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.
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99% accurate*
Results within minutes
Speculum not required
No gestational age limit
AmniSure® is recommended by the RANZCOG guidelines.
For the detection of PAMG-1 in amniotic fluid found in vaginal discharge of pregnant women
99% sensitive and 98% specific to support accuracy of negative and positive ROM clinical results
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
Saves time and the costs of additional ROM diagnostic methods
No confirmatory test required for a positive ROM result
Consistent performance across all gestation ages
99% correlation with the gold standard- indigo carmine dye infusion
Sensitive (99%) and specific (98%), to support diagnostic accuracy of negative and positive ROM results
Reliable in blood (see literature summary)
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 |
Overall sensitivity |
98.9% without speculum |
99.1% without speculum |
90.1% without speculum |
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%) |