Test for Rupture of Fetal Membranes

A new test for the rupture of fetal membranes (ROM) in pregnant women is noninvasive and has been found to be reliable.

The results of a study in the July 2005 issue of the American Journal of Perinatology showed that the test demonstrated a sensitivity of 98.9%, a specificity of 100%, a positive predictive value of 100%, and a negative predictive value of 99.1%. Called Amni-Sure, the test is the first ROM immunoassay to be approved by the U.S. Food and Drug Administration (FDA). The test was developed by Sepal Reproductive Devices (Sudbury, MA, USA).

The Amni-Sure test detects placental alpha microglobulin-1 (PAMG-1), a protein abundant in amniotic fluid. The test involves collecting a sample with a sterile swab inserted only two-three inches into the vagina for one minute, then placing the swab into a vial with a solvent for one minute, followed by dipping an Amni-Sure test strip into the vial. The test result is indicated visually over the next five-10 minutes by the presence of one or two lines.

The test eliminates the need for nitrazine, ferning, and a speculum examination, and is highly specific: semen, urine, and vaginal infections do not interfere with the results of the test. Sepal Reproductive Devices supplies a full range of devices for assisted reproductive technologies as well as advances in diagnostic testing devices that promote the health of women.






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