Objective: 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).
Methods: We compared this improved AFP test with the ROM-check and/or the nitrazine tests in 46 preterm patients.
Results: 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.
Conclusion: This study has confirmed a great clinical utility of the improved AFP test kit as a method of PROM diagnosis.