AmniSure is 99% accurate in aiding a diagnosis of ROM as part of the overall clinical assessment (1).
Bro Picture
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Collect sample
Transfer to solvent
Insert test strip
Read result
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 Tests | Sensitivity (%) | 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 |
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) detected | PAMG-1 | IGFBP-1 (PP12) & AFP | IGFBP-1 |
Overall sensitivity | 98.9% | 99.1% | 90.1% without speculum 95.5% with speculum |
Overall specificity | 98.1% | 75% | 91.0% without speculum 86.4% with speculum |
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).
AmniSure provides correlation to the PROM testing gold standard of indigo carmine amniotic-dye infusion
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