February 25, 2008 - Barr Pharmaceuticals Inc. have launched AmniScreen, an FDA-approved at-home screening test for amniotic fluid leakage during pregnancy, said the company.
AmniScreen is a prescription-only panty liner device that includes a proprietary polymer-coated polyester strip designed to detect amniotic fluid leakage, which could indicate a potential problem with a pregnancy.
“AmniScreen may offer reassurance to women concerned about unexplained vaginal wetness during pregnancy,” said Nancy Jasper, M.D., assistant clinical professor, Department of Ob/Gyn, Columbia University, College of Physicians and Surgeons. “The product detects amniotic fluid leakage that can lead to serious complications, such as infection and preterm labor. It’s important for women to know when wetness may be caused by amniotic fluid leakage.”
AmniScreen reportedly works by detecting elevated pH levels, which may indicate amniotic fluid leakage. Patients are instructed to report or show test results to their healthcare provider for interpretation and medical care.
Pregnant women who experience unexplained vaginal wetness are potential candidates for AmniScreen, said the company. The company said additional candidates include high-risk pregnant women, women who have undergone amniocentesis, have experienced prior amniotic leakage and those who are concerned about unexplained wetness.
The AmniScreen Home Detection Liner Kit is designed to detect possible leakage of amniotic fluid when vaginal wetness is experienced during pregnancy by indicating pH level. pH levels greater than or equal to 5.2 produce a blue-green color. Patients are instructed to report or show test results to their healthcare provider for interpretation and medical care.
AmniScreen should not be used if less than 12 hours have passed since sexual intercourse or vaginal douching. AmniScreen should not be used if there is vaginal bleeding or spotting. A healthcare provider should be consulted if there is unexplained wetness, vaginal bleeding or spotting, or suspicion of vaginal infection.
For more information: www.barrlabs.com