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Press Release by SPIDERSPLAT CONSULTING, INC. in Medical: OB / GYN
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AmniSure Test for ROM Featured in the American Journal of Perinatology
View all releases by SPIDERSPLAT CONSULTING, INC.
This press release is about: amnisure, perinatology, membranes, test, clinical, featured, american, diagnostic, devices, journal, rupture
2005-09-14, SPIDERSPLAT CONSULTING, INC. - A new test for ROM (Rupture Of (fetal) Membranes) in pregnant women that is both reliable and non–invasive is featured in a clinical study in the July issue of the American Journal of Perinatology.PRWEB) September 14, 2005 -- A new test for ROM (Rupture Of (fetal) Membranes) in pregnant women that is both reliable and non–invasive is featured in a clinical study in the July issue of the American Journal of Perinatology.
The purpose of this study was to compare the AmniSure rapid immunoassay with standard methods for diagnosing rupture of fetal membranes. In the final analysis, the AmniSure diagnostic test demonstrated a sensitivity of 98.9%, specificity of 100%, positive predictive value of 100%, and a negative predictive value of 99.1%.
AmniSure™ is the first FDA approved ROM immunoassay. AmniSure detects Placental Alpha Microglobulin-1 (PAMG-1), a protein that is abundant in amniotic fluid. Eliminating the need for nitrazine, ferning and a speculum exam, AmniSure™ simply involves collecting a sample with a sterile swab, inserted only 2-3 inches into the vagina for one minute, then placing the swab into a vial with a solvent for one minute, followed by dipping an AmniSure™ test strip into the vial. The test result is indicated visually over the next 5-10 minutes by the presence of one or two lines. AmniSure is highly specific; semen, urine and vaginal infections do not interfere with the efficacy of the test. Clinical studies and additional information about AmniSure is available at: http://www.sepalsolutions.com.
To view the clinical study abstract please visit:
http://www.thieme-connect.com/ejournals/abstract/ajp/doi/10.1055/s-2005-870896
Sepal Reproductive Devices is a distinguished leader in the design, discovery and marketing of innovative medical products. Sepal supplies a full range of devices for assisted reproductive technologies as well as the latest advances in diagnostic testing devices that promote the health and well-being of women. Sepal’s range of testing kits includes ovulation and menopause detection kits, and a rapid diagnostic test that detects rupture of (fetal) membranes (ROM). Sepal is a privately held company based in Sudbury, Massachusetts. Since its inception in 2000, Sepal has serviced hundreds of healthcare professionals, infertility centers and hospitals around the world. We continue to expand our product line and reinforce our commitment to becoming the vanguard of women’s healthcare by bringing the most advanced technologies and devices to the medical industry. For additional information please visit: http://www.sepalreprodevices.com
Source: PR Web™
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