AmniSure ROM Test

Add to your clinical confidence

Around 20 to 25% of all pregnant women will present with a suspected Premature Rupture of Membranes or PROM and up to half of all cases will not be obvious to the patient or clinician.

AmniSure is 99% accurate in aiding a diagnosis of ROM as part of the overall clinical assessment (1).

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Test procedure

Collect sample

Transfer to solvent

Insert test strip

Read result

AmniSure and traditional PROM diagnosis

Technology for ROM diagnosis have evolved dramatically since the methods of ferning and nitrazine were developed. In the mid-2000s, the first biomarker test for PROM came to the market. This new technology has improved patient outcomes thanks to its high accuracy, non-invasiveness and rapid turnaround time.

ROM TestsSensitivity (%)Specificity (%)
AmniSure ROM Test (1)99%98%
Pooling (2)Inaccurate/subjective
Nitrazine (pH) (3)88%68%
Ferning (4, 5, 6)50–63%71–86%
Ultrasound (7)Does not detect ROM independently
Amnio-Dye injection (7)“Gold Standard” for diagnosis of ROM

Accurate ROM insights

Think about the number of unnecessary treatments you may be able to avoid with the right ROM Test. AmniSure delivers 98% specificity to aid in the detection of ROM – only a 2% false positive rate. Other tests have up to a 25% false positive rate.

AmniSure ROM Test (1)ROM Plus Test (8)Actim PROM (9)
Amniotic fluid biomarker(s) detectedPAMG-1IGFBP-1 (PP12) & AFPIGFBP-1
Overall sensitivity 98.9%99.1%90.1% without speculum
95.5% with speculum
Overall specificity98.1%75%91.0% without speculum
86.4% with speculum

A reliable solution in the presence of vaginal bleeding

With up to 30% of suspected PROM patients presenting with vaginal bleeding (10), it is critical to have a PROM test that is reliable even in the presence of blood.

In an article in the Journal of Perinatology, AmniSure was shown to have higher specificity in the presence of vaginal bleeding (11).

The only test with 99% correlation to the gold standard

AmniSure provides correlation to the PROM testing gold standard of indigo carmine amniotic-dye infusion

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Learn how AmniSure can be part of your clinical assessment of ROM

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