Devices for detection of an analyte based upon light interference

• US 5,468,606 A
• Filed: 07/31/1992
• Issued: 11/21/1995
• Est. Priority Date: 09/18/1989
• Status: Expired due to Term

• Current Assignee: Inverness Medical-Biostar, Inc. (Abbott Laboratories)
• Original Assignee: BioStar, Inc. (Thermo Fisher Scientific Incorporated)
• Inventors: Bogart, Gregory R., Etter, Jeffrey B., Moddel, Garret R., Maul, Diana M.
• Primary Examiner(s): Saunders, David
• Assistant Examiner(s): Chin, Christopher L.
• Application Number:
  US07/923,304
• Time in Patent Office: 1,208 Days
• Field of Search: 356/369, 359/580, 359/581, 359/585, 359/586, 359/589, 422/55-58, 422/82.05, 428/429, 428/446, 428/447, 428/448, 428/450, 435/5, 435/6, 435/7.21, 435/7.22, 435/7.23, 435/7.32, 435/7.34, 435/808, 436/164, 436/513, 436/524, 436/525, 436/527, 436/531, 436/805, 436/807
• US Class Current: 435/5
• CPC Class Codes: B82Y 15/00 Nanotechnology for interacting, sensing or actuating, e.g. quantum dots as markers in protein assays or molecular motors
• CPC Class Codes: B82Y 30/00 Nanotechnology for materials or surface science, e.g. nanocomposites
• CPC Class Codes: G01N 21/211 Ellipsometry optical thickness measurement G01B11/06
• CPC Class Codes: G01N 21/45 using interferometric methods; using Schlieren methods
• CPC Class Codes: G01N 21/4738 Diffuse reflection precedence is given to G01N21/55 - G01N21/57 if specular component is taken into consideration, e.g. also for testing fluids, fibrous materials
• CPC Class Codes: G01N 21/77 by observing the effect on a chemical indicator
• CPC Class Codes: G01N 33/54366 Apparatus specially adapted for solid-phase testing
• CPC Class Codes: G01N 33/54373 involving physiochemical end-point determination, e.g. wave-guides, FETS, gratings
• CPC Class Codes: G01N 33/551 the carrier being inorganic
• CPC Class Codes: G01N 33/552 Glass or silica
• CPC Class Codes: Y10S 435/808 Optical sensing apparatus
• CPC Class Codes: Y10S 436/805 Optical property

Abstract

Device for detecting the presence or amount of an analyte of interest, having a substrate possessing an optically active surface which exhibits a first color in response to light impinging thereon, and exhibits a second color comprising a combination of wavelengths of light different from the first color or comprising an intensity of at least one wavelength of light different from the first color, in response to the light when the analyte is present on the surface in any amount selected from 0.1 nM, 0.1 ng/ml, 50 fg, and 2×10³ organisms comprising the analyte.

Claims

1. An optical assay device for detecting the presence or amount of an analyte of interest comprising:

a substrate consisting of one or more layers having an optically active surface exhibiting a first color in response to light impinging thereon, and exhibiting a second color comprising a combination of wavelengths of light different from said first color in response to said light when said analyte is present on said surface,

an anti-reflective film provided on said substrate,

an attachment layer selected from the group consisting of a polymeric silane, polymeric siloxane, and a dendrimer, on said anti-reflective film and,

a specific binding layer for said analyte, attached to said attachment layer.

2. The device of claim 1, wherein said substrate comprises glass;

an aluminum layer of between 1900 and 2100 Å

thickness is provided on said glass;

an amorphous silicon layer having a thickness between 900 and 1100 nm, is provided on said aluminum layer;

said anti-reflective film lies on top of said amorphous silicon layer and has a thickness between 480 and 520 Å

;

said attachment layer is an aminoalkyl-T-structured branched siloxane of between 90 and 110 Å

thickness; and

said specific binding layer is an antibody layer of between 30 and 60 Å

thickness.

3. The device of claim 1, wherein said substrate comprises monocrystalline silicon;

the anti-reflective film is selected from the group consisting of silicon nitride, composites of silicon/silicon dioxide, titanates and titanium dioxide and is is 480-520 Å

thick;

the attachment layer is aminoalkyl-T-structured branched siloxane and is between 90 and 110 Å

thick;

and the specific binding layer is an antibody and is between 30 and 60 Å

thick.

4. The device of claim 1, wherein said substrate is glass;

and further comprises

an amorphous silicon layer between 900 and 1100 nm thick is provided on said glass;

the anti-reflective film lies on top of said amorphous silicon layer and is composed of a material selected from the group consisting of silicon nitride, composites of silicon/silicon dioxide, titanates, and titanium dioxide and is 480-520 Å

thick;

the attachment layer is an aminoalkyl-T-structured branched siloxane and is between 90 and 110 Å

thick;

and the specific binding layer is an antibody and is between 30 and 60 Å

thick.

