Kishida T, Hirao A, Matsuura T, Katamine T, Yamada H, Sagawa T, Fujimoto S
Department of Obstetrics and Gynecology, Hokkaido University School of Medicine, Sapporo, Japan.
Clin Chem. 1995 Oct;41(10):1500-3.
We developed a new kit for detecting alpha-fetoprotein (AFP) in leaked amniotic fluid (Eur J Obstet Gynecol Reprod Biol 1995;58:67-72). Later, we developed an improved AFP kit utilizing the same AFP monoclonal antibody. We compared this improved AFP test with the nitrazine test for 137 patients. The nitrazine test correctly diagnosed 62.1% of the cases, but the improved AFP kit diagnosed 98.0% for < 37 weeks of gestation (P < 0.001). The nitrazine test showed a specificity of 58.3%, whereas the AFP kit showed a 100% rate for detecting > or = 37 weeks of gestation (P < 0.01). The reaction time with the AFP kit is 90 s. This study has confirmed a high clinical efficacy of the improved AFP test kit as a method of diagnosis of premature rupture of fetal membranes.
我们开发了一种用于检测羊水渗漏中甲胎蛋白（AFP）的新试剂盒（《欧洲妇产科与生殖生物学杂志》1995年；58：67 - 72）。后来，我们利用相同的AFP单克隆抗体开发了一种改进的AFP试剂盒。我们将这种改进的AFP检测与137例患者的石蕊试纸检测进行了比较。石蕊试纸检测正确诊断了62.1%的病例，但改进的AFP试剂盒对妊娠< 37周的诊断率为98.0%（P < 0.001）。石蕊试纸检测的特异性为58.3%，而AFP试剂盒对妊娠≥37周的检测率为100%（P < 0.01）。AFP试剂盒的反应时间为90秒。本研究证实了改进的AFP检测试剂盒作为诊断胎膜早破方法具有较高的临床疗效。
