USRE42924E1 - Electrochemical biosensor test strip - Google Patents
Electrochemical biosensor test strip Download PDFInfo
- Publication number
- USRE42924E1 USRE42924E1 US10/692,031 US69203103A USRE42924E US RE42924 E1 USRE42924 E1 US RE42924E1 US 69203103 A US69203103 A US 69203103A US RE42924 E USRE42924 E US RE42924E
- Authority
- US
- United States
- Prior art keywords
- test
- test strip
- insulating substrate
- capillary channel
- roof
- 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.)
- Expired - Lifetime
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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
-
- 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
- G01N33/50—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing
- G01N33/53—Immunoassay; Biospecific binding assay; Materials therefor
- G01N33/543—Immunoassay; Biospecific binding assay; Materials therefor with an insoluble carrier for immobilising immunochemicals
- G01N33/54366—Apparatus specially adapted for solid-phase testing
- G01N33/54373—Apparatus specially adapted for solid-phase testing involving physiochemical end-point determination, e.g. wave-guides, FETS, gratings
- G01N33/5438—Electrodes
-
- Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
- Y10—TECHNICAL SUBJECTS COVERED BY FORMER USPC
- Y10S—TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
- Y10S435/00—Chemistry: molecular biology and microbiology
- Y10S435/817—Enzyme or microbe electrode
Definitions
- This invention relates to a biosensor and its use in the detection or measurement of analytes in fluids.
- test strips including electrochemical biosensor test strips, for measuring the amount of an analyte in a fluid.
- test strips have been used by diabetics and health care professionals for monitoring their blood glucose levels.
- the test strips are usually used in conjunction with a meter, which measures light reflectance, if the strip is designed for photometric detection of a dye, or which measures some electrical property, such as electrical current, if the strip is designed for detection of an electroactive compound.
- test strip When the test strip is a capillary fill device, that is, when the chemical reaction chamber of the test strip is a capillary space, particular problems can occur with filling the chamber smoothly and sufficiently with the liquid sample to be tested. Due to the smallness of the capillary space and the composition of materials used to make the test strip, the test sample may hesitate entering the capillary reaction chamber. Further, insufficient sample may also be drawn into the capillary reaction chamber, thereby resulting in an inaccurate test result. It would be very useful if such problems could be minimized.
- the electrochemical, biosensor test strip of the present invention provides solutions to these above-stated problems found in prior art test strips.
- the first new feature is an indentation along one edge of the test strip for easy identification of the sample application port for vision impaired persons or for use in zero or low lighting conditions.
- the test strip has a capillary test chamber, and the roof of the test chamber includes the second new feature of the biosensor test strip.
- the second new feature is a transparent or translucent window which operates as a “fill to here” line, thereby identifying when enough test sample (a liquid sample, such as blood) has been added to the test chamber to accurately perform a test.
- the window defines the minimum sample amount, or dose, required to accurately perform a test, and, therefore, represents a visual failsafe which reduces the chances of erroneous test results due to underdosing of a test strip.
- FIG. 1 is an exploded view of a preferred embodiment of the present invention.
- FIG. 4 is a cross sectional view of the test strip of FIG. 2 through line 28 — 28 .
- calibration curve 30 ( FIG. 6 ) may be constructed. This calibration will be stored in the Read Only Memory (ROM) key of the meter and will be applicable to a particular lot of test strips. Lines 31 and 32 in FIG. 6 represent other hypothetical calibration curves for two other different lots of test strips. Calibration for these biosensor lots would generate slightly different values for C and d in the above algorithm.
- ROM Read Only Memory
Abstract
Description
- Step 1: Prepare a solution of NATROSOL in deionized water. This is accomplished by adding 0.45 grams (g) of NATROSOL-250M (a microcrystalline hydroxyethylcellulose available from Aqualon) to 414 g of deionzied water while stirring at a speed of no less than 250 revolutions per minute (rpm) for a period of no less than 30 minutes. Mixing is best accomplished with an overhead rotating impeller using a three or four bladed turbine type propeller. The selection of propeller size and configuration is largely based on the radius of the mixing vessel being used. The selected propeller will typically have a radius greater than 75% of the radius of the mixing vessel.
