Diagnostic test strip

• US 5,296,192 A
• Filed: 04/03/1992
• Issued: 03/22/1994
• Est. Priority Date: 04/03/1992
• Status: Expired due to Term

• Current Assignee: Trividia Health, Inc. (Sinocare, Inc.)
• Original Assignee: Home Diagnostics Incorporated
• Inventors: Carroll, Patrick J., Wiscovitch, Robin A.
• Primary Examiner(s): ALEXANDER, LYLE
• Application Number:
  US07/862,733
• Time in Patent Office: 718 Days
• Field of Search: 422/56-58, 436/63, 436/164, 436/805, 436/14
• US Class Current: 422/408
• CPC Class Codes: G01N 33/525 Multi-layer analytical elements
• CPC Class Codes: Y10S 436/805 Optical property

Abstract

Disclosed is a multi-layered test strip device for receiving whole blood on which a test for a suspected analyte is performed. The test confirms the presence, absence, or the amount of analyte, if present. The multi-layered device comprises two outside support layers between which are, in descending order relative to the horizontal plane, a) a spreading screen having defined characteristics, b) a separating layer which removes red blood cells at least partially via a red blood cell binding agent, and c) a membrane reagent layer; wherein the screen and each layer is in close and contiguous contact with the layer which follows it, and wherein at least one of layers a), b), and c) is conditioned by a pre-treatment.

The screen can have openings of from 10-200 microns. The blood cell binding agents are antibodies to red blood cells, chemical agents, or lectins. The separating layer has screen opening of preferably 20-200 microns.

Claims

1. A test strip device for measuring an analyte in a liquid sample consisting essentially of relative to a horizontal plane,

a) a top support layer which provides support to the test strip device, such layer having a sample receiving port therein,

b) a spreading screen physically attached to said top layer and located directly below said sample receiving port whereby sample applied at said port encounters said screen, wherein said screen has mesh openings sufficient in size

i) to act as a retaining screen for said sample until substantially all of such screen in said port has been contacted with said sample, and

ii) to allow the sample to proceed vertically through the screen in a uniform flow,

c) a screen mesh separating layer adjacent to and in contact spreading screen in vertical alignment with said sample port, said layer having fixed thereon an agent capable of capturing red blood cells,

d) a reaction membrane having a surface which is in direct physical contact with said separation layer, said reaction membrane

i) being capable of excluding red blood cells from a liquid sample containing the same, and

ii) having reactants and an indicator system incorporated within its matrix capable of reacting with the analyte of interest in the sample and causing a color change at the reaction membrane which is a measure of the presence or amount of analyte in the sample, and

e) a bottom support layer in physical contact with said reaction membrane and which provides support to the test strip device, said layer having a reaction viewing opening in vertical alignment with the sample receiving port.

2. The test strip of claim 1 wherein the screen mesh openings are from 50-200 microns.

3. The test strip of claim 2 wherein the mesh openings of the separating layer are smaller than the mesh openings of the spreading screen.

4. The test strip of claim 1 wherein the mesh openings of the separating layer are between 10-200 microns.

5. The test strip of claim 4 wherein the mesh openings of the separating layer are between 50-100 microns.

6. The test strip of claim 5 wherein the red blood cell binding agents on the separating layer are lectins.

7. The test strip device of claim 1 wherein the spreading screen is a single layer, the separating layer is a single layer, and the reaction membrane is a single layer.

8. The test strip device of claim 1 wherein the reactants and the indicator system incorporated into the membrane are specific for the determination of glucose in blood plasma.