WO2004113917A2 - Method and reagent for producing narrow, homogenous reagent strips - Google Patents

Method and reagent for producing narrow, homogenous reagent strips Download PDF

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Publication number
WO2004113917A2
WO2004113917A2 PCT/US2004/019591 US2004019591W WO2004113917A2 WO 2004113917 A2 WO2004113917 A2 WO 2004113917A2 US 2004019591 W US2004019591 W US 2004019591W WO 2004113917 A2 WO2004113917 A2 WO 2004113917A2
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WO
WIPO (PCT)
Prior art keywords
reagent
support material
stripe
solid support
coating
Prior art date
Application number
PCT/US2004/019591
Other languages
French (fr)
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WO2004113917A3 (en
Inventor
Christopher D. Wilsey
Dan Mosoiu
Original Assignee
Roche Diagnostics Gmbh
F. Hoffmann-La Roche Ag
Priority date (The priority date 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 date listed.)
Filing date
Publication date
Application filed by Roche Diagnostics Gmbh, F. Hoffmann-La Roche Ag filed Critical Roche Diagnostics Gmbh
Priority to JP2006517430A priority Critical patent/JP2007524816A/en
Priority to PL04755635T priority patent/PL1639352T3/en
Priority to CN2004800239248A priority patent/CN1846131B/en
Priority to MXPA05013635A priority patent/MXPA05013635A/en
Priority to ES04755635.2T priority patent/ES2675787T3/en
Priority to EP04755635.2A priority patent/EP1639352B8/en
Priority to CA2529378A priority patent/CA2529378C/en
Publication of WO2004113917A2 publication Critical patent/WO2004113917A2/en
Publication of WO2004113917A3 publication Critical patent/WO2004113917A3/en
Priority to HK07101708.4A priority patent/HK1094599A1/en

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Classifications

    • GPHYSICS
    • G01MEASURING; TESTING
    • G01NINVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N33/00Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
    • G01N33/48Biological material, e.g. blood, urine; Haemocytometers
    • G01N33/50Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing
    • G01N33/53Immunoassay; Biospecific binding assay; Materials therefor
    • G01N33/558Immunoassay; Biospecific binding assay; Materials therefor using diffusion or migration of antigen or antibody
    • GPHYSICS
    • G01MEASURING; TESTING
    • G01NINVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N27/00Investigating or analysing materials by the use of electric, electrochemical, or magnetic means
    • G01N27/26Investigating or analysing materials by the use of electric, electrochemical, or magnetic means by investigating electrochemical variables; by using electrolysis or electrophoresis
    • G01N27/28Electrolytic cell components
    • G01N27/30Electrodes, e.g. test electrodes; Half-cells
    • G01N27/327Biochemical electrodes, e.g. electrical or mechanical details for in vitro measurements
    • G01N27/3271Amperometric enzyme electrodes for analytes in body fluids, e.g. glucose in blood
    • YGENERAL 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
    • Y10TECHNICAL SUBJECTS COVERED BY FORMER USPC
    • Y10TTECHNICAL SUBJECTS COVERED BY FORMER US CLASSIFICATION
    • Y10T156/00Adhesive bonding and miscellaneous chemical manufacture
    • Y10T156/10Methods of surface bonding and/or assembly therefor
    • Y10T156/1052Methods of surface bonding and/or assembly therefor with cutting, punching, tearing or severing
    • Y10T156/1059Splitting sheet lamina in plane intermediate of faces
    • YGENERAL 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
    • Y10TECHNICAL SUBJECTS COVERED BY FORMER USPC
    • Y10TTECHNICAL SUBJECTS COVERED BY FORMER US CLASSIFICATION
    • Y10T156/00Adhesive bonding and miscellaneous chemical manufacture
    • Y10T156/10Methods of surface bonding and/or assembly therefor
    • Y10T156/1052Methods of surface bonding and/or assembly therefor with cutting, punching, tearing or severing
    • Y10T156/1084Methods of surface bonding and/or assembly therefor with cutting, punching, tearing or severing of continuous or running length bonded web

Definitions

  • Reagent Stripe application entitled “Reagent Stripe for Test Strip” (hereinafter “Reagent Stripe application”), filed on even date herewith and incorporated herein by reference in its entirety.
  • the present invention relates generally to reagents' used in biosensors or test strips and more particularly to the production of narrow, homogenous reagent stripes on flat surfaces of test strips.
  • electrochemical biosensors have mainly been produced by using printing techniques such as screen printing processes or dispensing techniques for liquid reagent application and subsequent drying, (see. e.g., U.S. Patent Number 5,437,999 and WO 97/02487).
  • printing techniques such as screen printing processes or dispensing techniques for liquid reagent application and subsequent drying, (see. e.g., U.S. Patent Number 5,437,999 and WO 97/02487).
  • these dispensing methods have successfully been employed, as in the production of Roche Diagnostics AccuChek ® Advantage test strips. While these techniques allow for the production of reliable electrochemical biosensors, they are not well suited for high throughput production lines.
  • reagent layers are cut into small stripes and then applied to the test strip substrate.
  • Blade coating of reagent masses has the disadvantage that - although the center portion of the film is homogenous in thickness - at the edge of the coated area inhomogeneities are found which are believed to be due to drying effects and edge effects. While these inhomogeneities are acceptable if broad bands of reagents are coated onto substrates since the inhomogeneous edge portions of the coating can be' discarded by edge trim, these inhomogeneities become more and more unacceptable as the reagent stripe to be coated becomes smaller/narrower.
  • WO 02/057781 discloses a method for manufacturing reagent strips from web material. Among other things, it discloses that the reagent material may be applied to the strip support material by laying down a narrow stripe of reagent material, which may or may not be supported by a support carrier.
  • U.S. Patent Application Publication 2003/0097981, U.S. Patent Publication Number 2003/0099773, U.S. Patent Numbers 6,676,995 and 6,689,411 and EP 1 316 367) disclose a solution stripping system for laying down stripes of reagent solutions on a substrate.
  • U.S. Patent Numbers 3,032,008; 3,886,898; and 4,106,437 teach coating apparatuses useful for coating liquid material onto solid supports.
  • U.S. Patent Number 6,036,919 discloses reagent films for optical blood glucose test strips.
  • the reagent composition comprises, among other things, a Xanthan gum.
  • U.S. Patent Application Publication Number 2003/0146113 discloses reagent films for electrochemical coagulation sensors.
  • the reagent composition comprises, among other things, carboxylated microcrystalline cellulose (Avicel ® R591) as a film former.
  • This object is reached by the present invention concerning a reagent for a slot-die-coating process for narrow and homogenous reagent stripes.
  • the present invention concerns a reagent composition showing shear thinning, slightly thixotropic or thixotropic behavior.
  • the present invention concerns a method of coating the shear thinning, slightly thixotropic or thixotropic reagent composition onto web material using a slot-die-coating process.
  • the present invention concerns analytical test elements comprising the shear thinning, slightly thixotropic or thixotropic reagent.
  • the present invention concerns reagent compositions that are shear thinning and at least slightly thixotropic. It also concerns analytic test elements and methods for making analytic test elements that include using shear thinning and at least slightly thixotropic reagent compositions.
  • Figure 1 shows schematically in 6 steps (A - F) how an electrochemical test element with a single reagent zone is manufactured using the slot-die-coating process of the present invention.
  • Figure 2 shows schematically in 6 steps (A - F) how an electrochemical test element with two reagent zones is manufactured using the slot-die-coating process of the present invention.
  • Figure 3 shows the results of a profilometric measurement across the reagent stripe according to Example 1.
  • Figure 4 represents the data of profilometric measurements across reagent stripes according to the present invention.
  • Figure 5 represents the data of profilometric measurements across reagent stripes without the use of rheological modifiers of the present invention.
  • Figure 6 is a photograph of a microscope view of a reagent stripe coated onto a web material according to the present invention.
  • Figure 7 shows two photographs (Fig. 7A and 7B) of a microscope view of a reagent stripe coated onto a web material without the use of rheological modifiers of the present invention.
  • the reagent composition of the present invention is shear thinning, slightly thixotropic or thixotropic.
  • Thixotropic reagent compositions are reagent compositions that show rheologic behavior depending on whether or not external shear force is applied to the reagent composition.
  • Shear thinning reagent compositions are reagent compositions that become thinner, i.e., less viscous, when a shear force is applied to them.
  • the composition before applying a shear force to the reagent composition of the present invention, the composition has a certain viscosity. When a shear force is applied to the composition, its viscosity is reduced.
  • the reagent composition shall be regarded as being "shear thinning.” If viscosity increases only with a certain delay after the shear force is stopped the reagent composition shall be regarded as being "thixotropic.”
  • Thixotropy is a special case of pseudoplasticity.
  • the thixotropic fluid undergoes "shear thinning.” But as shear forces are reduced, viscosity rebuilds and increases at a slower rate, thus producing a hysteresis loop. Slightly thixotropic fluids have a less pronounced hysteresis.
  • the thixotropic behavior is influenced considerably by the shear history of the material under investigation. In comparative measurements, care should be taken to ensure that an identical or at least very similar history of the samples to be compared is given.
  • the reagent compositions of the present invention are useful in slot-die- coating processes.
  • the fluid reagent composition is applied to a solid substrate, preferably a substrate in the form of a web material, by forcing the reagent liquid or slurry through the slot of a slot-die-coating head.
  • a solid substrate preferably a substrate in the form of a web material
  • the web material passes the slot at a certain distance with certain speed.
  • the slot-die-coating head moves across the web material, or that the slot-die head and web both move.
  • the rheologic properties of the reagent composition used as a coating mass are within certain preferred ranges:
  • the viscosity preferably is between about 70 and about 130 mPa-s, most preferably in the range between 95 and 115 mPa-s.
  • the surface tension ranges advantageously between 30 and 50 mN/m and preferably is about 40 + 2 mN/m. It is also important that the coating mass shows shear thinning, slightly thixotropic or thixotropic behavior.
  • One aspect of the present invention is the inclusion of Xanthan gum into the reagent coating mass.
  • Xanthan gum One brand of Xanthan gum that can be used is Keltrol ® . This component shows an influence on the thixotropy of the reagent mass.
  • Reagent coating masses containing Xanthan gum, for example, Keltrol ® allow the production of extremely thin reagent layers.
  • the reagent layer dried films have a thickness less than 10 ⁇ m, particularly preferred are dried reagent layers in the range of 1.5 to 5 ⁇ m thick.
  • the incorporation of silica into the reagent compositions of the present invention has an advantageous effect for the viscosity and thixotropy behavior of the reagent. Both properties are enhanced by the addition of silica.
  • untreated, hydrophilic silica is used.
  • the particle size of a preferred form of silica ranges from about 1 to 7 ⁇ m.
  • silica unexpectedly enhances the thixotropic behavior of other components of the coating mass, in particular of carboxymethyl cellulose and Keltrol ® .
  • silica particles in the dry film prevent backside transfer between the coated stripe and the backside of the web, allowing storage of the coated web material as rolls of material.
  • silica particles in the dry film increase the specific surface of the reagent coating, enabling, for example, rapid dissolving of the reagent in a sample liquid.
  • silica also improves capillary fill times and migration of components in the reagent stripe.
  • CMC carboxymethyl cellulose
  • Xanthan gum for example, Keltrol ® , silica and CMC.
  • the reagent compositions of the present invention allow the formation of thin reagent layers, for example, the production of electrochemical biosensors.
  • Thin reagent layers have several advantages: Sample components are in excess compared to the reagent components, therefore not limiting in the determination reactions.
  • Thin reagent layers can be made homogenous in thickness. Thin reagent layers contain only small amounts of reagent, which in turn lead to fast reaction times. The reactions only have short diffusion times.
  • the thin reagent layers are quickly soluble and therefore lead to quick reagent availability and a rapid equilibration of the matrix after sample rehydration of the reagent stripe, which in turn leads to fast measurements.
  • the inventive reagent layers can not only be made very thin but also show a high homogeneity down web and across web in the reaction area.
  • the reagent layer in the test area is flat and uniform in thickness. Thickness variations in the coated stripe occur preferably only on the outer 0.2 cm (or less) edges of the stripe. In preferred embodiments, these areas advantageously can either be covered during sensor assembly by spacer layers or can be trimmed from the completed sensor in the final assembly process.
  • the reagent may further comprise one or more substances (ingredients) of the following substance classes.
  • Substances, additives and ingredients that may be added to the reagent includes, but are not limited to, the following: buffers, for example, phosphate buffers; enzymes, such as, glucose dehydrogenase, glucose dye oxidoreductase, glucose oxidase and other oxidases or dehydrogenases such as for lactate or cholesterol determination, esterases etc.; mediators such as nitrosoanilines, ferricyanide, ruthenium hexamine, osmium complexes; stabilizers, such as trehalose, sodium succinate; thickeners, such as Keltrol ® , CMC proteins, such as enzymes, bovine serum albumin indicators; dyes; surfactants, such as Mega 8 ® , Geropon ® ; Triton
  • Non-limiting examples of enzymes and mediators that may be used in measuring particular analytes are listed below in Table 1.
  • Triglycerides Lipoprotein Lipase, Ferricyanide or Phenazine Methosulfate Glycerol Kinase and Phenazine Glycerol-3-Phosphate Ethosulfate Oxidase
  • Uric Acid Uricase Ferricyanide in some of the examples shown in Table 1, at least one additional enzyme is used as a reaction catalyst. Also, some of the examples shown in Table 1 may utilize an additional mediator, which facilitates electron transfer to the oxidised form of the mediator. The additional mediator may be provided to the reagent in lesser amount than the oxidized form of the mediator. While the above assays are described, it is contemplated that current, charge, impedance, conductance, potential, or other electrochemically indicated property of the sample might be accurately correlated to the concentration of the analyte in the sample with an electrochemical biosensor in accordance with this disclosure.
  • Examples of reagent compositions are given as Examples 1, 2, 3 and 4 for electrochemical blood glucose and coagulation sensors, respectively.
  • the above reagent compositions are applied to substrates which already contain the electrode traces or circuits of an electrochemical sensor by means of a slot-die-coating process.
  • An example of this process is given in Example 5.
  • the preferred fabrication technique for these electrode circuits uses a laser ablation process.
  • laser ablation For a further discussion of laser ablation, please see WO 01/25775, which is hereby incorporated by reference in its entirety.
  • the technique uses a reel-to-reel laser ablation process. This process can be used in reel-to-reel fashion to form extremely thin metal structures on polymeric substrates, which metal structures can be used as electrode traces in electrochemical sensors.
  • the reagent can be applied to these structures using the above process.
  • the capillary channel and spacer structure of the sensor can be formed by using a double sided adhesive tape with a respective cutout as a spacer structure and covering parts of the reagent layer on the electrode substrate.
  • the invention concerns a method or process for producing a reagent layer on a solid support material using the shear thinning, slightly thixotropic or thixotropic reagent composition of the invention.
  • the process includes providing a solid support material such as a web of plastics material like Melinex ® 329 of DuPont.
  • the solid support material is moved relative to a slot-die-coating head.
  • the solid support web material is transported in a reel-to-reel process across the slot of the die-coating head.
  • the coating gap is in the range of between 30 and 90 ⁇ m; typically between 68 and 83 ⁇ m, most preferred between 72 and 76 ⁇ m.
  • the reagent is deposited onto the solid support material, forming a continuous stripe of reagent on the solid support material.
  • the web material may comprise electrode traces and the reagent stripe may partly cover these traces.
  • the reagent stripe has a width of less than 1 cm and a height of less than 10 ⁇ m.
  • the solid support material is moved relative to the slot-die- coating head at a speed of between 20 and 80 m/min, most preferably at a speed of between 30 and 40 m/min.
  • the reagent composition is delivered to the solid support material at a coating flux of 5.5 to 30 g/min, most preferably at a flux of 13 to 15 g/min.
  • the deposited reagent stripe is dried either under ambient conditions or in a heated airflow.
  • the invention concerns analytical test elements that comprise the above reagent composition.
  • the analytical test elements of the present invention are manufactured according to the process as described above. The invention has the following advantages:
  • Sensors requiring small sample volumes can easily be constructed using the slot die coated dry film and spacer/capillary channel lamination processes.
  • the dry film stripe is of uniform thickness and is homogeneous over the electrochemical reaction area.
  • the required capillary dimensions/imprecision of the sensor is dependent on the variation in spacer thickness and the construction of the capillary channel.
  • the slot-die-coating technology can be paired with a sophisticated layout of the electrodes design, thus enabling the capability of miniaturizing and creating multiple applications in the sensor capillary, (for example, staggering two or more lines/stripes of different reagents within an adequately designed layout of electrodes).
  • Two staggered slot dies or a special slot die assembly designed for two or more fluids can be used to achieve this goal.
  • the coating fluids preferably will have properly matching rheologic properties. The best technological case is achieved if the coating windows of the different fluids have a consistent overlapping region.
  • the slot-die-coating film application technology paired and combined with the rheologic properties of the reagent enables homogeneous coatings using a reel to reel coating process for rapid production of diagnostic sensors.
  • Thixotropy or shear thinning behavior is the main rheologic feature of the fluid to be coated in respect to the mass distribution and its profile across the coated layer, impacting on the flatness, repeatability and homogeneity of the wet and dried layer. This feature is reached by using Xanthan gum, for example, Keltrol ® , CMC and Silica in a concentration and combination to match the desired shear thinning, slightly thixotropic or thixotropic behavior of the coating fluid.
  • silica in particular the preferred untreated, hydrophilic silica, preferably with a particle size D50 (i.e., 50 % of the particles have a size of the given size or below) of 1 to 7 ⁇ m, in the "wet" status (in the coating fluid) is that in combination with the film thickeners (Keltrol ® and CMC, either one or both of them) silica increases the viscosity and enhances the shear thinning, slightly thixotropic or thixotropic behavior of the coating fluid.
  • a particle size D50 i.e., 50 % of the particles have a size of the given size or below
  • Silica acts in the dried state to, among other things: a) prevent back transfer of the dried film on the un-coated side of the foil/carrier if the web material is wound to rolls after the coating and drying processes, and b) enlarge the specific surface of the dried coating layer as compared to a smooth coating layer. Without wishing to be tied to any specific theory, this is likely due to the particle-size distribution of silica particles. Since the speed of fluid transport is increased by the ratio between the surface area and the fluid volume, this enlarged specific surface is speeding up the wetting process of the dried film and in consequence leads to a shorter capillary fill time.
  • Figures 1 and 2 are schematic representations of the several steps that are done during the manufacturing process for electrochemical test elements using the reagent composition and process of the present invention. A person of ordinary skill in the art would readily recognize that the process can be used with other electrode configurations and with multiple stripes having the same or different composition and different positions on the strip. It is to be noted that the processes described in Figures 1 and 2 could also be carried out without electrodes present on the test strips. A person of ordinary skill in the art would readily recognize that the process and reagent described herein can also be adapted to optical test elements as well.
  • Parts A and B of Figures 1 and 2 are identical and show a polymer web (1), preferably an inert plastic material such as Melinex ® 329 of DuPont (see, e.g., part A), on which is coated a metal layer (2) (see, e.g., part B) by conventional techniques such as sputtering, chemical, electrochemical or physical vapor deposition, etc.
  • a polymer web (1) preferably an inert plastic material such as Melinex ® 329 of DuPont (see, e.g., part A)
  • a metal layer (2) see, e.g., part B
  • sputtering chemical, electrochemical or physical vapor deposition, etc.
  • the metal layer (2) subsequently is structured by for example a laser ablation process.
  • This process removes parts of the metal layer (2) and discrete structures of metal which can act as electrodes (3, 4) remain on the surface of the polymer web (1).
  • conventional printing techniques or lithographic processes can also be used to create electrodes (3, 4) on the polymer web (1).
  • a spacer layer (6) is laminated to the electrode structure of part D of Figures 1 and 2.
  • the spacer (6) is preferably a double-sided adhesive tape that covers all parts of the reagent and electrode structures that are not to be brought into contact with liquid sample.
  • the spacer (6) has a cutout that defines the reactive area of the reagent and the underlying electrodes.
  • the spacer (6) leaves free parts of the electrode structures that can be used to connect the test strip to a respective test strip reading meter.
  • Spacer (6) preferably covers a narrow part (less than 2 mm) of the reagent
  • a top foil (7) preferably an inert plastics cover, is placed onto the surface of the spacer (6) that is not in contact with the polymer web (1).
  • the polymer web (1), the spacer (6) and the top foil (7) form a 3D capillary channel which is defined by the thickness of the spacer (6) and the dimensions of the cut-out in the spacer.
  • the top foil (7) or the polymer web (1) has a vent opening (8).
  • the surfaces of either the polymer web (1) or the top foil (7) that face the capillary space can be rendered hydrophilic by a respective hydrophilic treatment, for example, by coating with a surfactant or plasma treatment.
  • Example 1 Reagent composition for use in an electrochemical amperometric glucose biosensor.
  • Keltrol ® F (Xanthan gum) Kelco 0.2136 %
  • Carboxymethyl cellulose (CMC) Hercules-Aqualon 0.5613 %
  • Glucose-dye-oxidoreductase (GlucDOR) Roche Diagnostics (E.C. 1.1.99.17) 0.3310 % pyrroloquinoline quinine (PQQ) Roche Diagnostics 0.0092 %. .
  • Sipernat ® 320 DS synthetic, amorphous Degussa E[ ⁇ ls precipitated silica) 2.0039 %
  • Geropon ® T 77 (Sodium N-methyl N-oleyl Rhodia Chimie taurate) 0.0298 %
  • the reagent matrix was custom modified to meet the demands of the slot- die-coating process.
  • CMC CMC
  • surfactants were added to the coating matrix to modify the rheology of the reagent mass.
  • Surfactant concentrations were adjusted to obtain surface tensions (measured with a Tensiometer K10T (Kruess)) in the most preferred range of 33 to 42 mN/m. Surface tension in this range promotes better adhesion and controlled spreading of the coated stripe on the web.
  • the most preferred viscosity range measured using a Rheomat 115 (Contraves) for the coating mass is 95 to 115 mPa-s.
  • the polymers and the silica also impart thixotropic behavior to the coating. Coatings shear thin as they are dispensed through the slot die head onto the web. This reduces the apparent viscosity of the coating.
  • Stripes of reagent coating mass with these lower viscosities show a migration of the stripe edges and reagent components toward the center of the stripe during the drying process. This migration leads to an irregular and irreproducible surface profile in the middle of the dried stripe. Dispense of coatings having shear thinning, slightly thixotropic or thixotropic properties show the same shear thinning effects. However, the viscosity of the coated stripe returns to near the apparent viscosity shortly after being dispensed and before entering the drying region. The migration of the stripe edges towards the center during drying is retarded. As illustrated in Figure 3, this leads to a flat reproducible region in the center of the stripe, in the reaction area. Thinner films further retard the migration of the coating edges to the center of the coated stripe.
  • Example 2 Reagent composition for an electrochemical amperometric coagulation sensor. An aqueous mixture of the following components was prepared:
  • Keltro F (Xanthan gum) Kelco 2.89 g/l
  • Example 3 Alternative reagent composition for an electrochemical amperometric glucose biosensor.
  • Keltro F (Xanthan gum) Kelco 0.20 %
  • Gantrez® S97 Metal vinylether/maleic ISP anhydride copolymer
  • Glucose-dye-oxidoreductase (GlucDOR) Roche Diagnostics (E.C. 1.1.99.17?) 0.33 % pyrroloquinoline quinine (PQQ) Roche Diagnostics 0.0093 %
  • Geropon® T 77 (Sodium N-methyl N-oleyl Rhodia Chimie taurate) 0.030 %
  • Example 4 Alternative reagent composition for an electrochemical amperometric glucose biosensor.
  • KeltroKDF (Xanthan gum) Kelco 0.20 %
  • Gantrez ® S97 Metal vinylether/maleic ISP anhydride copolymer 0.50 %
  • Carboxymethyl cellulose (CMC) Hercules-Aqualon 0.50 %
  • Glucose-dye-oxidoreductase (GlucDOR) Roche Diagnostics (E.G. 1.1.99.17?) 0.34 % pyrroloquinoline quinine (PQQ) Roche Diagnostics 0.0093 %
  • Geropon ® T 77 (Sodium N-methyl N-oleyl Rhodia Chimie taurate) 0.030 %
  • the polymer web (Melinex ® 329, DuPont) is moved into the coating area, containing a slot die head and a back up roller.
  • the slot die head (TSE, Switzerland) is zeroed to the web surface and adjusted to a slot to web gap of 74 ⁇ m. Web speed is ramped up from 0 to 38 m/min for deposition of coating on the web.
  • the reagent matrix can be delivered to the slot die head using a variety of means including gear pumps, pistons, syringes, bladder systems.
  • the reagent delivery system is adjusted to a water flow of 13.58 ml/min to deliver a coat weight of 53 g/m 2 through the coating head.
  • the width of the resulting coated stripe is 7.0 + 0.3 mm.
  • the coating is dried in the heated drying zone (length 15 m, temperature 110 °C, at a speed of 38 m/min) and rewound on spools at the rewind station.
  • Figures 3 to 5 show the results of profilometric measurements across the reagent stripe according to this example.
  • the profilometer system used was a Dektak IIA Surface Profile Measuring System (Neeco Instruments Inc., Sloan Technology Division, Dallas, Texas). Profile data from the Dektak IIA were baseline corrected.
  • P (mm) denotes the x-position of the scan across the web and reagent stripe (in mm) and H ( ⁇ m) denotes the respective relative height of the coating (in ⁇ m).
  • the reagent mass was prepared according to Example 1.
  • the reagent stripe has a cross-sectional width of about 7 mm and a respective average center height of approximately 5 ⁇ m.
  • the edges of the reagent coating are relatively sharp.
  • the homogeneous plateau region of the coating fills approximately 80 % of the reagent stripe width.
  • the profile of the reagent coating as depicted in Figure 3 is typical for coatings according to the present invention.
  • reagent stripes of 10 mm or less in width sharp edges can be obtained, which ramp up from the underlying web material (corresponding to a coating height of zero) to the plateau region in the center of the coating within 1 mm on each side or less (i.e. 80 % or more of the coating belong to the homogeneous center plateau region).
  • the reagent coating is practically uniform in thickness.
  • Figure 4 shows the results of profilometric measurements across the reagent stripe prepared according to this example.
  • Scan Distance ( ⁇ m) denotes the x- position of the scan across the web and reagent stripe (in ⁇ m) and Height ( ⁇ m) denotes the respective relative height of the coating (in ⁇ m).
  • the reagent mass was prepared according to Example 1 with milled silica.
  • Figures 4A to 4E give the results for coating weights of 20, 25, 30, 40 and 50 mg/m 2 , respectively.
  • Figure 5 illustrates the results of profilometric measurements across a reagent stripe prepared according to a comparative example, i.e., not in accordance with the teachings of the present invention.
  • Scan Distance ( ⁇ m) denotes the x- position of the scan across the web and reagent stripe (in ⁇ m) and Height ( ⁇ m) denotes the respective relative height of the coating (in ⁇ m).
  • the reagent mass was prepared according to Example 1 however without the presence of the rheological modifiers Keltrol ® , CMC and silica.
  • Figure 5A and 5B show that without rheological modifiers the dried reagent coating tends to form inhomogeneous reagent stripes on the web material.
  • the reagent concentrates in the center portion of the coated stripe; in Fig. 5B, the reagent concentrates in two regions located between the center and the edge portions of the reagent stripes. In both cases, the edge portions are depleted from reagent.
  • Comparison of Fig. 5 (comparative example) with Figs. 3 and 4 both according to the present invention reveals the advantageous effects of the reagent composition and process of the present invention.
  • Figure 6 is a photograph of a microscope view of a reagent stripe (central dark rectangular area) coated onto a web material (light areas around the central stripe) from a reagent composition according to Example 1 (and comparable to the profilometric data shown in Figure 4). Coating was done according to Example 5. The coated stripe shows good homogeneity across the coating direction (coating direction was from top to bottom) as well as along this direction.
  • Figures 7 A and 7B are photographs of microscope views (comparative examples) of reagent stripes coated onto web material with profilometric data comparable to that shown in Figure 5. Coating was done according to Example 5; however, the reagent did not contain the rheological modifiers. The coated stripes clearly show inhomogeneities across the coating direction (coating direction was from top to bottom). For example, regions of thicker reagent are manifested by the dark bands running along the stripes. Figure 7A shows one such dark band positioned in about the middle of the stripe (compare Fig. 5 A), whereas Fig. 7B shows two dark bands (compare Fig. 5B). These one or two regions of thicker reagent coatings (dark zones) within the reagent stripe are believed due to drying effects of the reagent coating materials.
  • Example 6 Variation of rheological modifiers in the reagent composition of Example 1.
  • Example 1 In the reagent composition of Example 1 the contents of the ingredients CMC, Keltrol ® , Propiofan ® and PNP were varied in accordance with the following

