Specific Features and Advantages

SIMPLE PROCEDURE - no need for speculum examination, additional reagents or equipment. The result can be evaluated visually.

ONE SHORT INCUBATION - gives a quick result in 0.5-10 minutes

MONOCLONAL ANTIBODIES - specifically goal-selected, these ensure high sensitivity, specificity, positive predictive value, and negative predictive value.

ONE TEST - In trials, AmniSure® correlated with the clinical diagnosis obtained through the combined usage of three other routinely used tests (Nitrazine, Ferning, and Pooling)

Premature ruptures of fetal membranes (PROM) occur in 10% of pregnancies. In 35% of cases, a rupture occurs prior to 37 weeks of pregnancy gestation. The most serious consequences of PROM for both the woman and the fetus may be premature delivery (PROM is responsible for the majority of pre-term deliveries), and the threat of intrauterine infection and pulmonary hypoplasia of the fetus. Other possible complications include placental abruption, prolapse of the umbilical cord, development of fetal deformities and postnatal endometritis.

All these consequences of premature rupture of fetal membranes significantly increase neonatal and maternal morbidity and mortality.

Diagnosis of ruptured fetal membranes is of crucial importance at any term in a pregnancy to ensure timely and proper hospitalization and treatment.

AmniSure® detects trace amounts of PAMG-1, one of the amniotic fluid proteins that appear in vaginal discharge after the membrane ruptures. With intact fetal membranes, the test does not normally detect PAMG-1, due to its low background concentration.

The AmniSure® test does not require invasive speculum examination. The sample is taken by sterile swab only, and inserted 5-7cm (2-3 inches) deep. The clear yes/no result can be read in 0.5-10 minutes.