Source: http://www.google.com/patents/US7288174?dq=5998925
Timestamp: 2015-04-26 19:30:31
Document Index: 689671824

Matched Legal Cases: ['Application No. 10', 'art 100', 'art 100', 'art 100', 'art 100', 'art 100', 'Application No. 200410028372', 'Application No. 04', 'Application No. 200410028372']

Patent US7288174 - Reducing measurement bias during hematocrits; using fatty acid and ... - Google PatentsSearch Images Maps Play YouTube News Gmail Drive More »Sign inAdvanced Patent SearchPatentsThere is provided the reagent layer composition that can substantially reduce the measurement bias arising from hematocrits. The addition of fatty acid (4-20 carbons) and quaternary ammonium salt to a commonly used reagent layer composition composed of an enzyme, an electron transfer mediator, and several...http://www.google.com/patents/US7288174?utm_source=gb-gplus-sharePatent US7288174 - Reducing measurement bias during hematocrits; using fatty acid and quaternary ammonium compoundAdvanced Patent SearchPublication numberUS7288174 B2Publication typeGrantApplication numberUS 10/778,685Publication dateOct 30, 2007Filing dateFeb 12, 2004Priority dateJun 9, 2003Fee statusPaidAlso published asCN1323293C, CN1573324A, DE602004003288D1, DE602004003288T2, EP1486778A2, EP1486778A3, EP1486778B1, US20050000808Publication number10778685, 778685, US 7288174 B2, US 7288174B2, US-B2-7288174, US7288174 B2, US7288174B2InventorsGang Cui, Jae-Hyun Yoo, Moon-Hwan Kim, Ju-Yong Kim, Jung-Hee Uhm, Hakhyun Nam, Geun-Sig ChaOriginal AssigneeI-Sens, Inc.Export CitationBiBTeX, EndNote, RefManPatent Citations (35), Non-Patent Citations (9), Referenced by (16), Classifications (10), Legal Events (2) External Links: USPTO, USPTO Assignment, EspacenetReducing measurement bias during hematocrits; using fatty acid and quaternary ammonium compound US 7288174 B2Abstract
a reaction layer containing a glucose oxidase enzyme, electron transfer mediator, water soluble polymers, water soluble fatty acid or its salt, and quaternary ammonium salt, wherein the reaction layer is formed over the working electrode and is not formed over the reference electrode;
a spacer formed between the lower and the upper substrates, wherein the spacer is provided with a cut out pattern of a sample introducing bay, an air discharge channel, and a void at the cross of a sample introducing bay and an air discharge channel; and
wherein the electrochemical biosensor is capable of analyzing a whole blood sample.
3. The biosensor according to claim 1, wherein the working electrode and the reference electrode are formed on different substrates.
4. The biosensor according to claim 1, further comprising a fluidity determining electrode on the lower substrate, wherein the fluidity determining electrode is used to correct a hematocrit level-dependent measurement bias.
5. The biosensor according to claim 1, wherein the fatty acid or its salt has an alkyl chain of 4�20 carbons and is added in a range of 0.1 to 20 weight percent of all components.
6. The biosensor according to claim 1, wherein fatty acid is selected from the group consisting of saturated fatty acid, caproic acid, heptanoic acid, caprylic acid, nonanoic acid, capric acid, undecanoic acid, lauric acid, tridecanoic acid, myristic acid, pentadecanoic acid, palmitic acid, hepadecanoic acid, stearic acid, nonadecanoic acid, and arachidic acid.
7. The biosensor according to claim 1, wherein said fatty acid results in the effect of reducing the measurement bias arising from hematocrits.
10. The biosensor according to claim 1, wherein the electron transfer mediator is selected from the group consisting of hexaamineruthenium (III) chloride, potassium ferricyanide, potassium ferrocyanide, dimethylferrocene, ferricinium, ferocene-monocarboxylic acid, 7,7,8,8-tetracyanoquinodimethane, tetrathiafulvalene, nickelocene, N-methylacridinium, tetrathiatetracene, N-methylphenazinium, hydroquinone, 3-dimethylaminobenzoic acid, 3-methyl-2-benzothiazolinone hydrazone, 2-methoxy-4-allylphenol, 4-aminoantipyrin, dimethylaniline, 4-aminoantipyrene, 4-methoxynaphthol, 3,3′,5,5′-tetramethylbenzidine, 2,2-azino-di-[3-ethylbenzthiazoline sulfonate], o-dianisidine, o-toluidine, 2,4-dichloro phenol, 4-aminophenazone, and benzidine and Prussian blue.
