Actim® PROM

Overview

The original rapid test for detecting premature rupture of fetal membranes

Actim^® PROM is the world’s first rapid test for reliably detecting premature rupture of fetal membranes (PROM) in all patients. The superior performance of the easy-to-use rapid test has revolutionized pregnancy monitoring for millions of women.

PROM is the most common identifiable cause of preterm births and a major cause of maternal and fetal morbidity. Correct PROM diagnosis is important to guide treatment and to minimize complications. However, PROM symptoms differ between patients, which makes diagnosis difficult.

The original Actim PROM test is the fastest and most accurate rapid test on the market: it gives reliable results in minutes, even in the presence of blood or other interfering substances, making the test suitable for all women with suspected PROM. As Actim PROM has been carefully designed to detect even non-visible ruptures in fetal membranes, correct treatment can be started early. Accurate PROM diagnosis targets treatment to those who need it, which improves patient safety and reduces costs.

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, lubricants, 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 it works

Vaginal IGFBP-1 indicates membrane rupture

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 test	97	97	97
Nitrazine test	97	16	56
AFI < 80 mm	94	91	92

TABLE 1. Actim PROM has outstanding sensitivity, specificity, and accuracy in PROM diagnosis. (Erdemoglu & Mungan, 2004)

	No. of patients	Sensitivity %	Specificity %	PPV %	NVP %
Rutanen et al., 1996	130	100	95	93	100
Ragosh et al., 1996	75	100	83	83	100
Jain and Morris, 1998	100	100	89	76	100
Kubota and Takeuchi, 1998	90	95	93	90	96
Akercan et al., 2005	87	100	92	84	100

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

Fast results at the bedside in minutes

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.

How to order

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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