一種用于妊娠婦女胎膜破裂(ROM)檢測(cè)方法具有很好的可靠性與非創(chuàng)傷性。

AmniSure是第一種獲得美國(guó)食品藥品管理局批準(zhǔn)的ROM免疫檢測(cè)法。這種檢測(cè)方法檢測(cè)胎盤(pán)alpha IgG1(PAMG-1)，這種蛋白在羊水中含量豐富。AmniSure檢測(cè)法使用消毒棉簽收集樣本，將其插入陰道內(nèi)2~3英寸大約1分鐘，然后將AmniSure檢測(cè)條帶浸入小瓶中。檢測(cè)結(jié)果在隨后的5~10分鐘表現(xiàn)為1或者2個(gè)條帶。

新型檢測(cè)方法免除了患者使用二硝基苯基偶氮萘酚二磺酸鈉、ferning以及金屬陰道窺器檢查的需求。AmniSure是一種高度特異性的檢測(cè)方法。精液、尿液以及陰道感染都不會(huì)干擾檢測(cè)效果。這種免疫檢測(cè)方法是由Sepal生殖檢測(cè)設(shè)備公司(Sudbury, MA, USA)研制開(kāi)發(fā)的，該公司提供全系列的生殖輔助檢測(cè)設(shè)備以及婦女健康的診斷設(shè)備。該公司的產(chǎn)品在全世界范圍的醫(yī)院和不孕中心得到了廣泛應(yīng)用。

2005年5月在美國(guó)圣弗朗西斯科舉行的美國(guó)婦產(chǎn)科年會(huì)上展示了AmniSure這種產(chǎn)品。
 
Test for Rupture of Fetal Membranes
 
A new test for rupture of fetal membranes (ROM) in pregnant women is reliable and noninvasive.

AmniSure is the first ROM immunoassay to be cleared by the U.S. Food and Drug Administration (FDA). The test detects placental alpha microglobulin-1 (PAMG-1), a protein that is abundant in amniotic fluid. AmniSure involves collecting a sample with a sterile swab, inserted only two to three inches into the vagina for one minute, followed by dipping an AmniSure test strip into a vial. The test result is shown visually over the next five to 10 minutes by the presence of one or two lines.

The new test eliminates the need for nitrazine, ferning, and a speculum exam. AmniSure is highly specific. Semen, urine, and vaginal infections do not interfere with the efficacy of the test. The immunoassay was developed by Sepal Reproductive Devices (Sudbury, MA, USA), a company that supplies a full range of devices for assisted-reproductive technologies as well as advances in diagnostic testing that promote the health and well-being of women. The company’s products are used in hospitals and infertility centers around the world.

AmniSure was featured at the annual meeting of the American College of Obstetricians and Gynecologists in San Francisco (CA, USA) in May 2005.