5. The device of claim 1, wherein said substrate is plastic;

and further comprises

an amorphous silicon layer between 900 and 1100 nm thick is provided on said plastic;

the anti-reflective film lies on top of said amorphous silicon layer and is composed of a material selected from the group consisting of silicon nitride, composites of silicon/silicon dioxide, titanates, and titanium dioxide and is 480-520 Å

thick;

the attachment layer is an aminoalkyl-T-structured branched siloxane and is between 90 and 110 Å

thick;

and the specific binding layer is an antibody and is between 30 and 60 Å

thick.

6. The device of claim 1, wherein said substrate is plastic;

and further comprises

an aluminum layer between 1800 and 2200 Å

thickness is provided on said plastic

an amorphous silicon layer has a thickness between 900 and 1100 nm, and is provided on said aluminum layer;

the anti-reflective film is selected from the group consisting of silicon nitride, composites of silicon/silicon dioxide, titanates, and titanium dioxide and is 480-520 Å

thick and is provided on said amorphous silicon layer;

the attachment layer is aminoalkyl-T-structured branched siloxane and is between 90 and 110 Å

thick;

and the specific binding layer is an antibody and is between 30 and 60 Å

thick.

7. The device of claim 1, wherein said

anti-reflective film is composed of a material selected from the group consisting of silicon nitride, composites of silicon/silicon dioxide, titanates, silicon carbide, diamond, cadmium sulfide, titanium dioxide, and silicon oxynitride.

8. The device of claim 1 for detecting the presence or amount of an analyte of interest,

wherein said anti-reflective film, located below the attachment layer, comprises a material selected from the group consisting of silicon nitride, silicon/silicon dioxide composites, silicon oxynitride, titanium dioxide, titanates, diamond, oxides of zirconium, and silicon carbide.

9. The device of claim 1 for detecting the presence or amount of an analyte of interest,

wherein said substrate is a material selected from the group consisting of monocrystalline silicon, glass, a glass/amorphous silicon composite, a plastic, a plastic/amorphous silicon composite, a metal, a ceramic, polycrystalline silicon, and composites of these materials;

and

wherein said anti-reflective film comprises a material selected from the group consisting of silicon nitride, silicon/silicon dioxide composites, silicon oxynitride, titanium dioxide, titanates, diamond, oxides of zirconium, and silicon carbide.

10. The device of any of claims 8 or 9, wherein said anti-reflective film is coated on said device in a thickness between 480 Å

and 520 Å

.

11. The device of claim 1, wherein said first color is golden in appearance and said second color is purple or blue in appearance to the eye.

12. The device of claim 1, wherein said device is configured and arranged to provide a symbol detectable by eye in response to polychromatic light.

14. The device of claim 1 or 13 for detecting the presence or amount of an analyte of interest, wherein said analyte is present on said surface in an amount selected from the group consisting of 0.1 nM, 0.1 ng/ml, 50 fg, and 2×

10³ organisms comprising said analyte.

15. The device of claim 1 or 13 for detecting the presence or amount of an analyte of interest,

wherein said substrate is a material selected from the group consisting of monocrystalline silicon, a glass/amorphous silicon composite, a plastic/amorphous silicon composite, a ceramic, polycrystalline silicon, and composites of these materials.

16. The device of any of claims 1 or 13, wherein said second color is discernable in less than one hour after contact of said analyte with said device.

17. The device of any of claims 1 or 13, wherein said optically active surface is specular.

18. The device of any of claims 1 or 13, wherein said substrate has a non-specular surface or wherein a transparent layer having a non-specular surface is provided for viewing of said optically active surface.

19. The device of claim 18, wherein said substrate has a non-specular surface.

20. The device of claim 18, wherein said substrate is coated with a non-specular material.

21. The device of claim 18, wherein said substrate is selected from the group consisting of a solid support, a flexible support, a plastic, a glass, a metal and a non-metal,

22. The device of claim 18, wherein said substrate is light reflective or light transmissive.

23. The device of claim 18, wherein said light is monochromatic light, polychromatic light, ultraviolet light, or infrared light.

24. The device of claim 18, wherein said analyte is selected from the group consisting of rheumatoid factor, IgE antibodies specific for Birch pollen, carcinoembryonic antigen, Streptococcus Group A antigen, viral antigens, antigens associated with autoimmune disease, allergens, a tumor or an infectious microorganism, Streptococcus Group B antigen, HIV I or HIV II antigen or host response to said virus, antigens specific to Respiratory Syncytial virus or host response to said virus, and antigens specific to Hepatitis.

25. The device of claim 18, wherein said non-specular surface has a reading of between 2700 and 3295 with a profilometer, wherein said value represents the RMS roughness divided by the average peak of the textures, and whose specular reflectances measured by a HeNe laser light source is less than about 5%.

26. The device of claim 18, wherein said substrate is selected from the group consisting of glass, and plastic, and comprising a layer of amorphous silicon on its surface, whereby an optically active surface is produced.