Abstract

The present application concerns a reagent coating mass which can be used in slot-die-coating of flat support materials in the manufacturing processes of test strips. Advantageously, the reagent mass of the invention exhibits certain superior rheological properties such as viscosity, surface tension and thixotropy. The reagent typically comprises an enzyme, a redox radiator and viscosity modifiers and thickeners, eg. Xanthan gum, silica, caboxy methyl cellulose, and surfactants to yield between 70 and 130 mPa.s and a surface tension between 30 and 50 nM/m. The reagent mass is preferably used to coat thin, narrow and homogeneous stripes of reagent material onto flat web material.

Description

METHOD AND REAGENT FOR PRODUCING NARROW. HOMOGENOUS REAGENT STRIPS
RELATED APPLICATIONS
This application claims priority to U.S. Provisional Patent Application Serial No. 60/480,397, filed June 20, 2003. This application is related to a commonly assigned application entitled "Reagent Stripe for Test Strip" (hereinafter "Reagent Stripe application"), filed on even date herewith and incorporated herein by reference in its entirety.
FIELD OF THE INVENTION
The present invention relates generally to reagents' used in biosensors or test strips and more particularly to the production of narrow, homogenous reagent stripes on flat surfaces of test strips.
BACKGROUND AND SUMMARY
Of the numerous methods for applying reagents to test strips, in the past electrochemical biosensors have mainly been produced by using printing techniques such as screen printing processes or dispensing techniques for liquid reagent application and subsequent drying, (see. e.g., U.S. Patent Number 5,437,999 and WO 97/02487). In connection with so-called "capillary fill" test strips, these dispensing methods have successfully been employed, as in the production of Roche Diagnostics AccuChek® Advantage test strips. While these techniques allow for the production of reliable electrochemical biosensors, they are not well suited for high throughput production lines. In addition, these dispensing techniques suffer from the disadvantage of inhomogeneous drying of the reagent, which leads to non-uniform reagent thickness over the covered electrode area. Also, the above mentioned techniques are not suited for the reliable and reproducible production of extremely thin reagent layers (10 μm or less). Therefore, there exists a need for improved reagent application methods. Blade coating of reagent compositions onto flat substrates has been suggested and successfully been employed in the production of reagent films coated for example on transparent polymeric substrates (e.g., U.S. Patent Nos. 5,437,999 and 6,036,919). Usually, films of a width of several centimeters to several meters can be produced by this method. For the production of test strips, the so created reagent layers are cut into small stripes and then applied to the test strip substrate. Blade coating of reagent masses has the disadvantage that - although the center portion of the film is homogenous in thickness - at the edge of the coated area inhomogeneities are found which are believed to be due to drying effects and edge effects. While these inhomogeneities are acceptable if broad bands of reagents are coated onto substrates since the inhomogeneous edge portions of the coating can be' discarded by edge trim, these inhomogeneities become more and more unacceptable as the reagent stripe to be coated becomes smaller/narrower. WO 02/057781 discloses a method for manufacturing reagent strips from web material. Among other things, it discloses that the reagent material may be applied to the strip support material by laying down a narrow stripe of reagent material, which may or may not be supported by a support carrier.
U.S. Patent Application Publication 2003/0097981, U.S. Patent Publication Number 2003/0099773, U.S. Patent Numbers 6,676,995 and 6,689,411 and EP 1 316 367) disclose a solution stripping system for laying down stripes of reagent solutions on a substrate. The system allows slot-die-coating of reagent solutions to web material, e.g., for electrochemical glucose sensors, which solutions have a low viscosity, from about 0.5 to 25 centipoises (cP = mPa-s). U.S. Patent Numbers 3,032,008; 3,886,898; and 4,106,437 teach coating apparatuses useful for coating liquid material onto solid supports. U.S. Patent Number 6,036,919 discloses reagent films for optical blood glucose test strips. The reagent composition comprises, among other things, a Xanthan gum.
U.S. Patent Application Publication Number 2003/0146113 discloses reagent films for electrochemical coagulation sensors. The reagent composition comprises, among other things, carboxylated microcrystalline cellulose (Avicel® R591) as a film former.
None of the above-mentioned references satisfies the need for a reliable method for forming narrow (for example, less than 1 cm), thin (for example, less than 10 μ.m) and homogeneous reagent stripes on solid support material for producing test strips, in particular electrochemical test strips.
It is therefore an object of the invention to provide a method and a corresponding reagent composition with which extremely thin, narrow and homogeneous reagent lines or stripes can be deposited onto flat surfaces, for example, of web material and in particular onto the electrode areas of electrochemical biosensor test strips.
This object is reached by the present invention concerning a reagent for a slot-die-coating process for narrow and homogenous reagent stripes.
In a first aspect, the present invention concerns a reagent composition showing shear thinning, slightly thixotropic or thixotropic behavior.
In a second aspect, the present invention concerns a method of coating the shear thinning, slightly thixotropic or thixotropic reagent composition onto web material using a slot-die-coating process.
In a further aspect, the present invention concerns analytical test elements comprising the shear thinning, slightly thixotropic or thixotropic reagent.
In still another aspect, the present invention concerns reagent compositions that are shear thinning and at least slightly thixotropic. It also concerns analytic test elements and methods for making analytic test elements that include using shear thinning and at least slightly thixotropic reagent compositions. BRIEF DESCRIPTION OF THE DRAWINGS
Figure 1 shows schematically in 6 steps (A - F) how an electrochemical test element with a single reagent zone is manufactured using the slot-die-coating process of the present invention. Figure 2 shows schematically in 6 steps (A - F) how an electrochemical test element with two reagent zones is manufactured using the slot-die-coating process of the present invention.
Figure 3 shows the results of a profilometric measurement across the reagent stripe according to Example 1. Figure 4 represents the data of profilometric measurements across reagent stripes according to the present invention.
Figure 5 represents the data of profilometric measurements across reagent stripes without the use of rheological modifiers of the present invention.
Figure 6 is a photograph of a microscope view of a reagent stripe coated onto a web material according to the present invention.
Figure 7 shows two photographs (Fig. 7A and 7B) of a microscope view of a reagent stripe coated onto a web material without the use of rheological modifiers of the present invention.
DESCRIPTION OF THE PREFERRED EMBODIMENTS
For the purposes of promoting an understanding of the principles of the invention, reference will now be made to the specific embodiments illustrated herein and specific language will be used to describe the same. It will nevertheless be understood that no limitation of the scope of the invention is thereby intended. Any alterations and further modifications in the described processes or devices and any further applications of the principles of the invention as described herein, are contemplated as would normally occur to one skilled in the art to which the invention relates. Preferred embodiments of the invention are subject of the dependent claims.
The reagent composition of the present invention is shear thinning, slightly thixotropic or thixotropic. Thixotropic reagent compositions are reagent compositions that show rheologic behavior depending on whether or not external shear force is applied to the reagent composition. Shear thinning reagent compositions are reagent compositions that become thinner, i.e., less viscous, when a shear force is applied to them. In general, before applying a shear force to the reagent composition of the present invention, the composition has a certain viscosity. When a shear force is applied to the composition, its viscosity is reduced. If viscosity increases again - with a certain time-dependency - after the shear force is stopped, the reagent composition shall be regarded as being "shear thinning." If viscosity increases only with a certain delay after the shear force is stopped the reagent composition shall be regarded as being "thixotropic."
Thixotropy is a special case of pseudoplasticity. The thixotropic fluid undergoes "shear thinning." But as shear forces are reduced, viscosity rebuilds and increases at a slower rate, thus producing a hysteresis loop. Slightly thixotropic fluids have a less pronounced hysteresis. In addition, the thixotropic behavior is influenced considerably by the shear history of the material under investigation. In comparative measurements, care should be taken to ensure that an identical or at least very similar history of the samples to be compared is given. The reagent compositions of the present invention are useful in slot-die- coating processes. During slot-die-coating, the fluid reagent composition is applied to a solid substrate, preferably a substrate in the form of a web material, by forcing the reagent liquid or slurry through the slot of a slot-die-coating head. Usually, the web material passes the slot at a certain distance with certain speed. However, it is also possible that the slot-die-coating head moves across the web material, or that the slot-die head and web both move.
To achieve the objects of the present inventions, it is advantageous that the rheologic properties of the reagent composition used as a coating mass are within certain preferred ranges: The viscosity preferably is between about 70 and about 130 mPa-s, most preferably in the range between 95 and 115 mPa-s. The surface tension ranges advantageously between 30 and 50 mN/m and preferably is about 40 + 2 mN/m. It is also important that the coating mass shows shear thinning, slightly thixotropic or thixotropic behavior.
One aspect of the present invention is the inclusion of Xanthan gum into the reagent coating mass. One brand of Xanthan gum that can be used is Keltrol®. This component shows an influence on the thixotropy of the reagent mass.
Reagent coating masses containing Xanthan gum, for example, Keltrol®, allow the production of extremely thin reagent layers. Preferably, the reagent layer dried films have a thickness less than 10 μm, particularly preferred are dried reagent layers in the range of 1.5 to 5 μm thick. It has turned out that the incorporation of silica into the reagent compositions of the present invention has an advantageous effect for the viscosity and thixotropy behavior of the reagent. Both properties are enhanced by the addition of silica. Preferably, untreated, hydrophilic silica is used. The particle size of a preferred form of silica ranges from about 1 to 7 μm. It has turned out that silica unexpectedly enhances the thixotropic behavior of other components of the coating mass, in particular of carboxymethyl cellulose and Keltrol®. Also, silica particles in the dry film prevent backside transfer between the coated stripe and the backside of the web, allowing storage of the coated web material as rolls of material. In addition, silica particles in the dry film increase the specific surface of the reagent coating, enabling, for example, rapid dissolving of the reagent in a sample liquid. i capillary fill biosensors comprising reagent stripes including the reagent composition of the present invention, silica also improves capillary fill times and migration of components in the reagent stripe.
Yet another additive for the enhancement of viscosity and thixotropy of the reagent is carboxymethyl cellulose (CMC). Especially preferred embodiments of the inventive reagent composition therefore comprise Xanthan gum, for example, Keltrol®, silica and CMC.
The reagent compositions of the present invention allow the formation of thin reagent layers, for example, the production of electrochemical biosensors. Thin reagent layers have several advantages: Sample components are in excess compared to the reagent components, therefore not limiting in the determination reactions.
Thin reagent layers can be made homogenous in thickness. Thin reagent layers contain only small amounts of reagent, which in turn lead to fast reaction times. The reactions only have short diffusion times.
The thin reagent layers are quickly soluble and therefore lead to quick reagent availability and a rapid equilibration of the matrix after sample rehydration of the reagent stripe, which in turn leads to fast measurements.
The inventive reagent layers can not only be made very thin but also show a high homogeneity down web and across web in the reaction area. The reagent layer in the test area is flat and uniform in thickness. Thickness variations in the coated stripe occur preferably only on the outer 0.2 cm (or less) edges of the stripe. In preferred embodiments, these areas advantageously can either be covered during sensor assembly by spacer layers or can be trimmed from the completed sensor in the final assembly process.
Apart from the above-mentioned components, which influence the rheologic properties of the reagent composition of the present invention, the reagent may further comprise one or more substances (ingredients) of the following substance classes. Substances, additives and ingredients that may be added to the reagent includes, but are not limited to, the following: buffers, for example, phosphate buffers; enzymes, such as, glucose dehydrogenase, glucose dye oxidoreductase, glucose oxidase and other oxidases or dehydrogenases such as for lactate or cholesterol determination, esterases etc.; mediators such as nitrosoanilines, ferricyanide, ruthenium hexamine, osmium complexes; stabilizers, such as trehalose, sodium succinate; thickeners, such as Keltrol®, CMC proteins, such as enzymes, bovine serum albumin indicators; dyes; surfactants, such as Mega 8®, Geropon®; Triton®, Tween®, Mega 9®, DONS; film formers, such as Keltrol®, Propiofan®, polyvinyl pyrrolidone, polyvinyl alcohol, Klucel®; co-factors for enzymes, such as NAD, NADH, PQQ; and silica, for example, DS 300, DS 320, milled silica of DS 300, milled silica of
DS 320.
Non-limiting examples of enzymes and mediators that may be used in measuring particular analytes are listed below in Table 1.
TABLE 1
A partial list of some analytes, enzymes and mediators that can be used to measure the levels of particular analytes.
Analvte Enzvmes Mediator Additional Mediator (Oxidized Form)
Glucose Glucose Dehydrogenase Ferricyanide and Diaphorase
Glucose Glucose-Dehydrogenase Ferricyanide (Quinoprotein)
Cholesterol Cholesterol Esterase and Ferricyanide 2,6-Dimethyl-l,4- Cholesterol Oxidase Benzoquinone
2,5-Dichloro-l,4- Benzoquinone or Phenazine Ethosulfate
HDL Cholesterol Esterase and Ferricyanide 2,6-Dimethy 1-1,4-
Cholesterol Cholesterol Oxidase Benzoquinone 2,5-Dichloro-l,4- Benzoquinone or Phenazine Ethosulfate
Triglycerides Lipoprotein Lipase, Ferricyanide or Phenazine Methosulfate Glycerol Kinase and Phenazine Glycerol-3-Phosphate Ethosulfate Oxidase
Lactate Lactate Oxidase Ferricyanide 2,6-Dichloro-l,4- Benzoquinone
Lactate Lactate Dehydrogenase Ferricyanide and Diaphorase Phenazine Ethosulfate, or Phenazine Methosulfate
Lactate Diaphorase Ferricyanide Phenazine Ethosulfate, or Dehydrogenase Phenazine Methosulfate
Pyruvate Pyruvate Oxidase Ferricyanide
Alcohol Alcohol Oxidase Phenylenediamine
Bilirubin Bilirubin Oxidase 1-Methoxy-
Phenazine
Methosulfate
Uric Acid Uricase Ferricyanide In some of the examples shown in Table 1, at least one additional enzyme is used as a reaction catalyst. Also, some of the examples shown in Table 1 may utilize an additional mediator, which facilitates electron transfer to the oxidised form of the mediator. The additional mediator may be provided to the reagent in lesser amount than the oxidized form of the mediator. While the above assays are described, it is contemplated that current, charge, impedance, conductance, potential, or other electrochemically indicated property of the sample might be accurately correlated to the concentration of the analyte in the sample with an electrochemical biosensor in accordance with this disclosure.
Examples of reagent compositions are given as Examples 1, 2, 3 and 4 for electrochemical blood glucose and coagulation sensors, respectively.
In a preferred embodiment, the above reagent compositions are applied to substrates which already contain the electrode traces or circuits of an electrochemical sensor by means of a slot-die-coating process. An example of this process is given in Example 5.
The preferred fabrication technique for these electrode circuits uses a laser ablation process. For a further discussion of laser ablation, please see WO 01/25775, which is hereby incorporated by reference in its entirety. Most preferably, the technique uses a reel-to-reel laser ablation process. This process can be used in reel-to-reel fashion to form extremely thin metal structures on polymeric substrates, which metal structures can be used as electrode traces in electrochemical sensors. The reagent can be applied to these structures using the above process. Surprisingly, it has been found that the capillary channel and spacer structure of the sensor can be formed by using a double sided adhesive tape with a respective cutout as a spacer structure and covering parts of the reagent layer on the electrode substrate. Unexpectedly, no leakage of sample liquid can be observed at the positions where the double-sided adhesive tape covers the reagent film. Therefore, it is possible to first make structured electrode traces by a laser ablation process on a web material, then slot-die-coat the reagent material and subsequently define the active reagent area which comes into contact with the blood sample by using a respectively formed double sided adhesive spacer. This process can advantageously be used to eliminate tolerances in the production line. Especially, masking the reagent coating with the spacer can be used to precisely define the actual reaction area.
In the second aspect of the present invention, the invention concerns a method or process for producing a reagent layer on a solid support material using the shear thinning, slightly thixotropic or thixotropic reagent composition of the invention. The process includes providing a solid support material such as a web of plastics material like Melinex® 329 of DuPont. During the process of the present invention, the solid support material is moved relative to a slot-die-coating head. Usually, the solid support web material is transported in a reel-to-reel process across the slot of the die-coating head. However, it is also possible, to move the die-coating head and keep the web material stationary. During the movement of the web material relative to the die-coating head, a defined distance between the web and the die-coating head is maintained. Preferably, the coating gap is in the range of between 30 and 90 μm; typically between 68 and 83 μm, most preferred between 72 and 76 μm. By forcing the reagent composition through the slot of the slot-die-coating head, the reagent is deposited onto the solid support material, forming a continuous stripe of reagent on the solid support material. As mentioned above, the web material may comprise electrode traces and the reagent stripe may partly cover these traces. Preferably, in the dried state the reagent stripe has a width of less than 1 cm and a height of less than 10 μm. Preferably, the solid support material is moved relative to the slot-die- coating head at a speed of between 20 and 80 m/min, most preferably at a speed of between 30 and 40 m/min.
Preferably, the reagent composition is delivered to the solid support material at a coating flux of 5.5 to 30 g/min, most preferably at a flux of 13 to 15 g/min. Subsequently, the deposited reagent stripe is dried either under ambient conditions or in a heated airflow. In a further aspect, the invention concerns analytical test elements that comprise the above reagent composition. Preferably, the analytical test elements of the present invention are manufactured according to the process as described above. The invention has the following advantages:
1. Sensors requiring small sample volumes (typically 100 to 1000 nl) can easily be constructed using the slot die coated dry film and spacer/capillary channel lamination processes. The dry film stripe is of uniform thickness and is homogeneous over the electrochemical reaction area. The required capillary dimensions/imprecision of the sensor is dependent on the variation in spacer thickness and the construction of the capillary channel.
2. The slot-die-coating technology can be paired with a sophisticated layout of the electrodes design, thus enabling the capability of miniaturizing and creating multiple applications in the sensor capillary, (for example, staggering two or more lines/stripes of different reagents within an adequately designed layout of electrodes). Two staggered slot dies or a special slot die assembly designed for two or more fluids can be used to achieve this goal. The coating fluids preferably will have properly matching rheologic properties. The best technological case is achieved if the coating windows of the different fluids have a consistent overlapping region.
3. The slot-die-coating film application technology paired and combined with the rheologic properties of the reagent enables homogeneous coatings using a reel to reel coating process for rapid production of diagnostic sensors. 4. Thixotropy or shear thinning behavior is the main rheologic feature of the fluid to be coated in respect to the mass distribution and its profile across the coated layer, impacting on the flatness, repeatability and homogeneity of the wet and dried layer. This feature is reached by using Xanthan gum, for example, Keltrol®, CMC and Silica in a concentration and combination to match the desired shear thinning, slightly thixotropic or thixotropic behavior of the coating fluid. Surprisingly, it has been found that the role of silica, in particular the preferred untreated, hydrophilic silica, preferably with a particle size D50 (i.e., 50 % of the particles have a size of the given size or below) of 1 to 7 μm, in the "wet" status (in the coating fluid) is that in combination with the film thickeners (Keltrol® and CMC, either one or both of them) silica increases the viscosity and enhances the shear thinning, slightly thixotropic or thixotropic behavior of the coating fluid.
Silica acts in the dried state to, among other things: a) prevent back transfer of the dried film on the un-coated side of the foil/carrier if the web material is wound to rolls after the coating and drying processes, and b) enlarge the specific surface of the dried coating layer as compared to a smooth coating layer. Without wishing to be tied to any specific theory, this is likely due to the particle-size distribution of silica particles. Since the speed of fluid transport is increased by the ratio between the surface area and the fluid volume, this enlarged specific surface is speeding up the wetting process of the dried film and in consequence leads to a shorter capillary fill time.
The present invention is further elucidated by the following Examples and Figures. With respect to the Figures whenever possible like numbers, letters and symbols refer to like structures, features and elements. For example, unless otherwise stated in the application the following key applies:
indicates a web; indicates a sputtered metal film; indicates a working electrode of electrode pair 1; indicates a working electrode of electrode pair 2; indicates a reference/counter electrode of electrode pair 1 ; indicates a reference/counter electrode of electrode pair 2; indicates a reagent stripe 1; indicates a reagent stripe 2; indicates a spacer (e.g., double sided adhesive); indicates a top foil; and indicates a vent opening in top foil. Figures 1 and 2 are schematic representations of the several steps that are done during the manufacturing process for electrochemical test elements using the reagent composition and process of the present invention. A person of ordinary skill in the art would readily recognize that the process can be used with other electrode configurations and with multiple stripes having the same or different composition and different positions on the strip. It is to be noted that the processes described in Figures 1 and 2 could also be carried out without electrodes present on the test strips. A person of ordinary skill in the art would readily recognize that the process and reagent described herein can also be adapted to optical test elements as well.
Parts A and B of Figures 1 and 2 are identical and show a polymer web (1), preferably an inert plastic material such as Melinex® 329 of DuPont (see, e.g., part A), on which is coated a metal layer (2) (see, e.g., part B) by conventional techniques such as sputtering, chemical, electrochemical or physical vapor deposition, etc.
Preferably, the metal layer (2) subsequently is structured by for example a laser ablation process. This process removes parts of the metal layer (2) and discrete structures of metal which can act as electrodes (3, 4) remain on the surface of the polymer web (1). It should be understood, however, that conventional printing techniques or lithographic processes can also be used to create electrodes (3, 4) on the polymer web (1).
After the laser ablation step in Figure 1, part C, two electrodes (3, 4) are formed on the polymer web. In Figure 2, part C, two pairs of electrodes (3, 3', 4, 4') are formed. In the next step (shown in part D of Figure 1 and 2), reagent stripes 5, 5' are deposited over the active area of the working and counter electrodes (3, 3', 4, 4'). The reagent composition is applied on the electrode structure by the slot-die- coating process of the present invention.
In part E of Figures 1 and 2, a spacer layer (6) is laminated to the electrode structure of part D of Figures 1 and 2. The spacer (6) is preferably a double-sided adhesive tape that covers all parts of the reagent and electrode structures that are not to be brought into contact with liquid sample. In addition, the spacer (6) has a cutout that defines the reactive area of the reagent and the underlying electrodes.
At the opposite end of the spacer (6), i.e., the end where the electrode leads are located that are not covered by reagent composition, the spacer (6) leaves free parts of the electrode structures that can be used to connect the test strip to a respective test strip reading meter.
Spacer (6) preferably covers a narrow part (less than 2 mm) of the reagent
(5 in Fig. 1, 5' in Fig. 2) to mask eventual inhomogeneous edge regions of the reagent coating. After laminating the spacer (6) to the electrode and reagent web, in a preferred embodiment, part of the web material is cut off to trim the reagent stripe
(5).
In part F of Figures 1 and 2, a top foil (7), preferably an inert plastics cover, is placed onto the surface of the spacer (6) that is not in contact with the polymer web (1). The polymer web (1), the spacer (6) and the top foil (7) form a 3D capillary channel which is defined by the thickness of the spacer (6) and the dimensions of the cut-out in the spacer. To enable a filling of the capillary space, preferably either the top foil (7) or the polymer web (1) has a vent opening (8). As is clear for those skilled in the art, the surfaces of either the polymer web (1) or the top foil (7) that face the capillary space can be rendered hydrophilic by a respective hydrophilic treatment, for example, by coating with a surfactant or plasma treatment.
EXAMPLES
The following Examples provided by way of illustration and not by way of limitation, will disclose more details of the invention:
Example 1: Reagent composition for use in an electrochemical amperometric glucose biosensor.
An aqueous mixture of the following components was prepared:
Substance Source % w/w
Keltrol®F (Xanthan gum) Kelco 0.2136 %
Carboxymethyl cellulose (CMC) Hercules-Aqualon 0.5613 %
Polyvinylpyrrolidone (PNP) K25 BASF 1.8952 %
Propiofan® (polyvinylchloride) (50% water) BASF 2.8566 %
Glucose-dye-oxidoreductase (GlucDOR) Roche Diagnostics (E.C. 1.1.99.17) 0.3310 % pyrroloquinoline quinine (PQQ) Roche Diagnostics 0.0092 %. .
Sipernat® 320 DS (synthetic, amorphous Degussa E[ϋls precipitated silica) 2.0039 %
Νa-Succinat x 6 H2O Mallinckrodt Chmeicals 0.4803 %
Trehalose Sigma-Aldrich 0.4808 %
KH2PO4 J. T. Baker 0.4814 %
K2HPO4 J. T. Baker 1.1166 %
Ν,Ν-Bis-(hydroxyethyl)-3-methoxy-p- Roche Diagnostics nitroso aniline 0.6924 %
Mega 8® (n-Octanoyl-N-methylglucamide) Dojindo 0.2806 %
Geropon® T 77 (Sodium N-methyl N-oleyl Rhodia Chimie taurate) 0.0298 %
KOH Merck 0.1428 %
Water, double distilled 89.9558 %
The reagent matrix was custom modified to meet the demands of the slot- die-coating process. Silica, Keltrol® (Xanthan Gum), carboxymethyl cellulose
(CMC) and surfactants were added to the coating matrix to modify the rheology of the reagent mass. Surfactant concentrations were adjusted to obtain surface tensions (measured with a Tensiometer K10T (Kruess)) in the most preferred range of 33 to 42 mN/m. Surface tension in this range promotes better adhesion and controlled spreading of the coated stripe on the web. The most preferred viscosity range measured using a Rheomat 115 (Contraves) for the coating mass is 95 to 115 mPa-s. The polymers and the silica also impart thixotropic behavior to the coating. Coatings shear thin as they are dispensed through the slot die head onto the web. This reduces the apparent viscosity of the coating.
Stripes of reagent coating mass with these lower viscosities show a migration of the stripe edges and reagent components toward the center of the stripe during the drying process. This migration leads to an irregular and irreproducible surface profile in the middle of the dried stripe. Dispense of coatings having shear thinning, slightly thixotropic or thixotropic properties show the same shear thinning effects. However, the viscosity of the coated stripe returns to near the apparent viscosity shortly after being dispensed and before entering the drying region. The migration of the stripe edges towards the center during drying is retarded. As illustrated in Figure 3, this leads to a flat reproducible region in the center of the stripe, in the reaction area. Thinner films further retard the migration of the coating edges to the center of the coated stripe.
Example 2: Reagent composition for an electrochemical amperometric coagulation sensor. An aqueous mixture of the following components was prepared:
Substance Source End Concentration in Reagent
Glycine Sigma 23 g/l
Polyethylenglycol Sigma 23 g/l
Sucrose Sigma 55 g/l
Bovine Serum Albumin Sigma 6.9 g/l
Mega 8® (n-Octanoyl-N- Dojindo l g/1 methylglucamide)
Resazurin Sigma-Aldrich Chemie GmbH 1.4 g/l 5.6 mmol/1
Polybrene® (hexadimethrine Sigma 0.015 g/l bromide)
Moviol® 4/86 (poly vinyl Clariant GmbH 20 g/l alcohol)
Keltro F (Xanthan gum) Kelco 2.89 g/l
Electrozym TH Roche Diagnostics 1.226 g/l (reduced Chromozy TH; reduced tosyl-glycyl-prolyl- 1.9 mmol 1 arginine-4-nitranilide acetate) soy bean phospholipids solution of recombinant tissue Dade-Behring 109 μg/1 factor
Example 3; Alternative reagent composition for an electrochemical amperometric glucose biosensor.
An aqueous mixture of the following components was prepared:
Substance Source % w/w
Keltro F (Xanthan gum) Kelco 0.20 %
Gantrez® S97 (Methyl vinylether/maleic ISP anhydride copolymer) 2.48
Polyvinylpyrrolidone (PVP) K25 BASF 1.93 %
Propiofan® (polyvinylchloride) (50% water) BASF 2.94 %
Glucose-dye-oxidoreductase (GlucDOR) Roche Diagnostics (E.C. 1.1.99.17?) 0.33 % pyrroloquinoline quinine (PQQ) Roche Diagnostics 0.0093 %
Silica FK 300 DS Degussa Hiils 1.77 %
KH2P04 J. T. Baker 0.48 % .
K2HP04 J. T. Baker 1.47 %
N,N-Bis-(hydroxyethyl)-3-methoxy-p-nitroso Roche Diagnostics aniline 0.69 %
Mega 8® (n-Octanoyl-N-methylglucamide) Dojindo 0.29 %
Geropon® T 77 (Sodium N-methyl N-oleyl Rhodia Chimie taurate) 0.030 %
KOH Merck 1.14 %
Water, double distilled 86.227 %
Example 4: Alternative reagent composition for an electrochemical amperometric glucose biosensor.
An aqueous mixture of the following components was prepared:
Substance Source % w/w
KeltroKDF (Xanthan gum) Kelco 0.20 %
Gantrez®S97 (Methyl vinylether/maleic ISP anhydride copolymer) 0.50 %
Carboxymethyl cellulose (CMC) Hercules-Aqualon 0.50 %
Polyvinylpyrrolidone (PNP) K25 BASF 1.90 %
Propiofan® (polyvinylchloride) (50% water) BASF 2.89 %
Glucose-dye-oxidoreductase (GlucDOR) Roche Diagnostics (E.G. 1.1.99.17?) 0.34 % pyrroloquinoline quinine (PQQ) Roche Diagnostics 0.0093 %
KH2PO4 J. T. Baker 0.48 %
K2HPO4 J. T. Baker 1.46 %
Ν,Ν-Bis-(hydroxyethyl)-3~methoxy-p- Roche Diagnostics nitroso aniline 0.71 %
Mega 8® (n-Octanoyl-N-methylglucamide) Dojindo 0,28 % •
Geropon® T 77 (Sodium N-methyl N-oleyl Rhodia Chimie taurate) 0.030 %
KOH Merck 0.31 %
Water, double distilled 90.384 %
Example 5; Coating process
The polymer web (Melinex® 329, DuPont) is moved into the coating area, containing a slot die head and a back up roller. The slot die head (TSE, Switzerland) is zeroed to the web surface and adjusted to a slot to web gap of 74 μm. Web speed is ramped up from 0 to 38 m/min for deposition of coating on the web. The reagent matrix can be delivered to the slot die head using a variety of means including gear pumps, pistons, syringes, bladder systems. The reagent delivery system is adjusted to a water flow of 13.58 ml/min to deliver a coat weight of 53 g/m2 through the coating head. The width of the resulting coated stripe is 7.0 + 0.3 mm. The coating is dried in the heated drying zone (length 15 m, temperature 110 °C, at a speed of 38 m/min) and rewound on spools at the rewind station.
Figures 3 to 5 show the results of profilometric measurements across the reagent stripe according to this example. The profilometer system used was a Dektak IIA Surface Profile Measuring System (Neeco Instruments Inc., Sloan Technology Division, Dallas, Texas). Profile data from the Dektak IIA were baseline corrected.
In Figure 3, P (mm) denotes the x-position of the scan across the web and reagent stripe (in mm) and H (μm) denotes the respective relative height of the coating (in μm). The reagent mass was prepared according to Example 1. As can be seen, the reagent stripe has a cross-sectional width of about 7 mm and a respective average center height of approximately 5 μm. The edges of the reagent coating are relatively sharp. The homogeneous plateau region of the coating fills approximately 80 % of the reagent stripe width. The profile of the reagent coating as depicted in Figure 3 is typical for coatings according to the present invention. For reagent stripes of 10 mm or less in width, sharp edges can be obtained, which ramp up from the underlying web material (corresponding to a coating height of zero) to the plateau region in the center of the coating within 1 mm on each side or less (i.e. 80 % or more of the coating belong to the homogeneous center plateau region). Within the center region, the reagent coating is practically uniform in thickness.
Figure 4 shows the results of profilometric measurements across the reagent stripe prepared according to this example. Scan Distance (μm) denotes the x- position of the scan across the web and reagent stripe (in μm) and Height (μm) denotes the respective relative height of the coating (in μm). The reagent mass was prepared according to Example 1 with milled silica. Figures 4A to 4E give the results for coating weights of 20, 25, 30, 40 and 50 mg/m2, respectively.
Figure 5 illustrates the results of profilometric measurements across a reagent stripe prepared according to a comparative example, i.e., not in accordance with the teachings of the present invention. Scan Distance (μm) denotes the x- position of the scan across the web and reagent stripe (in μm) and Height (μm) denotes the respective relative height of the coating (in μm). The reagent mass was prepared according to Example 1 however without the presence of the rheological modifiers Keltrol®, CMC and silica.
Figure 5A and 5B show that without rheological modifiers the dried reagent coating tends to form inhomogeneous reagent stripes on the web material. In Fig. 5 A, the reagent concentrates in the center portion of the coated stripe; in Fig. 5B, the reagent concentrates in two regions located between the center and the edge portions of the reagent stripes. In both cases, the edge portions are depleted from reagent. Comparison of Fig. 5 (comparative example) with Figs. 3 and 4 (both according to the present invention) reveals the advantageous effects of the reagent composition and process of the present invention.
Figure 6 is a photograph of a microscope view of a reagent stripe (central dark rectangular area) coated onto a web material (light areas around the central stripe) from a reagent composition according to Example 1 (and comparable to the profilometric data shown in Figure 4). Coating was done according to Example 5. The coated stripe shows good homogeneity across the coating direction (coating direction was from top to bottom) as well as along this direction.
In stark contrast to the smooth and uniform reagent layer shown in Figure 6, Figures 7 A and 7B are photographs of microscope views (comparative examples) of reagent stripes coated onto web material with profilometric data comparable to that shown in Figure 5. Coating was done according to Example 5; however, the reagent did not contain the rheological modifiers. The coated stripes clearly show inhomogeneities across the coating direction (coating direction was from top to bottom). For example, regions of thicker reagent are manifested by the dark bands running along the stripes. Figure 7A shows one such dark band positioned in about the middle of the stripe (compare Fig. 5 A), whereas Fig. 7B shows two dark bands (compare Fig. 5B). These one or two regions of thicker reagent coatings (dark zones) within the reagent stripe are believed due to drying effects of the reagent coating materials. Example 6; Variation of rheological modifiers in the reagent composition of Example 1.
In the reagent composition of Example 1 the contents of the ingredients CMC, Keltrol®, Propiofan® and PNP were varied in accordance with the following
Table. Ingredient contents are given in % w/w and viscosity is given in mPa-s.
Figure imgf000024_0001
All publications, patents and patent applications cited in this specification are herein incorporated by reference, as if each individual publication, patent, or patent application was specifically and individually indicated to be incorporated by reference and set forth in its entirety herein.
While preferred embodiments incorporating the principles of the present invention have been disclosed hereinabove, the present invention is not limited to the disclosed embodiments. Instead, this application is intended to cover such departures from the present disclosure as come within known or customary practice in the art to which this invention pertains and which fall within the limits of the appended claims.

