Multi-layer devices and methods of assaying for fructosamine
First Claim
1. 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.
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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.
42 Citations
25 Claims
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1. A multi-layer test device for analyzing the concentration of fructosamine in a liquid sample, comprising:
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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. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8)
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9. A multi-layer test device for analyzing the concentration of fructosamine in a liquid sample, comprising:
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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. - View Dependent Claims (10, 11, 12, 13, 14, 15, 16)
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17. A multi-layer test device for analyzing the concentration of fructosamine in a liquid sample, comprising:
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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.
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18. A method for analyzing the concentration of fructosamine in a liquid sample, comprising the steps of:
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(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. - View Dependent Claims (19, 20, 21)
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22. A method for analyzing the concentration of fructosamine in a liquid sample, comprising the steps of:
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(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. - View Dependent Claims (23, 24, 25)
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Specification