Advances in the Testing for Preterm Premature Rupture of Membrane - Episode 3

Risks Associated With Prelabor Rupture of Membrane

December 16, 2020

Experts in gynecology provide their perspective on the maternal and neonatal risks associated with the preterm premature rupture of membranes.

Supported by: Qiagen

Limitations of the Test

  • Each test is a single use disposable unit and cannot be reused.
  • The AmniSure ROM Test results are qualitative. Make no quantitative interpretation based on the test results.
  • When there is a significant presence of blood on the swab, the test can malfunction and is not recommended. In cases of only trace amounts of blood on the swab, the test still functions properly.
  • In very rare cases when a sample is taken 12 hours or later after a rupture, a false-negative result may occur due to obstruction of the rupture by fetus or resealing of the amniotic sac.
  • Test performance in patients without signs or symptoms of ROM is unknown.
  • Use results in conjunction with other clinical information.
  • Failure to detect membrane rupture does not assure the absence of membrane rupture.
  • Women may labor spontaneously despite a negative test result.
  • The performance of the AmniSure ROM Test has not been established in the presence of the following contaminants: anti-fungal creams or suppositories, K-Y® Jelly, Monistat Yeast Infection Treatment, Baby Powder (Starch and Talc), Replens Feminine Moisturizer, or Baby Oil.
  • The performance of the AmniSure ROM Test has not been established in the presence of meconium in the amniotic fluid.

AmniSure ROM Test should be used as part of the overall clinical assessment.


Supported by: Qiagen