11. The biosensor according to claim 10, wherein the electron transfer mediator is hexaamineruthenium (III) chloride.
12. The according to claim 1, wherein the water soluble polymers are used to disperse and stabilize the enzyme and selected from the group consisting of polyvinyl pyrrolidone (PVP), polyvinyl alcohol (PVA), perfluoro sulfonate, hydroxyethyl cellulose (HEC), hydroxypropy cellulose (HPC), carboxy methyl cellulose (CMC), cellulose acetate, dextran, and polyamide.
13. The biosensor according to claim 1, wherein the ratio of the width of the air discharge channel to that of the sample introducing bay is no more than 1:2.
14. The biosensor according to claim 1, wherein the sample introducing bay has a capacity to hold 0.1-1.0 μl of liquid sample.
15. The biosensor according to claim 1, wherein the sample introducing bay is crossed with the air discharge channel at an angle of 75-105� and the void is provided from the crossing point to the bay end.
16. The biosensor according to claim 1, further comprising a viewing window on the upper substrate, which is located at the crossing cover of the sample channel.
This application claims priority from Korean Patent Application No. 10-2003-0036804, filed Jun. 9, 2003. FIELD OF THE INVENTION
The electrode systems may be prepared on the same base substrate or on both lower and upper substrates: i.e., (1) a working electrode and an auxiliary electrode (or a reference electrode) formed on the same base substrate; and (2) a working electrode and an auxiliary electrode formed respectively on the base and cover substrates and arranged to face each other (converse-type electrodes: see, E. K. Bauman et al., Analytical Chemistry, vol 37, p 1378, 1965; K. B. Oldham in �Microelectrodes: Theory and Applications,� Kluwer Academic Publishers, 1991.). An extra electrode may be provided on the base substrate behind the working electrode to measure the fluidity of whole blood samples. Since hematocrits change the fluidity and electrical conductivity of blood, sampling times through a capillary channel of biosensor strips vary proportionally with the level of hematocrits in whole blood samples. Such variances in fluidity of blood samples may be used to correct the hematocrit level-dependent bias in the blood glucose measurements.
In FIG. 1, the angle of communication (φ) between the sample introducing bay 101 and the air discharge channel 102 is shown as 90�. But, according to another embodiment of the present invention, this angle may be varied within a range of from about 45� to about 135�, preferably, from about 75� to about 105�.
FIG. 2 illustrates a converse-type biosensor with a sample introducing part 100, characterized in that a lower substrate 400 on which a working electrode 104 and an electrode connector 106 are printed, and an oxidase and an electron transfer mediator are immobilized on the working electrode 104; a sample introducing spacer 200 having the sample introducing part 100; and an upper substrate 300 on which a reference electrode 105, and an electrode connector 106 are printed on the bottom side. The sample introducing part 100 may be formed as shown, but the present invention is satisfied as long as the sample introducing bay 101 communicates with the air discharge channel 102 and the void 103 is formed at the point of communication; the structure of the void 103 may also be modified as detailed above.
As shown in FIG. 3, illustrated is a converse type biosensor with sample fluidity determining capacity, characterized in that lower substrate 400 on which a working electrode 104, an electrode connector 106, fluidity determining electrode 107, and the biosensor identification electrode 108 are printed, and an oxidase and an electron transfer mediator are immobilized on the working electrode 104; a sample introducing spacer 200 having the sample introducing part 100; and an upper substrate 300 on which a reference electrode 105, and an electrode connector 106 are printed on the bottom side. Note that the reference electrode may be printed on whole upper substrate except the area for viewing window 301 for sample fill and the trade mark of the strip, providing more elegant outlook. The sample introducing part 100 may be formed as shown, but the present invention is satisfied as long as the sample introducing bay 101 communicates with the air discharge channel 102 and the void 103 is formed at the point of communication; the structure of the void 103 may also be modified as detailed above. The fluidity of a sample is determined as a function of sample filling speed between the first contact point of electrode 105 near the sample introducing mouth and the fluidity determining electrode 107 which is located either at the void 103 or at the air discharge channel 102.
The electron transfer mediator provided for the working electrode may employ ferrocene or its derivatives, quinone or its derivatives, organic conducting salts, or viologen. Preferably, the electron transfer mediator is a mixed-valence compound capable of forming redox couples, including hexaamineruthenium (III) chloride, potassium ferricyanide, potassium ferrocyanide, dimethylferrocene, ferricinium, ferocene-monocarboxylic acid, 7,7,8,8-tetracyanoquinodimethane, tetrathiafulvalene, nickelocene, N-methylacidinium, tetrathiatetracene, N-methylphenazinium, hydroquinone, 3-dimethylaminobenzoic acid, 3-methyl-2-benzothiazolinone hydrazone, 2-methoxy-4-allyiphenol, 4-aminoantipyrin, dimethylaniline, 4-aminoantipyrene, 4-methoxynaphthol, 3,3′,5,5′-tetramethylbenzidine, 2,2-azino-di-[3-ethylbenzthiazoline sulfonate], o-dianisidine, o-toluidine, 2,4-dichioro phenol, 4-aminophenazone, benzidine, and Prussian blue. Of those, hexaamineruthenium (III) chloride is a preferred electron transfer mediator for the proposed biosensor system, since it satisfies several conditions: (1) both an oxidized and a reduced states thereof in aqueous solution are stable and reversible; (2) the reduced electron transfer mediator is non-reactive to oxygen; (3) its formal potential is low enough to minimize the influence of interfering materials such as ascorbic acid, uric acid, and acetaminophen; (4) the oxidation of the reduced electron transfer mediator is not sensitive to PH; and (5) it does not react with electrochemically interfering materials, such as ascorbic acid, acetaminophen, and uric acid.
