KR20110046307A - Test meter for use with a dual chamber, multi-analyte test strip with opposing electrodes - Google Patents
Test meter for use with a dual chamber, multi-analyte test strip with opposing electrodes Download PDFInfo
- Publication number
- KR20110046307A KR20110046307A KR1020100103297A KR20100103297A KR20110046307A KR 20110046307 A KR20110046307 A KR 20110046307A KR 1020100103297 A KR1020100103297 A KR 1020100103297A KR 20100103297 A KR20100103297 A KR 20100103297A KR 20110046307 A KR20110046307 A KR 20110046307A
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- KR
- South Korea
- Prior art keywords
- analyte
- test strip
- dual chamber
- counter
- contact
- Prior art date
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B5/00—Measuring for diagnostic purposes; Identification of persons
- A61B5/145—Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissue
- A61B5/1468—Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissue using chemical or electrochemical methods, e.g. by polarographic means
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- C—CHEMISTRY; METALLURGY
- C12—BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
- C12Q—MEASURING OR TESTING PROCESSES INVOLVING ENZYMES, NUCLEIC ACIDS OR MICROORGANISMS; COMPOSITIONS OR TEST PAPERS THEREFOR; PROCESSES OF PREPARING SUCH COMPOSITIONS; CONDITION-RESPONSIVE CONTROL IN MICROBIOLOGICAL OR ENZYMOLOGICAL PROCESSES
- C12Q1/00—Measuring or testing processes involving enzymes, nucleic acids or microorganisms; Compositions therefor; Processes of preparing such compositions
- C12Q1/001—Enzyme electrodes
- C12Q1/005—Enzyme electrodes involving specific analytes or enzymes
- C12Q1/006—Enzyme electrodes involving specific analytes or enzymes for glucose
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- G—PHYSICS
- G01—MEASURING; TESTING
- G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
- G01N27/00—Investigating or analysing materials by the use of electric, electrochemical, or magnetic means
- G01N27/26—Investigating or analysing materials by the use of electric, electrochemical, or magnetic means by investigating electrochemical variables; by using electrolysis or electrophoresis
- G01N27/28—Electrolytic cell components
- G01N27/30—Electrodes, e.g. test electrodes; Half-cells
- G01N27/327—Biochemical electrodes, e.g. electrical or mechanical details for in vitro measurements
- G01N27/3271—Amperometric enzyme electrodes for analytes in body fluids, e.g. glucose in blood
- G01N27/3272—Test elements therefor, i.e. disposable laminated substrates with electrodes, reagent and channels
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- G—PHYSICS
- G01—MEASURING; TESTING
- G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
- G01N27/00—Investigating or analysing materials by the use of electric, electrochemical, or magnetic means
- G01N27/26—Investigating or analysing materials by the use of electric, electrochemical, or magnetic means by investigating electrochemical variables; by using electrolysis or electrophoresis
- G01N27/28—Electrolytic cell components
- G01N27/30—Electrodes, e.g. test electrodes; Half-cells
- G01N27/327—Biochemical electrodes, e.g. electrical or mechanical details for in vitro measurements
- G01N27/3271—Amperometric enzyme electrodes for analytes in body fluids, e.g. glucose in blood
- G01N27/3274—Corrective measures, e.g. error detection, compensation for temperature or hematocrit, calibration
-
- G—PHYSICS
- G01—MEASURING; TESTING
- G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
- G01N33/00—Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
- G01N33/48—Biological material, e.g. blood, urine; Haemocytometers
- G01N33/483—Physical analysis of biological material
- G01N33/487—Physical analysis of biological material of liquid biological material
- G01N33/4875—Details of handling test elements, e.g. dispensing or storage, not specific to a particular test method
Abstract
Description
The present invention generally relates to medical devices, in particular analyte test strips, test meters and related methods.
Measurement of analytes (eg, detection and / or concentration measurements) in fluid samples is of particular interest in the medical arts. For example, it may be desirable to measure glucose, ketone, cholesterol, acetaminophen and / or HbA1c concentrations in samples of body fluids such as urine, blood or interstitial fluid. Such measurements can be achieved using analyte test strips, for example based on relevant test meters in combination with photometric or electrochemical techniques.
