Detection of amniotic fluid in vaginal secretions of pregnant women due to premature rupture of fetal membranes

摘要

A method is taught for the accurate determination of the premature rupture of membranes (PROM), defined as spontaneous rupture of membranes before the onset of uterine contractions. More specifically, a lateral flow assay strip tests for at least two antigens to greatly limit or eliminate the possibility of false negatives. A built in timer in the cassette holding the lateral flow assay further increases the accuracy of the test. A collection buffer vial with self-contained shipping and dropper caps and built in stand is also taught.

主权项

1) 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 AFP;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 PP-12;iii) a first set of monoclonal antibodies for the detection of said first biomarker, said first biomarker being indicative of said premature rupture of fetal membranes, said first set of monoclonal antibodies being specific for AFP; andiv) a second set of monoclonal antibodies for the detection of second biomarker, said second set of monoclonal antibodies being specific for PP-12;
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, wherein the ratio of the PP-12 antibodies to AFP antibodies ranges from about 5:1 to about 10:1.