US5968765A
Expired / Lapsed
US
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Opaque reaction matrix for the analysis of the whole blood
Assignee: Roche Diabetes Care Inc
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Filing: 1997-10-31
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Granted: 1999-10-19
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Expires: 2017-10-31
Abstract
Abstract A test strip for use in determining the presence or concentration of an analyte in whole blood is disclosed. The test strip is a porous membrane having disposed thereon (a) a separating agent capable of separating from whole blood, red blood cells and a fluid component substantially free of red blood cells; (b) an indicating reagent system capable of indicating the presence or concentration of an analyte in the fluid component by producing a spectrophotometric change upon contact with the fluid component; and (c) an opaque filler capable of reducing spectrophotometric interference caused by the presence of the red blood cells. Also disclosed are methods of testing whole blood for the presence or concentration of an analyte using the test strip.
Inventors
- 👤 Henry M. Grage
- 👤 Joel S. Douglas
- 👤 Pat S. Lee
Bibliographic Details
Application Number
—
Jurisdiction
US
Data Source
google_patents
Last Synchronized
2026-11-05 13:36
CPC Classifications
G; G01; G01N; G01N33/00; G01N33/48; G01N33/50; G01N33/52; B; B01; B01D; B01D69/00; B01D69/14; B01D69/141; C; C12; C12Q; C12Q1/00; C12Q1/26; C12Q1/54; G01N33/5002; G01N33/521; Y; Y10; Y10S; Y10S435/00; Y10S435/968; Y10S435/97
Claims Analysis
Total Claims: 34
Claim 1
Independent Claim
113 words
A test strip for use in determining the presence or concentration of an analyte in whole blood, said test strip comprising a porous membrane having disposed thereon (a) a separating agent capable of separating from whole blood, red blood cells and a fluid component substantially free of red blood cells; (b) an indicating reagent system capable of indicating the presence or concentration of an analyte in the fluid component by producing a spectrophotometric change upon contact with the fluid component, said indicating reagent system comprising 3-methyl-6-(M sulfonate)-benzothiazolinone-(2)-hydrazone, where M is sodium, potassium or ammonium; and (c) an opaque filler capable of reducing spectrophotometric interference caused by the presence of the red blood cells.
Claim 2
Dependent Claim
113 words
A test strip for use in determining the presence or concentration of an analyte in whole blood, said test strip comprising a porous membrane having disposed thereon (a) a separating agent capable of separating from whole blood, red blood cells and a fluid component substantially free of red blood cells; (b) an indicating reagent system capable of indicating the presence or concentration of an analyte in the fluid component by producing a spectrophotometric change upon contact with the fluid component, said indicating reagent system comprising 3-methyl-6-(M sulfonate)-benzothiazolinone-(2)-hydrazone, where M is sodium, potassium or ammonium; and (c) an opaque filler capable of reducing spectrophotometric interference caused by the presence of the red blood cells.
Claim 3
Dependent Claim
27 words
The test strip of claim 1 wherein the porous membrane is selected from the group consisting of a polyethersulfone membrane, a polysulfone membrane and a nylon membrane.
Claim 4
Dependent Claim
14 words
The test strip of claim 1 wherein the porous membrane is a polyethersulfone membrane.
Claim 5
Dependent Claim
32 words
The test strip of claim 2 wherein the membrane is from about 0.002 to about 0.20 inches in thickness and has a mean pore size of about 0.1 to about 1 micron.
Claim 6
Dependent Claim
28 words
The test strip of claim 4 wherein the membrane is cast with a skin structure on one side and is isotropic through the remaining thickness of the membrane.
Claim 7
Dependent Claim
47 words
The test strip of claim 1 wherein the separating agent is selected from the group consisting of polyvinyl sulfonic acid, polyethylene glycol, polystyrene sulfonic acid, hydroxypropyl cellulose, polyvinyl alcohol, polyvinylpyrrolidone, polyacrylic acid, citrates, formates, sulfates, amino acids, chitosan, citric acid, phytic acid, malic acid and mixtures thereof.
Claim 8
Dependent Claim
16 words
The test strip of claim 6 wherein the separating agent is distributed homogeneously within the membrane.
Claim 9
Dependent Claim
18 words
The test strip of claim 6 wherein the separating agent is coated on the surface of the membrane.
Claim 10
Dependent Claim
17 words
The test strip of claim 6 wherein the separating agent forms an interior layer within the membrane.
Claim 11
Dependent Claim
31 words
The test strip of claim 1 wherein the opaque finer is selected from the group consisting of titanium dioxide, lime stone dust, plastic beads, talcum powder, calcium powder and mixtures thereof.
Claim 12
Dependent Claim
13 words
The test strip of claim 10 wherein the opaque filer is titanium dioxide.
Claim 13
Dependent Claim
16 words
The test strip of claim 10 wherein the opaque filler is distributed homogeneously within the membrane.
Claim 14
Dependent Claim
18 words
The test strip of claim 10 wherein the opaque filler is coated on the surface of the membrane.
Claim 15
Dependent Claim
17 words
The test strip of claim 10 wherein the opaque filler forms an interior layer within the membrane.
