Diagnosis of preterm premature rupture of the membranes using a newly developed AFP monoclonal antibody test kit.

We have developed a new anti-AFP monoclonal antibody kit which is easier to use than other examination methods for detecting AFP in the leaked amniotic fluid. In this study, we investigate the clinical value of this test in the diagnosis of preterm premature rupture of the membranes (PROM). We employed 103 patients of less than 37 weeks of gestational age for this preliminary study. We compared the clinical usefulness of this new AFP test with that of the nitrazine test and measured the concentration of AFP in vaginal fluid or cervical secretion by EIA. The nitrazine test showed a correct diagnostic rate of 62.1%, in contrast the AFP test kit had a 98.0% rate (P < 0.001). The reaction time using the kit is 3 min. The AFP test is a simple and non-invasive test which can be easily carried out repeatedly as a bedside examination. This study has confirmed the high clinical efficacy of the newly developed AFP test kit as a method of PROM diagnosis.