Claims

WHAT IS CLAIMED IS:
1. A shear thinning, slightly thixotropic or thixotropic reagent composition useful in a slot-die-coating process having the following properties: a viscosity between about 70 and about 130 mPa s; and a surface tension between 30 and 50 mN/m.
2. The reagent of claim 1 having a viscosity in the range between 95 and 115 mPa s
3. The reagent of claim 1 or 2 having a surface tension of about 40 ± 2 mN/m.
4. The reagent of claim 1, 2, or 3 comprising silica.
5. The reagent of any of claims 1 to 4, further comprising buffers or enzymes or mediators or stabilizers or thickeners or proteins or indicators or dyes or film formers or surfactants or co-factors or a combination of the said ingredients.
6. The reagent of any of the preceding claims, comprising a xanthan gum.
7. The reagent of any of the preceding claims, comprising carboxymethyl cellulose.
8. The reagent of claim 4, further comprising a xanthan gum and carboxymethyl cellulose.
9. Process for producing a reagent layer on a polymer web as a solid support material, comprising the following steps: providing a solid support material; moving the solid support material relative to a slot-die-coating head by moving either the solid support material or the slot-die-coating head, thereby maintaining a defined distance between the surface of the solid support material and the slot-die-coating head; depositing the reagent of any of claims 1 to 8 through the slot-die-coating head to create a continuous stripe of reagent on the solid support material; and drying the coated reagent stripe on the web.
10. The process of claim 9 in which the stripe of reagent has a width of less than 1 cm.
11. The process of claim 9 in which the stripe of reagent has a height of less than 10 μm dry film thickness.
12. The process of claim 9 in which the speed of moving the solid support material relative to the slot-die-coating head is between 20 and 80 m/min.
13. The process of claim 9 in which the speed of moving the support material relative to the slot-die-coating head is between 30 and 40 m/min.
14. The process of claim 9 or 12 in which the reagent is delivered to the support material at a coating flux of 5.5 to 30 g/min.
15. The process of claim 9 or 12 in which the reagent is delivered to the support material at a coating flux of 13 to 15 g/min.
16. The process of claim 9 in which the distance between the slot-die-coating head and the support material is between 30 and 90 μm.
17. Analytical test element comprising a polymer web as a first solid support material; and a reagent stripe coated onto the first solid support material; characterized in that the reagent of the reagent stripe is the reagent according to any of claims 1 to 8.
18. Analytical test element comprising a polymer web as a first solid support material; and a reagent stripe coated onto the first solid support material; characterized in that the reagent is coated onto the first solid support material by a process according to any of claims 9 to 16.
19. The analytical test element of claim 17 or 18, further comprising a double-sided adhesive tape which acts as a spacer layer to define a capillary gap and which covers parts of the reagent stripe; and a second solid support material attached to the spacer layer and creating in cooperation with the first solid support material, the reagent stripe, and the spacer layer a capillary space over those parts of the reagent stripe that are not covered by the double-sided adhesive tape.
20. The analytical test element of claim 17, 18, or 19, further comprising at least two electrodes on the first solid support material, the electrodes being partly covered by the reagent stripe.
PCT/US2004/019591 2003-06-20 2004-06-18 Method and reagent for producing narrow, homogenous reagent strips WO2004113917A2 (en)

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CN2004800239248A CN1846131B (en) 2003-06-20 2004-06-18 Method and reagent for producing narrow, homogenous reagent strips
MXPA05013635A MXPA05013635A (en) 2003-06-20 2004-06-18 Method and reagent for producing narrow, homogenous reagent strips.
ES04755635.2T ES2675787T3 (en) 2003-06-20 2004-06-18 Method and reagent to produce narrow and homogeneous test strips
EP04755635.2A EP1639352B8 (en) 2003-06-20 2004-06-18 Method and reagent for producing narrow, homogenous reagent strips
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Cited By (8)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2006096619A2 (en) 2005-03-04 2006-09-14 Bayer Healthcare Llc Stabilizing the activity of pqq-dependent glucose dehydrogenase in electrochemical biosensors
EP1772728A1 (en) 2005-10-05 2007-04-11 Roche Diagnostics GmbH Method and system for testing electrochemical sensors
JP2008523415A (en) * 2004-12-13 2008-07-03 バイエル・ヘルスケア・エルエルシー Size self-regulating composition and test apparatus for measuring analytes in biological fluids
US8025788B2 (en) 2009-04-24 2011-09-27 Lifescan Scotland Limited Method for manufacturing an enzymatic reagent ink
US8317988B2 (en) 2004-10-12 2012-11-27 Bayer Healthcare Llc Concentration determination in a diffusion barrier layer
US20140061045A1 (en) * 2007-12-10 2014-03-06 Bayer Healthcare Llc Electrochemical test sensor and method of forming the same
US8871069B2 (en) 2008-12-08 2014-10-28 Bayer Healthcare Llc Low total salt reagent compositions and systems for biosensors
US11697279B2 (en) 2013-06-10 2023-07-11 Roche Diagnostics Operations, Inc. Method and device for producing a test element

