Actim® PROM
A specific PROM test for all pregnancies – even those with bleeding.
Overview
A rapid test that accurately detects PROM, even when the swab specimen includes blood.
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.
Blood Does Not Interfere with the Test Result of Actim PROM
*References:
- Kallioniemi H. et al. Usefulness of the insulin-like growth factor binding protein-1 bedside test for ruptured fetal membranes. Obstet Gynecol Scand (2014) 93:1282-1289.
- Erdemoglu E., Mungan T. Significance of detecting insulin-like growth factor binding protein-1 in cervicovaginal secretions: comparison with nitrazine test and amniotic fluid volume assessment. Acta Obstet Gynecol Scand 2004, 83:622-626.
Actim PROM in a nutshell
Can be performed at any gestational age when there is a suspicion of PROM.
The test result is available in just 5 minutes, with sampling completed in a matter of seconds.
Blood, semen, urine, vaginal medications, bathing products or infectious agents do not affect the test result*.
* Refer to the Actim PROM Instructions for Use for a complete list of the potentially interfering substances that have been tested.
Innovation behind Actim® PROM
Vaginal IGFBP-1 and ruptured fetal membranes
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.
Key facts about IGFBP-1
- IGFBP-1 is a highly specific biomarker for PROM.
- It is produced in decidual cells and secreted into amniotic fluid.
- It is present in large amounts in amniotic fluid.
- IGFBP-1 in a cervicovaginal sample indicates presence of amniotic fluid.
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.
How Actim PROM helps
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).
Actim PROM saves time and valuable resources
Medical attention can be directed to patients who need it most.
Unnecessary interventions and their possible side-effects can be minimized.
Actim PROM brings peace of mind to expecting people.
How to use the test
Results available at the bedside in 5 minutes.
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:
1. Collect the specimen with or without a speculum.
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.
2. Extract the specimen.
Insert the swab into the extraction buffer. Swirl vigorously for 10 to15 seconds and discard the swab.
3. Activate the test.
Place the yellow dip area into the extracted specimen.
4. Remove the dipstick from the specimen.
Remove the dipstick from the buffer once you see the liquid front enter the result area and place it on horizontal position.
5. Interpret the test result:
- A positive result can be read as soon as it becomes visible.
Two blue lines = membranes are ruptured.
- A negative result should be confirmed at 5 minutes.
One blue line = membranes are intact.
Product information
At a glance
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:
- 1 Dipstick
- 1 Extraction buffer tube
- 1 Sterile polyester swab
This product version is not available in the United States of America.
Actim PROM Controls
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.
Product codes
- Actim PROM, 20 tests | product code 30832ETAC
- Actim PROM, 10 tests | product code 30831ETAC
- Actim PROM, 1 test | product code 30830ETAC
- Actim PROM Controls | product code 30800ETAC
Materials
Downloadable materials
- Brochures & leaflets
- Brochure
- Technical specifications leaflet
- Actim Partus and Actim PROM flowchart
- Instructions for use
- Actim PROM instructions for use
- Actim PROM Controls instructions for use
- Scientific materials
- List of publications mentioning Actim PROM
- Actim PROM oral presentation | ECPM 2018
- Material safety data sheet
- If you wish to receive a Material safety data sheet, please contact regulatory@actimtest.com
This version of Actim® PROM is not registered in the USA.
MDSAP 13485 and ISO 13485 certificates can be found here.