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EP0345781B1 Expired / Lapsed EP ⏱️ 0.0 years remaining

Defined volume test device

Assignee: Roche Diagnostics Corp
•
Filing: 1989-06-08
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Granted: 1995-08-30
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Expires: 2009-06-08
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Abstract

Abstract This invention concerns the use of an asymmetrically porous membrane having progressively smaller pores from the upper surface to the lower surface as a reagent matrix layer in a test device for determining the amount of an analyte in such a way that a sample is applied to the large pore surface as well as a corresponding method for determining the amount of an analyte in a liquid sample.

Inventors

  • 👤 George M. Daffern
  • 👤 Tracy N. Thompson

Bibliographic Details

Application Number —
Jurisdiction EP
Data Source google_patents
Last Synchronized 2026-10-23 16:26
CPC Classifications
C; C12; C12Q; C12Q1/00; C12Q1/54; G; G01; G01N; G01N33/00; G01N33/48; G01N33/50; G01N33/52; G01N33/525

Claims Analysis

Total Claims: 12
Claim 1
Independent Claim 204 words
A device for determining the concentration of an analyte in a liquid sample comprising: (a) a reagent matrix layer having an upper and a lower surface and a defined saturation volume, the reagent matrix layer containing reagent means for producing an amount of a detectable species correlating with the concentration of the analyte in the reagent matrix layer; (b) an absorbent layer for absorbing excess sample liquid, the absorbent layer having an upper and a lower surface and comprising means for absorbing liquid standing on the reagent matrix layer and being in contact with the absorbent layer sufficiently slowly to permit saturation of the reagent matrix layer; and (c) a waterproof barrier layer for preventing contact of liquid in the absorbent layer with liquid in the reagent matrix layer, the barrier layer having an upper and a lower surface, the upper surface of the barrier layer contacting the lower surface of the absorbent layer, the lower surface of the barrier layer contacting the upper surface of the reagent matrix layer; wherein the absorbent layer and barrier layer include an aperture which extends through the absorbent layer and the barrier layer for application of the sample onto the upper surface of the reagent matrix layer.
Claim 2
Dependent Claim 13 words
The device of claim 1 wherein the absorbent layer comprises a hydrophilic paper.
Claim 3
Dependent Claim 13 words
The device of claim 1 wherein the barrier layer comprises a polymer film.
Claim 4
Dependent Claim 17 words
The device of claim 3 wherein the polymer film has adhesive on its upper and lower surfaces.
Claim 5
Dependent Claim 25 words
The device of any one of claim 1 to 4 further comprising a support layer which contacts the lower surface of the reagent matrix layer.
Claim 6
Dependent Claim 12 words
The device of claim 5 wherein the support layer includes an aperture.
Claim 7
Independent Claim 42 words
The device of any one of claims 1 to 6 wherein the reagent matrix layer comprises an asymmetrically porous membrane having progressively smaller pores from the upper surface of the reagent matrix layer to the lower surface of the reagent matrix layer.
Claim 8
Independent Claim 16 words
The device of any of claims 1 to 7 wherein the detectable species is a dye.
Claim 9
Dependent Claim 21 words
The device of claim 8 wherein the dye is the oxidation product of dye precursors 3,5-dimethylaminobenzoic acid and 3-methyl-2-benzothiazolinone hydrazone hydrochloride.
Claim 10
Independent Claim 39 words
The device of any one of claims 1 to 9 wherein the reagent matrix layer contains reagent means for producing an amount of a detectable species correlating with the concentration of an analyte selected from glucose, cholesterol and alcohol.
Claim 11
Independent Claim 28 words
The device of any one of claims 1 to 10 wherein the upper surface of the reagent matrix layer is larger than the aperture in the barrier layer.
Claim 12
Independent Claim 31 words
The device of any one of claims 1 to 11 wherein the lower surface of the absorbent layer extends beyond an edge of the upper surface of the reagent matrix layer.

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