Families Citing this family (307)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US6036924A (en) 1997-12-04 2000-03-14 Hewlett-Packard Company Cassette of lancet cartridges for sampling blood
US6391005B1 (en) 1998-03-30 2002-05-21 Agilent Technologies, Inc. Apparatus and method for penetration with shaft having a sensor for sensing penetration depth
US20050103624A1 (en) * 1999-10-04 2005-05-19 Bhullar Raghbir S. Biosensor and method of making
CN100363739C (en) 1999-11-15 2008-01-23 松下电器产业株式会社 Biosensor, method of forming thin-film electrode, and method and apparatus for quantitative determination
DE10057832C1 (en) * 2000-11-21 2002-02-21 Hartmann Paul Ag Blood analysis device has syringe mounted in casing, annular mounting carrying needles mounted behind test strip and being swiveled so that needle can be pushed through strip and aperture in casing to take blood sample
US8641644B2 (en) * 2000-11-21 2014-02-04 Sanofi-Aventis Deutschland Gmbh Blood testing apparatus having a rotatable cartridge with multiple lancing elements and testing means
US8337419B2 (en) 2002-04-19 2012-12-25 Sanofi-Aventis Deutschland Gmbh Tissue penetration device
WO2002100254A2 (en) * 2001-06-12 2002-12-19 Pelikan Technologies, Inc. Method and apparatus for lancet launching device integrated onto a blood-sampling cartridge
US7025774B2 (en) 2001-06-12 2006-04-11 Pelikan Technologies, Inc. Tissue penetration device
US9226699B2 (en) 2002-04-19 2016-01-05 Sanofi-Aventis Deutschland Gmbh Body fluid sampling module with a continuous compression tissue interface surface
ATE497731T1 (en) 2001-06-12 2011-02-15 Pelikan Technologies Inc DEVICE FOR INCREASING THE SUCCESS RATE OF BLOOD YIELD OBTAINED BY A FINGER PICK
CA2448905C (en) 2001-06-12 2010-09-07 Pelikan Technologies, Inc. Blood sampling apparatus and method
US7981056B2 (en) 2002-04-19 2011-07-19 Pelikan Technologies, Inc. Methods and apparatus for lancet actuation
ATE485766T1 (en) 2001-06-12 2010-11-15 Pelikan Technologies Inc ELECTRICAL ACTUATING ELEMENT FOR A LANCET
US7344507B2 (en) 2002-04-19 2008-03-18 Pelikan Technologies, Inc. Method and apparatus for lancet actuation
US9795747B2 (en) 2010-06-02 2017-10-24 Sanofi-Aventis Deutschland Gmbh Methods and apparatus for lancet actuation
US20070100255A1 (en) * 2002-04-19 2007-05-03 Pelikan Technologies, Inc. Method and apparatus for body fluid sampling and analyte sensing
US7316700B2 (en) * 2001-06-12 2008-01-08 Pelikan Technologies, Inc. Self optimizing lancing device with adaptation means to temporal variations in cutaneous properties
US9427532B2 (en) 2001-06-12 2016-08-30 Sanofi-Aventis Deutschland Gmbh Tissue penetration device
ATE479089T1 (en) * 2001-11-16 2010-09-15 Stefan Ufer FLEXIBLE SENSOR AND MANUFACTURING METHOD
US20070142748A1 (en) * 2002-04-19 2007-06-21 Ajay Deshmukh Tissue penetration device
US8221334B2 (en) 2002-04-19 2012-07-17 Sanofi-Aventis Deutschland Gmbh Method and apparatus for penetrating tissue
US8267870B2 (en) 2002-04-19 2012-09-18 Sanofi-Aventis Deutschland Gmbh Method and apparatus for body fluid sampling with hybrid actuation
US7226461B2 (en) * 2002-04-19 2007-06-05 Pelikan Technologies, Inc. Method and apparatus for a multi-use body fluid sampling device with sterility barrier release
US7674232B2 (en) 2002-04-19 2010-03-09 Pelikan Technologies, Inc. Method and apparatus for penetrating tissue
US7491178B2 (en) 2002-04-19 2009-02-17 Pelikan Technologies, Inc. Method and apparatus for penetrating tissue
US8579831B2 (en) 2002-04-19 2013-11-12 Sanofi-Aventis Deutschland Gmbh Method and apparatus for penetrating tissue
US7244265B2 (en) * 2002-04-19 2007-07-17 Pelikan Technologies, Inc. Method and apparatus for penetrating tissue
US7582099B2 (en) * 2002-04-19 2009-09-01 Pelikan Technologies, Inc Method and apparatus for penetrating tissue
US7547287B2 (en) 2002-04-19 2009-06-16 Pelikan Technologies, Inc. Method and apparatus for penetrating tissue
US7901362B2 (en) 2002-04-19 2011-03-08 Pelikan Technologies, Inc. Method and apparatus for penetrating tissue
US8360992B2 (en) 2002-04-19 2013-01-29 Sanofi-Aventis Deutschland Gmbh Method and apparatus for penetrating tissue
US7291117B2 (en) 2002-04-19 2007-11-06 Pelikan Technologies, Inc. Method and apparatus for penetrating tissue
US7909778B2 (en) * 2002-04-19 2011-03-22 Pelikan Technologies, Inc. Method and apparatus for penetrating tissue
US7976476B2 (en) 2002-04-19 2011-07-12 Pelikan Technologies, Inc. Device and method for variable speed lancet
US7648468B2 (en) 2002-04-19 2010-01-19 Pelikon Technologies, Inc. Method and apparatus for penetrating tissue
US9795334B2 (en) * 2002-04-19 2017-10-24 Sanofi-Aventis Deutschland Gmbh Method and apparatus for penetrating tissue
US7232451B2 (en) 2002-04-19 2007-06-19 Pelikan Technologies, Inc. Method and apparatus for penetrating tissue
US7892185B2 (en) 2002-04-19 2011-02-22 Pelikan Technologies, Inc. Method and apparatus for body fluid sampling and analyte sensing
US9314194B2 (en) 2002-04-19 2016-04-19 Sanofi-Aventis Deutschland Gmbh Tissue penetration device
US7331931B2 (en) * 2002-04-19 2008-02-19 Pelikan Technologies, Inc. Method and apparatus for penetrating tissue
US7892183B2 (en) 2002-04-19 2011-02-22 Pelikan Technologies, Inc. Method and apparatus for body fluid sampling and analyte sensing
US7229458B2 (en) 2002-04-19 2007-06-12 Pelikan Technologies, Inc. Method and apparatus for penetrating tissue
US7297122B2 (en) * 2002-04-19 2007-11-20 Pelikan Technologies, Inc. Method and apparatus for penetrating tissue
US7410468B2 (en) * 2002-04-19 2008-08-12 Pelikan Technologies, Inc. Method and apparatus for penetrating tissue
US8784335B2 (en) * 2002-04-19 2014-07-22 Sanofi-Aventis Deutschland Gmbh Body fluid sampling device with a capacitive sensor
US8702624B2 (en) 2006-09-29 2014-04-22 Sanofi-Aventis Deutschland Gmbh Analyte measurement device with a single shot actuator
US7524293B2 (en) * 2002-04-19 2009-04-28 Pelikan Technologies, Inc. Method and apparatus for penetrating tissue
US7717863B2 (en) * 2002-04-19 2010-05-18 Pelikan Technologies, Inc. Method and apparatus for penetrating tissue
US7371247B2 (en) 2002-04-19 2008-05-13 Pelikan Technologies, Inc Method and apparatus for penetrating tissue
US9248267B2 (en) 2002-04-19 2016-02-02 Sanofi-Aventis Deustchland Gmbh Tissue penetration device
US20040067481A1 (en) * 2002-06-12 2004-04-08 Leslie Leonard Thermal sensor for fluid detection
US7244264B2 (en) * 2002-12-03 2007-07-17 Roche Diagnostics Operations, Inc. Dual blade lancing test strip
US7265881B2 (en) * 2002-12-20 2007-09-04 Hewlett-Packard Development Company, L.P. Method and apparatus for measuring assembly and alignment errors in sensor assemblies
US7214200B2 (en) * 2002-12-30 2007-05-08 Roche Diagnostics Operations, Inc. Integrated analytical test element
US8574895B2 (en) 2002-12-30 2013-11-05 Sanofi-Aventis Deutschland Gmbh Method and apparatus using optical techniques to measure analyte levels
ATE476137T1 (en) 2003-05-30 2010-08-15 Pelikan Technologies Inc METHOD AND DEVICE FOR INJECTING LIQUID
WO2004107964A2 (en) 2003-06-06 2004-12-16 Pelikan Technologies, Inc. Blood harvesting device with electronic control
WO2006001797A1 (en) 2004-06-14 2006-01-05 Pelikan Technologies, Inc. Low pain penetrating
US8071030B2 (en) 2003-06-20 2011-12-06 Roche Diagnostics Operations, Inc. Test strip with flared sample receiving chamber
US8679853B2 (en) * 2003-06-20 2014-03-25 Roche Diagnostics Operations, Inc. Biosensor with laser-sealed capillary space and method of making
MXPA05013747A (en) * 2003-06-20 2006-03-08 Hoffmann La Roche Devices and methods relating to electrochemical biosensors.
ES2681398T3 (en) * 2003-06-20 2018-09-12 F. Hoffmann-La Roche Ag Test strip with widened sample reception chamber
US8148164B2 (en) 2003-06-20 2012-04-03 Roche Diagnostics Operations, Inc. System and method for determining the concentration of an analyte in a sample fluid
US7920906B2 (en) 2005-03-10 2011-04-05 Dexcom, Inc. System and methods for processing analyte sensor data for sensor calibration
EP1671096A4 (en) * 2003-09-29 2009-09-16 Pelikan Technologies Inc Method and apparatus for an improved sample capture device
EP1680014A4 (en) 2003-10-14 2009-01-21 Pelikan Technologies Inc Method and apparatus for a variable user interface
US9247900B2 (en) 2004-07-13 2016-02-02 Dexcom, Inc. Analyte sensor
US7822454B1 (en) 2005-01-03 2010-10-26 Pelikan Technologies, Inc. Fluid sampling device with improved analyte detecting member configuration
US9012232B2 (en) 2005-07-15 2015-04-21 Nipro Diagnostics, Inc. Diagnostic strip coding system and related methods of use
EP1706026B1 (en) 2003-12-31 2017-03-01 Sanofi-Aventis Deutschland GmbH Method and apparatus for improving fluidic flow and sample capture
US8828203B2 (en) 2004-05-20 2014-09-09 Sanofi-Aventis Deutschland Gmbh Printable hydrogels for biosensors
US9775553B2 (en) * 2004-06-03 2017-10-03 Sanofi-Aventis Deutschland Gmbh Method and apparatus for a fluid sampling device
EP1765194A4 (en) 2004-06-03 2010-09-29 Pelikan Technologies Inc Method and apparatus for a fluid sampling device
EP1761383B1 (en) * 2004-06-23 2009-04-01 tesa AG Medical biosensor by means of which biological liquids are analyzed
US20060270922A1 (en) 2004-07-13 2006-11-30 Brauker James H Analyte sensor
US7310544B2 (en) 2004-07-13 2007-12-18 Dexcom, Inc. Methods and systems for inserting a transcutaneous analyte sensor
US8211038B2 (en) 2004-09-17 2012-07-03 Abbott Diabetes Care Inc. Multiple-biosensor article
DE102004058794A1 (en) * 2004-12-07 2006-06-08 Roche Diagnostics Gmbh Process for coating membranes
US8652831B2 (en) 2004-12-30 2014-02-18 Sanofi-Aventis Deutschland Gmbh Method and apparatus for analyte measurement test time
US20080214917A1 (en) * 2004-12-30 2008-09-04 Dirk Boecker Method and apparatus for analyte measurement test time
JP5289666B2 (en) * 2005-01-24 2013-09-11 住友電気工業株式会社 Sensor chip assembly and manufacturing method thereof
US20060184065A1 (en) * 2005-02-10 2006-08-17 Ajay Deshmukh Method and apparatus for storing an analyte sampling and measurement device
JP4913355B2 (en) * 2005-03-29 2012-04-11 シーシーアイ株式会社 Biosensor
US8323464B2 (en) * 2005-05-25 2012-12-04 Universal Biosensors Pty Ltd Method and apparatus for electrochemical analysis
US8192599B2 (en) * 2005-05-25 2012-06-05 Universal Biosensors Pty Ltd Method and apparatus for electrochemical analysis
US7922883B2 (en) 2005-06-08 2011-04-12 Abbott Laboratories Biosensors and methods of using the same
US8999125B2 (en) 2005-07-15 2015-04-07 Nipro Diagnostics, Inc. Embedded strip lot autocalibration
US20070023285A1 (en) * 2005-07-29 2007-02-01 Health & Life Co., Ltd. Three-dimensional bioelectrochemical sensor strip structure
MX2008002056A (en) * 2005-08-16 2008-04-19 Home Diagnostics Inc Method for test strip manufacturing and analysis.
US7846311B2 (en) * 2005-09-27 2010-12-07 Abbott Diabetes Care Inc. In vitro analyte sensor and methods of use
US20070191736A1 (en) * 2005-10-04 2007-08-16 Don Alden Method for loading penetrating members in a collection device
WO2007058999A1 (en) * 2005-11-14 2007-05-24 Bayer Healthcare Llc Test sensor reagent having cellulose polymers
US7955484B2 (en) * 2005-12-14 2011-06-07 Nova Biomedical Corporation Glucose biosensor and method
US20090143658A1 (en) * 2006-02-27 2009-06-04 Edwards Lifesciences Corporation Analyte sensor
US7811430B2 (en) * 2006-02-28 2010-10-12 Abbott Diabetes Care Inc. Biosensors and methods of making
JP2007268385A (en) * 2006-03-30 2007-10-18 Fujifilm Corp Applicator, application method and manufacturing method of optical film
US8529751B2 (en) * 2006-03-31 2013-09-10 Lifescan, Inc. Systems and methods for discriminating control solution from a physiological sample
US8398443B2 (en) * 2006-04-21 2013-03-19 Roche Diagnostics Operations, Inc. Biological testing system and connector therefor
WO2007133457A2 (en) * 2006-05-08 2007-11-22 Bayer Healthcare Llc Electrochemical test sensor with reduced sample volume
US20080020452A1 (en) * 2006-07-18 2008-01-24 Natasha Popovich Diagnostic strip coding system with conductive layers
EP1884188A1 (en) * 2006-08-02 2008-02-06 F.Hoffmann-La Roche Ag Packaging for an object with a hydrophilic surface coating
EP3543348B1 (en) 2006-09-22 2020-11-18 Ascensia Diabetes Care Holdings AG Biosensor system having enhanced stability and hematocrit performance
US20090280551A1 (en) * 2006-10-05 2009-11-12 Lifescan Scotland Limited A reagent formulation using ruthenium hexamine as a mediator for electrochemical test strips
US9046480B2 (en) 2006-10-05 2015-06-02 Lifescan Scotland Limited Method for determining hematocrit corrected analyte concentrations
US7797987B2 (en) * 2006-10-11 2010-09-21 Bayer Healthcare Llc Test sensor with a side vent and method of making the same
JP5221549B2 (en) * 2006-10-12 2013-06-26 コーニンクレッカ フィリップス エレクトロニクス エヌ ヴィ High-speed biosensor with reagent layer
WO2008044179A1 (en) * 2006-10-12 2008-04-17 Koninklijke Philips Electronics N.V. Biosensors and preparation thereof
US7312042B1 (en) * 2006-10-24 2007-12-25 Abbott Diabetes Care, Inc. Embossed cell analyte sensor and methods of manufacture
JP5009929B2 (en) * 2006-11-06 2012-08-29 アークレイ株式会社 Cartridge and analysis system
KR101165200B1 (en) * 2006-11-10 2012-07-17 주식회사 인포피아 Bio-sensor
EP1935843A1 (en) * 2006-12-22 2008-06-25 Nederlandse Organisatie voor Toegepast-Natuuurwetenschappelijk Onderzoek TNO Device built by joining a plurality of layers
US7802467B2 (en) 2006-12-22 2010-09-28 Abbott Diabetes Care Inc. Analyte sensors and methods of use
US8460524B2 (en) * 2007-04-18 2013-06-11 Nipro Diagnostics, Inc. System and methods of chemistry patterning for a multiple well biosensor
TW200911205A (en) * 2007-04-29 2009-03-16 Arkray Inc Analyzing system
WO2009051901A2 (en) * 2007-08-30 2009-04-23 Pepex Biomedical, Llc Electrochemical sensor and method for manufacturing
US8702932B2 (en) 2007-08-30 2014-04-22 Pepex Biomedical, Inc. Electrochemical sensor and method for manufacturing
WO2009034284A1 (en) * 2007-09-05 2009-03-19 Lifescan Scotland Ltd Strip for an electrochemical meter
US8778168B2 (en) 2007-09-28 2014-07-15 Lifescan, Inc. Systems and methods of discriminating control solution from a physiological sample
KR100890988B1 (en) * 2007-10-29 2009-03-31 주식회사 아이센스 Electrochemical biosensor equipped with sampling port which enables uniform introduction of a small amount of sample
ES2637381T3 (en) 2007-10-31 2017-10-13 F. Hoffmann-La Roche Ag Electrical standards for biosensors and manufacturing procedure
TW200925594A (en) * 2007-12-07 2009-06-16 Apex Biotechnology Corp Biochemical test system, measurement device, biochemical test strip and method of making the same
ES2664574T3 (en) 2007-12-10 2018-04-20 Ascensia Diabetes Care Holdings Ag Reactive compositions of porous particles, devices and methods for biosensors
US8603768B2 (en) * 2008-01-17 2013-12-10 Lifescan, Inc. System and method for measuring an analyte in a sample
US7678250B2 (en) * 2008-01-22 2010-03-16 Home Diagnostics, Inc. Reagent compositions for use in electrochemical detection
DE102008006225A1 (en) 2008-01-25 2009-07-30 Tesa Ag Biosensor and its production
EP2254699A1 (en) * 2008-03-11 2010-12-01 Koninklijke Philips Electronics N.V. Filtering apparatus for filtering a fluid
JP2009250806A (en) * 2008-04-07 2009-10-29 Panasonic Corp Biosensor system, sensor chip and measuring method of concentration of analyte in blood sample
EP2265324B1 (en) 2008-04-11 2015-01-28 Sanofi-Aventis Deutschland GmbH Integrated analyte measurement system
US20100072062A1 (en) * 2008-05-05 2010-03-25 Edwards Lifesciences Corporation Membrane For Use With Amperometric Sensors
US8551320B2 (en) 2008-06-09 2013-10-08 Lifescan, Inc. System and method for measuring an analyte in a sample
EP2144061A1 (en) * 2008-07-11 2010-01-13 F. Hoffmann-Roche AG Continuous method for inline application of tensides on coated sensor film
WO2010007432A2 (en) * 2008-07-15 2010-01-21 L3 Technology Limited Assay device and methods
US9161714B2 (en) * 2008-08-21 2015-10-20 Palo Alto Research Center Incorporated Specificity of analyte detection in etalons
US8900431B2 (en) 2008-08-27 2014-12-02 Edwards Lifesciences Corporation Analyte sensor
BRPI0913784A2 (en) * 2008-09-30 2015-10-20 Menai Medical Technologies Ltd "sample measurement system, sampling plate, measuring device, adapter, data charger, sampling plate production method, continuous sheet production method, continuous sheet, apparatus, method for testing a medical condition, and , diagnostic kit to test a medical condition "
KR101003077B1 (en) * 2008-10-16 2010-12-21 세종공업 주식회사 Electrochemical biosensor structure and measuring method using the same
US20100112612A1 (en) * 2008-10-30 2010-05-06 John William Dilleen Method for determining an analyte using an analytical test strip with a minimal fill-error viewing window
US8012428B2 (en) * 2008-10-30 2011-09-06 Lifescan Scotland, Ltd. Analytical test strip with minimal fill-error sample viewing window
EP2352429A4 (en) * 2008-10-31 2012-08-01 Edwards Lifesciences Corp Analyte sensor with non-working electrode layer
US8506740B2 (en) 2008-11-14 2013-08-13 Pepex Biomedical, Llc Manufacturing electrochemical sensor module
US8951377B2 (en) 2008-11-14 2015-02-10 Pepex Biomedical, Inc. Manufacturing electrochemical sensor module
US9445755B2 (en) 2008-11-14 2016-09-20 Pepex Biomedical, Llc Electrochemical sensor module
KR101285520B1 (en) 2008-12-23 2013-07-17 에프. 호프만-라 로슈 아게 Structured testing method for diagnostic or therapy support of a patient with a chronic disease and devices thereof
US10456036B2 (en) 2008-12-23 2019-10-29 Roche Diabetes Care, Inc. Structured tailoring
US10437962B2 (en) * 2008-12-23 2019-10-08 Roche Diabetes Care Inc Status reporting of a structured collection procedure
US8849458B2 (en) * 2008-12-23 2014-09-30 Roche Diagnostics Operations, Inc. Collection device with selective display of test results, method and computer program product thereof
US20120011125A1 (en) 2008-12-23 2012-01-12 Roche Diagnostics Operations, Inc. Management method and system for implementation, execution, data collection, and data analysis of a structured collection procedure which runs on a collection device
US9117015B2 (en) 2008-12-23 2015-08-25 Roche Diagnostics Operations, Inc. Management method and system for implementation, execution, data collection, and data analysis of a structured collection procedure which runs on a collection device
US9918635B2 (en) 2008-12-23 2018-03-20 Roche Diabetes Care, Inc. Systems and methods for optimizing insulin dosage
US20100187132A1 (en) * 2008-12-29 2010-07-29 Don Alden Determination of the real electrochemical surface areas of screen printed electrodes
CN102439445A (en) * 2009-01-16 2012-05-02 理德免疫诊断有限责任公司 Detection devices and methods
US9375169B2 (en) 2009-01-30 2016-06-28 Sanofi-Aventis Deutschland Gmbh Cam drive for managing disposable penetrating member actions with a single motor and motor and control system
US8608937B2 (en) * 2009-03-30 2013-12-17 Roche Diagnostics Operations, Inc. Biosensor with predetermined dose response curve and method of manufacturing
KR101032691B1 (en) * 2009-04-17 2011-05-06 (주)디지탈옵틱 Biosensor for the use of diagnosis that prompt blood separation is possible
KR101104400B1 (en) * 2009-06-02 2012-01-16 주식회사 세라젬메디시스 Biosensor for measuring biomaterial
US20100331652A1 (en) 2009-06-29 2010-12-30 Roche Diagnostics Operations, Inc. Modular diabetes management systems
