AmniSure Introduction

A rapid, non-invasive test that aids in the detection of ROM in pregnant women with signs and symptoms suggestive of the condition. It provides an easy-to-interpret, accurate, and timely diagnosis that enables clinicians to take opportune measures to prevent complications.

Diagnosing Rupture Of fetal Membranes (ROM) is of critical importance for the clinician. An accurate diagnosis of ROM at any term during pregnancy is crucial to timely and proper treatment and to determine the need for prompt hospitalization.  The failure to identify patients with ROM can result in a delay or inability to implement salutary obstetric measures. Conversely, the false positive diagnosis of ROM can lead to inappropriate or untimely interventions such as hospitalization or induction of labor.

The accurate diagnosis of ROM, however, remains a frequent clinical problem in obstetrics. Many currently-used tests have significant limitations and are to some degree invasive, requiring sample collection using speculum examination.

The AmniSure® test does not require a speculum examination. The sample is taken by sterile swab, which is inserted only 5-7 cm deep into the vagina. A clear “Yes/No” result can be read in minutes (Figure 1).