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Get it right the first time. Start with AmniSure®

AmniSure® solves a long-standing problem in obstetric practice – diagnosis of ruptured fetal membranes (ROM). Premature ROM (PROM) occurs in about one out of ten pregnant women, and constitutes the major factor of pre-and post-natal complications.  PROM occurs when a woman’s amniotic fluid breaks prematurely (not followed by labor in 24-48 hours). If the rupture of the amniotic sac that results in the leakage of the fluid is not detected and treated in a timely and accurate manner (during 24 hours since the rupture’s occurrence), infection and other serious complications for the neonate and the mother may occur.

AmniSure® detects the PAMG-1 protein in the amniotic fluid, and allows accurate diagnosis so early intevention can occur.

Amnisure Logo 199% accurate*

Amnisure Logo 1Results within minutes

Amnisure Logo 1Speculum not required

Amnisure Logo 1No gestational age limit

AmniSure® is recommended by the RANZCOG guidelines.

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 For the detection of PAMG-1 in amniotic fluid found in vaginal discharge of pregnant women

Amnisure Logo 1 99% sensitive and 98% specific to support accuracy of negative and positive ROM clinical results 

She’s counting on you for accurate, reliable results. 

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AmniSure® is 99% accurate and is the only ROM test with proven correlation to the gold standard indigo carmine. The AmniSure® ROM rest is a rapid immune assay supplied as a single. Cost-effective test for in vitro diagnostics. The 4-step test procedure detects placental alpha microglobulin-1 (PAMG-1) protein that is found in high concentrations in amniotic fluid and low concentrations in cervicovaginal fluid.5

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Saves time and the costs of additional ROM diagnostic methods

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No confirmatory test required for a positive ROM result

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Consistent performance across all gestation ages

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99% correlation with the gold standard- indigo carmine dye infusion

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Sensitive (99%) and specific (98%), to support diagnostic accuracy of negative and positive ROM results

Download the brochure and flyer below for more informationAmnisure Logo

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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 100% 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-1

IGFBP-1 (PP12) & AFP

IGFBP-1

Overall specificity

100% without speculum

75% without speculum

91.0% without speculum
86.4% with speculum

Overall sensitivity

98.9% without speculum

99.1% 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).

Test

Sensivity

Specificity

Overall accuracy

PPV

NPV

Tests 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%)

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