Patent US5470752A successfully refreshed from Google Patents.
US5470752A
Expired / Lapsed
US
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Multi-layer devices and methods of assaying for fructosamine
Assignee: Diabetes Diagnostics Inc
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Filing: 1994-06-29
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Granted: 1995-11-28
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Expires: 2014-06-29
Abstract
Abstract The present invention is directed to a multi-layer test device and method for analyzing the concentration of fructosamine in a liquid sample. The multi-layer test device has a buffer layer containing a buffer having a pH value of at least 9 which is either superposed above or juxtaposed to an indicator layer containing an indicator capable of being reduced by fructosamine. Supporting the buffer layer, the indicator layer, and any additional layers in the multi-layer device is at least one support member which optionally has a detection aperture for analyzing the concentration of fructosamine on the indicator layer. An additional support member having a sample aperture can be used. Where two support members are used the multi-layers are sandwiched between the first support member having a sample aperture and the second support member optionally having a detection aperture.
Inventors
- 👤 John F. Burd
- 👤 Talei Hoblitzell
- 👤 Gebhard Neyer
Bibliographic Details
Application Number
—
Jurisdiction
US
Data Source
google_patents
Last Synchronized
2026-10-31 08:45
CPC Classifications
G; G01; G01N; G01N33/00; G01N33/48; G01N33/50; G01N33/52; G01N33/525; G01N33/526; Y; Y10; Y10S; Y10S435/00; Y10S435/805; Y10S436/00; Y10S436/825; Y10T; Y10T436/00; Y10T436/25; Y10T436/25375; Y10T436/255
Claims Analysis
Total Claims: 30
Claim 1
Independent Claim
63 words
A multi-layer test device for analyzing the concentration of fructosamine in a liquid sample, comprising: a non-opaque, liquid permeable buffer layer containing a buffer having a pH value of at least 9; an indicator layer containing an indicator capable of being reduced by fructosamine; and a support member optionally having a detection aperture; wherein the buffer layer is superposed above the indicator layer.
Claim 2
Dependent Claim
63 words
A multi-layer test device for analyzing the concentration of fructosamine in a liquid sample, comprising: a non-opaque, liquid permeable buffer layer containing a buffer having a pH value of at least 9; an indicator layer containing an indicator capable of being reduced by fructosamine; and a support member optionally having a detection aperture; wherein the buffer layer is superposed above the indicator layer.
Claim 3
Dependent Claim
32 words
The multi-layer test device of claim 1 further comprising an additional support member having a sample aperture and wherein the buffer layer and the indicator layer are sandwiched between the support members.
Claim 4
Dependent Claim
17 words
The multi-layer test device according to claim 2 wherein the support members are substantially planar support members.
Claim 5
Dependent Claim
15 words
The multi-layer test device according to claim 1 further comprising one or more additional layers.
Claim 6
Dependent Claim
44 words
The multi-layer test device according to claim 4 wherein the additional layers are selected from the group consisting of a separation layer, a radiation blocking layer, an interference removal layer, a contamination prevention layer, a dialysis layer, a filtering layer, and a support layer.
Claim 7
Dependent Claim
22 words
The multi-layer test device according to claim 1 wherein the buffer has a pH value of between about 10 to about 12.
Claim 8
Dependent Claim
25 words
The multi-layer test device according to claim 1 wherein the indicator is selected from a group consisting of a chromogenic dye and a fluorescent reagent.
Claim 9
Dependent Claim
15 words
The multi-layer test device according to claim 7 wherein the indicator is a tetrazolium dye.
Claim 10
Dependent Claim
60 words
A multi-layer test device for analyzing the concentration of fructosamine in a liquid sample, comprising: a buffer layer containing a buffer having a pH value of at least 9; an indicator layer containing an indicator capable of being reduced by fructosamine; and a support member optionally having a detection aperture; wherein the buffer layer and the indicator layer are juxtaposed.
Claim 11
Dependent Claim
60 words
A multi-layer test device for analyzing the concentration of fructosamine in a liquid sample, comprising: a buffer layer containing a buffer having a pH value of at least 9; an indicator layer containing an indicator capable of being reduced by fructosamine; and a support member optionally having a detection aperture; wherein the buffer layer and the indicator layer are juxtaposed.
Claim 12
Dependent Claim
32 words
The multi-layer test device of claim 9 further comprising an additional support member having a sample aperture and wherein the buffer layer and the indicator layer are sandwiched between the support members.
Claim 13
Dependent Claim
16 words
The multi-layer test device according claim 10 wherein the support members are substantially planar support members.
Claim 14
Dependent Claim
15 words
The multi-layer test device according to claim 9 further comprising one or more additional layers.
Claim 15
Dependent Claim
44 words
The multi-layer test device according to claim 12 wherein the additional layers are selected from the group consisting of a separation layer, a radiation blocking layer, an interference removal layer, a contamination prevention layer, a dialysis layer, a filtering layer, and a support layer.
Claim 16
Dependent Claim
22 words
The multi-layer test device according to claim 9 wherein the buffer has a pH value of between about 10 to about 12.
