Department of Obstetrics and Gynecology, Ain Shams University, Cairo, Egypt,
Arch Gynecol Obstet. 2014 Sep;290(3):457-64. doi: 10.1007/s00404-014-3225-5. Epub 2014 Apr 9.
To compare accuracy of fetal fibronectin (fFN) versus placental alpha microglobulin-1 for detection of premature rupture of fetal membranes (PROM).
Two hundred and twenty pregnant women >34 and <37 weeks were included in this comparative prospective study and divided into two groups according to presence or absence of PROM. The diagnosis of PROM was based on patient's history of sudden gush of water, pooling of amniotic fluid, positive ferning, positive nitrazine test, confirmed by visualization of fluid passing from the cervical canal and amniotic fluid index ≤5 cm measured by trans-abdominal ultrasound. Patients included in this study were examined by sterile speculum for visualization of membranes and for collection of samples (swabs) from posterior vaginal fornix.
Sensitivity and specificity of AmniSure test to diagnose PROM were 97.3 and 98.2 %, respectively, compared with 94.5 and 89.1 %, respectively, for fFN test. Positive predictive value, negative predictive value, and accuracy of AmniSure test to diagnose PROM were 98.2, 97.3, and 97.7 %, respectively, compared with 89.7, 94.2, and 91.8 %, respectively, for fFN test. Predictive values and accuracy of fFN test to diagnose PROM were statistically insignificant compared with predictive values and accuracy of ferning, nitrazine and AmniSure tests.
fFN bedside test is better than nitrazine and ferning tests in detection of PROM, but is not suited for identification of clinically difficult cases with suspected PROM, because, it is influenceable and can give false-positive results in preterm labor, women >34 gestational weeks and after any vaginal manipulation without PROM.
比较纤维连接蛋白（fFN）和胎盘α-微球蛋白-1 检测胎膜早破（PROM）的准确性。
本前瞻性对比研究纳入了 220 名孕 34 周至 37 周之间的孕妇，根据是否存在 PROM 将其分为两组。PROM 的诊断基于患者突然大量流水、羊水积聚、羊齿结晶阳性、硝嗪试验阳性、宫颈管内可见液体流出以及经腹超声测量羊水指数≤5cm 的病史。本研究中的患者经无菌窥器检查以观察胎膜并从后阴道穹隆采集样本（拭子）。
AmniSure 试验诊断 PROM 的灵敏度和特异性分别为 97.3%和 98.2%，而 fFN 试验分别为 94.5%和 89.1%。AmniSure 试验诊断 PROM 的阳性预测值、阴性预测值和准确率分别为 98.2%、97.3%和 97.7%，而 fFN 试验分别为 89.7%、94.2%和 91.8%。fFN 试验诊断 PROM 的预测值和准确率与硝嗪试验和羊齿结晶试验相比无统计学意义。
fFN 床边试验在检测 PROM 方面优于硝嗪试验和羊齿结晶试验，但不适合识别有临床疑似 PROM 的困难病例，因为它在早产、孕 34 周以上和无 PROM 的任何阴道操作后都会受到影响，并可能导致假阳性结果。
