一種檢查妊娠婦女胎膜(ROM)破裂的方法，具有無創(chuàng)傷性的特點而且十分可靠。

2005年7月《美國圍產期醫(yī)學期刊》上發(fā)表的臨床研究結果顯示：這種檢測方法敏感性為98.9%，特異性為100%，陽性預測值為100%，陰性預測值為99.1%。這種檢查方法叫做Amni-Sure，是第一種獲得美國食品藥品管理局批準的ROM免疫分析檢測方法。該檢測方法是由Sepal生殖設備(Sudbury, MA, USA)公司研制成功的。

Amni-Sure檢測胎盤alpha微球蛋白-1 (PAMG-1)，這是一種在羊水中十分豐富的蛋白質。檢測中使用消毒拭子插入陰道中2～3英寸共1分鐘以收集樣本，然后將拭子放入裝有溶劑的小瓶中共1分鐘，隨后將Amni-Sure檢測條帶放入小瓶之中。隨后5～10分鐘內檢測結果顯示為1或者2個條帶。

這種檢測方法不需使用二硝基苯基偶氮萘酚二磺酸鈉、蕨樣變、以及陰道鏡檢查，而且高度特異：精子、尿液、和陰道感染都不會干擾檢測結果。Sepal生殖設備公司供應全系列的輔助生殖技術產品，該公司在促進婦女健康的診斷檢測產品中保持領先地位。

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.