Actim® Partus

Fast and simple bedside test to rule out preterm or imminent delivery.

Overview

The reliable way to rule out the risk of preterm delivery

Actim® Partus is a fast and reliable point-of-care test to identify pregnant women with a real risk of preterm or imminent delivery, even before visible signs.

Preterm delivery (birth that occurs before the 37th week of pregnancy) is the leading cause of newborn morbidity and mortality. Early detection of high-risk pregnancies is challenging. Half of pregnant women experience associated symptoms, yet only 20 % of these are at real risk of immediate or preterm delivery.

Actim Partus is a simple and accurate rapid test to identify or rule out the risk of preterm delivery from week 22 until birth. The test can be used for all pregnant women, and it is reliable even in the presence of interfering substances. A negative Actim Partus result indicates that imminent delivery is highly unlikely; low-risk patients can thus return home, overtreatment is avoided, and valuable resources are saved.

Actim Partus | key facts

  • Reliably rules out the risk of imminent or preterm delivery when fetal membranes are unbroken
  • Can be used from week 22 onwards
  • Easy-to-use one-step dipstick test
  • Gives test results at the bedside in just 5 minutes, with sampling completed in seconds
  • Test results are not affected by urine, intercourse, semen, 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 it works

Cervical phIGFBP-1 indicates preterm delivery

Actim Partus identifies the risk of preterm delivery through a simple cervical swab sample. The rapid test is based on highly specific monoclonal antibodies that bind to the phosphorylated form of insulin-like growth factor binding protein-1 (phIGFBP-1). phIGFBP-1 is produced in the decidua, but leaks into the cervix when the decidua and chorion detach.

A positive Actim Partus test result indicates the presence of tissue damage, which may lead to preterm delivery. A negative test result, in turn, means that there are no significant changes in the choriodecidual layer. Delivery is therefore very unlikely within the next 1–2 weeks, even if the patient has contractions. Actim Partus is designed to give reliable answers in minutes, to support clinical decision-making.

Actim Partus has a very high (98%) negative predictive value (NPV). Therefore, a negative test result rules out the risk of imminent or preterm delivery.

Because Actim Partus is specific to phIGFBP-1, tests can be completed even in the presence of semen, urine, infections, and medical products.

About phIGFBP-1

  • Produced by decidua
  • Leaks into the cervix when decidua and chorion detach
  • phIGFBP-1 in a cervical swab is an indicator for tissue damage
 ReferenceNo. of patientsGA (wk)SensitivitySpecificityPPVNPV
Tripathi et al., 201646828-3695%92%86%97%
Azlin et al., 20105124-3680%94%57%98%
Brik Spinelli et al., 201027624-3473%66%22%95%
Tanir et al., 20096824-3793%79%56%98%
Eroglu et al., 20075124-3583%84%42%97%
Ting et al., 20079424-3469%78%39%92%
Lembet et al., 20023620-3694%85%83%94%
TABLE 1. Clinical evidence of Actim Partus as a predictor of delivery within 7 days

How it helps

Preterm delivery or harmless contractions?

Identifying patients who have harmless contractions from those at real risk of preterm delivery can be difficult. In practice, this means that over-diagnosis and over-treatment are common.

Actim Partus is already in use all over the world and it has been included in several national treatment guidelines.

Actim Partus saves lives, time, and money

  • Medical attention can be directed to patients who need it
  • Early identification of high-risk pregnancies allows timely treatment
  • Low-risk patients who do not need immediate care can be sent home
  • Unnecessary use of medication and their side-effects can be avoided
  • Reduces unrequired hospitalization and patient transfers
  • Gives expecting mothers peace of mind

How to use it

Fast results at the bedside in minutes

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

Collect a cervical secretion sample using a speculum

Hold the swab in for 10-15 seconds.

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

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 = risk of preterm or imminent delivery is high.
  • A negative result should be confirmed at 5 minutes.
    One blue line = preterm or imminent delivery is highly unlikely.
Actim Partus can be interpreted digitally with Actim® 1ngeni instrument.

How to order it

How to order Actim Partus

Actim Partus 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 Partus 10 test kit | product code 31931ETAC
  • Actim Partus 1 test kit | product code 31930ETAC
  • Actim Partus Controls | product code 31900ETAC

Actim® Partus Controls are intended to be used with the Actim Partus 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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