Claim 16
Dependent Claim
15 words
The test strip of claim 1 wherein the indicating reagent system comprises a glucose oxidase.
Claim 17
Independent Claim
156 words
A method of testing whole blood for the presence or concentration of an analyte comprising: (a) providing a test strip comprising a porous membrane having disposed thereon (i) a separating agent capable of separating from whole blood, red blood cells and a fluid component substantially free of red blood cells; (ii) an indicating reagent system capable of indicating the presence or concentration of an analyte in the fluid component by producing a spectrophotometric change upon contact with the fluid component, said indicating reagent system comprising 3-methyl-6-(M sulfonate)-benzothiazolinone-(2)-hydrazone, where M is sodium, potassium or ammonium; and (iii) an opaque filler capable of reducing spectrophotometric interference caused by the presence of the red blood cells; (b) applying a whole blood sample to a first side of the test strip; and (c) reading or measuring on a second side of the test strip a spectrophotometric change in the fluid component to determine the presence or concentration of the analyte.
Claim 18
Independent Claim
156 words
A method of testing whole blood for the presence or concentration of an analyte comprising: (a) providing a test strip comprising a porous membrane having disposed thereon (i) a separating agent capable of separating from whole blood, red blood cells and a fluid component substantially free of red blood cells; (ii) an indicating reagent system capable of indicating the presence or concentration of an analyte in the fluid component by producing a spectrophotometric change upon contact with the fluid component, said indicating reagent system comprising 3-methyl-6-(M sulfonate)-benzothiazolinone-(2)-hydrazone, where M is sodium, potassium or ammonium; and (iii) an opaque filler capable of reducing spectrophotometric interference caused by the presence of the red blood cells; (b) applying a whole blood sample to a first side of the test strip; and (c) reading or measuring on a second side of the test strip a spectrophotometric change in the fluid component to determine the presence or concentration of the analyte.
Claim 19
Dependent Claim
15 words
The method of claim 1 wherein the reading or measurement is provided by an instrument.
Claim 20
Dependent Claim
13 words
The method of claim 1 wherein the reading or measurement is provided visually.
Claim 21
Dependent Claim
26 words
The method of claim 1 wherein the porous membrane is selected from the group consisting of a polyethersulfone membrane, a polysulfone membrane and a nylon membrane.
Claim 22
Dependent Claim
13 words
The method of claim 19 wherein the porous membrane is a polyethersulfone membrane.
Claim 23
Dependent Claim
31 words
The method of claim 19 wherein the membrane is from about 0.002 to about 0.20 inches in thickness and has a mean pore size of about 0.1 to about 1 micron.
Claim 24
Dependent Claim
27 words
The method of claim 21 wherein the membrane is cast with a skin structure on one side and is isotropic through the remaining thickness of the membrane.
Claim 25
Dependent Claim
46 words
The method of claim 16 wherein the separating agent is selected from the group consisting of polyvinyl sulfonic acid, polyethylene glycol, polystyrene sulfonic acid, hydroxypropyl cellulose, polyvinyl alcohol, polyvinylpyrrolidone, polyacrylic acid, citrates, formates, sulfates, amino acids, chitosan, citric acid, phytic acid, malic acid and mixtures thereof.
Claim 26
Dependent Claim
15 words
The method of claim 23 wherein the separating agent is distributed homogeneously within the membrane.
Claim 27
Dependent Claim
17 words
The method of claim 23 wherein the separating agent is coated on the surface of the membrane.
Claim 28
Dependent Claim
16 words
The method of claim 23 wherein the separating agent forms an interior layer within the membrane.
Claim 29
Dependent Claim
30 words
The method of claim 16 wherein the opaque filler is selected from the group consisting of titanium dioxide, lime stone dust, plastic beads, talcum powder, calcium powder and mixtures thereof.
Claim 30
Dependent Claim
12 words
The method of claim 27 wherein the opaque filler is titanium dioxide.
Claim 31
Dependent Claim
15 words
The method of claim 27 wherein the opaque filler is distributed homogeneously within the membrane.
Claim 32
Dependent Claim
17 words
The method of claim 27 wherein the opaque filler is coated on the surface of the membrane.
Claim 33
Dependent Claim
16 words
The method of claim 27 wherein the opaque filler forms an interior layer within the membrane.
Claim 34
Dependent Claim
14 words
The method of claim 16 wherein the indicating reagent system comprises a glucose oxidase.
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USPTO Annuity & Maintenance Windows
| Annuity Stage | Window Opens | Payment Deadline | Surcharge Period Until | Estimated Fee | Status |
|---|---|---|---|---|---|
| 3.5 Years (Year 4) | 2002-10-18 | 2003-04-19 | 2003-10-19 | $2000.00 | Window Closed / Lapsed |
| 7.5 Years (Year 8) | 2006-10-18 | 2007-04-19 | 2007-10-19 | $3760.00 | Window Closed / Lapsed |
| 11.5 Years (Year 12) | 2010-10-18 | 2011-04-19 | 2011-10-19 | $7700.00 | Window Closed / Lapsed |