US5482830A — Devices and methods for detection of an analyte b…

Claim 1

Independent Claim 140 words

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.

Claim 2

Dependent Claim 140 words

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.

Claim 3

Dependent Claim 44 words

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.

Claim 4

Dependent Claim 132 words

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.

Claim 5

Dependent Claim 132 words

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.

Claim 6

Dependent Claim 22 words

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

Claim 7

Dependent Claim 136 words

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.

Claim 8

Dependent Claim 136 words

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.

Claim 9

Dependent Claim 15 words

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

Claim 10

Dependent Claim 24 words

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

Claim 11

Dependent Claim 138 words

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.

Claim 12

Dependent Claim 138 words

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.

Claim 13

Dependent Claim 141 words

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.

Claim 14

Dependent Claim 141 words

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.

Claim 15

Dependent Claim 12 words

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

Claim 16

Dependent Claim 16 words

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

Claim 17

Dependent Claim 49 words

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.

Claim 18

Dependent Claim 132 words

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.

Claim 19

Dependent Claim 132 words

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.

Claim 20

Dependent Claim 46 words

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 2×10 3 organisms comprising said analyte.

Claim 21

Dependent Claim 47 words

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.

Claim 22

Dependent Claim 46 words

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.

Claim 23

Dependent Claim 83 words

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.

Claim 24

Dependent Claim 123 words

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.

Claim 25

Dependent Claim 123 words

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.

Claim 26

Dependent Claim 13 words

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

Claim 27

Dependent Claim 47 words

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 2×10 3 organisms comprising said analyte.

Claim 28

Dependent Claim 47 words

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.

Claim 29

Dependent Claim 145 words

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.

Claim 30

Dependent Claim 145 words

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.

Claim 31

Dependent Claim 45 words

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.

Claim 32

Dependent Claim 46 words

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.

Annuity Stage	Window Opens	Payment Deadline	Surcharge Period Until	Estimated Fee	Status
3.5 Years (Year 4)	1999-01-08	1999-07-10	2000-01-09	$2000.00	Window Closed / Lapsed
7.5 Years (Year 8)	2003-01-08	2003-07-10	2004-01-09	$3760.00	Window Closed / Lapsed
11.5 Years (Year 12)	2007-01-08	2007-07-10	2008-01-09	$7700.00	Window Closed / Lapsed

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

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