Specific Features and Advantages

• SIMPLE PROCEDURE - No need for speculum examination, additional reagents or equipment and the result can be evaluated visually

• ONE SHORT INCUBATION - Produces quick results - within minutes

• MONOCLONAL ANTIBODIES - New generation device employing immunochromatographic method

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

The timely and accurate diagnosis of rupture of fetal membranes (ROM) is crucial since the ROM may be associated with serious neonatal and maternal consequences. Failure to identify ROM can result in the failure to implement salutary obstetric measures. Conversely, the false diagnosis of membranes rupture can lead to inappropriate interventions (e.g., hospitalization or induction of labor). Therefore the correct and timely diagnosis of ROM is of crucial importance for the clinician. Accurate diagnosis of fetal membranes rupture, however, remains a frequent clinical problem in obstetrics.

Currently available tests are to some degree invasive, requiring sample-collection methods such as speculum examination.

AmniSure® is a rapid non-invasive strip test that can detect ROM, providing easy-to-interpret and timely diagnosis so that measures can be taken in a timely manner to prevent complications.

Diagnosis of ruptured fetal membranes is of crucial importance at any term in a pregnancy for prompt hospitalization and for timely and proper 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® assay does not require speculum examination. The sample is taken by sterile swab only, inserted 2-3 inches deep. The clear yes/no result can be read in minutes.