Typical electrochemical-based analyte test strips facilitate the electrochemical reaction with a single analyte of interest using the relevant counter / reference electrode and enzyme reagents along with the working electrode, thereby measuring the concentration of that single analyte. For example, electrochemical-based analyte test strips for the determination of glucose concentration in blood samples may use enzyme reagents including enzyme glucose oxidase and mediator ferricyanide. Such conventional analyte test strips are described, for example, in US Pat. No. 5,708,247; 5,951,836; 5,951,836; No. 6,241,862; And 6,284,125; Each of which is incorporated herein by reference in its entirety.
New features of the invention are particularly described in the appended claims. A more clear understanding of the features and advantages of the present invention will be obtained by reference to the following detailed description describing exemplary embodiments in which the principles of the invention have been utilized, and to the accompanying drawings in which like reference numerals designate like elements.
<Figure 1>
1 is a simplified exploded perspective view of a dual chamber multi-analyte test strip according to one embodiment of the invention.
2a to 2k
2A-2K illustrate the first insulating layer, the first electrically conductive layer, the first analyte reagent layer, the first patterned spacer layer, the first relative / reference of the dual chamber multi-analyte test strip of FIG. 1, respectively. Simplified plan view of the electrode layer, counter / reference insulating layer, second counter / reference electrode layer, second patterned spacer layer, second analyte reagent layer, second electrically conductive layer, and second insulating layer.
3,
3 is a simplified plan view of the dual chamber multi-analyte test strip of FIG.
Figure 4a
4A is a simplified diagram of the dual chamber multi-analyte test strip of FIGS. 1-3 in use with a test meter in accordance with one embodiment of the present invention.
Figure 4b
4B is a simplified end view of the dual chamber multi-analyte test strip and test meter electrical connector of FIG. 4A.
<Figure 5>
5 is a graph of current (unit: amps) versus time (unit: seconds) obtained during testing of a dual-chamber multi-analyte test strip according to one embodiment of the present invention.
6,
6 is a flow diagram illustrating the steps of a method for measuring multiple analytes in a single bodily fluid sample applied to a dual-chamber multi-analyte test strip in accordance with one embodiment of the present invention.
The following detailed description should be understood with reference to the drawings, wherein like elements are denoted by like reference numerals in different drawings. The drawings, which are not necessarily drawn to scale, illustrate exemplary embodiments for illustrative purposes only and are not intended to limit the scope of the invention. The detailed description describes by way of example, not by way of limitation, the principles of the invention. This description will clearly enable those skilled in the art to make and use the invention, and describes several embodiments, adaptations, variations, alternatives, and uses of the invention, including what is presently considered the best mode of carrying out the invention. .
A dual chamber multi-analyte test strip (also referred to herein simply as a test strip) according to an embodiment of the present invention is disposed on a first insulating layer, a first insulating layer (first working electrode and first analyte contact) A first electrically conductive layer having a pad, and a first patterned spacer layer. The first patterned spacer layer is positioned over the first electrically conductive layer, and a first sample-receiving chamber having a first end opening and a second end opening is formed therein. The first sample-receiving chamber is placed over the first working electrode. The test strip also includes a first counter / reference electrode layer exposed to the first sample receiving chamber and configured in an opposite (ie, co-facial) relationship with the first working electrode. The first counter / reference electrode layer has a first counter / reference contact pad.
The test strip further includes a counter / reference insulating layer disposed over the first counter / reference electrode layer, and a second counter / reference electrode layer (with a second counter / reference contact pad) disposed on the counter / reference insulating layer. . Also included in the test strip is a second patterned spacer layer located over the second counter / reference electrode layer. The second patterned spacer layer is formed therein with a second sample-receiving chamber having a first end opening and a second end opening. The test strip further includes a second electrically conductive layer (having a second working electrode and a second analyte contact pad) disposed over the second patterned spacer layer, a second insulating layer disposed over the second electrically conductive layer, a first A first analyte reagent layer disposed on the first working electrode in the sample-receiving chamber, and a second analyte reagent layer disposed on the second working electrode in the second sample-receiving chamber. The second counter / reference electrode layer is exposed to the second sample receiving chamber and is in an opposite (face-to-face) relationship with the second working electrode.
In a dual chamber multi-analyte test strip according to an embodiment of the present invention, for example, a plurality of non-identical analytes (eg, analyte glucose and ketone analyte 3-hydroxybutyrate) are applied to the test strip. It is advantageous in that it can be measured in a bodily fluid sample (eg, a single whole blood sample). In addition, since the dual chamber multi-analyte test strip has two separate sample-receiving chambers, harmful cross-contamination between analyte reagents, cross-contamination of reaction products and / or by-products, and / Or the possibility for cross-electrical interference during the measurement of two analytes is eliminated. Moreover, since the first counter / reference electrode is in opposing (ie, facing) relationship with the first working electrode, and the second counter / reference electrode layer is in opposing (ie, facing) relationship with the second working electrode, the double chamber multiple Analyte test strips are advantageously of small overall size and have a small sample-receiving chamber. Moreover, dual chamber multi-analyte test strips in accordance with embodiments of the present invention can be prepared using conventional simple and relatively inexpensive web-based techniques.
