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AmniSure®
International

Overview

AmniSure® is a new diagnostic that solves a long-standing problem in obstetric practice - diagnosis of ruptured fetal membranes (ROM). Premature ROM (PROM) occurs in about one out of ten pregnant women and constitutes the major factor of pre-and post-natal complications. In the U.S., at least 30% of pregnant women are checked for PROM during pregnancy.

Simply put, PROM occurs when a woman’s amniotic fluid breaks prematurely (not followed by labor in 24-48 hours). If the rupture of the amniotic sac that results in the leakage of the fluid is not detected and treated in a timely and accurate manner (during 24 hours since the rupture’s occurrence), infection and other serious complications for the neonate and the mother may occur. Diagnosis of ruptured fetal membranes is of crucial importance at any term in a pregnancy to ensure timely and proper hospitalization and treatment.

 

FDA Cleared, CE Marked

A specific, simple, convenient and reliable test, which allows rapid and accurate detection of fetal membranes rupture

New generation device employing immunochromatographic method 

Detects tiny (5 ng/ml) amounts of amniotic fluid in vaginal discharge (0.05-0.005 drop of the amniotic fluid) 

No need for speculum examination, additional reagents or equipment

The result can be evaluated visually 

A reliable aid for physicians, the test can also be performed by nurses and midwives 

One device, covering entire diagnostic spectrum - from the most difficult cases (sub-clinical ruptures) to confirmatory diagnosis 

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