Water soluble molecules (0.1-10 wt % in solid components before dissolving in PBS buffer, pH 6.5) are selected from water soluble polymers, the group consisting of polyvinyl pyrrolidone (PVP), polyvinyl alcohol (PVA), perfluoro sulfonate, hydroxyethyl cellulose (HEC), hydroxypropyl cellulose (HPC), carboxy methyl cellulose (CMC), cellulose acetate, polyamide, etc. . The water soluble molecules are added to the reagent layer composition solution to help disperse or stabilize the enzyme. PVP and HPC are preferred for preparing the reagent layer composition solution of present invention.
The quaternary ammonium salt such as the halide compounds of dodecyltrimethylammonium, myristyltrimethylammonium, cetyltrimethylammonium, octadecyltrimethylammonium, tetrahexylammonium, etc. with the fatty acid remedies the problem, while substantially reducing the hematocrit level-dependent bias. The quaternary ammonium salts are added to the reagent layer composition solution in 0.1�30 wt % of all components.
Preparation of the Reagent Layer Composition Solution Without Fatty Acid
A mixture containing 30 mg of hexaamineruthenium (III) chloride (41.6 wt %), 1 mg of carboxymethylcellulose(1.4 wt %), 1 mg of Triton X−100(1.4 wt %), and 40 mg of glucose oxidase (55.6 wt %) was dissolved in 1 ml PBS buffer solution (pH 6.5)(pH 6.4), and filtrated to eliminate particulates left in solution. The reagent solution was placed in the syringe of a pneumatic dispenser (EFD XL100)
Preparation of the Reagent Layer Composition Solution with Fatty Acid
A mixture containing 30 mg of hexaamineruthenium (III) chloride(32.6 wt %), 1 mg of carboxymethylcellulose(0.8 wt %), 5 mg of polyvinyl pyrrolidone(4 wt %), 1 mg of Triton X−100(0.8 wt %), 20 mg of lauric acid(15.7 wt %), 30 mg of myristyltrimethylammonium bromide(23.6 wt %), and 40 mg of glucose oxidase(31.5 wt %) was dissolved in 1 ml PBS buffer solution (pH 6.4), and filtrated to eliminate particulates left in solution. The reagent solution was placed in the syringe of a pneumatic dispenser (EFD XL100).
Fabrication of a Converse Type Two-Electrode Biosensor
As shown in FIG. 2, a working electrode 104 and an electrode connector 106 were screen-printed with conductive carbon paste, and a curing was carried out at 140� C. for five minutes. Then, a circuit connector was screen-printed with the silver paste on one end of the electrode connector 106. The upper substrate with the printed electrode as a reference (auxiliary) electrode 105 was screen-printed with carbon paste and was cured. Finally, the biosensor was fabricated such that the end of the reference electrode 105 was screen-printed with silver paste to be the circuit connector.
The reagent layer composition solution of Example 1 or Example 2 was applied to the working electrode 104, and was allowed to dry for thirty minutes at 45� C.
Fabrication of Biosensor with Fluidity Determining Electrode
Influence of Interfering Materials on a Converse Type Glucose Sensor
Calibration Curve of a Converse Type Glucose Sensor to Glucose Standard Solutions
Measurement of the Blood Fluidity and Hematocrit Bias Correction
Y=−72.23+0.58691X−0.00084073X 2−1.1211�10−6 X 3+5.7521�10−9 X 4−9.1172�10−12 X 5. [mathematical formula 1]
(where Y is the estimated hematocrit level from the sample filling time X measured with the fluidity determining electrode. Table 1 shows the level of hematocrit estimated from the speed of sample filling time.
y = 0.035934 x − 1.7228
y = 0.025831 x − 1.0137
y = 0.018322 x − 0.7054
Reduced Hematocrit Interference by Fatty Acid-Containing Reagent Layer
Example 1 Reagent based
*% Bias relative to 40% hematocrit level = {(glucose level by the biosensor/glucose level by YSI)/(glucose level by the biosensor at 40% hematocrit/glucose level by YSI at 40% hematocrit) − 1} � 100.
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