1 is a simplified exploded perspective view of a dual chamber
1, 2A-2K and 3, dual chamber
The dual chamber
The first counter /
The dual chamber
The dual chamber
The second electrically
The second
In the dual chamber
The dual chamber
1, 2A-2K and 3, the first
The first insulating
In the embodiments of FIGS. 1, 2A-2K and 3, the first
First, electrically
The first counter /
The first
The patterned spacer layers 108, 116 can be, for example, a 95 μm thick double sided pressure sensitive adhesive layer, a heat activated adhesive layer, or a thermoset adhesive plastic layer. The patterned spacer layers 108, 116 are for example about 1 micrometer to about 500 micrometers, preferably about 10 micrometers to about 400 micrometers, and more preferably about 40 micrometers to about 200 micrometers. It can have a thickness in the meter range.
The first
The second
When the second analyte is ketone 3-hydroxybutyrate, the mediator can be, for example, a mixture of potassium ferricyanide and NAD, and the enzyme can be, for example, a mixture of diaphorase and hydroxybutyrate dehydrogenase.
Once the present invention is known, those of ordinary skill in the art will appreciate that suitable buffers (eg, Tris HCl, citraconate, citrate) may be required if the first
In the embodiment of FIGS. 1-3, it should be noted that the first
A test meter for use with a dual chamber multi-analyte test strip according to an embodiment of the present invention includes a test strip receiving module and a signal processing module. The test strip receiving module includes a first electrical connector configured to contact a first analyte contact pad of a first working electrode of the test strip; A second electrical connector configured to contact the second analyte contact pad of the second working electrode of the test strip, a third electrical connector configured to contact the first counter / reference contact pad of the first counter / reference electrode layer of the test strip, and And a fourth electrical connector configured to contact the second counterpart / reference contact pad of the second counterpart / reference electrode layer of the test strip.
The signal processing module of the test meter receives the first electrical signal through the first electrical connector and the third electrical connector, such that the first in the bodily fluid sample (eg, whole blood sample) applied to the dual-chamber multi-analyte test strip. And use the first signal for measurement of the analyte (eg glucose). Moreover, the signal processing module also receives a second electrical signal via the second electrical connector and the fourth electrical connector, such that the second analyte (eg, ketone) in the bodily fluid sample applied to the dual-chamber multi-analyte test strip. The second electrical signal for measurement of the analyte). Moreover, the third electrical connector is configured to contact the first mating / reference contact pad in an opposing manner with respect to the contact of the fourth electrical connector and the second mating / reference contact pad.
4A is a simplified diagram of a dual chamber
The test strip receiving module 202 includes a first
The
The
In the embodiment of FIGS. 4A and 4B, the
Successful operation of the dual chamber multi-analyte test strip according to one embodiment of the present invention has been demonstrated as follows. Dual chamber multi-analyte test strips were made from the following materials.
First and Second Insulation and Counter / Reference Insulation Layers-Polyester film having a thickness of about 178 μm (trade name Mellinex 329 from Dupont Teijin Films, Hopewell, Va.) Available for purchase);
First conductive layer and second conductive layer—palladium;
First Relative / Reference Layer and Second Relative / Reference Layer-Gold:
First patterned spacer layer and second patterned spacer layer—total thickness of about 95 μm (consisting of a layer of about 50 um thick PET coated on both major surfaces with a thermoplastic heat-activated adhesive of about 22.5 um thick) ;
First analyte reagent layer (for glucose measurement):
100 mM Tris buffer, pH 7.4;
% w / v hydroxyethyl cellulose;
10% w / v potassium hexacyano iron (III) acid;
1% w / v glucose oxidase;
Second analyte reagent layer (for ketone measurement)
100 mM Tris buffer, pH 7.4;
% w / v hydroxyethyl cellulose;
10% w / v potassium hexacyano iron (III) acid;
1% w / v hydroxybutyrate dehydrogenase;
1% w / v diaphorase.
