROM have vaginal bleeding*.
Actim PROM provides a reliable test result even when the specimen includes blood or other interfering substances — such as semen, urine, vaginal medications, bathing products or infectious agents — making the test suitable for all women suspected with PROM.
As Actim PROM has been carefully designed to detect even non-visible ruptures in fetal membranes, a treatment plan can be designed early on.
*References:
* Refer to the Actim PROM Instructions for Use for a complete list of the potentially interfering substances that have been tested.
Actim PROM is based on highly specific monoclonal antibodies that bind to the insulin-like growth factor binding protein-1 (IGFBP-1) present in amniotic fluid in high amounts. While amniotic fluid is normally not present in the vagina, ruptured fetal membranes cause amniotic fluid to leak, leading to a higher concentration of IGFBP-1. Actim PROM detects IGFBP-1 in cervicovaginal swab samples and helps to identify membrane ruptures.
Thanks to its high sensitivity, Actim PROM detects even low concentrations of IGFBP-1 caused by micro-ruptures in the fetal membranes. While these tiny ruptures cannot be detected with traditional methods, they are clinically relevant as they can induce delivery, cause infections, and threaten the health of both the birth-giver and the child.
Because Actim PROM is specific to amniotic fluid IGFBP-1, the test can be performed even in the presence of blood, other bodily fluids, or infectious agents in the specimen.
Table 1. Actim PROM has outstanding sensitivity, specificity and accuracy in PROM diagnosis (Erdemoglu & Mungan, 2004).
Table 2. Clinical evidence of accurate PROM diagnosis with Actim PROM.
Traditionally, diagnosis of PROM has been based on a variety of clinical symptoms. As the symptoms can differ greatly between birth-givers, diagnosing premature rupture of fetal membranes can be a challenge and time-consuming. A timely and reliable PROM diagnosis with Actim PROM can improve patient care and save valuable resources.
IGFBP-1-testing is mentioned in several national guidelines as a recommendation to detect PROM when the rupture of fetal membranes remains uncertain*.
*Examples include “Preterm labour and birth”, NICE (National Institute for Health and Care Excellence), 2015:
www.nice.org.uk/guidance/ng25 (cited on 17.11.2022) and “Permature Birth”. Working group established by the
Finnish Medical Society Duodecim and the Finnish Gynecological Association. Finnish Medical Society Duodecim, 2018: www.kaypahoito.fi/hoi50089 (cited on 20.09.2022).
The Actim PROM test kit contains all the necessary items, and it can be conveniently stored at room temperature (+2… +25 °C).
Learn how to use the test in the video below:
Hold the swab in the posterior fornix for 10 to 15 seconds.
If Actim PROM is combined with Actim Partus, separate samples need to be taken for the two tests. A cervicovaginal sample from the posterior fornix is used for Actim PROM test, while the sample for Actim Partus test must be taken from the cervical o.s.
Insert the swab into the extraction buffer. Swirl vigorously for 10 to15 seconds and discard the swab.
Place the yellow dip area into the extracted specimen.
Remove the dipstick from the buffer once you see the liquid front enter the result area and place it on horizontal position.
Product information
The Actim PROM test kits are available in multiple package sizes. All test kits contain one Instructions for Use booklet and tests that are individually packed in pouches.
Each of the pouches include:
The Actim PROM Controls are intended to be used with Actim PROM for quality control purposes. The controls may also be used to demonstrate negative and positive test results.
The controls set includes negative, low positive and high positive controls as well as a reconstitution solution.
Contact us for more info or visit https://www.actimtest.com/about-us
