CA2245941C - Disposable test strips for determination of blood analytes, and methods and compositions for making same - Google Patents

Disposable test strips for determination of blood analytes, and methods and compositions for making same Download PDF

Info

Publication number
CA2245941C
CA2245941C CA002245941A CA2245941A CA2245941C CA 2245941 C CA2245941 C CA 2245941C CA 002245941 A CA002245941 A CA 002245941A CA 2245941 A CA2245941 A CA 2245941A CA 2245941 C CA2245941 C CA 2245941C
Authority
CA
Canada
Prior art keywords
glucose
test strip
enzyme
silica
mediator
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Expired - Lifetime
Application number
CA002245941A
Other languages
French (fr)
Other versions
CA2245941A1 (en
Inventor
Jerome F. Mcaleer
David Scott
Geoff Hall
Manuel Alvarez-Icaza
Elliot V. Plotkin
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Diabetes Diagnostics Inc
Original Assignee
Diabetes Diagnostics Inc
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
Family has litigation
First worldwide family litigation filed litigation Critical https://patents.darts-ip.com/?family=24406681&utm_source=google_patent&utm_medium=platform_link&utm_campaign=public_patent_search&patent=CA2245941(C) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.
Application filed by Diabetes Diagnostics Inc filed Critical Diabetes Diagnostics Inc
Publication of CA2245941A1 publication Critical patent/CA2245941A1/en
Application granted granted Critical
Publication of CA2245941C publication Critical patent/CA2245941C/en
Anticipated expiration legal-status Critical
Expired - Lifetime legal-status Critical Current

Links

Classifications

    • C—CHEMISTRY; METALLURGY
    • C12—BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
    • C12Q—MEASURING OR TESTING PROCESSES INVOLVING ENZYMES, NUCLEIC ACIDS OR MICROORGANISMS; COMPOSITIONS OR TEST PAPERS THEREFOR; PROCESSES OF PREPARING SUCH COMPOSITIONS; CONDITION-RESPONSIVE CONTROL IN MICROBIOLOGICAL OR ENZYMOLOGICAL PROCESSES
    • C12Q1/00—Measuring or testing processes involving enzymes, nucleic acids or microorganisms; Compositions therefor; Processes of preparing such compositions
    • C12Q1/001—Enzyme electrodes
    • C12Q1/002—Electrode membranes
    • C—CHEMISTRY; METALLURGY
    • C12—BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
    • C12Q—MEASURING OR TESTING PROCESSES INVOLVING ENZYMES, NUCLEIC ACIDS OR MICROORGANISMS; COMPOSITIONS OR TEST PAPERS THEREFOR; PROCESSES OF PREPARING SUCH COMPOSITIONS; CONDITION-RESPONSIVE CONTROL IN MICROBIOLOGICAL OR ENZYMOLOGICAL PROCESSES
    • C12Q1/00—Measuring or testing processes involving enzymes, nucleic acids or microorganisms; Compositions therefor; Processes of preparing such compositions
    • C12Q1/001—Enzyme electrodes
    • C12Q1/004—Enzyme electrodes mediator-assisted
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N33/00—Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
    • G01N33/48—Biological material, e.g. blood, urine; Haemocytometers
    • G01N33/50—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing
    • G01N33/5002—Partitioning blood components
    • Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y10—TECHNICAL SUBJECTS COVERED BY FORMER USPC
    • Y10S—TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y10S435/00—Chemistry: molecular biology and microbiology
    • Y10S435/817—Enzyme or microbe electrode

Abstract

An improved disposable glucose test strip for use in a test meter of the type which receives a disposable test strip and a sample of blood from a patient and performs an electrochemical analysis is made using a working formulation containing a filler, an enzyme effective to oxidize glucose, e.g., glucose oxidase, and a mediator effective to transfer electrons from the enzyme. The working formulation is printed over a conductive carbon base layer to form a working electrode. The filler, for example a silica filler, is selected to have a balance of hydrophobicity and hydrophilicity such that one drying it forms a two- dimensional network on the surface of the conductive base layer. The response of this test strip is essentially temperature independent over relevant temperature ranges and is substantially insensitive to the hematocrit of the patient.

