EP0769558A1
Expired / Lapsed
EP
⏱️ 0.0 years remaining
Blood glucose strip having reduced sensitivity to hematocrit
Assignee: LifeScan Inc
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Filing: 1996-10-16
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Granted: —
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Expires: 2016-10-16
Abstract
Abstract A reagent strip for measuring glucose concentration in whole blood has reduced interference of hematocrit with the glucose measurement. When a biological fluid contacts the strip, it causes, in a reagent impregnated in the strip, a color change that is a measure of the glucose concentration in the fluid. However, the color change is also affected by the red blood cell concentration (hematocrit), thereby reducing the accuracy of the glucose measurement. The hematocrit effect is reduced by adding to the reagent an acrylic acid polymer.
Inventors
- 👤 Yeung S. Yu
Bibliographic Details
Application Number
—
Jurisdiction
EP
Data Source
google_patents
Last Synchronized
2026-10-24 16:24
CPC Classifications
G; G01; G01N; G01N33/00; G01N33/48; G01N33/50; G01N33/52; G01N33/521; G01N33/523; C; C12; C12Q; C12Q1/00; C12Q1/54; G01N33/525; G01N33/526; Y; Y10; Y10T; Y10T436/00; Y10T436/14; Y10T436/142222; Y10T436/143333; Y10T436/144444
Claims Analysis
Total Claims: 10
Claim 1
Independent Claim
139 words
A reagent strip for measuring glucose concentration in a sample of whole blood that contains red cells, comprising: (a) an anisotropic membrane having a sample side with relatively large pores and a testing side with relatively smaller pores, the membrane being adapted to accept the sample on the sample side and pass it toward the testing side; and (b) a testing reagent impregnated in the membrane, the testing reagent comprising (i) a component for creating hydrogen peroxide from glucose and oxygen, (ii) an indicator for reacting with the hydrogen peroxide to cause a change in the color of the indicator, and (iii) an acrylic acid polymer, whose concentration is in a range from about 0.1% to about 4% w/v, whereby any effect of the red blood cells on the glucose concentration measurement is reduced by the acrylic acid polymer.
Claim 2
Dependent Claim
14 words
The reagent strip of claim 1 further comprising a thermoplastic support for the membrane.
Claim 3
Dependent Claim
23 words
The reagent strip of claim 1 or claim 2 wherein the component for creating hydrogen peroxide from glucose and oxygen comprises glucose oxidase.
Claim 4
Dependent Claim
71 words
The reagent strip of any one of claims 1 to 3 wherein the indicator comprises a peroxidase and a composition selected from the group consisting of (a) 3-methyl-2-benzothiazolinone hydrazone hydrochloride (MBTH) combined with 3-dimethylaminobenzoic acid (DMAB); (b) MBTH combined with 3,5-dichloro-2-hydroxybenzene-sulfonic acid (DCHBS); and [3-methyl-2-benzothiazolinone hydrazone] N-sulfonyl benzenesulfonate monosodium (MBTHSB) combined with 8-anilino-1-naphthalene sulfonic acid ammonium (ANS) and preferably comprises a peroxidase and MBTHSB-ANS and preferably comprises a peroxidase and MBTHSB-ANS.
Claim 5
Dependent Claim
35 words
The reagent strip of any one of claims 1 to 4, wherein the molecular weight of the acrylic acid polymer is in the range from about 200,000 to about 4,000,000 and is preferably about 750,000.
Claim 6
Dependent Claim
43 words
The reagent strip of any one of claims 1 to 5 further comprising a porous transport layer attached to the sample side of the membrane for accepting the sample and passing a detectable portion of it to the sample side of the membrane.
Claim 7
Dependent Claim
28 words
The reagent strip of any one of claims 1 to 6 wherein the testing reagent further comprises an inhibitor to inhibit the change in color of the indicator.
Claim 8
Independent Claim
129 words
A method for measuring glucose concentration in a sample of whole blood that contains red blood cells, which comprises the steps of: (a) providing an anisotropic membrane, which (i) has a sample side having relatively large pores and a testing side having relatively smaller pores and (ii) is impregnated with a testing reagent that can react with glucose to cause a change in color of the testing side, the reagent comprising glucose oxidase, a peroxidase, an oxidizable dye or dye couple, and an acrylic acid polymer whose concentration is in a range from about 0.1% to about 4% w/v; (b) applying the blood to the sample side of the membrane; and (c) measuring the change in color of the testing side to determine the glucose concentration in the blood.
Claim 9
Dependent Claim
23 words
The method of claim 8 wherein the glucose concentration in the blood is in the range from about 50 to about 400 mg/dL.
Claim 10
Dependent Claim
23 words
The method of claim 8 or 9 wherein the blood has a hematocrit level in the range from about 25% to about 60%.
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