WO2002014535A2 - Electrochemical strip test for small volumes - Google Patents
Electrochemical strip test for small volumes Download PDFInfo
- Publication number
- WO2002014535A2 WO2002014535A2 PCT/GB2001/003615 GB0103615W WO0214535A2 WO 2002014535 A2 WO2002014535 A2 WO 2002014535A2 GB 0103615 W GB0103615 W GB 0103615W WO 0214535 A2 WO0214535 A2 WO 0214535A2
- Authority
- WO
- WIPO (PCT)
- Prior art keywords
- sample
- reagents
- glucose
- volume
- cell
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
- Ceased
Links
Classifications
-
- 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
-
- 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
Definitions
- This invention relates to an electrochemical test cell for the measurement of reactive species.
- a sensor can be used for the measurement of enzymes, enzyme substrates, cofactors or mediators.
- One particular application is the measurement of glucose for use in diabetes.
- Diabetes mellitus is the most common endocrine disease and affects between 3-8% of the population.
- Various studies, such as the UK Prospective Diabetes Study (UKPDS, Lancet, 12th September 1998) have pointed out the importance of maintaining a normal glucose level in the blood or plasma, in order to delay the onset of diabetic complications.
- the present invention is based on the realisation that, by using appropriate chemistry etc, an adequate signal can be achieved if a cavity is provided that is smaller than has previously been used, i.e. which holds 500 nL or less of blood.
- the invention allows the detection of glucose in whole blood, using a simple to use strip test, characterised in that the volume of sample required is very small, e.g. less than 200 nL and down to 50 nL.
- a device of the invention can be made from known materials. However, it has been found that its size can be reduced, because sufficient current density can be achieved that there is adequate sensitivity for the analyte, typically 90-100 nA mM glucose.
- the small volume of blood that can be utilised in the invention means that the sample can be taken from a part of the body having a low vasculature. Thus, for example, the sample can be taken from the arm.
- the drawings show a cell or sample area 1 , a cover 2, a spacer layer 3, a reference/counter electrode 4, a working electrode 5, a cell-defining layer 6, a counter electrode 7, a reference electrode 8, and a strip/sample electrode 9.
- Electrochemical strips for the detection of glucose in whole blood typically comprise an working, reference and counter electrode, or combination thereof, for the detection and quantitation of the activity of reagents or reaction products on the strip.
- these reagents may include enzymes, enzyme products or mediators accepting electrons from redox enzymes on the strip.
- the electrodes are preferably printed or deposited onto an elongate substrate, configured for ease of use by the diabetic and for insertion into a reader.
- a substrate may also include other tests of use for the diabetic such as, but not limited to, glycosylated haemoglobin, glucose and potassium.
- Some of the reagents may be deposited directly onto the electrodes themselves or onto other structures incorporated in the device, including wetting meshes such as is known in the art.
- the mesh is preferably as described in WO-A- 00/28068.
- the use of a mesh in the cavity e.g. having an open area of about 30%, can reduce the sample volume.
- Appropriate reagents may be placed on the electrochemical strip test by methods including, but not limited to, screen printing and dosing the enzymes or enzyme-mediator couples.
- such reagents may be, for example: glucose oxidase and ferrocene/ferricyanide glucose oxidase and oxygen to yield hydrogen peroxide glucose dehydrogenase and ferricyanide glucose dehydrogenase and NAD and Meldola's Blue
- the effect of interferents in the test may be reduced by including enzymes or chemicals to reduce ascorbate interference, e.g. ascorbate oxidase.
- Haematocrit interference may be reduced by including saponin, digitonin, or other lysing agents.
- PVP, PVA and other polymers may be included, to increase linearity.
- Surfactants may be added to the device, to aid filling.
- the assay may also incorporate features such as filling via the side of the elongate substrate, to assist the diabetic in using the device. This is described in WO-A-00/28086 and also WO-A-98/55856 (the contents of both of which are incorporated herein by reference).
- the output from the device may also be quantitated on small electronic instrument. Analysis of the output from the device may be via coulometry, amperometry, analysis or cyclic voltamogram or other electrochemical analytical methods known in the art.
- the arrangement of the device may include provision for the sequential exposure of reagents to the sample, to allow the reactions to proceed in a sequential or time-delayed manner, to optimise the readout.
