Barr Pharmaceuticals is announcing the US launch of the first at-home detection test of amniotic fluid leakage during pregnancy. The product, called AmniScreen, is a fancy pantyliner that has a special chemical strip that detects an elevated pH that amniotic fluid is known for, and turns the strip from yellow to blue-green in color. The device is based on technology initially developed and implemented by Israel-based Common Sense, Ltd., a firm that has been selling overseas a product called AL-SENSE Kit (pictured). We have no image of the AmniScreen due to Barr Pharmaceuticals choosing not to respond to our multiple requests.
From the press release:
AmniScreen 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. The pivotal trial demonstrated that AmniScreen detected amniotic fluid leakage about 96% of the time. During the trial, patient-read results and clinician-read results matched more than 97% of the time.
Pregnant women who experience unexplained vaginal wetness are potential candidates for AmniScreen. 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.