Description

vv w CA 02245941 2006-09-27 a a, arv07 rrv~av,r a DISPOSABLE TEST STRIPS-FOR DETERMINATION OF BLOOD ANALYTES, AND METHODS AND COMPOSITIONS FOR MAKING SAME
DESCRIPTION
BACKGROUND OF THE INVENTION
This application relates to disposable test strips for use in electrochemical determinations of blood analytes such as glucose, and to methods and compositions for use in making such strips.
Glucose monitoring is a fact of everyday life for diabetic individuals, and the accuracy of such monitoring can literally mean the difference between life and death.
To accommodate a normal life style to the need for frequent monitoring of glucose levels, a number of glucose meters are now available which permit the individual to test the glucose level in a small amount of blood.
Many of these meters detect glucose in a blood sam-ple electrochemically, by detecting the oxidation of blood glucose using an enzyme such as glucose oxidase provided as part of a disposable, single use electrode system. Examples of devices of this type are disclosed in European Patent No.
0 127 958, and US Patents Nos. 5,141,868, 5,286,362, 5,288,636, and 5,437,999.=
In general, existing glucose test strips for use in electrochemical meters comprise a substrate, working and reference electrodes formed on the surface of the substrate, and a means for making connection between the electrodes and the meter. The working electrode is coated with an enzyme capable of oxidizing glucose, and a mediator compound which transfers electrons from the enzyme to the electrode result-ing in a measurable current when glucose is present. Repre-sentative mediator compounds include ferricyanide, metallo-cene compounds such as ferrocene, quinones, phenazinium salts, redox indicator DCPIP, and imidazole-substituted osmium compounds.
Working electrodes of this type have been formulated in a number of ways. For example, mixtures of conductive wv y rr.rv.r~y CA 02245941 2006-09-27 rl, 1/uDY IlUL103 carbon, glucose oxidase and a mediator have been formulated into a paste or ink and applied to a substrate (e.g. EP 0 127 958 and US 5,286,362). In the case of disposable glucose strips, this application is done by screen printing in order to obtain the thin layers suitable for a small flat test strip. The use of screen printing, however, introduces problems to the operation of the electrode.
Unlike a thicker carbon paste electrode which remains fairly intact during the measurement, screen printed electrodes formed from carbon pastes or inks are prone to break up on contact with the sample. The consequences of this breakup are two-fold. Firstly, the components of the electrode formulation are released into solution. Once these components drift more than a diffusion length away from the underlying conductive layer, they no longer con-tribute toward the measurement, but in fact diminish the response by depleting inwardly-diffusing analyte. Secondly, the breakup of the screen printed electrode means that the effective electrode area is falling over time.
The combination of these two effects results in current transients which fall rapidly from an initial peak over the period of the measurement, and a high sensitivity to oxygen which quickly competes with the mediator for the enzyme. This fact is clearly demonstrated by the much lower currents measured in blood samples than in plasma samples or other aqueous media, and can result in erroneous readings.
A further consequence is that the transients are often "lumpy" as the electrode breaks up in a chaotic manner.
Lumpy transients either give rise to erroneous readings or rejected strips, neither of which are acceptable.
In addition to the potential for electrode breakup of screen-printed carbon-based electrodes, known electrodes used in disposable glucose test strips have been kinetically-controlled, i.e., the current depends on the rate of conversion of glucose by the enzyme. Because the response measured by the instrument represents a balance between the reactions of enzyme and mediator, enzyme and glucose and enzyme and oxygen, and because each of these -reactions has its own dependence on temperature, the response of a kinetically-controlled test strip is very sensitive to the temperature of the sample. Substantial variation in the measured glucose value can therefore occur = as a result of variations in sample handling.
Because of the importance of obtaining accurate glucose readings to the well-being of a patient using the meter and disposable test strips, it would be highly desirable to have a glucose test strip which did not suffer from these drawbacks, and which therefore provided a more consistent and reliable indication of actual blood glucose values, regardless of actual conditions. It is therefore an object of the present invention to provide disposable glu-cose test strips which are not prone to electrode breakup on contact with a sample.
It is a further object of this invention to provide glucose test strips which provide a glucose reading that is essentially independent of the hematocrit of the sample.
It is a further object of the present invention to provide glucose test strips which are substantially independent of temperature over a range between normal body temperature and room temperature.
It is a further object of the invention to provide test strips which provide a substantially flat current transient, without significant decay for periods of at least 10 seconds after the peak current level is obtained.

