Detection of amniotic fluid in vaginal secretions of pregnant women due to premature rupture of fetal membranes
AssigneeClinical Innovations, LLC
InventorsGlen Ford, William Dean Wallace
Life of this patent
Estimating the term…
Abstract
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.
Claims10
-43. (canceled)
A method for detecting biomarkers in a fluid sample taken from the vaginal secretions of a pregnant woman, the method comprising:
- a) adding buffer solution that has been contacted with the fluid sample to a chromatographic specific binding assay strip device comprising:
- i) a non-permeable platform strip;
- ii) a permeable membrane testing strip positioned adjacent the non-permeable platform strip, the permeable membrane testing strip comprising a test site for detecting the premature rupture of fetal membranes, the test site comprising a blend, wherein the blend comprises at least:
- 1) a first set of polyclonal antibodies for detecting α-fetoprotein;
- 2) a second set of polyclonal antibodies for detecting placental protein 12;
- 3) a first set of monoclonal antibodies specific for detecting α-fetoprotein;
- and
- 4) a second set of monoclonal antibodies specific for detecting placental protein 12;
- wherein the ratio of polyclonal antibodies blended together are from about 75% placental protein 12 to about 25% α-fetoprotein antibodies;
- iii) 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;
- iv) 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 the permeable membrane test strip;
- and
- v) a conjugate pad positioned on top of or below the sample receiving pad, the conjugate pad comprising a permeable membrane containing a conjugate, the conjugate comprising a colorant attached to antibodies that bind with analytes in the sample, wherein the conjugate of the sample binds to the analytes to form conjugate tagged analytes;
- b) allowing time for conjugate tagged analytes to migrate along the length of the permeable membrane strip to the test site;
- and
- c) detecting binding between α-fetoprotein, placental protein 12, and their respective monoclonal and polyclonal antibodies at the test site.
Dependencies are inferred from the claim text.