Diffraction-based diagnostic devices

• US 7,118,855 B2
• Filed: 05/03/2002
• Issued: 10/10/2006
• Est. Priority Date: 05/03/2002
• Status: Expired due to Fees

• Current Assignee: Kimberly-Clark Worldwide Incorporated (Kimberly-Clark Corporation)
• Original Assignee: Kimberly-Clark Worldwide Incorporated (Kimberly-Clark Corporation)
• Inventors: Kaylor, Rosann, Cohen, David
• Primary Examiner(s): Chin, Christopher L.
• Application Number:
  US10/138,882
• Publication Number:
  US 20030207255A1
• Time in Patent Office: 1,621 Days
• Field of Search: 435/4, 435/6, 435/7.31, 435/7.32, 435/287.2, 436/518, 436/524, 436/525, 422/82.11, 427/271
• US Class Current: 435/4
• CPC Class Codes: G01N 21/4788 Diffraction for sizing particles G01N15/0205
• CPC Class Codes: G01N 33/543 with an insoluble carrier for immobilising immunochemicals

Abstract

A biosensor includes a substrate with a layer of receptive material disposed thereon. The receptive material is specific for an analyte of interest. A pattern of active and inactive areas of the receptive material are defined in the receptive material layer by a masking process.

Claims

1. A method of making a biosensor, comprising the steps of:

forming a receptive material layer generally uniformly over a surface of a substrate member, the layer containing a receptive material specific for an analyte of interest;

defining at least one active area and at least one inactive area of the receptive material in a masking process wherein a blocking agent is used to render the receptive material inactive in the defined inactive area; and

wherein when the biosensor is exposed to a medium containing the analyte of interest, the analyte binds to the receptive material in the active areas and facilitates subsequent diffraction of transmitted light or reflected light in a diffraction pattern corresponding to the active areas.

2. The method as in claim 1, wherein the masking process comprises applying an activatable blocking agent generally uniformly over the receptive material layer;

placing a mask over the substrate member, the mask having a configuration so as to shield at least one underlying area of the substrate while exposing at least one adjacent area;

exposing the mask and substrate to a stimulus for activating the blocking agent such that the blocking agent in the exposed areas affixes to the receptive material;

removing the mask from the substrate and disassociating the blocking agent from the receptive material in the areas that were underlying the mask;

wherein a resulting pattern of active and inactive areas of the receptive material are defined, the inactive areas corresponding to the areas exposed by the mask and the active areas corresponding to the areas shielded by the mask.

3. The method as in claim 2, comprising defining a pattern of the active and inactive areas with the mask, the pattern comprising a plurality of the active areas and a plurality of the inactive areas.

4. The method as in claim 1, wherein the blocking agent is a ligand which binds with the receptive material, the ligand being modified with a cross-linking agent that is activated by a stimulus for affixing the ligand to the receptive material.

5. The method as in claim 4, wherein the cross-linking agent is light sensitive and the stimulus is a light source sufficient for activating the cross-linking agent.

6. The method as in claim 5, wherein the cross-linking agent comprises N-hydroxy-succinimidyl-4-azidosalicylic acid (NHS-ASA).

7. The method as in claim 4, comprising disassociating the ligand in the active areas by washing the substrate member with a solution sufficient to disrupt the bond between the ligand and the receptive material.

8. The method as in claim 1, comprising selecting the substrate member from the group of materials consisting of plastics, metal coated plastics and glass, functionalized plastics and glass, silicon wafers, glass, and foils.

9. The method as in claim 1, wherein the substrate member comprises a polymer film coated with a metal.

10. The method as in claim 9, wherein the polymer film comprises polyethylene-terephthalate.

11. The method as in claim 9, comprising selecting the metal from the group consisting of gold, silver, chromium, nickel, platinum, aluminum, iron, copper, gold oxide, titanium, chromium oxide, silver oxide, and zirconium.

12. The method as in claim 9, wherein the metal is gold.

13. The method as in claim 1, comprising viewing the diffraction pattern of active areas with the naked eye.

14. The method as in claim 1, wherein the receptive material is an antibody and the blocking agent is a cognate antigen modified with a light sensitive cross-linking agent.

15. The method as in claim 14 comprising affixing the antigens to the receptive material by exposing the substrate to a light sufficient for activating the cross-linking agent.

16. The method as in claim 1, comprising selecting the receptive material from at least one of antigens, antibodies, nucleotides, chelators, enzymes, bacteria, yeasts, fungi, viruses, bacterial pili, bacterial flagellar materials, nucleic acids, polysaccharides, lipids, proteins, carbohydrates, metals, hormones, peptides, aptamers, and respective receptors for said materials.

17. The method as in claim 1, wherein the analyte of interest is selected from at least one of a bacteria, yeast, fungus, virus, rheumatoid factor, IgG, IgM, IgA, IgD, and IgE antibodies, carcinoembryonic antigen, streptococcus Group A antigen, viral antigens, antigens associated with autoimmune disease, allergens, tumor antigens, streptococcus group B antigen, HIV I or HIV II antigen, antibodies viruses, antigens specific to RSV, an antibody, antigen, enzyme, hormone, polysaccharide, protein, lipid, carbohydrate, drug, nucleic acid, Neisseria meningitides groups A, B, C, Y and W sub 135, Streptococcus pneumoniae, E. coil K1, Haemophllus influenza type A/B, an antigen derived from microorganisms, PSA and CRP antigens, a hapten, a drug of abuse, a therapeutic drug, an environmental agents, or antigens specific to Hepatitis.