TS JMI+qARY OF THE INVENTION
The present invention provides an improved dispos-able test strip for use in a test meter of the type which receives a disposable test strip and a sample of blood from a patient and performs an electrochemical analysis of the amount of a blood analyte such as glucose in the sample.
The test strip comprises:
(a) a substrate;
(b) a reference electrode;
(c) a working electrode; and (d) means for making an electrical connection between the reference and working electrode and a glucose test meter. The working electrode comprises a conductive base layer disposed on the substrate and a non-conductive coating disposed over the conductive base layer. In the case of a glucose test strip, the non-conductive coating comprises a filler which has both hydrophobic and hydrophilic surface regions, an enzyme effective to oxidize glucose, e.g., glucose oxidase, and a mediator effective to transfer electrons from the enzyme to the conductive base layer. The filler is selected to have a balance of hydrophobicity and hydrophilicity such that on drying it forms a two-dimensional network on the surface of the conductive base layer. Preferred fillers are non-conductive silica fillers. The response of this test strip is dependent on the diffusion rate of glucose, not on the rate at which the enzyme can oxidize glucose, such that the performance of the test strip is essentially temperature independent over relevant temperature ranges. Further, the silica appears to form a two-dimensional network which excludes red blood cells, thus rendering the test strip substantially insensitive to the hematocrit of the patient.

BRIEF DESCRIPTION OF THE DRAWINGS
Figs. lA and 1B show an electrode structure useful in a disposable test strip in accordance with the invention;
Fig. 2 shows a test strip in accordance with the invention;
Figs. 3A - 3C show the current measured as a function of glucose concentration for three different hematocrit levels;
Fig. 4 shows the relationship of the glucose-concentration dependence of the measured current as a function of hematocrit;
Figs. 5A - 5C show the current measured as a function of glucose in blood and a control solution for three different conductive base layers;
= Figs. 6A and 6B show the current measured as a function of glucose at two different temperatures;
= Fig. 7 shows a further embodiment of a glucose test strip according to the invention; and Figs 8A and 8B show current transients observed using a test strip according to the invention and a commercial carbon-based test strip.

