Rapid, reliable, non-invasive test for PROM and PPROM
Results in 5 minutes
Improved patient management
Recommended in: NICE (25), RCOG Green-top (no. 73) and European Guidelines
>20 peer reviewed studies
No speculum required
No gestational age limit
Not affected by urine, semen, infections or trace amount of blood
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What is AmniSure®?
AmniSure® is a non-invasive, one-step immunochromatographic assay which detects the placental alpha microglobulin-1 protein (PAMG-1) using specific monoclonal antibodies. AmniSure® has been evaluated in more than 20 peer reviewed clinical studies. It has been found to have a sensitivity of 98.9% and specificity of 100%1.
How does it work?
With intact membranes, the background concentration of PAMG-1 in vaginal discharge is 0.05-0.22 ng/ml2. PAMG-1 concentration is much higher in amniotic fluid (2,000-25,000 ng/ml)1 regardless of gestational age. Therefore, any leakage of amniotic fluid due to a rupture will significantly increase the vaginal PAMG-1 concentrations. AmniSure® has a sensitive threshold of 5 ng/ml, enabling the detection of even a miniscule amount of amniotic fluid leakage.
Clinical benefits of using AmniSure®
Proven Accuracy of AmniSure®
- In cases with suspicion of PROM but no visible leakage of amniotic fluid, AmniSure® provides a rapid and reliable bedside test with 98.9% sensitivity and 100% specificity1.
- AmniSure® is the only PROM diagnostic method with 99% correlation to the indigo carmine injection, the gold standard of PROM testing6.
- AmniSure® is demonstrated in multiple studies to be a more accurate aid in detecting PROM than other tests, including IGFBP-1 biomarker tests7-10.
- AmniSure® is more accurate than the IGFBP-1 test in women with or without vaginal bleeding9,10.
- AmniSure® significantly increases clinician confidence3,11, leading to a change of intended management3.
A low vaginal swab test; no speculum is required.
Can be used at any gestation.
Results available within 5 minutes after collecting the sample.
Improved ward management by reducing unnecessary admissions.
AmniSure can be used in antenatal clinics, triage, delivery suite or in the community.
- AmniSure® is sold in boxes of 25 tests.
- Store the kit in a dry place at 4 – 25°C, do not freeze.
- The test is stable until the “Use By” date on the foil pouch if stored at the correct temperature.
- The AmniSure® ROM Test should be used within six hours after removing from foil pouch.
- Product code FMRT-1-25, available to purchase directly or through NHSSC.