Sintered polymer membrane for analyte detection device

• US 20030096424A1
• Filed: 06/03/2002
• Published: 05/22/2003
• Est. Priority Date: 08/28/2001
• Status: Active Grant

• Current Assignee: Porex Corporation (FGI Equity LLC)
• Original Assignee: Porex Corporation (FGI Equity LLC)
• Inventors: Mao, Guoqiang, Yao, Li, Coppola, Richard J., Greene, George Warren
• Granted Patent: US 7,456,025 B2
• Time in Patent Office: Days
• US Class Current: 506/32
• CPC Class Codes: G01N 33/521 Single-layer analytical elements
• CPC Class Codes: G01N 33/54353 with ligand attached to the carrier via a chemical coupling agent coatings G01N33/54393
• CPC Class Codes: G01N 33/54366 Apparatus specially adapted for solid-phase testing
• CPC Class Codes: G01N 33/54393 Improving reaction conditions or stability, e.g. by coating or irradiation of surface, by reduction of non-specific binding, by promotion of specific binding
• CPC Class Codes: G01N 33/558 using diffusion or migration of antigen or antibody immunochromatographic test strips G01N33/54387
• CPC Class Codes: Y10T 428/249953 Composite having voids in a component [e.g., porous, cellular, etc.]
• CPC Class Codes: Y10T 428/249991 Synthetic resin or natural rubbers
• CPC Class Codes: Y10T 428/249992 Linear or thermoplastic
• CPC Class Codes: Y10T 428/249993 Hydrocarbon polymer

Abstract

The present invention relates to a sintered porous polymeric material useful as membrane in an analyte detection device, such as a lateral flow device, flow through device, or a dipstick device. The invention encompasses an analyte detection device that comprises such a sintered porous polymeric material and method of analyte detection using such a device. Specific sintered porous polymeric materials encompassed by the invention are surface activated and further coated with one or more layers of a variety of materials.

Claims

1. An analyte detection device for detecting an analyte in a liquid sample, which comprises a sintered, hydrophilic, porous, polymeric membrane.

2. The analyte detection device of claim 1, wherein the membrane is a polyolefin, polyester, polyurethane, polycarbonate, polyetheretherketone, poly(phenylene oxide), poly(ether sulfone), or nylon.

3. The analyte detection device of claim 2, wherein the polyolefin is ethylene vinyl acetate, ethylene methyl acrylate, polyethylene, polypropylene, ethylene-propylene rubber, ethylene-propylene-diene rubbers, poly(1-butene), polystyrene, poly(2-butene), poly(1-pentene), poly(2-pentene), poly(3-methyl1-pentene), poly(4-methyl-1-pentene), 1,2-poly-1,3-butadiene, 1,4-poly-1,3-butadiene;

polyisoprene, polychloroprene, poly(vinyl acetate), poly(vinylidene chloride), poly(vinylidene fluoride), poly(tetra fluoro ethylene), or mixture thereof.

4. The analyte detection device of claim 1, wherein the membrane further comprises a solid wetting agent.

5. The analyte detection device of claim 1, wherein the membrane has been treated with an aqueous or organic solution of one or more wetting agents.

6. The analyte detection device of claim 1, wherein the membrane has been surface activated.

7. The analyte detection device of claim 6, wherein the surface activation is by means of chemical treatment, plasma discharge, corona discharge, electron-beam, or combinations thereof.

8. The analyte detection device of claim 6, wherein the membrane has been further coated with a polyelectrolyte, a surfactant, a neutral polymer, a small molecule, a biomolecule, or a combination thereof.

9. The analyte detection device of claim 6, wherein the membrane has been further coated with a first layer and a second layer, the first layer comprising molecules bound to a surface of the polymeric material through covalent bounds, electrostatic interactions, or combinations thereof;

and the second layer comprising molecules bound to the first layer through covalent bounds, electrostatic interactions, or combinations thereof.