DETAILED DESCRIPTION OF THE INVE ION
Figs. lA and 1B show electrodes useful in a dispos-able test strip in accordance with the invention. As shown, the electrodes are formed on a substrate 10. On the sub-strate 10 are placed a conductive base layer 16, a working electrode track 15, a reference electrode track 14 ending in reference electrode 14', and conductive contacts 11, 12, and 13. An insulating mask 18 is then formed, leaving a portion of the conductive base layer 16, and the contacts 11, 12 and 13 exposed. A region of a working coating 17 is then applied over the insulating mask 18 to make contact with conductive base layer 16.
The assembly shown in Fig. 1 provides a fully func-tional assembly for the measurement of a blood analyte when connected to a meter. Advantageously, however, the elec-trode strips of the invention are finished by applying a polyester mesh 21 over the region of the working coating 17 of the electrode assembly 22, and then a top cover 23 to prevent splashing of the blood sample. (Fig. 2) The poly-ester mesh acts to guide the sample to the reference electrode 141, thereby triggering the device and initiating = the test.
The substrate 10 used in making the test strips of the invention can be any non-conducting, dimensionally stable material suitable for insertion into a glucose test meter. Suitable materials include polyester films, for example a 330 micron_polyester film, and other insulating substrate materials.
The working electrode track 15, the reference electrode track 14, and conductive contacts 11, and 12 can be formed from essentially any conductive material including silver, Ag/AgCI, gold, or platinum/carbon.
The conductive base layer 16 is preferably formed from conductive carbon. Preferred conductive carbon are ERCON ERC1, ERCON ERC2 and Acheson Carbon Electrodag 423.
Carbon with these specifications is available from Ercon Inc. (Waltham, Massachusetts, USA), or Acheson Colloids, (Princes Rock, Plymouth, England). The conductive base layer 16 makes contact with working electrode track 15, and is close to, but not contacting the end of reference elec-trode track 14.
The insulating layer 18 can be formed from polyester-based printable dielectric materials such as ERCON
R488-B(HV)-B2 Blue. The top cover 23 is suitably formed from a polyester strip or a "hot melt" coated plastic.
The test strips of the present invention do not require the formation of a discrete exit port to permit air to escape from the device as sample enters the electrode chamber but instead uses a distributed exit along all of the edges of the mesh. As the sample fluid wicks along the mesh, air seeps out of the edges of the mesh all around the device underneath the top layer. The sample fluid does not seep out because the insulation layer imparts significant hydrophobicity to that part of the mesh. The liquid sample therefore remains in the central hydrophilic region.
The key to the performance achieved using the present invention is in the nature of the coating 17. This coating contains a filler which has both hydrophobic and hydrophilic surface regions, and in the case of a glucose test strip, an enzyme which can oxidize glucose, and a mediator which can transfer electrons from the enzyme to the underlying conductive base layer 16. This coating is suitably formed by formulating an ink which contains the filler, the enzyme and the mediator in a suitable carrier and using this ink to print the coating 17 onto the device.
A preferred filler for use in the coating 17 is silica. Silica is available in a variety of grades and with a variety of surface modifications. While all silica compounds tested resulted in a product which could measure glucose under some conditions, the superior performance characteristics of glucose test strip of the invention are obtained when a silica having a surface modification to render it partially hydrophobic is used. Materials of this type include Cab-O-Sil TS610, a silica which is modified by partial surface treatment with methyl dichlorosilane; Cab-o-Sil 530, a silica which is modified by full surface treatment with hexamethyl disilazane; Spherisorb C4 silica, which is surface modified with 4 carbon chains; and other similarly modified silicas, or combinations thereof. Silica with a surface modification which is too hydrophobic should be avoided, however, since it has been observed that C18-modified silica is too hydrophobic to form a printable ink.
During the process of manufacturing the ink of the invention,,the particles are broken down by homogenization to expose hydrophilic inner portions of the silica parti-cles. The actual particles present in the ink therefore have both hydrophilic and hydrophobic regions. The hydrophilic regions form hydrogen bonds with each other and with water.
When this material is formulated into an ink as described below in Example 1, and screen printed onto the conductive base layer 16, the dual nature of the material causes it two form layers of two-dimensional networks which take form as a kind of honeycomb. On rehydration, this layer does not break up, but swells to form a gelled reaction zone in the vicinity of the underlying conductive base layer 16. Reactants such as enzyme, mediator and glucose move freely within this zone, but interfering species such as red blood cells containing oxygenated hemoglobin are excluded. This results in a device in which the amount of current generated in response to a given amount of glucose varies by less than 10 percent over a hematocrit range of 40 to 60 %, and which is thus substantially insensitive to the hematocrit of the sample, and in fact performs substantially the same in blood as in a cell-free control solution. (Figs. 3A-C, Fig. 4 and Fig. 5A
- 5C) Furthermore, the gelled reaction zone presents a greater barrier to entry of blood analytes such as glucose which makes the device diffusion, rather than kinetically limited. This leads to a device in which the measured current varies by less than 10 percent over a temperature range from 20 C to 37 C and which is thus essentially temperature independent. (Figs. 6A and 6B) When making a glucose test strip, the working layer is advantageously formed from an aqueous composition containing 2 to 10 % by weight, preferably 4 to 10 % and more preferably about 4.5 % of a binder such as hydroxyethylcellulose or mixtures of hydroxyethylcellulose with alginate or other thickeners; 3 to 10 % by weight, preferably 3 to 5 % and more preferably about 4 % silica; 8 to 20 % by weight, preferably 14 to 18 % and more preferably about 16 % of a mediator such as ferricyanide; and .4 to 2 %
by weight, preferably 1 to 2 % and more preferably about 1.6 % of an enzyme such as glucose oxidase, assuming a specific activity of about 250 units/mg, or about 1000 to 5000 units per gram of ink formulation.
The working layer may also include additional ingredients without departing from the scope of the invention. For example, the nonconducting layer may include an antifoam. In addition, the nonconducting layer may be formulated with a buffering agent to control the pH of the reaction zone. The pH may be maintained at a level within the range from about pH 3 to pH 10. It is of particular -utility to maintain the pH of the device at a level above 8 because at this pH oxygen bound to hemoglobin is not released. Further, at this pH, the reaction rate of glucose _ 9 _ oxidase with oxygen is very low. Thus, selection of an appropriate pH can further stabilize the performance of the test strip against the effects of varying hematocrit.
While a preferred embodiment of the invention is a glucose test strip as described above, the test strips of the invention which include a first working coating disposed over the conductive base layer, said first working coating comprising a filler having both hydrophobic and hydrophilic surface regions. For example, a fructosamine test strip could include two layers disposed over the conductive base layer. The first, lower layer is formed from an ink comprising a carbonate buffer (pH>10) in a silica mix substantially as described in Example 7 but without enzyme, mediator or citrate buffer. The second, upper layer is formed form an ink further comprising an oxidant such a ferri.cyanide.
Fig. 7 shows an alternative embodiment of the invention. In this embodiment, a second working layer 71 is disposed over the first working layer 17. This layer is formed from a composition which is identical to the first working layer except that the enzyme or both the enzyme and the mediator are omitted. This layer further isolates the conductive base layer from contact with oxygen-carrying red blood cells, thus reducing the effects of oxygen.
Furthermore, to the extent that enzyme may tend to diffuse away from the surface of the electrode during the course of the measurement, such a layer containing mediator can provide an increased region in which it will have mediator available for the transfer of electrons.

