Diagnosis of premature rupture of the membranes in preterm patients, using an improved AFP kit: comparison with ROM-check and/or nitrazine test.
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.


CONCLUSIONS
This study has confirmed a great clinical utility of the improved AFP test kit as a method of PROM diagnosis.
Department of Obstetrics and Gynecology, Hokkaido University School of Medicine, Sapporo, Japan.
T
T
Kishida
H
H
Yamada
H
H
Negishi
T
T
Sagawa
S
S
Makinoda
S
S
Fujimoto
D000653:Amniotic Fluid / Q000737:chemistry* / Q000276:immunology; D000911:Antibodies, Monoclonal; D005189:False Positive Reactions; D005260:Female; D005322:Premature Rupture of Fetal Membranes / Q000175:diagnosis*; D006801:Humans; D007163:Immunosorbent Techniques; D011247:Pregnancy; D011296:Prenatal Diagnosis / Q000379:methods*; D011446:Prospective Studies; D011933:Reagent Kits, Diagnostic; D015203:Reproducibility of Results; D012680:Sensitivity and Specificity; D013997:Time Factors; D000509:alpha-Fetoproteins / Q000032:analysis* / Q000276:immunology
D000911:Antibodies, Monoclonal; D011933:Reagent Kits, Diagnostic; D000509:alpha-Fetoproteins