- the device comprises two electrodes placed approximately 100 ⁇ m or more apart: a counter/reference electrode preferably made of Ag/AgCI and a second conductor of either Au, Pt, Pt/C or C.
- a well is constructed by laminating a plastics layer around the cell or printing a layer around the cell, as shown in Figure 1.
- a top cover may then be added to complete the cell.
- the electrodes are approximately 100 ⁇ m wide and 1000 ⁇ m long.
- the reagents are dosed onto the device. Strips made with a Au, Pt or Pt/C conductor may contain glucose oxidase. Hydrogen peroxide is detected electrochemically on the strip.
- Strips made of a carbon conductor may contain a redox enzyme (glucose oxidase or glucose dehydrogenase) and a mediator for the enzyme (potassium ferricyanide or phenoxazines including Meldola's Blue).
- a device comprises 3 conducting electrodes, namely a working electrode (carbon, Pt, Au or Pt/C), a reference electrode made of Ag/AgCI and a counter electrode (C, Pt, Au or Pt/C), as shown in Figure 2.
- the reagents, i.e. enzyme, cofactor and mediator are deposited on the working electrode as a single or multiple layers. Alternatively, the reagents are dried over the whole of the cell.
- a channel is created over the reagents by laminating a thin plastic layer or printing a layer of adhesive around the cell.
- a clear cover with an air exit hole is placed over the device to complete the test strip.
- the cell volume can be further reduced by sandwiching a mesh layer between the substrate containing the conducting electrodes and reagents and the cover.
- a device comprises 3 conducting electrodes, namely a working electrode (carbon, Pt, Au or Pt/C), a reference/counter electrode made of Ag/AgCI and a strip/sample detection electrode (C, Pt, Au or Pt/C), as shown in Figure 3.
- the reagents i.e. enzyme, cofactor and mediator, are deposited on the working electrode as a single or multiple layers. Alternatively, the reagents are dried over the whole of the cell. A channel is created over the reagents by laminating a thin plastic layer or printing a layer of adhesive around the cell. A clear cover with an air exit hole is placed over the device to complete the test strip.
- the cell volume can be further reduced by sandwiching a mesh layer between the substrate containing the conducting electrodes and reagents and the cover.
Landscapes
- Life Sciences & Earth Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Health & Medical Sciences (AREA)
- Organic Chemistry (AREA)
- Zoology (AREA)
- Physics & Mathematics (AREA)
- Analytical Chemistry (AREA)
- Engineering & Computer Science (AREA)
- General Health & Medical Sciences (AREA)
- Immunology (AREA)
- Biophysics (AREA)
- Molecular Biology (AREA)
- Biochemistry (AREA)
- Wood Science & Technology (AREA)
- Proteomics, Peptides & Aminoacids (AREA)
- Microbiology (AREA)
- Bioinformatics & Cheminformatics (AREA)
- General Engineering & Computer Science (AREA)
- Biotechnology (AREA)
- Genetics & Genomics (AREA)
- Hematology (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Electrochemistry (AREA)
- General Physics & Mathematics (AREA)
- Pathology (AREA)
- Investigating Or Analysing Biological Materials (AREA)
- Measuring Or Testing Involving Enzymes Or Micro-Organisms (AREA)
Abstract
Description
Claims
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| AU2001277625A AU2001277625A1 (en) | 2000-08-11 | 2001-08-13 | Electrochemical strip test for small volumes |
Applications Claiming Priority (2)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| GB0019694A GB0019694D0 (en) | 2000-08-11 | 2000-08-11 | Electrochemical strip test for small volumes |
| GB0019694.9 | 2000-08-11 |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| WO2002014535A2 true WO2002014535A2 (en) | 2002-02-21 |
