Kishida T, Yamada H, Negishi H, Sagawa T, Makinoda S, Fujimoto S
Department of Obstetrics and Gynecology, Hokkaido University School of Medicine, Sapporo, Japan.
Eur J Obstet Gynecol Reprod Biol. 1996 Nov;69(2):77-82. doi: 10.1016/0301-2115(95)02519-7.
We developed a new kit for detecting AFP in leaked amniotic fluid. Later, we developed an improved AFP kit utilizing the same anti alpha-fetoprotein (AFP) monoclonal antibody. In this study, we evaluate the clinical usefulness of this improved kit in the diagnosis of preterm premature rupture of membranes (PROM).
We compared this improved AFP test with the ROM-check and/or the nitrazine tests in 46 preterm patients.
The ROM-check and nitrazine tests showed a diagnostic accuracy of 89.1 and 87.0%, respectively, compared with 95.7% with the improved AFP test. The sensitivity of the improved AFP test on cervical samples was significantly higher than that of the nitrazine test on vaginal samples (P < 0.05). The reaction time with the improved AFP kit test is 90 s.
This study has confirmed a great clinical utility of the improved AFP test kit as a method of PROM diagnosis.
我们研发了一种用于检测羊水渗漏中 AFP 的新试剂盒。之后，我们利用相同的抗甲胎蛋白（AFP）单克隆抗体研发了一种改进的 AFP 试剂盒。在本研究中，我们评估这种改进试剂盒在早产胎膜早破（PROM）诊断中的临床实用性。
我们将这种改进的 AFP 检测与 ROM 检查和/或石蕊试纸试验在 46 例早产患者中进行了比较。
ROM 检查和石蕊试纸试验的诊断准确率分别为 89.1%和 87.0%，而改进的 AFP 检测为 95.7%。改进的 AFP 检测对宫颈样本的敏感性显著高于石蕊试纸试验对阴道样本的敏感性（P < 0.05）。改进的 AFP 试剂盒检测的反应时间为 90 秒。
本研究证实了改进的 AFP 检测试剂盒作为一种 PROM 诊断方法具有很大的临床实用性。
