Clinical Utility Data of the AmniSure ROM Test

The AmniSure ROM Test:

  • Contributes to improved patient outcomes
  • Allows for improved physician confidence in PROM diagnosis

Improved Patient Outcomes

Multiple randomized controlled trials (RCTs) have shown that quickly treating patients with PROM significantly reduces the incidence of related comorbidities. The superior accuracy of the PAMG-1 immunoassay compared with traditional methods allows clinicians to quickly and accurately distinguish those patients in need of obstetrical intervention from those patients not in need.

Table IIIA: Incidence of ROM Comorbidity Reduction With Respect to Treatment
False Negative Rate of ROM Diagnosis of Traditional Methods 12, 16, 35, 36 Treatment Condition Incidence w/o Treatment Incidence w/Treatment Incidence Reduction of Condition w/Treatment
11%-28% Antibiotics37 Maternal Chorioamnionitis 25% 16% 34%
Neonatal Infection 17% 10% 38%
Corticosterolds38 Fetal and Neonatal Death 19% 14% 23%
Respiratory Distress Syndrome (RDS) 26% 17% 34%
Intra-ventricular Hemorrhage (IVH) 11% 6% 44%
Necrotizing Enterocolitis (NEC) 6% 3% 54%
Systematic Infection within 48 hours 9% 5% 44%
Cerebral Palsy (CP) 7% 4% 40%

Improved Physician Confidence

Recently-published, peer-reviewed findings in the Australian and New Zealand Journal of Obstetrics and Gynaecology (ANZJOG) show that clinicians are uncertain about their diagnosis of ROM in 47% of patient cases. Uncertainty in diagnosis of PROM is the unfortunate result of inaccuracy in current testing methodologies. Not only are clinicians using multiple methods for a single diagnosis, but they are keeping patients under observation for longer times to establish confidence in that diagnosis. The same peer-reviewed study shows that the presence of a negative AmniSure ROM Test gave clinicians the confidence to immediately discharge 21% of women they falsely believed to have preterm Premature ROM.

Additionally, private practice providers can now reliably diagnose ROM with AmniSure. Doing this would effectively reduce the number of patients admitted to the hospital or ER.

ANZJOG authors, Neil & Wallace, add that "when there was a diagnostic uncertainty in the preterm cohort...clinicians were more likely to manage the woman as if she had ruptured membranes, planning admission for observation, pad checks, follow-up diagnostic tests, and antenatal glucocorticoids if < 34 weeks gestation". The authors go on to say that "such caution reflects the anxieties about the dangers of missing PROM" but that "AmniSure altered this cautious approach, giving the clinician the confidence to immediately discharge" patients thought to have PPROM when there was a negative AmniSure test result.

Use of AmniSure as Reference Method

The AmniSure ROM Test has entered the space of high-risk obstetrics as an established and prevalent aid in the diagnosis of ROM. Aside from the widespread usage of this test in birthing hospitals across both the US and 60 countries worldwide, the utility of the AmniSure ROM Test can further be seen by the inclusion of the test in many guidelines & peer-reviewed publications.

  • Di Renzo GC, Cabero L, et al. "Guidelines for the management of spontaneous preterm labor." J Matern Fetal Neonatal Med 2011; 24(5): 659-667.
  • Lee SE, Park JS, Norwitz ER, Kim KW, Park HS, Jun JK Obstet Gynecol. 2007 Mar;109(3):634-40.
  • Cousins LM, Smok DP, Lovett SM, Poeltler DM Am J Perinatol. 2005 Aug;22(6):317-20.

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