| WO2002014535A3 WO2002014535A3 (en) | 2002-06-13 |
Family
ID=9897375
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| PCT/GB2001/003615 Ceased WO2002014535A2 (en) | 2000-08-11 | 2001-08-13 | Electrochemical strip test for small volumes |
Country Status (3)
| Country | Link |
|---|---|
| AU (1) | AU2001277625A1 (en) |
| GB (1) | GB0019694D0 (en) |
| WO (1) | WO2002014535A2 (en) |
Cited By (12)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| JP2004340923A (en) * | 2003-02-11 | 2004-12-02 | Bayer Healthcare Llc | Method for reducing influence of hematocrit on measurement of analyzed object in whole blood, and test kit and test article useful for the method |
| EP1486778A3 (en) * | 2003-06-09 | 2005-01-05 | I-Sens, Inc. | Electrochemical biosensor |
| WO2005029070A1 (en) * | 2003-09-20 | 2005-03-31 | Cambridge Sensors Limited | Biosensors having reduced haemocrit effect |
| WO2009094297A3 (en) * | 2008-01-22 | 2009-09-17 | Home Diagnostics, Inc. | Improved reagent compositions for use in electrochemical detection |
| US7727467B2 (en) | 2003-06-20 | 2010-06-01 | Roche Diagnostics Operations, Inc. | Reagent stripe for test strip |
| US7972861B2 (en) | 2004-05-14 | 2011-07-05 | Bayer Healthcare Llc | Methods for performing hematocrit adjustment in glucose assays and devices for same |
| US8071030B2 (en) | 2003-06-20 | 2011-12-06 | Roche Diagnostics Operations, Inc. | Test strip with flared sample receiving chamber |
| US8287703B2 (en) | 1999-10-04 | 2012-10-16 | Roche Diagnostics Operations, Inc. | Biosensor and method of making |
| US8298828B2 (en) | 2003-06-20 | 2012-10-30 | Roche Diagnostics Operations, Inc. | System and method for determining the concentration of an analyte in a sample fluid |
| US8663442B2 (en) | 2003-06-20 | 2014-03-04 | Roche Diagnostics Operations, Inc. | System and method for analyte measurement using dose sufficiency electrodes |
| AU2012268873B2 (en) * | 2008-01-22 | 2014-07-03 | Trividia Health, Inc. | Improved reagent compositions for use in electrochemical detection |
| EP3415634A1 (en) * | 2017-06-13 | 2018-12-19 | ARKRAY, Inc. | Biosensor and measuring method using the same |
Families Citing this family (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US7597793B2 (en) | 2003-06-20 | 2009-10-06 | Roche Operations Ltd. | System and method for analyte measurement employing maximum dosing time delay |
| US7604721B2 (en) | 2003-06-20 | 2009-10-20 | Roche Diagnostics Operations, Inc. | System and method for coding information on a biosensor test strip |
| US7569126B2 (en) | 2004-06-18 | 2009-08-04 | Roche Diagnostics Operations, Inc. | System and method for quality assurance of a biosensor test strip |
| US7556723B2 (en) | 2004-06-18 | 2009-07-07 | Roche Diagnostics Operations, Inc. | Electrode design for biosensor |
Family Cites Families (6)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US5762770A (en) * | 1994-02-21 | 1998-06-09 | Boehringer Mannheim Corporation | Electrochemical biosensor test strip |
| US5628890A (en) * | 1995-09-27 | 1997-05-13 | Medisense, Inc. | Electrochemical sensor |
| AU6157898A (en) * | 1997-02-06 | 1998-08-26 | E. Heller & Company | Small volume (in vitro) analyte sensor |
| GB9824627D0 (en) * | 1998-11-11 | 1999-01-06 | Cambridge Sensors Ltd | Test strips for small volumes |
| US6129823A (en) * | 1997-09-05 | 2000-10-10 | Abbott Laboratories | Low volume electrochemical sensor |
| JP3874321B2 (en) * | 1998-06-11 | 2007-01-31 | 松下電器産業株式会社 | Biosensor |
-
2000
- 2000-08-11 GB GB0019694A patent/GB0019694D0/en not_active Ceased
-
2001
- 2001-08-13 WO PCT/GB2001/003615 patent/WO2002014535A2/en not_active Ceased
- 2001-08-13 AU AU2001277625A patent/AU2001277625A1/en not_active Abandoned
