Abstract: The present invention relates to a diagnostic method for the detection of small quantities of amniotic fluid in the vagina. More specifically, the invention relates to the detection of PAMG-1 in the vagina using anti-PAMG-1 antibodies.

Abstract: Antibodies having binding affinity for free IGFBP-1, biological compositions including antibodies having binding affinity for free IGFBP-1, kits for detecting free IGFBP-1 using the antibodies, and cell lines for producing the antibodies are provided. Also provided are devices and methods for detecting free IGFBP-1 and a rupture in a fetal membrane based on the presence of amniotic fluid in a vaginal secretion, as indicated by the presence of free IGFBP-1 in the vaginal secretion. The antibodies that are provided may be characterized by their ability to selectively recognize those IGFBP-1 molecules which are free of IGF-1 and IGF-2, i.e., antibodies which have a binding affinity for free IGFBP-1 that is greater than a binding affinity of the antibody to bound IGFBP-1. These antibodies may also be characterized by their competition with IGF-1 and IGF-2 for binding to IGFBP-1.

Abstract: Antibodies having binding affinity for free IGFBP-1, biological compositions including antibodies having binding affinity for free IGFBP-1, kits for detecting free IGFBP-1 using the antibodies, and cell lines for producing the antibodies are provided. Also provided are devices and methods for detecting free IGFBP-1 and a rupture in a fetal membrane based on the presence of amniotic fluid in a vaginal secretion, as indicated by the presence of free IGFBP-1 in the vaginal secretion. The antibodies that are provided may be characterized by their ability to selectively recognize those IGFBP-1 molecules which are free of IGF-1 and IGF-2, i.e., antibodies which have a binding affinity for free IGFBP-1 that is greater than a binding affinity of the antibody to bound IGFBP-1. These antibodies may also be characterized by their competition with IGF-1 and IGF-2 for binding to IGFBP-1.

Abstract: Antibodies having binding affinity for free IGFBP-1, biological compositions including antibodies having binding affinity for free IGFBP-1, kits for detecting free IGFBP-1 using the antibodies, and cell lines for producing the antibodies are provided. Also provided are devices and methods for detecting free IGFBP-1 and a rupture in a fetal membrane based on the presence of amniotic fluid in a vaginal secretion, as indicated by the presence of free IGFBP-1 in the vaginal secretion. The antibodies that are provided may be characterized by their ability to selectively recognize those IGFBP-1 molecules which are free of IGF-1 and IGF-2, i.e., antibodies which have a binding affinity for free IGFBP-1 that is greater than a binding affinity of the antibody to bound IGFBP-1. These antibodies may also be characterized by their competition with IGF-1 and IGF-2 for binding to IGFBP-1.

Abstract: 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.