Tool for Detection of Amniotic Fluid Launched
AmniScreen, a new at home screening test to detect the presence of amniotic fluid leakage, has been introduced to the U.S. market. The product, developed and manufactured by Common Sense, will be marketed by Duramed Pharmaceuticals, Incorporated. Duramed is a subsidiary of Barr Pharmaceuticals, Incorporated. Launch of the AmniScreen was detailed on the Barr website.
The prescription-only device is in the form of a panty liner that includes a polymer-coated polyester strip. The strip is able detect the presence of amniotic fluid by assessing the pH levels of fluids that come into contact with the strip. Fluid pH levels higher or equal to 5.2 produce a blue-green color. After patients utilize the test and interpret the results based on the color produced, they are to report findings to their clinician for interpretation.
Data submitted to the FDA to procure approval for the AmniScreen indicated that the test was able to accurately detect leakage attributable to amniotic fluid almost 96 percent of the time. As well, results determined by patients were concordant with physician interpretation over 97 percent.
Leakage of amniotic fluid is often indicative of problems during pregnancy. This new test, the only approved for at-home screening, can help physicians and patients determine if vaginal wetness is attributable to this source. Patients who are candidates for use of this device include high-risk pregnancies, patients who have had previous amniotic leakage, and patients who have undergone amniocentesis.
February 29, 2008 Related topics: Product Launches, Product Approval & Certification, Diagnostic, Obstetrics, Gynecology & Neonatology