- Step 2: To the solution from
Step 1, 5.6 g of AVICEL RC-591F (a microcrystalline cellulose available from FMC Corp.) is dispersed by gradually adding this AVICEL to the solution while mixing at a speed of no less than 570 rpm for no less than 60 minutes. - Step 3: To the mixture from
Step 2, 8.4 g polyethylene oxide (300 kilodalton mean molecular weight) is added gradually while mixing at a speed of no less than 690 rpm for a period of no less than 45 minutes. - Step 4: A buffer solution is prepared by adding 12.1 g of monobasic potassium phosphate (anhydrous) and 21.3 g of dibasic potassium phosphate (anhydrous) to 450 g of deionized water.
- Step 5: A50 g aliquot of the buffer solution is removed from the preparation of
Step 4. To this 50 g aliquot, 12.5 mg of coenzyme PQQ (available from Fluka) is added. This solution is stirred until the coenzyme is completely dissolved. (A magnetic stir bar and magnetic stir plate are preferred for enzyme preparation.) - Step 6: To the solution from
Step 5, 1.21 million units of the apoenzyme of quinoprotein glucose dehydrogenase is added gradually while stirring at a low speed (less than 400 rpm on a magnetic stir plate) to prevent foaming. The resulting solution is mixed for no less than 2 hours to allow the association of the enzyme and coenzyme to stabilize, thereby resulting in a solution of quinoprotein glucose dehydrogenase. - Step 7: To the buffer solution from
Step 4, 59.1 g of potassium ferricyanicle is added. Next, 6.2 g of sodium succinate is added. The resulting solution is mixed until all solutes are completely dissolved. After dissolution, the pH of the solution is assessed and is required to be approximately 6.76 plus or minus 0.05. - Step 8: The solution from
Step 7 is gradually incorporated into the mixture fromStep 3, while mixing at a rate of no less than 190 rpm. - Step 9: To the mixture from
Step 8, 20 g trehalose is added, while mixing at a rate of no more than 190 rpm for a period of not less than 10 minutes. - Step 10 : 0.35 g of TRITON X-100 surfactant, available from Boehringer Mannheim Biochemicals, is added to the mixture from
Step 9, while mixing at a rate of no more than 190 rpm. This mixture must continue mixing for no less than 5 minutes. - Step 11: The enzyme solution from
Step 6 is added to the mixture fromStep 10 and the now complete reagent is mixed at a rate of no less than 190 rpm for a period of no less than 30 minutes. - Step 12: The reagent can now be filtered, as needed by the manufacturing equipment, by passing it through a 100 micron sieve bag or through a 100 micron filter integral to a pumping system.
-
- 62.2 milligrams (mg) polyethylene oxide
- 3.3 mg NATROSOL 250 M
- 41.5 mg AVICEL RC-591 F
- 89.4 mg monobasic potassium phosphate
- 157.9 mg dibasic potassium phosphate
- 437.3 mg potassium ferricyanide
- 46.0 mg sodium succinate
- 148.0 mg trehalose
- 2.6 mg TRITON X-100 surfactant.
[Analyte]=Ci7.5+d
wherein [Analyte] represents the concentration of the analyte in the sample (see
[Glucose]=C1i1+C2i2+C3i3+ . . . Cnin+d,
wherein i1 is the current measured at the first measurement time (3 seconds after application of the 300 millivolt potential difference), i2 is the current measured at the second measurement time (3.5 seconds after application of the 300 millivolt potential difference), i3 is the current measured at the third measurement time (4 seconds after application of the 300 millivolt potential difference), in is the current measured at the nth measurement time (in this example, at the 13th measurement time or 9 seconds after application of the 300 millivolt potential difference), C1, C2, C3, and Cn are coefficients derived from a muiltivariate regression analysis technique, such as Principle Components Analysis or Partial Least Squares, and d is the regression intercept (in glucose concentration units).
[Glucose]corrected=[Glucose]measured×(1−K(T−23° C.)),
wherein T is the environmental temperature (in ° C.) at the time of the sample measurement and K is a constant derived from the following regression equation:
Y=K(T−23),
wherein
In order to calculate the value of K, each of a multiplicity of glucose concentrations is measured by the meter at various temperatures, T, and at 23° C. (the base case). Next, a linear regression of Y on T−23 is performed. The value of K is the slope of this regression.
