Sepal公司推出胎膜破裂检测方法

一种用于妊娠妇女胎膜破裂(ROM)检测方法具有很好的可靠性与非创伤性。

AmniSure是第一种获得美国食品药品管理局批准的ROM免疫检测法。这种检测方法检测胎盘alpha IgG1(PAMG-1)，这种蛋白在羊水中含量丰富。AmniSure检测法使用消毒棉签收集样本，将其插入阴道内2~3英寸大约1分钟，然后将AmniSure检测条带浸入小瓶中。检测结果在随后的5~10分钟表现为1或者2个条带。

新型检测方法免除了患者使用二硝基苯基偶氮萘酚二磺酸钠、ferning以及金属阴道窥器检查的需求。AmniSure是一种高度特异性的检测方法。精液、尿液以及阴道感染都不会干扰检测效果。这种免疫检测方法是由Sepal生殖检测设备公司(Sudbury, MA, USA)研制开发的，该公司提供全系列的生殖辅助检测设备以及妇女健康的诊断设备。该公司的产品在全世界范围的医院和不孕中心得到了广泛应用。

2005年5月在美国圣弗朗西斯科举行的美国妇产科年会上展示了AmniSure这种产品。
 
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.