AmniSure International LLC was formed in 2005 to manufacture, market and distribute the AmniSure ROM Test worldwide. In 2012, AmniSure was acquired by QIAGEN. The Company’s objective is to establish AmniSure as a Gold-Standard test – a staple test for every pregnancy. AmniSure LLC works to achieve that objective through in-house sales capabilities and by working with an extensive network of worldwide distributors. AmniSure is a rapid, non-invasive test that aids in the detection of ROM in pregnant women with signs and symptoms suggestive of the condition. It provides an easy-to-interpret, accurate, and timely diagnosis that enables clinicians to take opportune measures to prevent complications.


The AmniSure ROM Test

The AmniSure ROM Test is a diagnostic device that solves a long-standing problem in obstetric practice – accurately diagnosing ruptured fetal membranes (ROM). Premature ROM occurs in about one out of ten pregnancies and constitutes a major factor of both pre and post-natal complications. In the United States, it is estimated that 30% of pregnant women are checked for PROM during pregnancy.

The AmniSure ROM Test does not require a speculum examination and specifically detects the Placental Alpha Microglobulin-1 (PAMG-1) protein in amniotic fluid. The sample is taken by sterile swab, which is inserted 2-3 inches deep (5-7 cm) into the vagina. A clear “Yes/No” result can be read in minutes.

If the rupture of the amniotic sac resulting in fluid leakage is not detected and treated in a timely and accurate manner (within 24 hours from the occurrence of the rupture), infection and other serious complications for the neonate and the mother may occur. Diagnosis of ruptured fetal membranes is of crucial importance at any period in a pregnancy for prompt hospitalization and for timely and proper treatment.

The AmniSure ROM Test:
Is ~99% accurate
Detects the PAMG-1 protein marker
Provides results within minutes
Does not require a speculum examination
Has no gestational age limitation
Is billable with CPT 84112