A non-conducting formulation for preparation of the working layer 17 was made as follows. 100 ml of 20 mM
aqueous trisodium citrate was adjusted to pH 6 by the addition of 0.1 M citric acid. To this 6 g of hydroxyethyl cellulose (HEC) was added and mixed by homogenization. The mixture was allowed to stand overnight to allow air bubbles ..v 7 11 OVa++ CA 02245941 2006-09-27 YC;'171J.1'97/02165 - 1.0 -to disperse and then used as a stock solution'for the formulation of the coating composition.
2 grams Cab-o-Sil TS610 silica and 0.1 grams of Dow Corning antifoam compound was gradually added by hand to 50 grams of the HEC solution until about 4/5 of the total amount had been added. The remainder was added with mixing by homogenization. The mixture was then cooled for ten minutes in a refrigerator. 8 g of potassium hexacyano-ferrate (III) was then added and mixed until completely dissolved. Finally, 0.8 g of glucose oxidase enzyme preparation (250 Units/mg) was added and then thoroughly mixed into the solution. The resulting formulation was ready for printing, or could be stored with refrigeration.

EX,AMPLE 2 To prepare glucose test strips using the ink formulation of Example 1, a series of patterns are used to screen print layers onto a 330 micron polyester substrate (Melinex*329). The first step is the printing of carbon pads. An array of 10 x 50 pads of carbon is formed on the surface of the polyester substrate by printing with EC2 carbon (Ercon*). The printed substrate is then passed through a heated dryer, and optionally cured at elevated temperature (e . g. 70oC) for a period of 1 to 3 weeks.
Next, an array of silver/silver chloride connecting tracks and contacts is printed onto the substrate using ERCON R-414 (DPM-68)1.25 bioelectrode sensor coating material and dried. One working track which makes contact with the carbon pad and one reference track is printed for each carbon pad in the array.
A dielectric layer is then printed using ERCON R488-B(HV)-B2 Blue and dried. The dielectric layer is printed in a pattern which covers substantially all of each device, leaving only the contacts, the tip of the reference electrode and the carbon pads uncovered.
*Trademark On top of the dielectric layer the ink of Example 1 is used to form a working layer overlaid on top of each conductive carbon pad.
Polyester mesh strips (Scrynel PET230 HC) are then laid down across the substrate in lines, covering the reactions areas exposed by the windows in the dielectric.
An 5 mm wide polyester strip (50 microns thick) is then applied over the top of the mesh strips, and the edges of the electrodes are heat sealed. Finally, the substrate is cut up to provide 50 individual electrodes, for example having a size of 5.5 mm wide and 30 mm long.

Test strips manufactured using the ink formulation of Example 1 in the manner described in Example 2 were placed in a test meter with an applied voltage of 500 mV and used to test blood samples having varying glucose concentrations and hematocrits ranging from 40% to 60%.
Figs. 3A-3C show the current measured 25 seconds after applying the voltage as a function of the glucose concentration, and Fig. 4 plots the slope of the glucose response as a function of hematocrit. As can be seen, the indicators produce highly reproducible current levels which are essentially independent of hematocrit.

Glucose test strips in accordance with the invention were made in accordance with Example 2, except the non-conductive layer was formed with 7 g Spherisorb C4 and 1 g Cab-o-Sil TS610. This formulation was laid down on three different types of carbon-containing conductive base layers as follows:
A: Ercon EC1 B: Ercon EC2 C: Ercon EC2 on top of Acheson Carbon, Electrodag 423 SS.

