Actim® PROM

A specific PROM test you can use on all pregnant women – even those with bleeding.

Overview

A rapid test that accurately detects premature rupture of fetal membranes, even when the swab specimen includes blood.

Premature rupture of fetal membranes is the most common identifiable cause of preterm births and a major cause of maternal and fetal morbidity. A timely and correct PROM diagnosis is essential to minimize complications for both the birth-giver and the fetus.

Actim® PROM is a rapid diagnostic test used to reliably detect premature rupture of fetal membranes (PROM), even when pregnant people have vaginal bleeding. In fact, about 20% of patients suspected with PROM have vaginal bleeding*.

Actim PROM provides reliable test results even when the specimen includes blood or other interfering substances, making the test suitable for all women suspected with PROM. The superior performance of the test has revolutionized pregnancy monitoring for millions of women.

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:

  1. 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.
  2. 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.

In a nutshell

Actim PROM in a nutshell

  • Actim PROM is a rapid test that reliably detects PROM, even before any clinically visible signs can be detected.
  • The test can be performed at any gestational age.
  • Actim PROM is an easy-to-use one-step dipstick test that gives test results at the bedside in just 5 minutes, with sampling completed in seconds – with or without speculum.
  • The test results are not affected by blood, intercourse, semen, urine, vaginal medications, bathing products, or infections.
  • The test kit contains all the materials required to perform the test and it can be stored at room temperature.
  • Actim PROM is available in multiple package sizes.

How Actim prom works

Actim® PROM and Vaginal IGFBP-1

Actim PROM rapid test 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. Amniotic fluid is normally not found in the vagina, but when fetal membranes rupture, amniotic fluid leaks into the vagina and the IGFBP-1 concentration quickly rises and remains high until delivery. Actim PROM detects IGFBP-1 in vaginal 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 membrane. These tiny ruptures cannot be detected with traditional methods, but are clinically relevant as they can induce delivery, cause infections, and threaten the health of both mother and child.

Because Actim PROM is specific to amniotic fluid IGFBP-1, tests can be completed even in the presence of blood and other bodily fluids, infections, and medical products.

About IGFBP-1

  • Highly specific biomarker
  • Produced in decidual cells and secreted into amniotic fluid
  • Exists in large amounts in amniotic fluid
  • IGFBP-1 in a vaginal sample indicates presence of amniotic fluid
Sensitivity %Specificity %Accuracy %
Actim PROM test979797
Nitrazine test971656
AFI < 80 mm949192
TABLE 1. Actim PROM has outstanding sensitivity, specificity, and accuracy in PROM diagnosis. (Erdemoglu & Mungan, 2004)
No. of patientsSensitivity %Specificity %PPV %NVP %
Rutanen et al., 19961301009593100
Ragosh et al., 1996751008383100
Jain and Morris, 19981001008976100
Kubota and Takeuchi, 19989095939096
Akercan et al., 2005871009284100
TABLE 2. Clinical evidence of accurate PROM diagnosis with Actim PROM.

How it helps

How Actim PROM helps

Traditionally, diagnosis of PROM has been based on a variety of clinical symptoms. As the symptoms can be very different between patients, PROM diagnosis has often difficult, inaccurate, and time-consuming. Rapid and reliable PROM diagnosis with Actim PROM improves patient care and saves valuable resources.

Actim PROM is a trusted option in over 70 countries and it is mentioned in several national treatment guidelines.

Actim PROM saves lives, time and valuable resources

  • With Actim PROM, medical attention can be directed to patients who need it in a timely manner.
  • Unnecessary use of medication and their side-effects can be avoided.
  • With Actim PROM, unrequired labor inductions are minimized.
  • Avoidable hospital visits and patient transfers are reduced.
  • Actim PROM brings peace of mind to expecting mothers.

How to use aCTIM prom

Results available in 5 minutes at the patient’s bedside

Actim PROM test kit contains all necessary materials and can be stored at room temperature (+2–25 °C).

Collect sample with or without speculum

Hold the swab in vagina for 10-15 seconds.

If Actim PROM is combined with Actim Partus, separate samples need to be taken for the two tests. A vaginal sample is used for Actim PROM test, while the sample for Actim Partus test must be taken from the cervix.

Extract specimen

Place the swab in the Specimen Extraction Solution, swirl around vigorously for 10-15 seconds, and discard the swab.

Activate the test

Place the yellow dip area into the extracted sample and hold it there until you see the liquid front enter the result area.

Remove the dipstick from the solution and place it in a horizontal position.

Interpret results

  • 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.
Actim PROM can be interpreted digitally with Actim® 1ngeni instrument.

ORDERING INFORMATION

How to order Actim PROM

Actim PROM test kits are available in multiple package sizes. All test kits contain instructions for use and individually packed test pouches including:

  • Dipstick
  • Specimen Extraction Solution tube
  • Sterile polyester swab
  • Brief instructions for use

Ordering information

  • Actim PROM 20 test kit | product code 30832ETAC
  • Actim PROM 10 test kit | product code 30831ETAC
  • Actim PROM 1 test kit | product code 30830ETAC
  • Actim PROM Controls | product code 30800ETAC

Actim® PROM Controls are intended to be used with Actim PROM test for external quality control. The controls may also be used to demonstrate negative results and weak and strong positive results. The control set includes negative, low positive, and high positive controls as well as reconstitution solution.

Materials

MDSAP 13485 and ISO 13485 certificates can be found here.

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