Reagents and kits for determination of fetal fibronectin in a vaginal sample
First Claim
Patent Images
1. A kit for detecting fetal fibronectin in a vaginal sample comprising:
- a. an anti-(fetal fibronectin) antibody;
b. an anti-fibronectin antibody,wherein either said anti-(fetal fibronectin) antibody or said anti-fibronectin antibody is adhered to an insoluble support; and
c. a device selected from the group consisting of a vaginal sample collection device, a vaginal sample filtration device, and a vessel containing a vaginal sample diluent.
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Abstract
This invention relates to methods, reagents and kits for detection of normal or ectopic pregnancy, the termination of pregnancy, or increased risk of preterm labor and rupture of membranes. Each embodiment involves sampling from the vaginal cavity, and determining the presence or absence of a specific analyte in the test sample. Sandwich or competition assay procedures can be used. Reagents and reagent kits for the above assays are included. The kit contains anti-(fetal fibronectin) antibody and an anti-fibronectin antibody.
54 Citations
46 Claims
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1. A kit for detecting fetal fibronectin in a vaginal sample comprising:
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a. an anti-(fetal fibronectin) antibody; b. an anti-fibronectin antibody, wherein either said anti-(fetal fibronectin) antibody or said anti-fibronectin antibody is adhered to an insoluble support; and c. a device selected from the group consisting of a vaginal sample collection device, a vaginal sample filtration device, and a vessel containing a vaginal sample diluent. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28, 29, 30, 31, 32, 33, 34, 35, 36, 37, 38, 39, 40, 41)
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42. A kit for detecting a fetal fibronectin in a vaginal sample comprising:
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a. an anti-(fetal fibronectin) antibody adhered to a well of a microtiter plate; b. an alkaline phosphatase-labeled anti-fibronectin antibody in an enzyme conjugate buffer comprising 50 mM Tris, pH 7.2;
2% D-Sorbitol;
2% bovine serum albumin;
0.01% Tween-20;
1 mM MgCl2 ;
0.1% ZnCl2 ; and
optionally 0.1% sodium azide;c. phenolphthalein monophosphate is in a enzyme substrate solution comprising 1 mg/ml phenolphthalein monophosphate;
0.4M 2-amino-2-methyl-1-propanol, pH 10;
0.1 mM MgCl2 ; and
, optionally 0.2% sodium azide; andd. a device selected from the group consisting of a vaginal sample collection device, a vaginal sample filtration device, and a vessel containing a vaginal sample diluent. - View Dependent Claims (43, 44)
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45. A kit for detecting a fetal fibronectin in a test sample comprising:
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a. an anti-(fetal fibronectin) antibody adhered to a nylon membrane, said membrane placed over an absorbent layer and having a flow control layer intermediate said membrane and said absorbent layer; b. a lyophilized gold-labeled anti-fibronectin antibody conjugate comprising 15 mM Tris;
2% bovine serum albumin;
0.1% Tween 20;
0.2% polyethylene glycol;
8% polyvinylpyrrolidine; and
, optionally 0.04% thimerosal; andc. a reconstitution buffer comprising 100 mM sodium acetate. - View Dependent Claims (46)
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Specification