27. The device of claim 18, wherein said specific binding layer is formed from material selected from the group consisting of antigens, antibodies, oligonucleotides, chelators, enzymes, nucleic acids, polysaccharides, lipids, carbohydrates, metals, and receptors for said materials.

28. The device of claim 18, wherein said first color is golden in appearance and said second color is purple or blue in appearance to the eye.

29. The device of claim 18, wherein said specific binding layer is formed from material selected from the group consisting of bacteria, bacterial pill, bacterial flagellar materials, viruses, hormones and receptors for said materials.

30. The device of any of claims 1 or 13, wherein said light is monochromatic light, polychromatic light, ultraviolet light, or infrared light.

31. The device of any of claims 1 or 13, wherein said analyte is selected from the group consisting of rheumatoid factor, IgE antibodies specific for Birch pollen, carcinoembryonic antigen, Streptococcus Group A antigen, viral antigens, antigens associated with autoimmune disease, allergens, a tumor or an infectious microorganism, Streptococcus Group B antigen, HIV I or HIV II antigen or host response to said virus, antigens specific to Respiratory Syncytial virus or host response to said virus, and antigens specific to Hepatitis.

32. The device of any of claims 1 or 13, wherein said substrate is selected from the group consisting of glass, and plastic, and comprising a layer of amorphous silicon on its surface, whereby an optically active surface is produced.

33. The device of claims 1 or 13, wherein said specific binding layer is formed from material selected form the group consisting of antigens, antibodies, oligonucleotides, chelators, enzymes, nucleic acids, polysaccharides, lipids, carbohydrates, metals, and receptors for said materials.

34. The device of any of claims 1 or 13, wherein said analyte is selected from the group consisting of an antibody, antigen, enzyme, hormone, polysaccharides, proteins, lipids, carbohydrates, drugs and nucleic acid.

35. The device of any of claims 1 or 13, wherein said substrate is selected from the group consisting of monocrystalline silicon, glass, fused silica, plastics, metals and semiconductor materials, and may be rigid or flexible.

36. The device of claim 1 or 13 wherein said analyte is selected from the group consisting of an antigen derived from a bacterium, an antigen derived form a virus, a microorganism, a hapten, a drug of abuse, a therapeutic drug, dioxane, PCB'"'"'s, heavy metals, total petroleum hydrocarbons, chlorinated hydrocarbons, petroleum byproducts, pentachlorophenol, PNA'"'"'s, an antibody, an enzyme, and a nucleic acid.

37. The device of any of claims 1 or 13, wherein said analyte of interest is sandwiched between said specific binding layer and a secondary binding reagent.

38. The device of any of claims 1 or 13, wherein the analyte of interest is the Streptococcus group A or B antigen.

39. The device of any of claims 1 or 13, wherein said analyte of interest is or is derived from the causative organisms for meningitis;

Neisseria meningitidis groups A, B, C, Y and W₁₃₅, Streptococcus pneumoniae, E. coli K1, Streptococcus group B, and Haemophilus influenzae type B.

40. The device of any of claims 1 or 13, wherein said substrate comprises:

a layer of base material positioned adjacent to and beneath a conducting metal layer comprising aluminum, chromium, or a transparent conducting oxide, and

a layer of amorphous silicon,

wherein said metal layer is positioned adjacent to and below said amorphous silicon.

41. The device of claim 40, wherein said base material is selected from any of the group consisting of glass, fused silica, plastics, semiconductors, ceramics, and metals, and may be either rigid or flexible.

42. The device of any of claims 1 or 13, for use in an optical assay for an analyte, wherein said substrate comprises a layer of base material, and a layer of amorphous silicon adjacent and positioned above said base material.

43. The device of claim 42, wherein said base material is selected from any of the group consisting of glass, fused silica, plastics, semiconductors, ceramics, and metals, and may be either rigid or flexible.

44. The device of claim 1 or 13, wherein the impinging light is reflected by said device and said reflected light is elliptically or linearly polarized, monochromatic, polychromatic, unpolarized, visible, UV, or IR, or any combination thereof.

46. The device of claim 1 or 13, wherein the transmitted light is elliptically or linearly polarized, monochromatic, polychromatic, unpolarized, visible, UV, IR, or any combination thereof.

47. The devices of any of claims 1 or 13, wherein said specific binding layer is formed from material selected from the group consisting of bacteria, bacterial pili, bacterial flagellar materials, viruses, hormones and receptors for said materials.

13. An optical assay device for detecting the presence or amount of an analyte of interest comprising:

a substrate consisting of one or more layers having an optically active surface exhibiting a first color in response to light impinging thereon, and exhibiting a second color comprising an intensity of at least one wavelength of light different from said first color, in response to said light when said analyte is present on said surface;

an attachment layer selected from the group consisting of a polymeric silane, polymeric siloxane, and a dendrimer, on said substrate and;

a specific binding layer for said analyte, attached to said attachment layer.

45. The device of claim 13, wherein said change is in the intensity of light transmitted through said surface.