Toda Amniodiag®5

Women's health

Test for the detection of premature rupture of fetal membranes (PROM test)

Toda Amniodiag® 5 est un test de diagnostic rapide pouvant détecter une rupture prématurée des membranes ( RPM) par détection de la protéine IGFBP-1 dans un échantillon de sécrétion vaginale d’une femme enceinte.

Discover the two available formats

Cassette format

Strip format

A simple, fast, and accurate diagnosis

The Benefits of TodaAmniodiag®

RAPID

Results obtained in just 5 minutes.

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EASY TO USE

Sampling is made easy with the swab included in the kit.

ENABLES MORE TAILORED CARE

Contributes to appropriate interventions and optimized care.

Performance

IGFBP-1
Sensitivity ≥ 99,9%
Specificity 98.8%

Screening for PROM: A major challenge for maternal and infant health

50%

des cas de RPM donnent lieu à un accouchement dans les 72 heures

Source : Mémoire d’État « État des lieux de la prise en charge des ruptures prématurées des membranes entre 34 et 37 semaines d’aménorrhée au CHU de Nantes », soutenu par Pauline Pacaud, École de Sages-Femmes de l’Université de Nantes (2015).

8 à 10%

c’est le pourcentage de grossesses globales qui font face à une rupture prématurée des membranes à terme.

Source : Article scientifique « Dans quel délai déclencher en cas de rupture prématurée des membranes à terme », rédigé par les Dr D. Gallot, A. Delabaere, M. Rouzaire, E. Devillard, L. Jaillet et E. Boulay, publié dans la revue Gynécologie Obstétrique Pratique (6 avril 2021).

x4

c’est l’augmentation du risque d’infection néonatale pour le nouveau-né lorsque la RPM dure plus de 18 heures avant la naissance sans prise en charge antibiotique immédiate.

Source : Principaux repères « Streptocoque du groupe B », publiés par l’Organisation mondiale de la Santé [OMS] (24 avril 2026).

An accurate test starts with proper technique

Discover in 3 simple steps how to use the Toda Amniodiag® 5 test based on the selected format.

This test is intended for use by healthcare professionals only.

Practical information

All kits contain:

References

  • 1050-10: cassette
  • 1052-10: strip

The test should be stored at room temperature (between 2°F and 30°F).

Helpful documents

Catalog & product sheet

Gynecology – Obstetrics Catalog

Toda Amniodiag®5 Product Sheets

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1. What is premature rupture of membranes (PROM)?

Premature rupture of membranes (PROM) is an obstetric complication in which the amniotic membranes rupture before the onset of labor and before the 37th week of gestation. This condition can have serious consequences for both the mother and the baby, including an increased risk of infection, preterm birth, and neonatal complications.

During pregnancy, the fetus is protected by a sac filled with amniotic fluid, known as the amniotic membranes. These membranes play a crucial role: they protect the baby against infections and impacts, and promote its proper development.

Rupture of the membranes

Under normal circumstances, the membranes rupture at the start of or during labor. This is known as membrane rupture. It may be accompanied by a sudden gush of clear fluid when contractions become regular. It is part of the natural process of childbirth and does not require any special intervention if everything is proceeding normally.

Premature Rupture of Membranes (PROM)

On the other hand, premature rupture of membranes (PROM) occurs when the membranes rupture before labor begins, while the woman is not yet experiencing contractions.
It can occur at any stage of pregnancy.

The Amniodiag® 5 test is primarily used from the second trimester of pregnancy, a period during which premature rupture of membranes (PROM) can occur and lead to complications.

It is indicated in cases of clinical suspicion, especially if the pregnant woman exhibits:

  • Unexplained clear fluid discharge,
  • A persistent sensation of dampness,
  • Or in case of doubt during a follow-up examination, even without obvious symptoms.

Easy to use, the test can be performed in a hospital setting, in obstetric emergencies, and also in outpatient clinics, enabling rapid decision-making and avoiding unnecessary hospitalizations or delays in care.

Complementary diagnostics in this range

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