Method for detecting free insulin-like growth-factor-binding protein 1 and a test device for detecting the ruptures of fetal membranes using the above method

摘要

A method and device for detecting fetal membrane rupture by detecting only that insulin-like growth-factor-binding protein 1 (IGFBP-1) which is free of insulin-like growth factors 1 and 2 (IGF-1 and IGF-2) are disclosed. The method is based on the fact that the concentration of free IGFBP-1 in the blood serum is about 10 times lower than that of the IGFBP- 1 bound to IGF-1 and IGF-2, while in the amniotic liquid which is contained in the amnion has more than 1000 times the concentration of free IGFBP-1 than the blood serum. Therefore, when even a small amount of amniotic liquid is contained in the vaginal secretion sample, this is clear evidence of the rupture of the fetal membrane having taken place. The method and the device make it possible to diagnose fetal membrane rupture with an extremely high accuracy. Because of the low concentration of the IGFBP-1 in the blood, the admixture of the blood serum to the sample does not affect the results of the test. The device comprises a one-pad-two-strips test kit which may be used to detect free IGFBP-1 in a range of concentrations from 5 ng/ml to 250 &mgr;g/ml.