Cited By (29)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US8287703B2 (en) | 1999-10-04 | 2012-10-16 | Roche Diagnostics Operations, Inc. | Biosensor and method of making |
| US8551308B2 (en) | 1999-10-04 | 2013-10-08 | Roche Diagnostics Operations, Inc. | Biosensor and method of making |
| US7323315B2 (en) | 2003-02-11 | 2008-01-29 | Bayer Healthcare Llc | Method for reducing effect of hematocrit on measurement of an analyte in whole blood |
| EP1447665A3 (en) * | 2003-02-11 | 2005-12-28 | Bayer HealthCare LLC | Method for reducing effect of hematocrit on measurement of an analyte in whole blood, and test kit and test article useful in the method |
| JP2004340923A (en) * | 2003-02-11 | 2004-12-02 | Bayer Healthcare Llc | Method for reducing influence of hematocrit on measurement of analyzed object in whole blood, and test kit and test article useful for the method |
| CN1558235B (en) * | 2003-02-11 | 2010-05-26 | 拜尔健康护理有限责任公司 | Method and detection element for determining the presence and/or amount of an analyte in a blood sample |
| US7288174B2 (en) | 2003-06-09 | 2007-10-30 | I-Sens, Inc. | Electrochemical biosensor |
| CN1323293C (en) * | 2003-06-09 | 2007-06-27 | 爱-森斯株式会社 | Electrochemical biosensor |
| EP1486778A3 (en) * | 2003-06-09 | 2005-01-05 | I-Sens, Inc. | Electrochemical biosensor |
| US7879618B2 (en) | 2003-06-20 | 2011-02-01 | Roche Diagnostics Operations, Inc. | Method and reagent for producing narrow, homogenous reagent strips |
| US7727467B2 (en) | 2003-06-20 | 2010-06-01 | Roche Diagnostics Operations, Inc. | Reagent stripe for test strip |
| US7749437B2 (en) | 2003-06-20 | 2010-07-06 | Roche Diagnostics Operations, Inc. | Method and reagent for producing narrow, homogenous reagent stripes |
| US7829023B2 (en) | 2003-06-20 | 2010-11-09 | Roche Diagnostics Operations, Inc. | Test strip with vent opening |
| US8663442B2 (en) | 2003-06-20 | 2014-03-04 | Roche Diagnostics Operations, Inc. | System and method for analyte measurement using dose sufficiency electrodes |
| US8298828B2 (en) | 2003-06-20 | 2012-10-30 | Roche Diagnostics Operations, Inc. | System and method for determining the concentration of an analyte in a sample fluid |
| US8071030B2 (en) | 2003-06-20 | 2011-12-06 | Roche Diagnostics Operations, Inc. | Test strip with flared sample receiving chamber |
| US8119414B2 (en) | 2003-06-20 | 2012-02-21 | Roche Diagnostics Operations, Inc. | Test strip with slot vent opening |
| US8142721B2 (en) | 2003-06-20 | 2012-03-27 | Roche Diagnostics Operations, Inc. | Test strip with slot vent opening |
| US8211379B2 (en) | 2003-06-20 | 2012-07-03 | Roche Diagnostics Operations, Inc. | Test strip with slot vent opening |
| US8222044B2 (en) | 2003-06-20 | 2012-07-17 | Roche Diagnostics Operations, Inc. | Test strip with flared sample receiving chamber |
| US8586373B2 (en) | 2003-06-20 | 2013-11-19 | Roche Diagnostics Operations, Inc. | System and method for determining the concentration of an analyte in a sample fluid |
| WO2005029070A1 (en) * | 2003-09-20 | 2005-03-31 | Cambridge Sensors Limited | Biosensors having reduced haemocrit effect |
| US7972861B2 (en) | 2004-05-14 | 2011-07-05 | Bayer Healthcare Llc | Methods for performing hematocrit adjustment in glucose assays and devices for same |
| US8062490B2 (en) | 2008-01-22 | 2011-11-22 | Nipro Diagnostics, Inc. | Reagent compositions for use in electrochemical detection |
| US7678250B2 (en) | 2008-01-22 | 2010-03-16 | Home Diagnostics, Inc. | Reagent compositions for use in electrochemical detection |
| WO2009094297A3 (en) * | 2008-01-22 | 2009-09-17 | Home Diagnostics, Inc. | Improved reagent compositions for use in electrochemical detection |
| AU2009206598B2 (en) * | 2008-01-22 | 2014-04-03 | Trividia Health, Inc. | Improved reagent compositions for use in electrochemical detection |
