Test Detects Premature Rupture of Fetal Membrane

A new test detects the premature rupture of fetal membrane (PROM), which occurs in around 10% of pregnant women, influencing pre- and postnatal morbidity and mortality.

PROM occurs when a pregnant woman's amniotic fluid sac breaks prematurely and is not followed by labor in 24-48 hours. About 30% of pregnant women are checked for PROM. If the rupture of the amniotic sac, which causes leakage of amniotic fluid, is not detected and treated in a timely manner, serious complications for the neonate and the mother may occur.

The test, called AmniSure, detects premature fetal membrane rupture. No reliable diagnostic for PROM exists today, states N-Dia, Inc. (Boston, MA, USA), which developed the test. The company believes that current tests (nitrazine test or ferning, for example) date from the 1950s and are both inaccurate and invasive (requiring a mandatory speculum examination). In contrast, AmniSure is a rapid noninvasive strip test that provides an answer in a few minutes, whether used in a clinic or at home.

N-Dia is a medical device company developing diagnostic products based on its research in cellular biology. These products utilize proprietary monoclonal antibodies against specific proteins associated with particular disorders and diseases. The company has developed a method that allows a diagnostic device to detect very small quantities of these proteins. The company states that this permits early and accurate detection of a dangerous medical condition and provides the possibility of timely treatment.




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