Dual chamber multi-analyte test strips were prepared using conventional thermal lamination and reagent layer application and drying techniques. The resulting test strips were tested on standard bi-potentiostats. The reference and counter electrodes of the bi-potentiostat were connected to the first counter / reference contact pad and the second counter / reference contact pad of the test strip. The working electrodes of the bi-potentiostat were connected to the first analyte contact pad and the second analyte contact pad of the test strip. These connections were made in a method that is electrically equivalent to that shown in FIG. 4A.
Glucose and ketone standard solutions were applied to the dual chamber multi-analyte test strip. After a 3 second preconditioning sequence (equivalent to an open circuit applied to the test strip for 3 seconds), a 0.4 V potential was applied to the test strip for 7 seconds. 5 shows the current output for a dual chamber multi-analyte test strip for a duration of 0.4 V applied potential. 6 shows that a sufficiently stable current is generated for the control solution sample introduced into both the first sample-receiving chamber and the second sample-receiving chamber of the test strip, which indicates that the test strip is successful in detecting both glucose and ketone. It can be used to indicate that there was no obvious cross contamination in any measurement.
FIG. 6 shows multiple analytes (eg, analyte glucose and ketone analytes 3-, in a single bodily fluid sample (eg, whole blood sample) applied to a dual chamber multi-analyte test strip according to one embodiment of the present invention). Is a flowchart illustrating the steps of the
In
The method also includes measuring at least a first analyte and a second analyte in a single bodily fluid sample applied to the test strip using a signal processing module of the test meter (see
During this measuring step, the signal processing module receives the first signal through the first electrical connector and the third electrical connector and uses the first signal for the measurement of the first analyte. During this measuring step, the signal processing module receives the second signal through the second electrical connector and the fourth electrical connector and uses the second signal for the measurement of the second analyte. In
Once the present invention is known, those of ordinary skill in the art will appreciate that the
While preferred embodiments of the invention have been shown and described herein, it will be apparent to those skilled in the art that such embodiments are provided by way of example only. Various modifications, changes, and substitutions will now occur to those skilled in the art without departing from the invention. It should be understood that various alternatives to the embodiments of the invention described herein may be used to practice the invention. The following claims define the scope of the present invention, which is intended to encompass the devices and methods within the scope of these claims and their equivalents.
Claims (10)
As test strip accommodating module:
A first electrical connector configured to contact a first analyte contact pad of a first working electrode of the dual chamber multi-analyte test strip,
A second electrical connector configured to contact a second analyte contact pad of a second working electrode of the dual chamber multi-analyte test strip,
A third electrical connector configured to contact the first counter / reference contact pad of the first counter / reference electrode layer of the dual chamber multi-analyte test strip, and
The test strip receiving module having a fourth electrical connector configured to contact the second counter / reference contact pad of the second counter / reference electrode layer of the dual chamber multi-analyte test strip; And
A signal processing module,
The signal processing module receives a first signal through the first electrical connector and the third electrical connector, such that the first signal for measurement of a first analyte in a bodily fluid sample applied to the dual chamber multi-analyte test strip. Is configured to utilize;
The signal processing module receives a second signal through the second electrical connector and the fourth electrical connector, such that the second signal is for measurement of a second analyte in a bodily fluid sample applied to the dual chamber multi-analyte test strip. Is also configured to utilize;
A third electrical connector is configured with the dual chamber multi-analyte test strip configured to contact the first mating / reference contact pad in an opposing manner with respect to the contact of the fourth electrical connector and the second mating / reference contact pad. Test meter for use.
Priority Applications (1)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
KR1020100103297A KR20110046307A (en) | 2009-10-27 | 2010-10-22 | Test meter for use with a dual chamber, multi-analyte test strip with opposing electrodes |
Applications Claiming Priority (2)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
US12/606,496 | 2009-10-27 | ||
KR1020100103297A KR20110046307A (en) | 2009-10-27 | 2010-10-22 | Test meter for use with a dual chamber, multi-analyte test strip with opposing electrodes |
Publications (1)
Publication Number | Publication Date |
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KR20110046307A true KR20110046307A (en) | 2011-05-04 |
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Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
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KR1020100103297A KR20110046307A (en) | 2009-10-27 | 2010-10-22 | Test meter for use with a dual chamber, multi-analyte test strip with opposing electrodes |
Country Status (1)
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KR (1) | KR20110046307A (en) |
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2010
- 2010-10-22 KR KR1020100103297A patent/KR20110046307A/en not_active Application Discontinuation
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