Sepal公司推出胎膜破裂的无创检查方法

 
 
一种检查妊娠妇女胎膜(ROM)破裂的方法，具有无创伤性的特点而且十分可靠。

2005年7月《美国围产期医学期刊》上发表的临床研究结果显示：这种检测方法敏感性为98.9%，特异性为100%，阳性预测值为100%，阴性预测值为99.1%。这种检查方法叫做Amni-Sure，是第一种获得美国食品药品管理局批准的ROM免疫分析检测方法。该检测方法是由Sepal生殖设备(Sudbury, MA, USA)公司研制成功的。

Amni-Sure检测胎盘alpha微球蛋白-1 (PAMG-1)，这是一种在羊水中十分丰富的蛋白质。检测中使用消毒拭子插入阴道中2～3英寸共1分钟以收集样本，然后将拭子放入装有溶剂的小瓶中共1分钟，随后将Amni-Sure检测条带放入小瓶之中。随后5～10分钟内检测结果显示为1或者2个条带。

这种检测方法不需使用二硝基苯基偶氮萘酚二磺酸钠、蕨样变、以及阴道镜检查，而且高度特异：精子、尿液、和阴道感染都不会干扰检测结果。Sepal生殖设备公司供应全系列的辅助生殖技术产品，该公司在促进妇女健康的诊断检测产品中保持领先地位。

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.