Patent ID: 8765487

Claim:
A chromatographic specific binding assay strip device for the detection of amniotic fluid in vaginal secretions of pregnant women due to premature rupture of fetal membranes, said chromatographic specific binding assay strip device comprising: a) a non-permeable platform strip; b) a permeable membrane testing strip positioned on top of the non-permeable platform strip, said permeable membrane testing strip further comprising a test site for the detection of said premature rupture of fetal membranes, said site comprising a blend of at least: i) a first set of polyclonal antibodies for the detection of a first biomarker, said first biomarker indicating said premature rupture of fetal membranes, said first set of polyclonal antibodies being specific for Alpha-Fetoprotein (AFP); and ii) a second set of polyclonal antibodies for the detection of a second biomarker, said second biomarker being indicative of said premature rupture of fetal membranes, said second set of polyclonal antibodies being specific for Placental Protein 12 (PP-12); iii) a first set of monoclonal antibodies for the detection of said first biomarker said indicating said premature rupture of fetal membranes said first set of monoclonal antibodies being specific for AFP; and iv) a second set of monoclonal antibodies for the detection of second biomarker, said second biomarker being indicative of said premature rupture of fetal membranes said second set of polyclonal antibodies being specific for PP-12; and wherein said first set of polyclonal antibodies and said second set of polyclonal antibodies are intermingled with said first set of monoclonal antibodies and said second set of monoclonal antibodies in said blend for said test site; c) a sample receiving pad positioned on top of and at a proximal end of the non-permeable platform strip while in contact with a proximal end of the permeable membrane testing strip; d) a reservoir pad positioned on top of and at a distal end of the non-permeable membrane testing strip while in contact with a distal end of said permeable membrane test strip; and e) a conjugate pad positioned on top of or below said sample receiving pad, said conjugate pad comprising a permeable membrane containing a conjugate, said conjugate comprising a colorant attached to a vehicle which can attach to said biomarker.