Diagnosis of premature rupture of membranes with an improved alpha-fetoprotein monoclonal antibody kit.
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.
Kishida
T
T
Department of Obstetrics and Gynecology, Hokkaido University School of Medicine, Sapporo, Japan.
Hirao
A
A
Matsuura
T
T
Katamine
T
T
Yamada
H
H
Sagawa
T
T
Fujimoto
S
S
D000653:Amniotic Fluid / Q000737:chemistry*; D000911:Antibodies, Monoclonal; D005260:Female; D005322:Premature Rupture of Fetal Membranes / Q000175:diagnosis*; D005865:Gestational Age; D006801:Humans; D011247:Pregnancy; D011933:Reagent Kits, Diagnostic / Q000706:statistics & numerical data; D015203:Reproducibility of Results; D012680:Sensitivity and Specificity; D000509:alpha-Fetoproteins / Q000032:analysis*
D000911:Antibodies, Monoclonal; D011933:Reagent Kits, Diagnostic; D000509:alpha-Fetoproteins