US9218453B2 (en) * 2009-06-29 2015-12-22 Roche Diabetes Care, Inc. Blood glucose management and interface systems and methods
US9237864B2 (en) 2009-07-02 2016-01-19 Dexcom, Inc. Analyte sensors and methods of manufacturing same
EP2281900A1 (en) * 2009-08-03 2011-02-09 Roche Diagnostics GmbH Fructosyl peptidyl oxidase and sensor for assaying a glycated protein
EP2287295A1 (en) 2009-08-03 2011-02-23 Roche Diagnostics GmbH Mutant Fructosyl amino acid oxidase
US20110054284A1 (en) * 2009-08-28 2011-03-03 Edwards Lifesciences Corporation Anti-Coagulant Calibrant Infusion Fluid Source
US8357276B2 (en) * 2009-08-31 2013-01-22 Abbott Diabetes Care Inc. Small volume test strips with large sample fill ports, supported test strips, and methods of making and using same
US8622231B2 (en) 2009-09-09 2014-01-07 Roche Diagnostics Operations, Inc. Storage containers for test elements
CN102511005B (en) * 2009-09-24 2015-02-25 霍夫曼-拉罗奇有限公司 Stack of test strips and method for the production thereof
US20120088989A1 (en) 2009-12-21 2012-04-12 Roche Diagnostic Operations, Inc. Management Method And System For Implementation, Execution, Data Collection, and Data Analysis of A Structured Collection Procedure Which Runs On A Collection Device
US20110151571A1 (en) 2009-12-23 2011-06-23 Roche Diagnostics Operations, Inc. Memory apparatus for multiuse analyte test element systems, and kits, systems, combinations and methods relating to same
US8101065B2 (en) * 2009-12-30 2012-01-24 Lifescan, Inc. Systems, devices, and methods for improving accuracy of biosensors using fill time
US20110186428A1 (en) 2010-01-29 2011-08-04 Roche Diagnostics Operations, Inc. Electrode arrangements for biosensors
JP5405361B2 (en) * 2010-03-10 2014-02-05 翰沃生電科技股▲分▼有限公司 Planar biometric sheet manufacturing method and product
GB201005359D0 (en) 2010-03-30 2010-05-12 Menai Medical Technologies Ltd Sampling plate
GB201005357D0 (en) 2010-03-30 2010-05-12 Menai Medical Technologies Ltd Sampling plate
US8965476B2 (en) 2010-04-16 2015-02-24 Sanofi-Aventis Deutschland Gmbh Tissue penetration device
WO2011137208A1 (en) * 2010-04-28 2011-11-03 Siemens Healthcare Diagnostics Inc. Method of forming reagent card
WO2011137172A1 (en) * 2010-04-29 2011-11-03 Siemens Healthcare Diagnostics Inc. Method of forming a reagent card
US8532933B2 (en) 2010-06-18 2013-09-10 Roche Diagnostics Operations, Inc. Insulin optimization systems and testing methods with adjusted exit criterion accounting for system noise associated with biomarkers
EP2402759B1 (en) * 2010-06-29 2014-02-26 Actherm Inc. Testing strip for detecting a fluidic sample
JP5580934B2 (en) * 2010-06-30 2014-08-27 エフ ホフマン−ラ ロッシュ アクチェン ゲゼルシャフト Method for manufacturing a dual biosensor test strip
US9182353B2 (en) 2010-07-22 2015-11-10 Hach Company Lab-on-a-chip for alkalinity analysis
CN103003440B (en) 2010-07-23 2015-11-25 霍夫曼-拉罗奇有限公司 Containing the composition of zwitterionic buffer and the purposes in electroanalysis apparatus and method thereof
WO2012028697A1 (en) 2010-09-01 2012-03-08 Eth Zürich, Institute Of Molecular Biology And Biophysics Affinity purification system based on donor strand complementation
US20130172464A1 (en) * 2010-09-20 2013-07-04 3M Innovative Properties Company Nanoparticle Processing Aide For Extrusion And Injection Molding
US10114020B2 (en) * 2010-10-11 2018-10-30 Mbio Diagnostics, Inc. System and device for analyzing a fluidic sample
US8427817B2 (en) 2010-10-15 2013-04-23 Roche Diagnostics Operations, Inc. Handheld diabetes manager with touch screen display
US20120122197A1 (en) 2010-11-12 2012-05-17 Abner David Jospeh Inkjet reagent deposition for biosensor manufacturing
US20120143085A1 (en) 2010-12-02 2012-06-07 Matthew Carlyle Sauers Test element ejection mechanism for a meter
JP2013544363A (en) * 2010-12-10 2013-12-12 紅電醫學科技股▲分▼有限公司 Manufacturing method of test strip
WO2012084194A1 (en) 2010-12-22 2012-06-28 Roche Diagnostics Gmbh Systems and methods to compensate for sources of error during electrochemical testing
US20120173151A1 (en) 2010-12-29 2012-07-05 Roche Diagnostics Operations, Inc. Methods of assessing diabetes treatment protocols based on protocol complexity levels and patient proficiency levels
US8771793B2 (en) 2011-04-15 2014-07-08 Roche Diagnostics Operations, Inc. Vacuum assisted slot die coating techniques
EP2518497A1 (en) * 2011-04-29 2012-10-31 Roche Diagnostics GmbH Electrochemical sensor element for body fluids and method for its production
CA2835194A1 (en) 2011-05-05 2012-11-08 Daktari Diagnostics, Inc. Conductive patterns and methods for making conductive patterns
US8755938B2 (en) 2011-05-13 2014-06-17 Roche Diagnostics Operations, Inc. Systems and methods for handling unacceptable values in structured collection protocols
US8766803B2 (en) 2011-05-13 2014-07-01 Roche Diagnostics Operations, Inc. Dynamic data collection
US9504162B2 (en) 2011-05-20 2016-11-22 Pepex Biomedical, Inc. Manufacturing electrochemical sensor modules
US8936693B2 (en) 2011-05-24 2015-01-20 Mark Andy, Inc. Methods of and apparatus for making a flexible composite having reservoirs and capillaries
US9733205B2 (en) 2011-06-16 2017-08-15 Panasonic Healthcare Holdings Co., Ltd. Sensor and sensor system equipped with same
US9754708B2 (en) 2011-07-29 2017-09-05 Roche Diabetes Care, Inc. Encoded biosensors and methods of manufacture and use thereof
US8888973B2 (en) 2011-07-29 2014-11-18 Roche Diagnostics Operations, Inc. Encoded biosensors and methods of manufacture and use thereof
JP6312593B2 (en) 2011-08-25 2018-04-18 エフ ホフマン−ラ ロッシュ アクチェン ゲゼルシャフト Glucose oxidase
EP2562251B1 (en) 2011-08-25 2016-08-17 Roche Diagnostics GmbH Cholesterol oxidase
US9914126B2 (en) 2011-11-28 2018-03-13 Roche Diabetes Care, Inc. Storage container for biosensor test elements
US9903830B2 (en) 2011-12-29 2018-02-27 Lifescan Scotland Limited Accurate analyte measurements for electrochemical test strip based on sensed physical characteristic(s) of the sample containing the analyte
WO2013109549A2 (en) 2012-01-16 2013-07-25 Abram Scientific, Inc. Methods, devices, and systems for measuring physical properties of fluid
FR2988736B1 (en) * 2012-04-02 2014-03-07 Onera (Off Nat Aerospatiale) PROCESS FOR OBTAINING A NICKEL ALUMINUM COATING ON A METALLIC SUBSTRATE, AND PART HAVING SUCH A COATING
US9759677B2 (en) * 2012-04-03 2017-09-12 Joinsoon Medical Technology Co., Ltd. Biosensor
US9180449B2 (en) 2012-06-12 2015-11-10 Hach Company Mobile water analysis
US8877023B2 (en) * 2012-06-21 2014-11-04 Lifescan Scotland Limited Electrochemical-based analytical test strip with intersecting sample-receiving chambers
EP2867660A4 (en) * 2012-06-28 2015-12-23 Siemens Healthcare Diagnostics Reader device and method of signal amplification
US8992750B1 (en) 2012-07-02 2015-03-31 Roche Diagnostics Operations, Inc. Biosensor and methods for manufacturing
US20140068487A1 (en) 2012-09-05 2014-03-06 Roche Diagnostics Operations, Inc. Computer Implemented Methods For Visualizing Correlations Between Blood Glucose Data And Events And Apparatuses Thereof
ES2603928T3 (en) * 2012-09-06 2017-03-02 F. Hoffmann-La Roche Ag Compositions and methods of improved matrix stability
US9588076B2 (en) 2012-09-19 2017-03-07 Panasonic Healthcare Holdings Co., Ltd. Biosensor and method for manufacturing biosensor
KR101413478B1 (en) * 2012-10-10 2014-07-02 케이맥(주) Loc and manufacturing method for the same
WO2014064978A1 (en) * 2012-10-22 2014-05-01 株式会社村田製作所 Biosensor and manufacturing method therefor
US9739714B2 (en) 2012-10-29 2017-08-22 Mbio Diagnostics, Inc. Particle identification system, cartridge and associated methods
US8920628B2 (en) 2012-11-02 2014-12-30 Roche Diagnostics Operations, Inc. Systems and methods for multiple analyte analysis
US8921061B2 (en) 2012-11-02 2014-12-30 Roche Diagnostics Operations, Inc. Reagent materials and associated test elements
EP2925229A4 (en) 2012-12-03 2017-01-25 Pepex Biomedical, Inc. Sensor module and method of using a sensor module
USD768872S1 (en) 2012-12-12 2016-10-11 Hach Company Cuvette for a water analysis instrument
WO2014114810A1 (en) 2013-01-28 2014-07-31 Roche Diagnostics Gmbh Novel glucose oxidases derived from aspergillus niger
GB2510371B (en) * 2013-01-31 2016-01-06 Lifescan Scotland Ltd Electrochemical-based analytical test strip with soluble acidic material coating
CA2897494A1 (en) * 2013-03-07 2014-09-12 Rapid Pathogen Screening, Inc. Method and device for combined detection of viral and bacterial infections
WO2014160210A1 (en) * 2013-03-13 2014-10-02 The Regents Of The University Of Michigan Method for determining tear glucose concentration with blood glucose test strips
US9097659B2 (en) * 2013-03-14 2015-08-04 Bayer Healthcare Llc Maintaining electrode function during manufacture with a protective layer
US10041901B2 (en) 2013-03-15 2018-08-07 Roche Diabetes Care, Inc. Electrode configuration for a biosensor
JP6356705B2 (en) 2013-03-15 2018-07-11 エフ.ホフマン−ラ ロシュ アーゲーF. Hoffmann−La Roche Aktiengesellschaft Scaling data method and device, apparatus and system using biosensor algorithm for construction
EP2972273B1 (en) 2013-03-15 2020-10-21 Roche Diabetes Care GmbH Methods of using information from recovery pulses in electrochemical analyte measurements as well as devices incorporating the same
EP2972268B1 (en) 2013-03-15 2017-05-24 Roche Diabetes Care GmbH Methods of failsafing electrochemical measurements of an analyte as well as devices, apparatuses and systems incorporating the same
EP3388824B1 (en) 2013-03-15 2021-04-14 Roche Diabetes Care GmbH Methods of detecting high antioxidant levels during electrochemical measurements and failsafing an analyte concentration therefrom as well as devices and systems incorporting the same
JP6300057B2 (en) * 2013-03-18 2018-03-28 大日本印刷株式会社 Concentration measurement sensor and method for manufacturing the same, sheet for concentration measurement sensor and flash annealing method
CN103412012B (en) 2013-03-28 2015-09-09 利多(香港)有限公司 Biology sensor
EP2796547B1 (en) 2013-04-24 2016-09-14 Fraunhofer-Gesellschaft zur Förderung der angewandten Forschung e.V. Novel glucose oxidase variants
EP2992813B1 (en) * 2013-05-02 2018-10-31 Echo Electricity Co. Ltd. Liquid-testing implement
US9523653B2 (en) 2013-05-09 2016-12-20 Changsha Sinocare Inc. Disposable test sensor with improved sampling entrance
GB2514846B (en) * 2013-06-07 2015-09-30 Lifescan Scotland Ltd Electrochemical-based analytical test strip with a soluble electrochemically-active coating opposite a bare electrode
US10376880B2 (en) * 2013-07-30 2019-08-13 Carehealth America Corporation Lateral flow devices and methods of manufacture and use
JP6311234B2 (en) * 2013-08-09 2018-04-18 大日本印刷株式会社 Biosensor electrode fabric, biosensor electrode and biosensor
US9459231B2 (en) 2013-08-29 2016-10-04 Lifescan Scotland Limited Method and system to determine erroneous measurement signals during a test measurement sequence
US9243276B2 (en) 2013-08-29 2016-01-26 Lifescan Scotland Limited Method and system to determine hematocrit-insensitive glucose values in a fluid sample
JP6657556B2 (en) * 2013-09-19 2020-03-04 株式会社リコー Fluid device, inspection apparatus, and method of manufacturing fluid device
EP3071970B1 (en) * 2013-11-19 2018-08-29 Tekinvest SPRL Kit, solid support unit strip, holder, and method for detecting at least two analytes
CA2931711C (en) * 2013-11-27 2019-06-25 F.Hoffmann-La Roche Ag A method for laser welding a disposable test-unit
US9518951B2 (en) 2013-12-06 2016-12-13 Changsha Sinocare Inc. Disposable test sensor with improved sampling entrance
US9897566B2 (en) 2014-01-13 2018-02-20 Changsha Sinocare Inc. Disposable test sensor
US9939401B2 (en) 2014-02-20 2018-04-10 Changsha Sinocare Inc. Test sensor with multiple sampling routes
ES2749925T3 (en) 2014-04-24 2020-03-24 Lucira Health Inc Colorimetric detection of nucleic acid amplification
CN107003264B (en) 2014-06-04 2020-02-21 普佩克斯生物医药有限公司 Electrochemical sensor and method of manufacturing an electrochemical sensor using advanced printing techniques
CN105277400A (en) * 2014-07-07 2016-01-27 闳伟科技股份有限公司 Electrochemical biosensing test piece and batch manufacture method thereof
US10111679B2 (en) * 2014-09-05 2018-10-30 Ethicon Llc Circuitry and sensors for powered medical device
US10378098B2 (en) 2015-03-18 2019-08-13 Materion Corporation Methods for optimized production of multilayer metal/transparent conducting oxide (TCO) constructs
US10197522B2 (en) 2015-03-18 2019-02-05 Materion Corporation Multilayer constructs for metabolite strips providing inert surface and mechanical advantage
US10934574B2 (en) * 2015-07-01 2021-03-02 Enicor Gmbh Diagnostic kit for viscoelastic analysis and uses and methods thereof
TWI551860B (en) * 2015-07-17 2016-10-01 台欣生物科技研發股份有限公司 Test strip
EP3170453B1 (en) 2015-11-19 2021-03-17 Roche Diabetes Care GmbH Sensor assembly for detecting at least one analyte in a body fluid and method of assembling a sensor assembly
EP3170451A1 (en) 2015-11-19 2017-05-24 Roche Diabetes Care GmbH Sensor and sensor assembly for detecting an analyte in a body fluid
EP3170452B1 (en) 2015-11-19 2021-01-27 Roche Diabetes Care GmbH Sensor assembly for detecting at least one analyte in a body fluid
EP3195795B1 (en) 2016-01-19 2023-08-23 Roche Diabetes Care GmbH Sensor assembly and method for detecting at least one analyte in a body fluid
DK3199121T3 (en) 2016-01-29 2018-12-10 Hoffmann La Roche FUNCTIONAL MEDICAL PACKAGING AND MEDICAL DEVICE FOR INSTALLING AT LEAST ONE SUB-SYSTEM IN A HOST
DE202016009188U1 (en) 2016-02-05 2023-08-30 Roche Diabetes Care Gmbh Medical device for detecting at least one analyte in a body fluid
ES2903121T3 (en) 2016-02-05 2022-03-31 Hoffmann La Roche Medical device for detecting at least one analyte in a body fluid
EP3909506B1 (en) 2016-02-05 2023-06-07 Roche Diabetes Care GmbH Medical device for detecting at least one analyte in a body fluid
DE202016009189U1 (en) 2016-02-05 2023-08-25 Roche Diabetes Care Gmbh Medical device for detecting at least one analyte in a body fluid
DE202016009190U1 (en) 2016-02-05 2023-08-23 Roche Diabetes Care Gmbh Medical device for detecting at least one analyte in a body fluid
EP3429752A4 (en) 2016-03-14 2019-10-30 Lucira Health, Inc. Systems and methods for performing biological assays
CA3015376C (en) 2016-03-14 2023-11-14 Diassess Inc. Devices and methods for biological assay sample preparation and delivery
AU2017232343B2 (en) * 2016-03-14 2022-03-31 Pfizer Inc. Devices and methods for modifying optical properties
AU2017232344B2 (en) 2016-03-14 2022-08-04 Pfizer Inc. Selectively vented biological assay devices and associated methods
SI3220137T1 (en) 2016-03-14 2019-05-31 F. Hoffmann-La Roche Ag Method for detecting an interferent contribution in a biosensor
EP3442708B1 (en) 2016-04-15 2020-11-04 enicor GmbH Pipette tip and uses and methods thereof
EP3242233B1 (en) 2016-05-03 2022-05-04 Roche Diabetes Care GmbH Sensor device for detecting at least one analyte in a body fluid of a user
EP3474729B1 (en) 2016-06-22 2023-04-19 Roche Diabetes Care GmbH Medical device for transcutaneously inserting an insertable element into a body tissue
EP3984451A1 (en) 2016-06-29 2022-04-20 Roche Diabetes Care GmbH Method for providing a signal quality degree associated with an analyte value measured in a continuous monitoring system
EP3278729B1 (en) 2016-08-04 2020-06-24 Roche Diabetes Care GmbH Medical device for detecting at least one analyte in a body fluid
KR102372113B1 (en) 2016-10-05 2022-03-07 에프. 호프만-라 로슈 아게 Detection reagents and electrode arrangements for multi-analyte diagnostic test elements, and methods of using the same
JP7271502B2 (en) * 2017-03-22 2023-05-11 フェポッド・オイ・リミテッド Electrochemical assay for detection of opioids
US11080848B2 (en) 2017-04-06 2021-08-03 Lucira Health, Inc. Image-based disease diagnostics using a mobile device
EP3609625A4 (en) 2017-04-10 2021-04-07 Roche Diabetes Care GmbH Multi-reagent slot die coating process and useful devices
US10182750B1 (en) * 2017-04-27 2019-01-22 Verily Life Sciences Llc Electrically-isolated and moisture-resistant designs for wearable devices
EP3406193B1 (en) 2017-05-23 2021-12-08 Roche Diabetes Care GmbH Sensor system and method for manufacturing thereof
WO2019007842A1 (en) 2017-07-03 2019-01-10 Roche Diabetes Care Gmbh Method and electronics unit for detecting in-vivo properties of a biosensor
US10549275B2 (en) 2017-09-14 2020-02-04 Lucira Health, Inc. Multiplexed biological assay device with electronic readout
EP3457121A1 (en) 2017-09-18 2019-03-20 Roche Diabetes Care GmbH Electrochemical sensor and sensor system for detecting at least one analyte
WO2019059930A1 (en) * 2017-09-22 2019-03-28 Emmanuel Mpock System for measuring total hemoglobin in blood and method of doing the same
EP3700407A1 (en) 2017-10-27 2020-09-02 Roche Diabetes Care GmbH A device and a method for detecting at least one analyte in a body fluid of a user
ES2831076T3 (en) * 2017-11-08 2021-06-07 Hoffmann La Roche Sensor for detecting an analyte in a body fluid and method of manufacturing the same
CN109085218A (en) * 2018-01-19 2018-12-25 上海荒岛科技有限公司 A kind of reagent and electrochemical sensor
CN109085090B (en) * 2018-01-19 2021-06-29 上海荒岛科技有限公司 Method, measuring instrument and system for detecting specific gravity of urine
JP7042140B2 (en) * 2018-03-30 2022-03-25 株式会社Provigate Sensor chip
DE102018114206A1 (en) 2018-06-14 2019-12-19 RUHR-UNIVERSITäT BOCHUM Biosensor and method for producing one
USD910200S1 (en) 2018-12-21 2021-02-09 Lucira Health, Inc. Test tube
US20220168727A1 (en) * 2019-03-24 2022-06-02 Mehul BALDWA Biosensor for detection of analytes in a fluid
WO2021138405A1 (en) 2019-12-30 2021-07-08 Roche Diabetes Care, Inc. Temperature compensated biosensors and methods of manufacture and use thereof
USD953561S1 (en) 2020-05-05 2022-05-31 Lucira Health, Inc. Diagnostic device with LED display
USD962470S1 (en) 2020-06-03 2022-08-30 Lucira Health, Inc. Assay device with LCD display
EP3928697A1 (en) 2020-06-23 2021-12-29 Roche Diabetes Care GmbH Analyte sensor and a method for producing an analyte sensor
TWI751591B (en) * 2020-06-23 2022-01-01 樂協生醫股份有限公司 An electrochemical test strip and a face shield; and a method for making the same
WO2022090113A1 (en) 2020-10-26 2022-05-05 F. Hoffmann-La Roche Ag Analyte sensor system and a method for its producing
TWI770667B (en) * 2020-11-11 2022-07-11 福永生物科技股份有限公司 Blood glucose control solution packaging and blood glucose test kits
EP4000514A1 (en) 2020-11-12 2022-05-25 Roche Diabetes Care GmbH Method for producing an analyte sensor, an analyte sensor, and a use thereof
KR20230104120A (en) 2020-11-12 2023-07-07 에프. 호프만-라 로슈 아게 Method for manufacturing at least one electrode of an analyte sensor
TWI768639B (en) * 2021-01-05 2022-06-21 國立雲林科技大學 Uric acid sensor and the method for manufacturing the same
WO2022197708A1 (en) * 2021-03-15 2022-09-22 Lasx Industries, Inc. Functional laminate packaging and method of manufacture
EP4085829A1 (en) 2021-05-06 2022-11-09 Roche Diabetes Care GmbH Analyte sensor and a method for its producing
JP1706794S (en) * 2021-06-17 2022-02-03 Blood glucose test strip
EP4137046A1 (en) 2021-08-18 2023-02-22 Roche Diabetes Care GmbH Analyte sensor and a method for its producing
WO2023167945A1 (en) * 2022-03-01 2023-09-07 Argonaut Manufacturing Services, Inc. Devices that include a dried reagent:substrate complex and methods for generating such complexes and devices

Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP0267724A1 (en) * 1986-10-31 1988-05-18 Unilever Plc Test devices with reagent layers formed by printing processes
WO1998030904A1 (en) * 1997-01-09 1998-07-16 Mercury Diagnostics, Inc. Method for applying a reagent to an analytical test device
US6036919A (en) * 1996-07-23 2000-03-14 Roche Diagnostic Gmbh Diagnostic test carrier with multilayer field
WO2002032559A1 (en) * 2000-10-19 2002-04-25 Inverness Medical Limited Paste, which can undergo screen printing, for producing a porous polymer membrane for a biosensor
EP1316367A1 (en) * 2001-11-28 2003-06-04 Lifescan, Inc. Solution striping system

Family Cites Families (438)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US3058079A (en) 1959-07-23 1962-10-09 Frank E Jones Hygrometer elements
US3501976A (en) * 1966-02-24 1970-03-24 Thompson Mfg Co Earl A Camshaft
BE754658A (en) 1969-08-12 1971-02-10 Merck Patent Gmbh INDICATOR SHEET, CONSISTING OF AN IMPREGNATED, ABSORBENT, SHEATHED HAIR MATERIAL
US3703696A (en) 1971-11-23 1972-11-21 Gen Electric Humidity sensor
FR2295419A1 (en) 1974-12-21 1976-07-16 Kyoto Daiichi Kagaku Kk REFLECTANCE MEASURING DEVICE AND COMPOSITE TEST PAPER STRUCTURE SUBJECT TO SUCH MEASUREMENT
US4065263A (en) 1976-04-02 1977-12-27 Woodbridge Iii Richard G Analytical test strip apparatus
US4081653A (en) 1976-12-27 1978-03-28 Western Electric Co., Inc. Removal of thin films from substrates by laser induced explosion
US4131484A (en) 1978-02-13 1978-12-26 Western Electric Company, Inc. Frequency adjusting a piezoelectric device by lasering
US4225410A (en) 1978-12-04 1980-09-30 Technicon Instruments Corporation Integrated array of electrochemical sensors
US4323536A (en) 1980-02-06 1982-04-06 Eastman Kodak Company Multi-analyte test device
US4642601A (en) 1980-07-21 1987-02-10 Hitachi, Ltd. Humidity-sensitive element
US4420564A (en) 1980-11-21 1983-12-13 Fuji Electric Company, Ltd. Blood sugar analyzer having fixed enzyme membrane sensor
US4426451A (en) 1981-01-28 1984-01-17 Eastman Kodak Company Multi-zoned reaction vessel having pressure-actuatable control means between zones
DE3133826A1 (en) 1981-08-27 1983-03-10 Boehringer Mannheim Gmbh, 6800 Mannheim ANALYSIS TEST STRIP AND METHOD FOR THE PRODUCTION THEREOF
DE3137174A1 (en) * 1981-09-18 1983-04-07 Boehringer Mannheim Gmbh, 6800 Mannheim DEVICE FOR THE OPTICAL DETECTION OF A CODING ON A DIAGNOSTIC TEST STRIP
DE3278334D1 (en) 1981-10-23 1988-05-19 Genetics Int Inc Sensor for components of a liquid mixture
US4455530A (en) 1982-03-30 1984-06-19 Westinghouse Electric Corp. Conductivity sensor for use in steam turbines
US4571292A (en) * 1982-08-12 1986-02-18 Case Western Reserve University Apparatus for electrochemical measurements
US4414059A (en) 1982-12-09 1983-11-08 International Business Machines Corporation Far UV patterning of resist materials
FI65674C (en) 1982-12-21 1984-06-11 Vaisala Oy CAPACITIVE FUEL FARTIGHETSGIVARE OCH FOERFARANDE FOER FRAMSTAELLNINGDAERAV
US4679562A (en) 1983-02-16 1987-07-14 Cardiac Pacemakers, Inc. Glucose sensor
CA1226036A (en) 1983-05-05 1987-08-25 Irving J. Higgins Analytical equipment and sensor electrodes therefor
US5509410A (en) * 1983-06-06 1996-04-23 Medisense, Inc. Strip electrode including screen printing of a single layer
US5682884A (en) 1983-05-05 1997-11-04 Medisense, Inc. Strip electrode with screen printing
DE3326689A1 (en) * 1983-07-23 1985-01-31 Boehringer Mannheim Gmbh, 6800 Mannheim METHOD AND DEVICE FOR PRODUCING A TEST STRIP
GB8406752D0 (en) 1984-03-15 1984-04-18 Unilever Plc Chemical and clinical tests
US5141868A (en) 1984-06-13 1992-08-25 Internationale Octrooi Maatschappij "Octropa" Bv Device for use in chemical test procedures
AU581669B2 (en) 1984-06-13 1989-03-02 Applied Research Systems Ars Holding N.V. Photometric instruments, their use in methods of optical analysis, and ancillary devices therefor
DE3581071D1 (en) 1984-10-31 1991-02-07 Unilever Nv DEVICE FOR USE IN ELECTRICAL, e.g. ELECTROCHEMICAL MEASUREMENT METHOD, THEIR PRODUCTION AND USE, AND THE COMPOSITIONS THAT CONTAIN THIS DEVICE.
US4671288A (en) 1985-06-13 1987-06-09 The Regents Of The University Of California Electrochemical cell sensor for continuous short-term use in tissues and blood
US5185256A (en) 1985-06-21 1993-02-09 Matsushita Electric Industrial Co., Ltd. Method for making a biosensor
DE3687646T3 (en) 1985-06-21 2001-05-31 Matsushita Electric Ind Co Ltd BIOSENSOR AND THEIR PRODUCTION.
CA1249333A (en) 1985-06-28 1989-01-24 James E. Jones Electrochemical sensor and membrane therefor
US4938860A (en) 1985-06-28 1990-07-03 Miles Inc. Electrode for electrochemical sensors
US4805624A (en) 1985-09-09 1989-02-21 The Montefiore Hospital Association Of Western Pa Low-potential electrochemical redox sensors
EP0215669A3 (en) 1985-09-17 1989-08-30 Seiko Instruments Inc. Analytical device and method for analysis of biochemicals, microbes and cells
US4684437A (en) 1985-10-31 1987-08-04 International Business Machines Corporation Selective metal etching in metal/polymer structures
US4714874A (en) 1985-11-12 1987-12-22 Miles Inc. Test strip identification and instrument calibration
US5066372A (en) 1986-05-02 1991-11-19 Ciba Corning Diagnostics Corp. Unitary multiple electrode sensor
GB8612861D0 (en) 1986-05-27 1986-07-02 Cambridge Life Sciences Immobilised enzyme biosensors
JPS636451A (en) * 1986-06-27 1988-01-12 Terumo Corp Enzyme sensor
US4713165A (en) 1986-07-02 1987-12-15 Ilex Corporation Sensor having ion-selective electrodes
GB8618022D0 (en) 1986-07-23 1986-08-28 Unilever Plc Electrochemical measurements
US5059394A (en) 1986-08-13 1991-10-22 Lifescan, Inc. Analytical device for the automated determination of analytes in fluids
US4935346A (en) * 1986-08-13 1990-06-19 Lifescan, Inc. Minimum procedure system for the determination of analytes
US5049487A (en) 1986-08-13 1991-09-17 Lifescan, Inc. Automated initiation of timing of reflectance readings
US4865873A (en) 1986-09-15 1989-09-12 General Electric Company Electroless deposition employing laser-patterned masking layer
GB2201248B (en) 1987-02-24 1991-04-17 Ici Plc Enzyme electrode sensors
CA1315181C (en) 1987-04-13 1993-03-30 Joel M. Blatt Test strip device with volume metering capillary gap
US4797256A (en) * 1987-06-05 1989-01-10 Boehringer Mannheim Corporation Registration device for blood test strips
DE3720189C1 (en) 1987-06-16 1988-12-29 Endress Hauser Gmbh Co Dew point sensor
US4761710A (en) 1987-06-23 1988-08-02 Industrial Technology Research Institute Polyimide capacitive humidity sensing element
US4874500A (en) 1987-07-15 1989-10-17 Sri International Microelectrochemical sensor and sensor array
US4877580A (en) 1988-02-09 1989-10-31 Technimed Corporation Assay kit including an analyte test strip and a color comparator
DE68924026T3 (en) 1988-03-31 2008-01-10 Matsushita Electric Industrial Co., Ltd., Kadoma BIOSENSOR AND ITS MANUFACTURE.
US5439826A (en) 1988-12-02 1995-08-08 Bio-Tek Instruments, Inc. Method of distinguishing among strips for different assays in an automated instrument
JP2654682B2 (en) 1989-02-17 1997-09-17 富士写真フイルム株式会社 Biochemical analyzer, biochemical analysis correction method and correction value recording medium
US5312762A (en) 1989-03-13 1994-05-17 Guiseppi Elie Anthony Method of measuring an analyte by measuring electrical resistance of a polymer film reacting with the analyte
DE3911539A1 (en) 1989-04-08 1990-10-11 Boehringer Mannheim Gmbh TEST CARRIER ANALYSIS SYSTEM
DE3922478A1 (en) 1989-07-06 1991-01-17 Schering Ag Excimer laser structuring or etching process - for plastics-coated copper-clad base materials
CH677149A5 (en) 1989-07-07 1991-04-15 Disetronic Ag
AU640162B2 (en) 1989-08-28 1993-08-19 Lifescan, Inc. Blood separation and analyte detection techniques
US6395227B1 (en) 1989-08-28 2002-05-28 Lifescan, Inc. Test strip for measuring analyte concentration over a broad range of sample volume
US5620863A (en) 1989-08-28 1997-04-15 Lifescan, Inc. Blood glucose strip having reduced side reactions
US5306623A (en) 1989-08-28 1994-04-26 Lifescan, Inc. Visual blood glucose concentration test strip
US5018164A (en) 1989-09-12 1991-05-21 Hughes Aircraft Company Excimer laser ablation method and apparatus for microcircuit fabrication
US5089103A (en) 1989-12-01 1992-02-18 Hewlett-Packard Company Electrophoresis capillary with agarose
GB8927377D0 (en) 1989-12-04 1990-01-31 Univ Edinburgh Improvements in and relating to amperometric assays
DE3940152A1 (en) 1989-12-05 1991-06-06 Boehringer Mannheim Gmbh TEST STRIP EVALUATOR FOR MULTIPLE TEST STRIPS
AU634863B2 (en) 1989-12-15 1993-03-04 Roche Diagnostics Operations Inc. Redox mediator reagent and biosensor
US5243516A (en) 1989-12-15 1993-09-07 Boehringer Mannheim Corporation Biosensing instrument and method
US5508171A (en) * 1989-12-15 1996-04-16 Boehringer Mannheim Corporation Assay method with enzyme electrode system
DE4003194A1 (en) 1990-02-03 1991-08-08 Boehringer Mannheim Gmbh Electrochemical determn. of analytes - using oxido-reductase and substance of being reduced, which is re-oxidised on the electrode
US5286362A (en) * 1990-02-03 1994-02-15 Boehringer Mannheim Gmbh Method and sensor electrode system for the electrochemical determination of an analyte or an oxidoreductase as well as the use of suitable compounds therefor
US5141850A (en) 1990-02-07 1992-08-25 Hygeia Sciences, Inc. Porous strip form assay device method
US5036704A (en) 1990-03-23 1991-08-06 Gas Research Institute Moisture sensor
US5187100A (en) * 1990-05-29 1993-02-16 Lifescan, Inc. Dispersion to limit penetration of aqueous solutions into a membrane
US5250439A (en) 1990-07-19 1993-10-05 Miles Inc. Use of conductive sensors in diagnostic assays
JPH0820412B2 (en) 1990-07-20 1996-03-04 松下電器産業株式会社 Quantitative analysis method and device using disposable sensor
US5104480A (en) 1990-10-12 1992-04-14 General Electric Company Direct patterning of metals over a thermally inefficient surface using a laser
DE4041905A1 (en) * 1990-12-27 1992-07-02 Boehringer Mannheim Gmbh TEST CARRIER ANALYSIS SYSTEM
ES2164641T3 (en) * 1991-02-27 2002-03-01 Roche Diagnostics Corp COMMUNICATION METHOD WITH INSTRUMENTS CONTROLLED BY MICROCOMPUTER.
US5192415A (en) 1991-03-04 1993-03-09 Matsushita Electric Industrial Co., Ltd. Biosensor utilizing enzyme and a method for producing the same
US5593852A (en) 1993-12-02 1997-01-14 Heller; Adam Subcutaneous glucose electrode
DE59108784D1 (en) 1991-04-01 1997-08-21 Akcionernoe Obscestvo Otkrytog MULTIPLE LAYER BOARD AND METHOD FOR THEIR PRODUCTION
JP3118015B2 (en) 1991-05-17 2000-12-18 アークレイ株式会社 Biosensor and separation and quantification method using the same
GB9113211D0 (en) 1991-06-19 1991-08-07 Hypoguard Uk Ltd Support membrane
US5264103A (en) 1991-10-18 1993-11-23 Matsushita Electric Industrial Co., Ltd. Biosensor and a method for measuring a concentration of a substrate in a sample
KR100274764B1 (en) 1991-11-29 2001-01-15 이사오 우치가사키 Manufacturing method of the wiring board
JP3135959B2 (en) 1991-12-12 2001-02-19 アークレイ株式会社 Biosensor and separation and quantification method using the same
US5336388A (en) 1991-12-26 1994-08-09 Ppg Industries, Inc. Analyte and pH measuring sensor assembly and method
US5296192A (en) * 1992-04-03 1994-03-22 Home Diagnostics, Inc. Diagnostic test strip
JP2541081B2 (en) 1992-08-28 1996-10-09 日本電気株式会社 Biosensor and method of manufacturing and using biosensor
US5498414A (en) * 1992-10-05 1996-03-12 University Of Victoria Attenuated strains of Aeromonas salmonicida useful as fish vaccines
GB9221099D0 (en) 1992-10-07 1992-11-18 Ecossensors Ltd Improvements in and relating to gas permeable membranes for amperometric gas electrodes
US5387327A (en) 1992-10-19 1995-02-07 Duquesne University Of The Holy Ghost Implantable non-enzymatic electrochemical glucose sensor
US5389215A (en) 1992-11-05 1995-02-14 Nippon Telegraph And Telephone Corporation Electrochemical detection method and apparatus therefor
JP2954436B2 (en) 1992-11-11 1999-09-27 株式会社日立製作所 Test piece supply device and analyzer using the same
US5344754A (en) 1993-01-13 1994-09-06 Avocet Medical, Inc. Assay timed by electrical resistance change and test strip
FR2701117B1 (en) 1993-02-04 1995-03-10 Asulab Sa Electrochemical measurement system with multizone sensor, and its application to glucose measurement.
DE4310106C1 (en) 1993-03-27 1994-10-06 Bruker Saxonia Analytik Gmbh Manufacturing process for switching grids of an ion mobility spectrometer and switching grids manufactured according to the process
DE4310583A1 (en) 1993-03-31 1994-10-06 Boehringer Mannheim Gmbh Test strip analysis system
US5390412A (en) 1993-04-08 1995-02-21 Gregoire; George D. Method for making printed circuit boards
DE59410066D1 (en) 1993-04-23 2002-04-11 Boehringer Mannheim Gmbh System for analyzing the contents of liquid samples
DE4313253A1 (en) 1993-04-23 1994-10-27 Boehringer Mannheim Gmbh System for analyzing the contents of liquid samples
US5843691A (en) 1993-05-15 1998-12-01 Lifescan, Inc. Visually-readable reagent test strip
WO1994028414A1 (en) 1993-05-29 1994-12-08 Cambridge Life Sciences Plc Sensors based on polymer transformation
DE4318519C2 (en) 1993-06-03 1996-11-28 Fraunhofer Ges Forschung Electrochemical sensor
US5385846A (en) * 1993-06-03 1995-01-31 Boehringer Mannheim Corporation Biosensor and method for hematocrit determination
JP2704046B2 (en) 1993-06-08 1998-01-26 ベーリンガー マンハイム コーポレーション Biosensing meter that detects the appropriate electrode connection and distinguishes between sample and check pieces
US5366609A (en) 1993-06-08 1994-11-22 Boehringer Mannheim Corporation Biosensing meter with pluggable memory key
AU680520B2 (en) 1993-06-21 1997-07-31 Roche Diagnostics Operations Inc. Diagnostic reagent stabilizer
US5413690A (en) 1993-07-23 1995-05-09 Boehringer Mannheim Corporation Potentiometric biosensor and the method of its use
US5658443A (en) 1993-07-23 1997-08-19 Matsushita Electric Industrial Co., Ltd. Biosensor and method for producing the same
EP0722563A4 (en) 1993-08-24 1998-03-04 Metrika Lab Inc Novel disposable electronic assay device
US5589326A (en) 1993-12-30 1996-12-31 Boehringer Mannheim Corporation Osmium-containing redox mediator
US5421189A (en) 1994-01-21 1995-06-06 Ciba Corning Diagnostics Corp. Electrical connection system for electrochemical sensors
US5762770A (en) 1994-02-21 1998-06-09 Boehringer Mannheim Corporation Electrochemical biosensor test strip
WO1995022881A1 (en) 1994-02-22 1995-08-24 Philips Electronics N.V. Laser etching method
US5437999A (en) 1994-02-22 1995-08-01 Boehringer Mannheim Corporation Electrochemical sensor
US5391250A (en) 1994-03-15 1995-02-21 Minimed Inc. Method of fabricating thin film sensors
DE4417245A1 (en) 1994-04-23 1995-10-26 Lpkf Cad Cam Systeme Gmbh High resolution structured metallisation prodn.
JP3331253B2 (en) 1994-05-10 2002-10-07 バイエルコーポレーション Test strip removal device for automatic analyzer
JP3027306B2 (en) 1994-06-02 2000-04-04 松下電器産業株式会社 Biosensor and manufacturing method thereof
US5494562A (en) 1994-06-27 1996-02-27 Ciba Corning Diagnostics Corp. Electrochemical sensors
US5547702A (en) 1994-07-08 1996-08-20 Polymer Technology International Corporation Method for continuous manufacture of diagnostic test strips
GB9415499D0 (en) 1994-08-01 1994-09-21 Bartlett Philip N Electrodes and their use in analysis
WO1996007908A1 (en) 1994-09-08 1996-03-14 Lifescan, Inc. Optically readable strip for analyte detection having on-strip standard
US6335203B1 (en) 1994-09-08 2002-01-01 Lifescan, Inc. Optically readable strip for analyte detection having on-strip orientation index
US5515170A (en) 1994-09-08 1996-05-07 Lifescan, Inc. Analyte detection device having a serpentine passageway for indicator strips
US5526120A (en) 1994-09-08 1996-06-11 Lifescan, Inc. Test strip with an asymmetrical end insuring correct insertion for measuring
US5597532A (en) 1994-10-20 1997-01-28 Connolly; James Apparatus for determining substances contained in a body fluid
KR0151203B1 (en) 1994-12-08 1998-12-01 이헌조 Multi-electrode type biosensor
US5533393A (en) 1995-01-13 1996-07-09 Honeywell Inc. Determination of dew point or absolute humidity
US5569608A (en) 1995-01-30 1996-10-29 Bayer Corporation Quantitative detection of analytes on immunochromatographic strips
US6153069A (en) 1995-02-09 2000-11-28 Tall Oak Ventures Apparatus for amperometric Diagnostic analysis
EP0727925A1 (en) 1995-02-14 1996-08-21 Lpkf Cad/Cam Systeme Gmbh Process for structured metallizing of the surface of substrates
US5582697A (en) 1995-03-17 1996-12-10 Matsushita Electric Industrial Co., Ltd. Biosensor, and a method and a device for quantifying a substrate in a sample liquid using the same
US5650062A (en) 1995-03-17 1997-07-22 Matsushita Electric Industrial Co., Ltd. Biosensor, and a method and a device for quantifying a substrate in a sample liquid using the same
US5788833A (en) 1995-03-27 1998-08-04 California Institute Of Technology Sensors for detecting analytes in fluids
US6170318B1 (en) 1995-03-27 2001-01-09 California Institute Of Technology Methods of use for sensor based fluid detection devices
JP3498105B2 (en) 1995-04-07 2004-02-16 アークレイ株式会社 Sensor, method for manufacturing the same, and measuring method using the sensor
US5620579A (en) 1995-05-05 1997-04-15 Bayer Corporation Apparatus for reduction of bias in amperometric sensors
US5677546A (en) 1995-05-19 1997-10-14 Uniax Corporation Polymer light-emitting electrochemical cells in surface cell configuration
US5656502A (en) 1995-06-07 1997-08-12 Diagnostic Chemicals Limited Test strip holder and method of use
AUPN363995A0 (en) 1995-06-19 1995-07-13 Memtec Limited Electrochemical cell
US6413410B1 (en) 1996-06-19 2002-07-02 Lifescan, Inc. Electrochemical cell
JPH10505463A (en) 1995-06-27 1998-05-26 フィリップス エレクトロニクス ネムローゼ フェンノートシャップ Multilayer electronic device manufacturing method
US5698083A (en) 1995-08-18 1997-12-16 Regents Of The University Of California Chemiresistor urea sensor
DE19535068C2 (en) 1995-09-21 1997-08-21 Lpkf Cad Cam Systeme Gmbh Coating for the structured production of conductor tracks on the surface of electrically insulating substrates, method for producing the coating and of structured conductor tracks
US5665215A (en) 1995-09-25 1997-09-09 Bayer Corporation Method and apparatus for making predetermined events with a biosensor
US5628890A (en) 1995-09-27 1997-05-13 Medisense, Inc. Electrochemical sensor
US5766789A (en) 1995-09-29 1998-06-16 Energetics Systems Corporation Electrical energy devices
AU722471B2 (en) 1995-10-17 2000-08-03 Lifescan, Inc. Blood glucose strip having reduced sensitivity to hematocrit
US20030180183A1 (en) 1995-10-30 2003-09-25 Takao Fukuoka Method for measuring substance and testing piece
US6638415B1 (en) 1995-11-16 2003-10-28 Lifescan, Inc. Antioxidant sensor
AUPN661995A0 (en) 1995-11-16 1995-12-07 Memtec America Corporation Electrochemical cell 2
US6174420B1 (en) 1996-11-15 2001-01-16 Usf Filtration And Separations Group, Inc. Electrochemical cell
US6521110B1 (en) 1995-11-16 2003-02-18 Lifescan, Inc. Electrochemical cell
US6863801B2 (en) 1995-11-16 2005-03-08 Lifescan, Inc. Electrochemical cell
JPH09207343A (en) 1995-11-29 1997-08-12 Matsushita Electric Ind Co Ltd Laser machining method
US5755953A (en) 1995-12-18 1998-05-26 Abbott Laboratories Interference free biosensor
US5897522A (en) 1995-12-20 1999-04-27 Power Paper Ltd. Flexible thin layer open electrochemical cell and applications of same
JP3365184B2 (en) 1996-01-10 2003-01-08 松下電器産業株式会社 Biosensor
US5830341A (en) 1996-01-23 1998-11-03 Gilmartin; Markas A. T. Electrodes and metallo isoindole ringed compounds
US5989917A (en) 1996-02-13 1999-11-23 Selfcare, Inc. Glucose monitor and test strip containers for use in same
US5605837A (en) * 1996-02-14 1997-02-25 Lifescan, Inc. Control solution for a blood glucose monitor
US6241862B1 (en) 1996-02-14 2001-06-05 Inverness Medical Technology, Inc. Disposable test strips with integrated reagent/blood separation layer
US5708247A (en) 1996-02-14 1998-01-13 Selfcare, Inc. Disposable glucose test strips, and methods and compositions for making same
DE19605583A1 (en) 1996-02-15 1997-08-21 Bayer Ag Electrochemical sensors with improved selectivity and increased sensitivity
GB2310493B (en) 1996-02-26 2000-08-02 Unilever Plc Determination of the characteristics of fluid
US5723284A (en) 1996-04-01 1998-03-03 Bayer Corporation Control solution and method for testing the performance of an electrochemical device for determining the concentration of an analyte in blood
US5962215A (en) 1996-04-05 1999-10-05 Mercury Diagnostics, Inc. Methods for testing the concentration of an analyte in a body fluid
US5890489A (en) 1996-04-23 1999-04-06 Dermal Therapy (Barbados) Inc. Method for non-invasive determination of glucose in body fluids
US6001307A (en) 1996-04-26 1999-12-14 Kyoto Daiichi Kagaku Co., Ltd. Device for analyzing a sample
DE19621241C2 (en) * 1996-05-25 2000-03-16 Manfred Kessler Membrane electrode for measuring the glucose concentration in liquids
US5800690A (en) 1996-07-03 1998-09-01 Caliper Technologies Corporation Variable control of electroosmotic and/or electrophoretic forces within a fluid-containing structure via electrical forces
US5691486A (en) 1996-07-30 1997-11-25 Bayer Corporation Apparatus and methods for selecting a variable number of test sample aliquots to mix with respective reagents
JP3510740B2 (en) 1996-08-26 2004-03-29 シャープ株式会社 Manufacturing method of integrated thin-film solar cell
US5958791A (en) 1996-09-27 1999-09-28 Innovative Biotechnologies, Inc. Interdigitated electrode arrays for liposome-enhanced immunoassay and test device
US5945341A (en) 1996-10-21 1999-08-31 Bayer Corporation System for the optical identification of coding on a diagnostic test strip
GB9622304D0 (en) 1996-10-26 1996-12-18 Univ Manchester Sensor
US5856195A (en) 1996-10-30 1999-01-05 Bayer Corporation Method and apparatus for calibrating a sensor element
US6632349B1 (en) 1996-11-15 2003-10-14 Lifescan, Inc. Hemoglobin sensor
US5767687A (en) 1996-11-29 1998-06-16 Geist; Jon Surface-capacitor type condensable-vapor sensor
KR100243656B1 (en) 1996-12-05 2000-02-01 정선종 A vertical-cavity surface-emitting LASER with hydrogenation treatment and method for fabricating the same
JP3460183B2 (en) 1996-12-24 2003-10-27 松下電器産業株式会社 Biosensor
US5743691A (en) * 1997-02-03 1998-04-28 Textron Inc. Clinch-type fastener member
EP0958495B1 (en) 1997-02-06 2002-11-13 Therasense, Inc. Small volume in vitro analyte sensor
AUPO581397A0 (en) 1997-03-21 1997-04-17 Memtec America Corporation Sensor connection means
AUPO585797A0 (en) 1997-03-25 1997-04-24 Memtec America Corporation Improved electrochemical cell
DE19714674A1 (en) 1997-04-09 1998-10-15 Lre Technology Partner Gmbh Test strip pack and measuring device for using one
GB9708585D0 (en) 1997-04-29 1997-06-18 Eastman Kodak Co Apparatus, magazine and method for electrochemical detection or measurement
US5759364A (en) 1997-05-02 1998-06-02 Bayer Corporation Electrochemical biosensor
JP3060991B2 (en) * 1997-05-08 2000-07-10 日本電気株式会社 Biosensor
US5798031A (en) * 1997-05-12 1998-08-25 Bayer Corporation Electrochemical biosensor
US5921925A (en) 1997-05-30 1999-07-13 Ndm, Inc. Biomedical electrode having a disposable electrode and a reusable leadwire adapter that interfaces with a standard leadwire connector
GB9711395D0 (en) 1997-06-04 1997-07-30 Environmental Sensors Ltd Improvements to electrodes for the measurement of analytes in small samples
GB9824627D0 (en) 1998-11-11 1999-01-06 Cambridge Sensors Ltd Test strips for small volumes
US6040195A (en) 1997-06-10 2000-03-21 Home Diagnostics, Inc. Diagnostic sanitary test strip
US6168957B1 (en) 1997-06-25 2001-01-02 Lifescan, Inc. Diagnostic test strip having on-strip calibration
US6309526B1 (en) 1997-07-10 2001-10-30 Matsushita Electric Industrial Co., Ltd. Biosensor
CN1129792C (en) 1997-07-22 2003-12-03 株式会社京都第一科学 Densitometer, test piece for densitometer, biosensor system, and method for forming terminal of test piece
JP3297630B2 (en) 1997-07-28 2002-07-02 松下電器産業株式会社 Biosensor
JP3375040B2 (en) 1997-07-29 2003-02-10 松下電器産業株式会社 Substrate quantification method
AUPO855897A0 (en) 1997-08-13 1997-09-04 Usf Filtration And Separations Group Inc. Automatic analysing apparatus II
US6121050A (en) 1997-08-29 2000-09-19 Han; Chi-Neng Arthur Analyte detection systems
US6764581B1 (en) 1997-09-05 2004-07-20 Abbott Laboratories Electrode with thin working layer
US6129823A (en) * 1997-09-05 2000-10-10 Abbott Laboratories Low volume electrochemical sensor
US6071391A (en) 1997-09-12 2000-06-06 Nok Corporation Enzyme electrode structure
US6259937B1 (en) 1997-09-12 2001-07-10 Alfred E. Mann Foundation Implantable substrate sensor
