When a patient presents with symptoms of premature rupture of membranes (PROM), she is counting on you for accurate and reliable results. The right decision for her and her baby starts with AmniSure. See why our clinicians include AmniSure as part of their clinical assessment of PROM – see why they love AmniSure.

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AmniSure is a rapid, non-instrumented, qualitative immunoassay to aid in the detection of ROM (rupture of [fetal] membranes). AmniSure is 98.9% sensitive and 98.1% specific when used as part of the overall clinical assessment.

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Accurate Insights

Think about the number of unnecessary treatments you may be able to avoid with the most accurate ROM Test. AmniSure delivers 98.1% specificity to aid in the detection of ROM.

AmniSure ROM Test (1)ROM Plus Test (2) Actim PROM (3)
Amniotic fluid biomarker(s) detected PAMG-1IGFBP-1 (PP12) & AFP IGFBP-1
Overall specificity 98.1% without speculum75% without speculum 91.0% without speculum
86.4% with speculum
Overall sensitivity 98.9% without speculum99.1% without speculum 90.1% without speculum
95.5% with speculum

Reliable in blood

With up to 30% of suspected ROM patients presenting with vaginal bleeding (4), it is critical to have a ROM test that is reliable, even in the presence of blood. In a published study, AmniSure was shown to be more accurate and readable in the presence of vaginal bleeding (4).

TestSensivity SpecificityOverall accuracy PPV NPVTests non-evaluable
AmniSure 97.8% 91.5% 95.3% 94.6% 96.4% 3 (1.9%)
Actim PROM 91.0% 75.0% 84.3% 83.5% 85.7% 17 (11.3%)

No age limit. No speculum required.

Improve your OB clinical assessment of ROM. AmniSure does not have a gestational age limit and speculum is not required when collecting a sample for AmniSure.

Evidence-based practice

AmniSure is cited in over 20 peer-reviewed studies and is used in birthing hospitals nationwide when diagnosing ROM.

The only test that stacks up to the gold standard

AmniSure is the only ROM diagnostic test that was compared to the gold standard, indigo carmine amnio-dye infusion. The published study shows AmniSure has a ~99% correlation with the indigo carmine test (5).

Read the Paper

Show your love for AmniSure and show your patients you care.

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1. AmniSure ROM (Rupture of [fetal] Membranes) Test Instructions for Use. QIAGEN, 2019.
2. ROM plus Rupture of Membranes Test Instructions for Use. P/N 050-0642 REV E, 2016.
3. Actim PROM Instructions for Use OACE30831-9. Medix Biochemica, 2016.
4. 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.
5. Sosa, C.G., Herrera, E., Restrepo, J.C., Strauss, A. and Alonso, J. (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, 611–6.

Check out our sister product for preterm birth, PartoSure

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