| AU2012268873B2 (en) * | 2008-01-22 | 2014-07-03 | Trividia Health, Inc. | Improved reagent compositions for use in electrochemical detection |
| EP3415634A1 (en) * | 2017-06-13 | 2018-12-19 | ARKRAY, Inc. | Biosensor and measuring method using the same |
Also Published As
| Publication number | Publication date |
|---|---|
| GB0019694D0 (en) | 2000-09-27 |
| WO2002014535A3 (en) | 2002-06-13 |
| AU2001277625A1 (en) | 2002-02-25 |
Similar Documents
| Publication | Publication Date | Title |
|---|---|---|
| JP3389106B2 (en) | Electrochemical analysis element | |
| US7138041B2 (en) | Electrochemical biosensor by screen printing and method of fabricating same | |
| KR100340174B1 (en) | Electrochemical Biosensor Test Strip, Fabrication Method Thereof and Electrochemical Biosensor | |
| KR100698961B1 (en) | Electrochemical Biosensor | |
| JP3842989B2 (en) | Biosensor with chromatographic porous thin film | |
| US6863800B2 (en) | Electrochemical biosensor strip for analysis of liquid samples | |
| JP3677500B2 (en) | Analytical element, measuring instrument using the same, and substrate quantification method | |
| AU2001276888B2 (en) | Antioxidant sensor | |
| JP3672525B2 (en) | Biosensor | |
| EP1203956B1 (en) | Biosensor with flow channel | |
| US6632349B1 (en) | Hemoglobin sensor | |
| WO2002014535A2 (en) | Electrochemical strip test for small volumes | |
| US8007645B2 (en) | Biosensor | |
| JPH11352093A (en) | Biosensor | |
| AU2001276888A1 (en) | Antioxidant sensor | |
| EP2018556A2 (en) | Electrochemical test sensor with reduced sample volume | |
| JP4469983B2 (en) | Biosensor for simultaneous measurement of multiple items and method of using the biosensor for simultaneous measurement of multiple items | |
| US8518236B2 (en) | Electrode preconditioning | |
| EP1357194A2 (en) | Adapter for the connection of a biosensor to a measuring device | |
| US7648624B2 (en) | Oxygen sensor | |
| JP2004020465A (en) | Biosensor | |
| JPH04501309A (en) | Method and apparatus for diagnostic analysis by current measurement | |
| KR100739865B1 (en) | Biosensor | |
| JP2004004057A (en) | Biosensor, adapter used therefor, and measuring device | |
| IL153584A (en) | Antioxidant sensor |
Legal Events
| Date | Code | Title | Description |
|---|---|---|---|
| AK | Designated states |
Kind code of ref document: A2 Designated state(s): AE AG AL AM AT AU AZ BA BB BG BR BY BZ CA CH CN CO CR CU CZ DE DK DM DZ EC EE ES FI GB GD GE GH GM HR HU ID IL IN IS JP KE KG KP KR KZ LC LK LR LS LT LU LV MA MD MG MK MN MW MX MZ NO NZ PL PT RO RU SD SE SG SI SK SL TJ TM TR TT TZ UA UG US UZ VN YU ZA ZW |
|
| AL | Designated countries for regional patents |
Kind code of ref document: A2 Designated state(s): GH GM KE LS MW MZ SD SL SZ TZ UG ZW AM AZ BY KG KZ MD RU TJ TM AT BE CH CY DE DK ES FI FR GB GR IE IT LU MC NL PT SE TR BF BJ CF CG CI CM GA GN GQ GW ML MR NE SN TD TG |
|
| 121 | Ep: the epo has been informed by wipo that ep was designated in this application | ||
| AK | Designated states |
Kind code of ref document: A3 Designated state(s): AE AG AL AM AT AU AZ BA BB BG BR BY BZ CA CH CN CO CR CU CZ DE DK DM DZ EC EE ES FI GB GD GE GH GM HR HU ID IL IN IS JP KE KG KP KR KZ LC LK LR LS LT LU LV MA MD MG MK MN MW MX MZ NO NZ PL PT RO RU SD SE SG SI SK SL TJ TM TR TT TZ UA UG US UZ VN YU ZA ZW |
|
| AL | Designated countries for regional patents |
Kind code of ref document: A3 Designated state(s): GH GM KE LS MW MZ SD SL SZ TZ UG ZW AM AZ BY KG KZ MD RU TJ TM AT BE CH CY DE DK ES FI FR GB GR IE IT LU MC NL PT SE TR BF BJ CF CG CI CM GA GN GQ GW ML MR NE SN TD TG |
|
| REG | Reference to national code |
Ref country code: DE Ref legal event code: 8642 |
|
| 122 | Ep: pct application non-entry in european phase | ||
| NENP | Non-entry into the national phase |
Ref country code: JP |