Rapid, reliable, non-invasive test for PROM and PPROM

AmniSure Summary
Why test for ROM?
Clinical Benefits
Cost Effectiveness
Literature

99% accurate

Results in 5 minutes

Improved patient management

Cost effective

 

 99% accurate1

 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.

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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.
AmniSure® vs ActimPROM: Performance metrics in patients with unknown membrane status and vaginal bleeding9
See References
AmniSure® vs ActimPROM: Performance metrics in patients with unknown membrane status10
See References
Performance of AmniSure® (PAMG-1) relative to the gold standard (indigo carmine intra-amniotic injection) of ROM diagnosis6
See References
Download literature review
Download product brochure and IFU

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.

Why should you test for Rupture of Membranes (ROM)?

 

20% of pregnancies present with suspicion of  PROM3. As clinical examination of amniotic pooling is subjective, clinical studies have found that clinicians may be uncertain on PROM diagnosis in 47% of cases3.

PROM occurs in around 8-10% of all pregnancies4 and occurs in around 3% of pregnancies before 37 weeks gestation5, termed Preterm PROM (PPROM). PPROM is associated with 30% of preterm births5. Therefore, accurate, rapid and reliable ROM diagnosis is critical at any stage of pregnancy to ensure that patients receive the most appropriate and timely management and care.

 

How many cases are you overtreating?

False positives can result in unnecessary and costly hospital admission, transfers, medications or induction of labour.

Are you missing cases?

False negatives can result in inappropriate patient discharge with PROM untreated, leading to serious maternal and neonatal infection.

Cost effectiveness

The use of the AmniSure® (PAMG-1) test ensures significant financial benefits which have also been demonstrated in studies11. Cost savings with AmniSure® are achieved through the reductions in misdiagnoses from using traditional methods or a less accurate test.

  • Minimising false positives can reduce unnecessary and costly hospital admissions, repeat testing, in utero transfers, induction of labour and other treatments.
  • Minimising the number of false negatives could reduce costly treatment of patients which develop severe infections due to undiagnosed PROM.
  • As AmniSure® is used to diagnose non-obvious cases, this reduces the need for repeat examinations and further clinical tests.

Do you know the cost of misdiagnosing with either a less accurate test or clinical examination alone?

We offer a simple cost benefit assessment, showing potential savings for your hospital. Send us your annual births with the cost of your current PROM method used and we’ll prepare a cost breakdown report.

Enquire for a cost analysis

Product information

  • 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.