A pregnant woman taking a break from work by sitting outside on a sunny day. AmniSure, Woman Health
Gynecological and maternal health

Start with AmniSure for results you can trust

When a patient presents with symptoms of rupture of membranes (ROM), she is counting on you for accurate and reliable results. Do you have the diagnostic tools you need to make the right decision for her and the baby?

When ROM is suspected, the clock is ticking

When not addressed quickly and appropriately, prelabor or premature ROM (PROM) can lead to complications. Traditional methods of ROM diagnosis, such as ferning or nitrazine, are more likely to result in either false positives or false negatives and may lead to the respective under- or overtreatment of patients (1).

When ROM is suspected, AmniSure provides accurate and reliable results to aid in clinical decision making and should be used as part of the overall clinical assessment to determine the next course of action.

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Female doctor and pregnant female patient using digital tablet in hospital

ROM misdiagnosis can lead to under- or overtreatment of pregnant patients.

1. Neil, P.R. and Wallace, E.M. (2010) Aust. N. Z. J. Obstet. Gynaecol. 50, 534-8.
Feature AmniSure
Cited in more than 30 publications ✔
~99% correlation to indigo carmine (3) ✔
Detects high concentration of PAMG-1 (4) ✔
No gestational age limitation (4) ✔
No speculum required (4) ✔
Reliability in blood (5) ✔

Rapid, reliable testing

AmniSure is the world’s leading ROM biomarker test and can be implemented quickly and easily within your facility’s existing policies and procedures. Including AmniSure as part of the ROM assessment can provide additional insight to guide clinical decisions.

Accurate insights

Other available ROM immunoassays measure the concentration of alternative biomarkers. However, IFU data of other commercially available ROM biomarker tests reveal that the presence of relevant PAMG-1 is a more accurate measure of ROM status (4,8,9).

See how AmniSure performance compares to other ROM biomarker tests available today.

 

AmniSure ROM Test (4)

  ROM Plus® test (8)

Actim® PROM (9)

Amniotic fluid biomaker(s)
detected

PAMG-1

  IGFBP-1 (PP12) & AFP

IGFBP-1

Overall specificity

98.1%

 75.0%

91.0% without speculum
86.4% with speculum

Overall sensitivity

98.9%

 99.1%

90.1% without speculum
95.5% with speculum

How it works

Regardless of gestational age, high concentrations of placental alpha microglobulin-1 (PAMG-1) exist in amniotic fluid, but low concentrations are found in normal vaginal discharge. Therefore, positive detection of PAMG-1 in vaginal discharge is a strong indicator that fetal membranes have ruptured (6).

AmniSure is a rapid, qualitative test that accurately detects PAMG-1 in patients presenting with signs, symptoms, or complaints suggestive of ROM. Including AmniSure as part of the ROM assessment can provide valuable insight to help guide clinical decisions.

AmniSure consistently outperforms traditional ROM diagnostic methods
When compared to nitrazine, ferning, and pooling, AmniSure demonstrates improved accuracy which can help guide clinical decisions to protect the health of mom and baby (1,6,7).
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Ready and reliable

AmniSure is accurate, is ready to use as packaged with no additional tools necessary, can be administered bedside or in the lab by qualified staff, and has no gestational age limitation – enabling a fast and effective response in almost any situation when ROM is suspected.

With up to 30% of suspected ROM patients presenting with vaginal bleeding (5), it is critical to have a ROM test that is easily accessible and performs as intended, even in the presence of blood. In a published study, AmniSure was shown to be the most accurate and readable in the presence of vaginal bleeding (5).

female older doctor discussing results on a tablet with a male health care worker

Ready to get started?

We offer numerous resources to support the implementation and ongoing training and validation requirements of AmniSure users.

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References
  1. Abdelazim, I.A. and Makhlouf, H.H. (2012) Arch. Gynecol. Obstet. 285, 985-989.
  2. Neil, P.R. and Wallace, E.M. (2010) Is Amnisure useful in the management of women with prelabour rupture of the membranes? Aust. N. Z. J. Obstet. Gynaecol. 50, 534–8.
  3. Sosa C.G., et al. (2014) Comparison of placental alpha microglobulin-1 in vaginal fluid with intra-amniotic injection of indigo carmine for the diagnosis of rupture of membranes. J Perinat Med. 42, 611-16.
  4. Amnisure IFU https://www.qiagen.com/de/resources/
    resourcedetail?id=d91f71db-e3bc-4c16-b654-1831d2fe322c&lang=en
  5. Ramsauer, B., Duwe, W., Shlehe, B., et al. (2015) Effect of blood on ROM diagnosis accuracy of PAMG-1 and IGFBP-1 detecting rapid tests. J. Perinat. Med. 43(4), 417
  6. Ng, B.K. et al. (2013) Biomed. Res. Int. 587438.
  7. Cousins, L. M. et al. (2005) Am. J. Perinatol. 22. 317-320.
  8. ROM Plus IFU https://www.laborie.com/wp-content/uploads/2021/07/OB-MAN-001-EN-ART0087REV02-ROM-Plus-IFU.pdf
  9. Actim PROM IFU https://www.coopersurgical.com/wp-content/uploads/Actim-PROM-Test-Kit-Instructions-for-Use.pdf