US6007775A (en) 1997-09-26 1999-12-28 University Of Washington Multiple analyte diffusion based chemical sensor
WO1999017117A1 (en) 1997-09-30 1999-04-08 Amira Medical Analytical device with capillary reagent carrier
FI107080B (en) 1997-10-27 2001-05-31 Nokia Mobile Phones Ltd measuring device
US6102872A (en) 1997-11-03 2000-08-15 Pacific Biometrics, Inc. Glucose detector and method
CA2305366C (en) 1997-11-12 2007-10-16 Lightouch Medical, Inc. Method for non-invasive measurement of an analyte
US6300142B1 (en) 1997-11-28 2001-10-09 Provalis Diagnostics Ltd Device and apparatus for conducting an assay
DE19753847A1 (en) * 1997-12-04 1999-06-10 Roche Diagnostics Gmbh Analytical test element with capillary channel
US6579690B1 (en) 1997-12-05 2003-06-17 Therasense, Inc. Blood analyte monitoring through subcutaneous measurement
US5997817A (en) 1997-12-05 1999-12-07 Roche Diagnostics Corporation Electrochemical biosensor test strip
EP1038176B1 (en) 1997-12-19 2003-11-12 Amira Medical Embossed test strip system
US7390667B2 (en) 1997-12-22 2008-06-24 Roche Diagnostics Operations, Inc. System and method for analyte measurement using AC phase angle measurements
JP3848993B2 (en) 1998-01-06 2006-11-22 アークレイ株式会社 Method and apparatus for measuring the amount of components in the presence of coexisting substances
US6165594A (en) 1998-01-15 2000-12-26 3M Innovative Properties Company Multilayer, temperature resistant, composite label
US6274326B1 (en) 1998-02-17 2001-08-14 Umm Electronics, Inc. Method and apparatus for detecting proper strip insertion into an optical reflectance meter
JP3978489B2 (en) 1998-02-26 2007-09-19 アークレイ株式会社 Blood measuring device
US6103033A (en) 1998-03-04 2000-08-15 Therasense, Inc. Process for producing an electrochemical biosensor
US6134461A (en) 1998-03-04 2000-10-17 E. Heller & Company Electrochemical analyte
US6475360B1 (en) 1998-03-12 2002-11-05 Lifescan, Inc. Heated electrochemical cell
US6091975A (en) 1998-04-01 2000-07-18 Alza Corporation Minimally invasive detecting device
EP0987544B1 (en) 1998-04-02 2007-10-17 Matsushita Electric Industrial Co., Ltd. Substrate determining method
JPH11304748A (en) * 1998-04-23 1999-11-05 Omron Corp Biosensor
US6175752B1 (en) * 1998-04-30 2001-01-16 Therasense, Inc. Analyte monitoring device and methods of use
US6271044B1 (en) 1998-05-06 2001-08-07 University Of Pittsburgh Of The Commonwealth System Of Higher Education Method and kit for detecting an analyte
GB2337122B (en) 1998-05-08 2002-11-13 Medisense Inc Test strip
CA2332112C (en) 1998-05-13 2004-02-10 Cygnus, Inc. Monitoring of physiological analytes
US6526298B1 (en) * 1998-05-18 2003-02-25 Abbott Laboratories Method for the non-invasive determination of analytes in a selected volume of tissue
JP4256588B2 (en) 1998-05-20 2009-04-22 アークレイ株式会社 Electrochemical measurement method and measurement apparatus using statistical methods
DE29809191U1 (en) 1998-05-20 1998-08-13 Lre Technology Partner Gmbh Test strip measuring system
JPH11337514A (en) * 1998-05-26 1999-12-10 Omron Corp Biosensor
DE69902265T2 (en) 1998-06-01 2003-03-27 Roche Diagnostics Corp REDOX REVERSIBLE IMIDAZOLE OSMIUM COMPLEX CONJUGATES
US6077660A (en) 1998-06-10 2000-06-20 Abbott Laboratories Diagnostic assay requiring a small sample of biological fluid
US6287595B1 (en) 1998-06-10 2001-09-11 Delsys Pharmaceuticals Corporation Biomedical assay device
JP3389106B2 (en) * 1998-06-11 2003-03-24 松下電器産業株式会社 Electrochemical analysis element
JP3874321B2 (en) 1998-06-11 2007-01-31 松下電器産業株式会社 Biosensor
AU4833899A (en) 1998-06-24 2000-01-10 Therasense, Inc. Multi-sensor array for electrochemical recognition of nucleotide sequences and methods
JP2000081407A (en) * 1998-06-25 2000-03-21 Omron Corp Biosensor, its manufacture and measuring method using biosensor
JP2000019147A (en) 1998-07-01 2000-01-21 Nok Corp Reaction product measuring device
US6656702B1 (en) 1998-07-03 2003-12-02 Matsushita Electric Industrial Co., Ltd. Biosensor containing glucose dehydrogenase
US6521182B1 (en) 1998-07-20 2003-02-18 Lifescan, Inc. Fluidic device for medical diagnostics
US6162397A (en) 1998-08-13 2000-12-19 Lifescan, Inc. Visual blood glucose test strip
US6251260B1 (en) 1998-08-24 2001-06-26 Therasense, Inc. Potentiometric sensors for analytic determination
US6638716B2 (en) 1998-08-24 2003-10-28 Therasense, Inc. Rapid amperometric verification of PCR amplification of DNA
US6281006B1 (en) 1998-08-24 2001-08-28 Therasense, Inc. Electrochemical affinity assay
US6087182A (en) 1998-08-27 2000-07-11 Abbott Laboratories Reagentless analysis of biological samples
US5902731A (en) 1998-09-28 1999-05-11 Lifescan, Inc. Diagnostics based on tetrazolium compounds
DE19844500A1 (en) * 1998-09-29 2000-03-30 Roche Diagnostics Gmbh Process for the photometric evaluation of test elements
US6591125B1 (en) 2000-06-27 2003-07-08 Therasense, Inc. Small volume in vitro analyte sensor with diffusible or non-leachable redox mediator
US6338790B1 (en) 1998-10-08 2002-01-15 Therasense, Inc. Small volume in vitro analyte sensor with diffusible or non-leachable redox mediator
GB9825992D0 (en) 1998-11-28 1999-01-20 Moorlodge Biotech Ventures Lim Electrochemical sensor
US6377894B1 (en) 1998-11-30 2002-04-23 Abbott Laboratories Analyte test instrument having improved calibration and communication processes
US6203952B1 (en) 1999-01-14 2001-03-20 3M Innovative Properties Company Imaged article on polymeric substrate
US6565738B1 (en) 1999-01-28 2003-05-20 Abbott Laboratories Diagnostic test for the measurement of analyte in abiological fluid
US6475372B1 (en) 2000-02-02 2002-11-05 Lifescan, Inc. Electrochemical methods and devices for use in the determination of hematocrit corrected analyte concentrations
CA2365609A1 (en) 1999-02-12 2000-08-17 Cygnus, Inc. Devices and methods for frequent measurement of an analyte present in a biological system
AU5646800A (en) 1999-03-02 2000-09-21 Helix Biopharma Corporation Card-based biosensor device
US6150124A (en) 1999-05-20 2000-11-21 Umm Electronics, Inc. Method for passively determining the application of a sample fluid on an analyte strip
US6287451B1 (en) 1999-06-02 2001-09-11 Handani Winarta Disposable sensor and method of making
US6258229B1 (en) 1999-06-02 2001-07-10 Handani Winarta Disposable sub-microliter volume sensor and method of making
US6193873B1 (en) 1999-06-15 2001-02-27 Lifescan, Inc. Sample detection to initiate timing of an electrochemical assay
WO2000078992A2 (en) 1999-06-18 2000-12-28 Therasense, Inc. Mass transport limited in vivo analyte sensor
US6514769B2 (en) 1999-07-29 2003-02-04 Jin Po Lee Multiple analyte assay device with sample integrity monitoring system
CA2305922C (en) 1999-08-02 2005-09-20 Bayer Corporation Improved electrochemical sensor design
DE19936693A1 (en) 1999-08-04 2001-02-08 Lre Technology Partner Gmbh Instrument for the measurement of blood sugar concentrations has a test field with electrodes for the test strip and a circuit for measurement/evaluation of the current strength for display
EP1130390A1 (en) 1999-09-13 2001-09-05 Matsushita Electric Industrial Co., Ltd. Process for producing lipid-modified enzyme and biosensor
US6662439B1 (en) 1999-10-04 2003-12-16 Roche Diagnostics Corporation Laser defined features for patterned laminates and electrodes
US6645359B1 (en) 2000-10-06 2003-11-11 Roche Diagnostics Corporation Biosensor
US6767440B1 (en) 2001-04-24 2004-07-27 Roche Diagnostics Corporation Biosensor
US7276146B2 (en) 2001-11-16 2007-10-02 Roche Diagnostics Operations, Inc. Electrodes, methods, apparatuses comprising micro-electrode arrays
CA2347594C (en) * 1999-10-05 2006-11-28 Matsushita Electric Industrial Co., Ltd. Glucose sensor
DE19951721A1 (en) 1999-10-27 2000-06-15 Lpkf Laser & Electronics Ag Very fine circuit production on polymer involves structurization by erosion with short wavelength electromagnetic radiation using metal coat penetrated by photons and erosion by plasma formed at interface with polymer
US6319719B1 (en) 1999-10-28 2001-11-20 Roche Diagnostics Corporation Capillary hematocrit separation structure and method
US6528254B1 (en) * 1999-10-29 2003-03-04 Stratagene Methods for detection of a target nucleic acid sequence
US20020139668A1 (en) 1999-11-03 2002-10-03 Raghbir Singh Bhullar Embedded metallic deposits
US6616819B1 (en) 1999-11-04 2003-09-09 Therasense, Inc. Small volume in vitro analyte sensor and methods
US6923894B2 (en) 1999-11-11 2005-08-02 Apex Biotechnology Corporation Biosensor with multiple sampling ways
JP2001296267A (en) * 2000-04-14 2001-10-26 Matsushita Electric Ind Co Ltd Forming method of membrane electrode, and biosensor equipped with same
DK1230249T3 (en) 1999-11-15 2004-08-30 Therasense Inc Transition metal complexes with bidentate ligand having an imidazole ring
WO2001036954A1 (en) 1999-11-15 2001-05-25 Arkray, Inc. Biosensor
CN100363739C (en) 1999-11-15 2008-01-23 松下电器产业株式会社 Biosensor, method of forming thin-film electrode, and method and apparatus for quantitative determination
JP4184572B2 (en) * 2000-04-27 2008-11-19 松下電器産業株式会社 Biosensor
CN1162699C (en) 1999-11-16 2004-08-18 松下电器产业株式会社 Biosensor
US6331438B1 (en) 1999-11-24 2001-12-18 Iowa State University Research Foundation, Inc. Optical sensors and multisensor arrays containing thin film electroluminescent devices
JP4050434B2 (en) 1999-11-29 2008-02-20 松下電器産業株式会社 Sample discrimination method
JP2001159618A (en) 1999-12-03 2001-06-12 Matsushita Electric Ind Co Ltd Biosensor
US6603548B2 (en) 1999-12-03 2003-08-05 Sciperio, Inc. Biosensor
US6413395B1 (en) 1999-12-16 2002-07-02 Roche Diagnostics Corporation Biosensor apparatus
US6316264B1 (en) 1999-12-17 2001-11-13 Bayer Corporation Test strip for the assay of an analyte in a liquid sample
US6541216B1 (en) 1999-12-22 2003-04-01 Roche Diagnostics Corporation Amperometric biosensor test strip
US6627057B1 (en) 1999-12-23 2003-09-30 Roche Diagnostic Corporation Microsphere containing sensor
JP2001249103A (en) * 1999-12-27 2001-09-14 Matsushita Electric Ind Co Ltd Biosensor
JP2001183330A (en) 1999-12-27 2001-07-06 Matsushita Electric Ind Co Ltd Biosensor
EP1126032B1 (en) 1999-12-27 2005-04-20 Matsushita Electric Industrial Co., Ltd. Biosensor
JP3982133B2 (en) 2000-01-25 2007-09-26 松下電器産業株式会社 Measuring device using biosensor and biosensor and dedicated standard solution used therefor
US6485923B1 (en) 2000-02-02 2002-11-26 Lifescan, Inc. Reagent test strip for analyte determination having hemolyzing agent
US6716577B1 (en) 2000-02-02 2004-04-06 Lifescan, Inc. Electrochemical test strip for use in analyte determination
CN1161075C (en) * 2000-02-18 2004-08-11 松下电器产业株式会社 Inspection chip for sensor measuring instrument
US6733655B1 (en) 2000-03-08 2004-05-11 Oliver W. H. Davies Measurement of substances in liquids
JP3985417B2 (en) 2000-03-08 2007-10-03 松下電器産業株式会社 Biosensor and manufacturing method thereof
EP1261860B1 (en) 2000-03-09 2006-12-27 Clinical Analysis Corp. Medical diagnostic system
KR100340173B1 (en) 2000-03-22 2002-06-12 이동준 Electrochemical Biosensor Readout Meter
CA2403579A1 (en) 2000-03-22 2001-09-27 All Medicus Co., Ltd. Electrochemical biosensor test strip with recognition electrode and readout meter using this test strip
US6571651B1 (en) 2000-03-27 2003-06-03 Lifescan, Inc. Method of preventing short sampling of a capillary or wicking fill device
US6612111B1 (en) 2000-03-27 2003-09-02 Lifescan, Inc. Method and device for sampling and analyzing interstitial fluid and whole blood samples
MXPA02009666A (en) 2000-03-28 2004-07-30 Inverness Medical Technology I Continuous process for manufacture of disposable electro-chemical sensor.
AU2001251097A1 (en) 2000-03-28 2001-10-08 Diabetes Diagnostics, Inc. Rapid response glucose sensor
US20020092612A1 (en) 2000-03-28 2002-07-18 Davies Oliver William Hardwicke Rapid response glucose sensor
JP2003528623A (en) 2000-03-28 2003-09-30 ライフスキャン・インコーポレイテッド Reagent system for detecting the presence of reduced cofactor in a sample and methods of use thereof
US6911131B2 (en) 2000-03-29 2005-06-28 Matsushita Electric Industrial Co., Ltd. Biosensor
JP2001281197A (en) 2000-03-30 2001-10-10 Matsushita Electric Ind Co Ltd Biosensor measuring apparatus
US6488827B1 (en) 2000-03-31 2002-12-03 Lifescan, Inc. Capillary flow control in a medical diagnostic device
CN1191475C (en) 2000-03-31 2005-03-02 生命扫描有限公司 Electrically-conductive patterns monitoring filling of medical devices
US6716620B2 (en) * 2000-04-17 2004-04-06 Purdue Research Foundation Biosensor and related method
JP4061816B2 (en) 2000-04-27 2008-03-19 松下電器産業株式会社 Biosensor
JP4467711B2 (en) * 2000-04-28 2010-05-26 グンゼ株式会社 Enzyme sensor and enzyme sensor device using the same
IT1314759B1 (en) 2000-05-08 2003-01-03 Menarini Farma Ind INSTRUMENTATION FOR MEASUREMENT AND CONTROL OF THE CONTENT OF GLUCOSIOLACTATE OR OTHER METABOLITES IN BIOLOGICAL FLUIDS
AU2001263022A1 (en) 2000-05-12 2001-11-26 Therasense, Inc. Electrodes with multilayer membranes and methods of using and making the electrodes
JP3643011B2 (en) 2000-05-18 2005-04-27 アークレイ株式会社 Quantitative analysis
US6696008B2 (en) 2000-05-25 2004-02-24 Westar Photonics Inc. Maskless laser beam patterning ablation of multilayered structures with continuous monitoring of ablation
EP1202059B1 (en) 2000-05-26 2006-07-12 Matsushita Electric Industrial Co., Ltd. Biosensor
US20030100030A1 (en) 2000-05-29 2003-05-29 Nadaoka Masakata . Biosensor and method for its preparation
US20020137200A1 (en) 2000-06-01 2002-09-26 Mie Takahashi Biosensor and blood component analyzing method
TW548095B (en) 2000-06-01 2003-08-21 Chih-Hui Lee Electrochemical electrode test piece and method for producing the same
US20020036291A1 (en) 2000-06-20 2002-03-28 Parker Ian D. Multilayer structures as stable hole-injecting electrodes for use in high efficiency organic electronic devices
EP1359838A2 (en) 2000-06-26 2003-11-12 Boston Medical Technologies, Inc. Glucose metering system
JP3543000B2 (en) 2000-06-28 2004-07-14 松下電器産業株式会社 Biosensor
US6561989B2 (en) 2000-07-10 2003-05-13 Bayer Healthcare, Llc Thin lance and test sensor having same
US6444115B1 (en) 2000-07-14 2002-09-03 Lifescan, Inc. Electrochemical method for measuring chemical reaction rates
GB2365123A (en) 2000-07-20 2002-02-13 Hypoguard Ltd Test strip
GB0017737D0 (en) 2000-07-20 2000-09-06 Hypoguard Limited Test device
US6833110B2 (en) * 2000-07-20 2004-12-21 Hypoguard Limited Test member
ES2331689T3 (en) 2000-07-24 2010-01-13 Panasonic Corporation BIOSENSOR
DE60119133T2 (en) 2000-07-31 2007-01-25 Matsushita Electric Industrial Co., Ltd., Kadoma BIOSENSOR
US6776888B2 (en) 2000-07-31 2004-08-17 Matsushita Electric Industrial Co., Ltd. Biosensor
CN1466677A (en) 2000-07-31 2004-01-07 ����ɨ�����޹�˾ Process and apparatus for detection of presence of a liquid on a test strip
GB0019694D0 (en) 2000-08-11 2000-09-27 Cambridge Sensors Ltd Electrochemical strip test for small volumes
US6420128B1 (en) 2000-09-12 2002-07-16 Lifescan, Inc. Test strips for detecting the presence of a reduced cofactor in a sample and method for using the same
EP1191127B1 (en) 2000-09-26 2004-10-13 Enthone-OMI (Deutschland) GmbH Process for selective metallization of dielectric materials
US7008524B2 (en) 2000-10-03 2006-03-07 Hrl Laboratories, Llc Sensors with variable response behavior
US6555061B1 (en) * 2000-10-05 2003-04-29 Lifescan, Inc. Multi-layer reagent test strip
WO2002030264A2 (en) 2000-10-10 2002-04-18 Microchips, Inc. Microchip reservoir devices using wireless transmission of power and data
AU2002210940A1 (en) * 2000-10-27 2002-05-06 Arkray, Inc. Biosensor
US7575939B2 (en) 2000-10-30 2009-08-18 Sru Biosystems, Inc. Optical detection of label-free biomolecular interactions using microreplicated plastic sensor elements
US6540890B1 (en) 2000-11-01 2003-04-01 Roche Diagnostics Corporation Biosensor
EP2096435B1 (en) 2000-11-30 2014-11-12 Panasonic Healthcare Co., Ltd. Method of quantifying substrate
US6967105B2 (en) 2000-12-02 2005-11-22 Queststar Medical, Inc. Surface-modified wick for diagnostic test strip
US6447657B1 (en) 2000-12-04 2002-09-10 Roche Diagnostics Corporation Biosensor
US6800488B2 (en) 2000-12-13 2004-10-05 Lifescan, Inc. Methods of manufacturing reagent test strips
US6620310B1 (en) * 2000-12-13 2003-09-16 Lifescan, Inc. Electrochemical coagulation assay and device
US7144495B2 (en) 2000-12-13 2006-12-05 Lifescan, Inc. Electrochemical test strip with an integrated micro-needle and associated methods
GB0030929D0 (en) 2000-12-19 2001-01-31 Inverness Medical Ltd Analyte measurement
US6558528B1 (en) 2000-12-20 2003-05-06 Lifescan, Inc. Electrochemical test strip cards that include an integral dessicant
IL156245A0 (en) * 2000-12-22 2004-01-04 Dca Design Int Ltd Drive mechanism for an injection device
JP4183902B2 (en) * 2000-12-27 2008-11-19 松下電器産業株式会社 Biosensor
US6560471B1 (en) 2001-01-02 2003-05-06 Therasense, Inc. Analyte monitoring device and methods of use
US6793802B2 (en) 2001-01-04 2004-09-21 Tyson Bioresearch, Inc. Biosensors having improved sample application and measuring properties and uses thereof
US7351323B2 (en) 2001-01-17 2008-04-01 Arkray, Inc. Quantitative analyzing method and quantitative analyzer using sensor
JP3971997B2 (en) 2001-01-17 2007-09-05 松下電器産業株式会社 Biosensor
US6841389B2 (en) * 2001-02-05 2005-01-11 Glucosens, Inc. Method of determining concentration of glucose in blood
US6525330B2 (en) 2001-02-28 2003-02-25 Home Diagnostics, Inc. Method of strip insertion detection
US6562625B2 (en) 2001-02-28 2003-05-13 Home Diagnostics, Inc. Distinguishing test types through spectral analysis
US6541266B2 (en) * 2001-02-28 2003-04-01 Home Diagnostics, Inc. Method for determining concentration of an analyte in a test strip
US20020133064A1 (en) 2001-03-14 2002-09-19 Matsushita Electric Industrial Co., Ltd. Blood sugar lever measuring device and semiconductor integrated circuit
US20030191415A1 (en) 2001-03-29 2003-10-09 Piet Moerman Integrated sample testing meter
US7041468B2 (en) 2001-04-02 2006-05-09 Therasense, Inc. Blood glucose tracking apparatus and methods
US20030175946A1 (en) 2001-04-16 2003-09-18 Hiroyuki Tokunaga Biosensor
US6932894B2 (en) 2001-05-15 2005-08-23 Therasense, Inc. Biosensor membranes composed of polymers containing heterocyclic nitrogens
DE60205702T2 (en) 2001-05-15 2006-02-02 Matsushita Electric Industrial Co., Ltd., Kadoma BIOSENSOR
US6491803B1 (en) 2001-05-18 2002-12-10 Apex Biotechnology Corporation Test strip and biosensor incorporating with nanometer metal particles
EP1399059B1 (en) 2001-05-18 2006-08-30 Polymer Technology Systems, Inc. Body fluid test apparatus with detachably mounted portable tester
JP4213361B2 (en) 2001-05-22 2009-01-21 パナソニック株式会社 Biosensor
US20020177763A1 (en) 2001-05-22 2002-11-28 Burns David W. Integrated lancets and methods
US7473398B2 (en) * 2001-05-25 2009-01-06 Roche Diagnostics Operations, Inc. Biosensor
US6549796B2 (en) * 2001-05-25 2003-04-15 Lifescan, Inc. Monitoring analyte concentration using minimally invasive devices
EP1288654B1 (en) 2001-05-29 2008-10-22 Matsushita Electric Industrial Co., Ltd. Biosensor
US6960287B2 (en) 2001-06-11 2005-11-01 Bayer Corporation Underfill detection system for a test sensor
US6501976B1 (en) 2001-06-12 2002-12-31 Lifescan, Inc. Percutaneous biological fluid sampling and analyte measurement devices and methods
US20060030028A1 (en) 2001-06-14 2006-02-09 Takahiro Nakaminami Biosensor
US6576416B2 (en) 2001-06-19 2003-06-10 Lifescan, Inc. Analyte measurement device and method of use
US7044911B2 (en) * 2001-06-29 2006-05-16 Philometron, Inc. Gateway platform for biological monitoring and delivery of therapeutic compounds
KR100426638B1 (en) 2001-07-07 2004-04-08 주식회사 인포피아 Glucose strip sensor and glucose measurement method by the strip sensor
US6767441B1 (en) 2001-07-31 2004-07-27 Nova Biomedical Corporation Biosensor with peroxidase enzyme
CN1242270C (en) 2001-08-09 2006-02-15 松下电器产业株式会社 Biosensors and measurement method
CN1279357C (en) 2001-08-10 2006-10-11 松下电器产业株式会社 Biosensor and method for analyzing blood components using it
US6814844B2 (en) * 2001-08-29 2004-11-09 Roche Diagnostics Corporation Biosensor with code pattern
US6787013B2 (en) * 2001-09-10 2004-09-07 Eumed Biotechnology Co., Ltd. Biosensor
US7163616B2 (en) * 2001-09-14 2007-01-16 Bayer Corporation Reagents and methods for detecting analytes, and devices comprising reagents for detecting analytes
JP2003107031A (en) * 2001-09-28 2003-04-09 Arkray Inc Method of manufacturing concentration measuring sensor
WO2003029804A1 (en) 2001-09-28 2003-04-10 Arkray, Inc. Measurement instrument and concentration measurement apparatus
IL156007A0 (en) 2001-10-10 2003-12-23 Lifescan Inc Electrochemical cell
US6797150B2 (en) 2001-10-10 2004-09-28 Lifescan, Inc. Determination of sample volume adequacy in biosensor devices
WO2003042680A1 (en) 2001-11-14 2003-05-22 Matsushita Electric Industrial Co., Ltd. Biosensor
CN1498344A (en) 2001-11-14 2004-05-19 松下电器产业株式会社 Biosensor
US6872298B2 (en) 2001-11-20 2005-03-29 Lifescan, Inc. Determination of sample volume adequacy in biosensor devices
US6749887B1 (en) 2001-11-28 2004-06-15 Lifescan, Inc. Solution drying system
WO2003048756A1 (en) 2001-12-05 2003-06-12 Matsushita Electric Industrial Co., Ltd. Biosensor
US6872299B2 (en) 2001-12-10 2005-03-29 Lifescan, Inc. Passive sample detection to initiate timing of an assay
US6856125B2 (en) 2001-12-12 2005-02-15 Lifescan, Inc. Biosensor apparatus and method with sample type and volume detection
KR100475634B1 (en) 2001-12-24 2005-03-15 주식회사 아이센스 Biosensor equipped with sample introducing part which enables quick introduction of a small amount of sample
CN1615434A (en) 2002-01-15 2005-05-11 埃葛梅崔克斯股份有限公司 Method and apparatus for processing electrochemical signals
US6863800B2 (en) 2002-02-01 2005-03-08 Abbott Laboratories Electrochemical biosensor strip for analysis of liquid samples
MXPA04007753A (en) 2002-02-10 2005-06-20 Agamatrix Inc Method and apparatus for assay of electrochemical properties.
US6881578B2 (en) 2002-04-02 2005-04-19 Lifescan, Inc. Analyte concentration determination meters and methods of using the same
GB2388898B (en) 2002-04-02 2005-10-05 Inverness Medical Ltd Integrated sample testing meter
GB2390602A (en) 2002-04-02 2004-01-14 Inverness Medical Ltd Test strip dispenser vial and cassette
EP1495074B9 (en) 2002-04-12 2009-10-21 MBA Polymers, Inc. Compositions of materials containing recycled plastics
US6837976B2 (en) * 2002-04-19 2005-01-04 Nova Biomedical Corporation Disposable sensor with enhanced sample port inlet
US7226461B2 (en) 2002-04-19 2007-06-05 Pelikan Technologies, Inc. Method and apparatus for a multi-use body fluid sampling device with sterility barrier release
US6743635B2 (en) 2002-04-25 2004-06-01 Home Diagnostics, Inc. System and methods for blood glucose sensing
US6946299B2 (en) * 2002-04-25 2005-09-20 Home Diagnostics, Inc. Systems and methods for blood glucose sensing
US6964871B2 (en) 2002-04-25 2005-11-15 Home Diagnostics, Inc. Systems and methods for blood glucose sensing
US20030143113A2 (en) 2002-05-09 2003-07-31 Lifescan, Inc. Physiological sample collection devices and methods of using the same
US6801041B2 (en) 2002-05-14 2004-10-05 Abbott Laboratories Sensor having electrode for determining the rate of flow of a fluid
CN1467496A (en) 2002-06-03 2004-01-14 松下电器产业株式会社 Biosensor
JP2004020465A (en) * 2002-06-19 2004-01-22 Matsushita Electric Ind Co Ltd Biosensor
DE10397018A5 (en) 2002-07-02 2015-05-28 Panasonic Healthcare Holdings Co., Ltd. Biosensor, biosensor chip and biosensor device
US6939450B2 (en) 2002-10-08 2005-09-06 Abbott Laboratories Device having a flow channel
KR101107630B1 (en) 2002-10-16 2012-01-25 듀크 유니버시티 Biosensor
US20040087034A1 (en) * 2002-10-30 2004-05-06 Ching Ho Lien Test strip
US7244264B2 (en) 2002-12-03 2007-07-17 Roche Diagnostics Operations, Inc. Dual blade lancing test strip
US20040127818A1 (en) 2002-12-27 2004-07-01 Roe Steven N. Precision depth control lancing tip
AU2003300941A1 (en) 2002-12-30 2004-07-29 F.Hoffmann-La Roche Ag Suspension for a blood acquisition system
EP1589873B1 (en) * 2003-01-29 2011-12-21 Roche Diagnostics GmbH Integrated lancing test strip
US6978518B2 (en) * 2003-06-09 2005-12-27 Peacock Apparel Group, Inc. Retail display strap for securing a tie to a shirt
US8071030B2 (en) * 2003-06-20 2011-12-06 Roche Diagnostics Operations, Inc. Test strip with flared sample receiving chamber
ES2681398T3 (en) 2003-06-20 2018-09-12 F. Hoffmann-La Roche Ag Test strip with widened sample reception chamber
US7452457B2 (en) 2003-06-20 2008-11-18 Roche Diagnostics Operations, Inc. System and method for analyte measurement using dose sufficiency electrodes
EP3361249B1 (en) 2003-06-20 2023-08-02 Roche Diabetes Care GmbH Method of using a test meter and associated test strip for measuring a concentration of an analyte in a biological fluid