Claim 17
Dependent Claim
25 words
The multi-layer test device according to claim 9 wherein the indicator is selected from a group consisting of a chromogenic dye and a fluorescent reagent.
Claim 18
Dependent Claim
15 words
The multi-layer test device according to claim 15 wherein the indicator is a tetrazolium dye.
Claim 19
Dependent Claim
97 words
A multi-layer test device for analyzing the concentration of fructosamine in a liquid sample, comprising: a plastic first substantially planar support member having a sample aperture; a plastic second substantially planar support member having a detection aperture; a non-opaque, liquid permeable buffer layer containing a buffer having a pH value of between about 10 and about 12; and an indicator layer containing a nitroblue tetrazolium chloride dye, wherein the buffer layer is superposed above the indicator layer and wherein the buffer layer and indicator layer are sandwiched between the first support member and the second support member.
Claim 20
Dependent Claim
97 words
A multi-layer test device for analyzing the concentration of fructosamine in a liquid sample, comprising: a plastic first substantially planar support member having a sample aperture; a plastic second substantially planar support member having a detection aperture; a non-opaque, liquid permeable buffer layer containing a buffer having a pH value of between about 10 and about 12; and an indicator layer containing a nitroblue tetrazolium chloride dye, wherein the buffer layer is superposed above the indicator layer and wherein the buffer layer and indicator layer are sandwiched between the first support member and the second support member.
Claim 21
Independent Claim
95 words
A method for analyzing the concentration of fructosamine in a liquid sample, comprising the steps of: (a) providing a test device having a non-opaque, liquid permeable buffer layer containing a buffer having a pH value of at least 9, an indicator layer containing an indicator capable of being reduced by fructosamine, and a support member optionally having a detection aperture, wherein the buffer layer is superposed above the indicator layer; (b) applying a liquid sample to the test device; and (c) analyzing the indicator layer for the concentration of fructosamine present in the liquid sample.
Claim 22
Independent Claim
95 words
A method for analyzing the concentration of fructosamine in a liquid sample, comprising the steps of: (a) providing a test device having a non-opaque, liquid permeable buffer layer containing a buffer having a pH value of at least 9, an indicator layer containing an indicator capable of being reduced by fructosamine, and a support member optionally having a detection aperture, wherein the buffer layer is superposed above the indicator layer; (b) applying a liquid sample to the test device; and (c) analyzing the indicator layer for the concentration of fructosamine present in the liquid sample.
Claim 23
Dependent Claim
37 words
The method of claim 18 wherein the test device of step (a) further comprises an additional support member having a sample aperture and wherein the buffer layer and the indicator layer are sandwiched between the support members.
Claim 24
Dependent Claim
31 words
The method according to claim 18 wherein the concentration of fructosamine is analyzed on the indicator layer by visually or instrumentally determining the intensity or degree of color change or fluorescence.
Claim 25
Dependent Claim
17 words
The method of claim 18 wherein the analysis of step (c) is carried out at ambient temperature.
Claim 26
Independent Claim
92 words
A method for analyzing the concentration of fructosamine in a liquid sample, comprising the steps of: (a) providing a test device having a buffer layer containing a buffer having a pH value of at least 9, an indicator layer containing an indicator capable of being reduced by fructosamine, and a support member optionally having a detection aperture, wherein the buffer layer and the indicator layer are juxtaposed; (b) applying a liquid sample to the test device; and (c) analyzing the indicator layer for the concentration of fructosamine present in the liquid sample.
Claim 27
Independent Claim
92 words
A method for analyzing the concentration of fructosamine in a liquid sample, comprising the steps of: (a) providing a test device having a buffer layer containing a buffer having a pH value of at least 9, an indicator layer containing an indicator capable of being reduced by fructosamine, and a support member optionally having a detection aperture, wherein the buffer layer and the indicator layer are juxtaposed; (b) applying a liquid sample to the test device; and (c) analyzing the indicator layer for the concentration of fructosamine present in the liquid sample.
Claim 28
Dependent Claim
37 words
The method of claim 22 wherein the test device of step (a) further comprises an additional support member having a sample aperture and wherein the buffer layer and the indicator layer are sandwiched between the support members.
Claim 29
Dependent Claim
31 words
The method according to claim 22 wherein the concentration of fructosamine is analyzed on the indicator layer by visually or instrumentally determining the intensity or degree of color change or fluorescence.
Claim 30
Dependent Claim
17 words
The method of claim 22 wherein the analysis of step (c) is carried out at ambient temperature.
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| Annuity Stage | Window Opens | Payment Deadline | Surcharge Period Until | Estimated Fee | Status |
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| 3.5 Years (Year 4) | 1998-11-27 | 1999-05-29 | 1999-11-28 | $2000.00 | Window Closed / Lapsed |
| 7.5 Years (Year 8) | 2002-11-27 | 2003-05-29 | 2003-11-28 | $3760.00 | Window Closed / Lapsed |
| 11.5 Years (Year 12) | 2006-11-27 | 2007-05-29 | 2007-11-28 | $7700.00 | Window Closed / Lapsed |