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<sup>®</sup> PROM
Key facts
  • First rapid test that reliably detects PROM, even before any clinically visible signs
  • Can be used at any gestational age
  • Easy-to-use one-step dipstick test
  • Gives test results at the bedside in just 5 minutes, with sampling completed in seconds – with or without speculum
  • Test results are not affected by blood, intercourse, semen, urine, vaginal medications, lubricants, bathing products, or infections
  • The test kit contains all necessary materials and can be stored at room temperature
  • Available in multiple package sizes

How Actim PROM works

The 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

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

Sensitivity % Specificity % Accuracy
Actim PROM test 97 97 97
Nitrazine test 97 16 56
AFI < 80 mm 94 91 92

 

TABLE 2. Clinical evidence of accurate PROM diagnosis with Actim PROM.

Number of patients Sensitivity % Specificity % PPV % NPV %
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

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 money

  • Medical attention can be directed to patients who need it
  • Unnecessary use of medication and their side-effects can be avoided
  • Unrequired labor inductions are minimized
  • Reduces avoidable hospital visits and patient transfers
  • Gives expecting mothers peace of mind

 

How to use Actim PROM

Actim® PROM test kit contains all necessary materials and can be stored at:

  • Room temperature: 2–25 °C
  • Up to 30 °C for 2 months

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, step 1

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

 

Activate the test, step 2

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 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, ref: 30832ETAC
  • Actim PROM 10 test kit, ref: 30831ETAC
  • Actim PROM 1 test kit, ref: 30830ETAC
  • Actim PROM Controls, ref: 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.

  • Actim PROM IEMA (ELISA) test, ref: 10851ETMB

How to get Actim PROM

Actim rapid tests are used by medical professionals worldwide. To ensure a prompt delivery, Actim tests are distributed via local companies.

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Disclaimer: Product availability and/or labeling may vary from country to country and is subject to varying regulatory requirements. Please contact your local representative for availability.