Patent Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP0267724A1 (en) * 1986-10-31 1988-05-18 Unilever Plc Test devices with reagent layers formed by printing processes
US6036919A (en) * 1996-07-23 2000-03-14 Roche Diagnostic Gmbh Diagnostic test carrier with multilayer field
WO1998030904A1 (en) * 1997-01-09 1998-07-16 Mercury Diagnostics, Inc. Method for applying a reagent to an analytical test device
WO2002032559A1 (en) * 2000-10-19 2002-04-25 Inverness Medical Limited Paste, which can undergo screen printing, for producing a porous polymer membrane for a biosensor
EP1316367A1 (en) * 2001-11-28 2003-06-04 Lifescan, Inc. Solution striping system

Non-Patent Citations (1)

* Cited by examiner, † Cited by third party
Title
FIETZEK H ET AL: "Verarbeitung von Dispersionshaftklebstoffen" ADHÄSION KLEBEN UND DICHTEN, vol. 37, no. 12, 1 December 1993 (1993-12-01), pages 17-20, XP000425502 ISSN: 0943-1454 *

Cited By (17)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US8317988B2 (en) 2004-10-12 2012-11-27 Bayer Healthcare Llc Concentration determination in a diffusion barrier layer
JP2008523415A (en) * 2004-12-13 2008-07-03 バイエル・ヘルスケア・エルエルシー Size self-regulating composition and test apparatus for measuring analytes in biological fluids
US9982289B2 (en) 2004-12-13 2018-05-29 Ascensia Diabetes Care Holdings Ag Size self-limiting compositions and test devices for measuring analytes in biological fluids
JP2012198218A (en) * 2005-03-04 2012-10-18 Bayer Healthcare Llc Stabilization of enzyme activity in electrochemical biosensor
US8921065B2 (en) 2005-03-04 2014-12-30 Bayer Healthcare Llc Reagent composition for electrochemical biosensors
WO2006096619A3 (en) * 2005-03-04 2006-11-23 Bayer Healthcare Llc Stabilizing the activity of pqq-dependent glucose dehydrogenase in electrochemical biosensors
WO2006096619A2 (en) 2005-03-04 2006-09-14 Bayer Healthcare Llc Stabilizing the activity of pqq-dependent glucose dehydrogenase in electrochemical biosensors
JP2008532047A (en) * 2005-03-04 2008-08-14 バイエル・ヘルスケア・エルエルシー Stabilization of enzyme activity with electrochemical biosensors
US7429865B2 (en) 2005-10-05 2008-09-30 Roche Diagnostics Operations, Inc. Method and system for error checking an electrochemical sensor
US7626401B2 (en) 2005-10-05 2009-12-01 Roche Diagnostics Operations, Inc. Method and system for error checking an electrochemical sensor
EP1772728A1 (en) 2005-10-05 2007-04-11 Roche Diagnostics GmbH Method and system for testing electrochemical sensors
US9829459B2 (en) * 2007-12-10 2017-11-28 Ascensia Diabetes Care Holdings Ag Electrochemical test sensor and method of forming the same
US20140061045A1 (en) * 2007-12-10 2014-03-06 Bayer Healthcare Llc Electrochemical test sensor and method of forming the same
US11442035B2 (en) 2007-12-10 2022-09-13 Ascensia Diabetes Care Holdings Ag Electrochemical test sensor
US8871069B2 (en) 2008-12-08 2014-10-28 Bayer Healthcare Llc Low total salt reagent compositions and systems for biosensors
US8025788B2 (en) 2009-04-24 2011-09-27 Lifescan Scotland Limited Method for manufacturing an enzymatic reagent ink
US11697279B2 (en) 2013-06-10 2023-07-11 Roche Diagnostics Operations, Inc. Method and device for producing a test element

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