Devices and methods for detection of an analyte based upon light interference

• US 5,482,830 A
• Filed: 06/10/1993
• Issued: 01/09/1996
• Est. Priority Date: 02/25/1986
• Status: Expired due to Term

• Current Assignee: Thermo 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:
  US08/076,320
• Time in Patent Office: 943 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, 435/7.36, 436/164, 436/513, 436/524, 436/525, 436/527, 436/531, 436/805, 436/518, 436/510
• 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 33/526 the element being adapted for a specific analyte
• 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 33/54386 Analytical elements
• 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 of 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 an analyte 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 an attachment layer,

said attachment layer selected from the group consisting of a polymeric silane, polymeric siloxane, a dendrimer, and film forming latexes, provided on an uppermost surface of said substrate and,

a layer of non-specific protein, provided on said attachment layer, present in an amount that allows said analyte to bind to said attachment layer and which improves signal generation when a specific secondary reagent binds to said analyte present on the attachment layer of the device.

2. The device of claim 1, wherein the specific secondary reagent comprises an enzyme linked to an analyte specific reagent and further comprising an enzyme substrate which produces a precipitate and the improvement in signal generation comprises increased adhesion of precipitate to said attachment layer.

3. An assay device for an analyte 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 an attachment layer,

said attachment layer, on an uppermost surface of said substrate, selected from the group consisting of a polymeric silane, polymeric siloxane, a dendrimer, and film forming latexes which promotes binding of the analyte to said attachment layer by hydrophobic interactions, and

a layer of non-specific protein provided on said attachment layer, said non-specific protein present in an amount that allows said analyte to bind to said attachment layer.

4. The device of claim 3, wherein analyte binding is detected by a fluorescent or chemiluminescent label attached to a specific binding reagent.

19. The device of claim 3, wherein said analyte is detected by an ELISA.

5. Device for the determination of Chlamydia or gram negative bacterial antigen 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 said wavelength of light different from said first color, in response to said light when said antigen is present on an attachment layer,

said attachment layer, on an uppermost surface of said substrate, selected from the group consisting of dendrimers, polymeric silanes, polymeric siloxanes, and film forming latexes which promote binding of the antigen to said attachment layer by hydrophobic interaction, and

a layer of non-specific protein provided on said attachment layer, said non-specific protein present in an amount that allows said antigen to bind to said attachment layer.

6. The device of claim 5, wherein binding of said antigen is detected by an ELISA.

7. The device of claim 5, wherein binding of said antigen is detected by a fluorescent or chemiluminescent label attached to a specific binding reagent.

10. The device of claim 5 or 9, wherein the antigen is lipopolysaccharide.

11. The device of claim 5 or 9, wherein the antigen is a major outer membrane protein.

8. An assay device for an analyte 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 an attachment layer,

an anti-reflective film provided on an uppermost surface of said substrate,

said attachment layer, provided on said anti-reflective film, selected from the group consisting of a polymeric silane, polymeric siloxane, a dendrimer, and film forming latexes which promotes binding of the analyte to said attachment layer by hydrophobic interactions, and

a layer of non-specific protein provided on said attachment layer, said non-specific protein present in an amount that allows said analyte to bind to said attachment layer.

12. The device of claim 8 or 9 for detecting the presence or amount of an analyte of interest, wherein said 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.

9. Device for the determination of Chlamydia or gram negative bacterial antigen 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 antigen is present on an attachment layer,

an anti-reflective film provided on an uppermost surface of said substrate,

said attachment layer, provided on said anti-reflective film, selected from the group consisting of dendrimers, polymeric silanes, polymeric siloxanes, and film forming latexes which promote binding of the antigen to said attachment layer by hydrophobic interaction, and

a layer of non-specific protein provided on said attachment layer, said non-specific protein present in an amount that allows said antigen to bind to said attachment layer.

13. An optical assay device for an analyte 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 an attachment layer,

an anti-reflective film, provided on an uppermost surface of said substrate,

said attachment layer, provided on said anti-reflective film, selected from the group consisting of a polymeric silane, polymeric siloxane, a dendrimer, and film forming latexes on said substrate, wherein the analyte of interest is captured by a non-specific interaction with said attachment layer and said analyte is detected by the binding of a specific secondary reagent to said analyte.

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

17. The device of claim 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, 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.

18. An optical assay device for an analyte 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 an attachment layer,

an attachment layer, provided on said substrate, selected from the group consisting of a polymeric silane, polymeric siloxane, a dendrimer, and film forming latexes on said substrate, wherein the analyte of interest is captured by a non-specific interaction with said attachment layer and said analyte is detected by the binding of a specific secondary reagent to said analyte.

20. The device of claim 18 for detecting the presence or amount of an analyte of interest wherein said analyte is present on said attachment layer 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.

21. The device of claim 18 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.

22. An optical assay device for an analyte 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 an attachment layer,

an anti-reflective film provided on an uppermost surface of said substrate,

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

a layer of non-specific protein, provided on said attachment layer, present in an amount that allows said analyte to bind to said attachment layer and which improves the signal generation when a specific secondary reagent binds to said analyte present on the surface of the device.

23. The device of claim 22, wherein the specific secondary reagent comprises an enzyme linked to an analyte specific reagent and further comprising an enzyme substrate which produce a precipitate and the improvement in signal generation comprises increased adhesion of the precipitate to said attachment layer.

24. The device of claim 22 for detecting the presence or amount of an analyte of interest, 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.