Claims (69)
Priority Applications (1)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
US10/692,031 USRE42924E1 (en) | 1997-12-05 | 2003-10-23 | Electrochemical biosensor test strip |
Applications Claiming Priority (3)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
US08/985,840 US5997817A (en) | 1997-12-05 | 1997-12-05 | Electrochemical biosensor test strip |
US10/008,788 USRE42953E1 (en) | 1997-12-05 | 2001-12-07 | Electrochemical biosensor test strip |
US10/692,031 USRE42924E1 (en) | 1997-12-05 | 2003-10-23 | Electrochemical biosensor test strip |
Related Parent Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
US08/985,840 Reissue US5997817A (en) | 1997-12-05 | 1997-12-05 | Electrochemical biosensor test strip |
Publications (1)
Publication Number | Publication Date |
---|---|
USRE42924E1 true USRE42924E1 (en) | 2011-11-15 |
Family
ID=25531850
Family Applications (8)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
US08/985,840 Ceased US5997817A (en) | 1997-12-05 | 1997-12-05 | Electrochemical biosensor test strip |
US09/386,562 Expired - Lifetime US6254736B1 (en) | 1997-12-05 | 1999-08-31 | Method of selectively increasing the hydrophilicity of a web |
US09/386,210 Expired - Lifetime US6270637B1 (en) | 1997-12-05 | 1999-08-31 | Electrochemical biosensor test strip |
US10/008,788 Expired - Lifetime USRE42953E1 (en) | 1997-12-05 | 2001-12-07 | Electrochemical biosensor test strip |
US10/409,721 Expired - Lifetime USRE41309E1 (en) | 1997-12-05 | 2003-04-09 | Electrochemical biosensor test strip |
US10/692,031 Expired - Lifetime USRE42924E1 (en) | 1997-12-05 | 2003-10-23 | Electrochemical biosensor test strip |
US10/693,305 Expired - Lifetime USRE42560E1 (en) | 1997-12-05 | 2003-10-24 | Electrochemical biosensor test strip |
US13/301,334 Expired - Lifetime USRE43815E1 (en) | 1997-12-05 | 2011-11-21 | Electrochemical biosensor test strip |
Family Applications Before (5)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
US08/985,840 Ceased US5997817A (en) | 1997-12-05 | 1997-12-05 | Electrochemical biosensor test strip |
US09/386,562 Expired - Lifetime US6254736B1 (en) | 1997-12-05 | 1999-08-31 | Method of selectively increasing the hydrophilicity of a web |
US09/386,210 Expired - Lifetime US6270637B1 (en) | 1997-12-05 | 1999-08-31 | Electrochemical biosensor test strip |
US10/008,788 Expired - Lifetime USRE42953E1 (en) | 1997-12-05 | 2001-12-07 | Electrochemical biosensor test strip |
US10/409,721 Expired - Lifetime USRE41309E1 (en) | 1997-12-05 | 2003-04-09 | Electrochemical biosensor test strip |
Family Applications After (2)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
US10/693,305 Expired - Lifetime USRE42560E1 (en) | 1997-12-05 | 2003-10-24 | Electrochemical biosensor test strip |
US13/301,334 Expired - Lifetime USRE43815E1 (en) | 1997-12-05 | 2011-11-21 | Electrochemical biosensor test strip |
Country Status (14)
Country | Link |
---|---|
US (8) | US5997817A (en) |
EP (3) | EP1036320B1 (en) |
JP (7) | JP3342477B2 (en) |
CN (4) | CN100538352C (en) |
AR (2) | AR017788A1 (en) |
AU (1) | AU732761B2 (en) |
BR (2) | BRPI9815122B8 (en) |
CA (3) | CA2481195C (en) |
DE (3) | DE69839250T2 (en) |
ES (1) | ES2153808T3 (en) |
NO (1) | NO328686B1 (en) |
NZ (1) | NZ504527A (en) |
TW (3) | TWI294521B (en) |
WO (1) | WO1999030152A1 (en) |
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WO2014140172A1 (en) | 2013-03-15 | 2014-09-18 | Roche Diagnostics Gmbh | Methods of failsafing electrochemical measurements of an analyte as well as devices, apparatuses and systems incorporating the same |
WO2016014162A1 (en) | 2014-07-25 | 2016-01-28 | Becton, Dickinson And Company | Analyte test strip assays, and test strips and kits for use in practicing the same |
EP3385706A1 (en) | 2013-03-15 | 2018-10-10 | Roche Diabetes Care GmbH | Methods of scaling data used to construct biosensor algorithms as well as devices, apparatuses and systems incorporating the same |
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