10. The analyte detection device of claim 9, wherein the molecules of the first layer and the second layer are independently selected from a polyelectrolyte, a surfactant, a neutral polymer, a small molecule, a biomolecule, or a combination thereof.

11. The analyte detection device of claim 10, wherein the polyelectrolyte is a surfactant, phosphate, polyethyleneimide, poly(vinylimidazoline), quaterized polyacrylamide, polyvinylpyridine, poly(vinylpyrrolidone), polyvinylamine, polyallylamine, chitosan, polylysine, poly(acrylate trialkyl ammonia salt ester), cellulose, poly(acrylic acid), polymethylacrylic acid, poly(styrenesulfuric acid), poly(vinylsulfonic acid), poly(toluene sulfuric acid), poly(methyl vinyl ether-alt-maleic acid), poly(glutamic acid), dextran sulfate, hyaluric acid, heparin, alginic acid, adipic acid, chemical dye, protein, enzyme, nucleic acid, peptide, or a salt, ester, and/or copolymer thereof.

12. The analyte detection device of claim 11, wherein the molecules of the first layer are polyethyleneimide, poly(vinylpyrrolidone), or a copolymer thereof.

13. The analyte detection device of claim 10, wherein the neutral polymer is an isocyannated terminated polymer, epoxy-terminated polymer, or hydroxylsuccimide terminated polymer.

14. The analyte detection device of claim 13, wherein the neutral polymer is polyurethane, poly(ethylene glycol), or polysiloxane.

15. The analyte detection device of claim 10, wherein the small molecule is sodium dodecylsulfonate, dodecyltrimethylamonium bromide, phosphate, sulfonate, bronate, sulfonate, dye, lipid, metal ion, or surfactant containing fluorine.

16. The analyte detection device of claim 10, wherein the biomolecule is a protein, enzyme, lipid, hormone, peptide, nucleic acid, oligonucleic acid, DNA, RNA, sugar, or polysaccharide.

17. The analyte detection device of claim 9, wherein the first layer comprises molecules of polyethyleneimide and the second layer comprises molecules of a poly(acrylic acid), a copolymer containing poly(acrylic acid), or a surfactant.

18. The analyte detection device of claim 17, wherein the second layer comprises a fluorinated surfactant.

19. The analyte detection device of claim 9, wherein the first layer comprises molecules of polyallylammoniumchloride, and the second layer comprises molecules of polyvinylsulfate.

20. The analyte detection device of claim 9, wherein the membrane has been further coated with one or more additional layers bound to the second or one of the additional layers through covalent bounds, electrostatic interactions, or combinations thereof.

21. The analyte detection device of claim 20, wherein the membrane is coated with three layers, the first layer comprising molecules of polyethyleneimide;

the second layer comprising molecules of a polyallylamine; and

the third layer comprising of molecules of polyethyleneimide, polyvinylamine, or a surfactant.

22. The analyte detection device of claim 1, wherein the device is a lateral flow device, a flow-through device, or a dipstick device.

23. The analyte detection device of claim 22, wherein the device is a lateral flow device comprising one or more of a sample application pad, a conjugate release pad, an analytical membrane, and an absorbant pad;

and wherein the polymeric membrane is one or more of the sample application pad, conjugate release pad, analytical membrane, or absorbant pad.

24. The analyte detection device of claim 23, wherein the polymeric membrane is an analytical membrane of the device.

25. The analyte detection device of claim 1, wherein the liquid sample comprises a body fluid of a mammal.

26. The analyte detection device of claim 25, wherein the body fluid is blood, urine, or saliva.

27. A method of detecting an analyte in a liquid sample, comprising contacting the liquid sample with a porous membrane of an analyte detection device, wherein the membrane is a sintered hydrophilic polymeric material.

28. An analyte detection device comprising a sintered, hydrophilic, porous, polymeric membrane, wherein the membrane comprises a substrate of ultra-high molecular weight polyethlyene, said substrate having been surface activated and coated with a first layer of polyethlyeneimine and a second layer of poly(acrylic acid) or a fluorine containing surfactant.