
Commercial products:
Amnisure
AmniSure is a one-step immunochromatographic test for a rapid in vitro detection of amniotic fluid in vaginal secretion of pregnant women. The test is used by health care professionals to aid in the detection of fetal membrane ruptures in pregnant women where there is a suspicion of such a rupture. Amnisure ensures high sensitivity, specificity, positive predictive value, and negative predictive value (>99% on all four measures). AmniSure is approved as a CE marked medical device for human treatment. AmniSure is FDA approved.
AmniSure is the most accurate test for membrane rupture in pregnant women. It is simple to use and it takes five minutes to get the result. Currently, the evaluation of rupture in the membrane is based on subjective judgment by the mid wives based on signs, symptoms or complaints from the pregnant woman. Rupture in the membrane is a very serious event, and if not discovered, can result in fetal and maternal morbidity and mortality.