These test strips were used to measure varying levels of glucose in either a-control solution (One Touch Control Solution, Lifescan Inc.) containing glucose in an inert solution or in blood at an applied voltage of 425 mV. The current observed 25 seconds after the voltage was applied was measured. Figs. 5A - 5C show the results obtained for the three formulations, A, B, and C, respectively. In all cases, the slope of the line showing the response of the meter to different glucose concentrations was essentially the same whether the measurements were made in blood or the control solution. Thus, this further demonstrates the independence of the test strips of the invention from the oxygen content and hematocrit of the sample, as well as the ability to use various materials as the conductive base layer.

Test strips prepared in accordance with Example 2 were tested at two different sample temperatures, namely 37 C and 20 C using an applied voltage of 425 mV. Figs. 6A
and 6B show the current measured 25 seconds after applying the voltage as a function of glucose concentration. As can be seen, the slopes of the two lines are essentially identi-cal (0.1068 at 20 C versus 0.1009 at 37 C), thus demon-strating that the test strips provide essentially temperature-independent behavior over a temperature range from ambient to physiological temperatures.

The current transient was measured for a test strip prepared in accordance with Example 2 and for a commercial test strip made with a carbon-containing ink. The results are shown in Figs. 8A and 8B. As shown, the test strip of the invention (Fig. 8A) provides a very flat transient which maintains more than 50% of the peak current for a period of more than 25 seconds after the initial response from the test strip. In contrast, the carbon-based electrode WO 97/30344 PCTlUS97/02165 exhibited an almost immediate decay in the current, having lost 50% of the peak current in a period of the first 1 to 2 seconds after the initial response from the test strip.
This makes timing of the measurement difficult if peak current values are to be captured, or reduces the dynamic range of the meter if current must be measured after substantial decay has occurred. Thus, the test strips of the invention are advantageous in that the current generated in response to a given amount of glucose decays by less than 50% in the 5 seconds following peak current generation.

An ink for printing glucose test strips in accordance with the invention was formulated as follows:
67.8 g 20 mM Citrate buffer, pH 6 0.68 g Polyvinyl alcohol (MW 85,000-146,000, 88%
hydrolysed) 0.68 g of Polyvinyl pyrrolidone-vinyl acetate 0.42 g of Dow Corning DC1500 antifoam 3.4 g of hydroxyethyl cellulose (Natrosol 250G, Hercules) 5.5 g of surface modified silica (Cabo-Sil TS 610, Cabot) 1.5 g glucose oxidase 20.0 g Potassium Ferricyanide.

Claims (27)

WHAT IS CLAIMED IS:
1. A disposable glucose test strip for use in a test meter of the type which receives a disposable test strip and a sample of blood from a patient and performs an electrochemical analysis of the amount of glucose in the sample, comprising:
(a) a substrate;

(b) a reference electrode;

(c) a working electrode, said working electrode comprising a conductive base layer disposed on the substrate and a first working layer disposed over the conductive base layer, said first working layer comprising a filler having both hydrophobic and hydrophilic surface regions such that it forms a network upon drying, an enzyme effective to oxidize glucose, and a mediator effective to transfer electrons from the enzyme to the conductive base layer; and (d) means for making an electrical connection between the reference and working electrode and a glucose test meter.
2. The test strip of claim 1, wherein the working layer is non-conductive.
3. The test strip of claim 2, wherein the filler is silica.
4. The test strip of claim 3, wherein the conductive base layer comprises conductive carbon.
5. The test strip of claim 3, wherein the enzyme is glucose oxidase.
6. The test strip according to claim 3, wherein the mediator is ferricyanide.
7. The test strip of claim 3, wherein the first working layer is formed from an aqueous composition comprising 2 to 10% by weight of a binder; 3 to 10% by weight of silica; 8 to 20% by weight of a mediator; and 1000 to 5000 units per gram of the aqueous composition of an enzyme for oxidizing glucose.
8. The test strip of claim 3, wherein the silica is a silica which has been modified by partial surface treatment with methyl dichlorosilane.
9. The test strip of claim 8, wherein the conductive base layer comprises conductive carbon.
10. The test strip of claim 8, wherein the enzyme is glucose oxidase.
11. The test strip of claim 8, wherein the mediator is ferricyanide.
12. The test strip of claim 8, wherein the first working layer is formed from an aqueous composition comprising 2 to 10% by weight of a binder; 3 to 10% by weight of silica; 8 to 20% by weight of a mediator; and 1000 to 5000 units per gram of the aqueous composition of an enzyme for oxidizing glucose.
13. The test strip of claim 3, further comprising a second working layer comprising silica, a binder and a mediator but no glucose-oxidizing enzyme.
14. The test strip of claim 3, further comprising a second working layer comprising silica and a binder but no glucose-oxidizing enzyme.
15. The test strip of claim 1, further comprising a second working layer comprising a filler, a binder and a mediator but no glucose-oxidizing enzyme.
16. The test strip of claim 1, further comprising a second working layer comprising a filler and a binder but no glucose-oxidizing enzyme.
17. A method for making a disposable test strip for the electrochemical detection of glucose, comprising the steps of:

(a) applying working and reference electrode tracks to a substrate;

(b) applying a conductive base layer in contact with the working electrode track; and (c) applying a working layer over the conductive base layer, wherein the working layer comprising a filler having both hydrophobic and hydrophilic surface regions such that it forms a network upon drying, an enzyme effective to oxidize glucose, and a mediator effective to transfer electrons from the enzyme to the conductive base layer.
18. The method of claim 17, wherein the filler is non-conductive.
19. The method of claim 18, wherein the filler is silica.
20. The method of claim 19, wherein the conductive base layer comprises conductive carbon.
21. The method of claim 19, wherein the enzyme is glucose oxidase.
22. The method of claim 19, wherein the mediator is ferricyanide.
23. The method of claim 19, wherein the first working layer is formed from an aqueous composition comprising 2 to 10% by weight of a binder; 3 to 10% by weight of silica; 8 to 20% by weight of a mediator; and 1000 to 5000 units per gram of the aqueous composition of an enzyme for oxidizing glucose.
24. The method of claim 23, wherein the silica is a silica which has been modified by partial surface treatment with methyl dichlorosilane.
25. A disposable glucose test strip as claimed in claim 1, wherein the amount of current generated by the electrodes in response to a given amount of glucose varies by less than 10 percent over a temperature range from 20°C to 37°C.
26. A disposable glucose test strip as claimed in claim 1, wherein the amount of current generated by the electrodes in response to a given amount of glucose varies by less than 10 percent over a hematocrit range of 40 to 60%.
27. A disposable glucose test strip as claimed in claim 1, wherein the amount of current generated by the electrodes in response to a given amount of glucose decays by less than 50% in the 5 seconds following peak current generation.
CA002245941A 1996-02-14 1997-02-11 Disposable test strips for determination of blood analytes, and methods and compositions for making same Expired - Lifetime CA2245941C (en)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US08/601,223 1996-02-14
US08/601,223 US5708247A (en) 1996-02-14 1996-02-14 Disposable glucose test strips, and methods and compositions for making same
PCT/US1997/002165 WO1997030344A1 (en) 1996-02-14 1997-02-11 Disposable test strips for determination of blood analytes, and methods and compositions for making same

Publications (2)

Publication Number Publication Date
CA2245941A1 CA2245941A1 (en) 1997-08-21
CA2245941C true CA2245941C (en) 2008-09-02

Family

ID=24406681

Family Applications (1)

Application Number Title Priority Date Filing Date
CA002245941A Expired - Lifetime CA2245941C (en) 1996-02-14 1997-02-11 Disposable test strips for determination of blood analytes, and methods and compositions for making same

Country Status (10)

Country Link
US (2) US5708247A (en)
EP (1) EP0880692B1 (en)
AT (1) ATE257595T1 (en)
AU (1) AU715340B2 (en)
CA (1) CA2245941C (en)
DE (1) DE69727128T2 (en)
DK (1) DK0880692T3 (en)
ES (1) ES2212077T3 (en)
PT (1) PT880692E (en)
WO (1) WO1997030344A1 (en)

Families Citing this family (429)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5593852A (en) * 1993-12-02 1997-01-14 Heller; Adam Subcutaneous glucose electrode
JPH04278450A (en) * 1991-03-04 1992-10-05 Adam Heller Biosensor and method for analyzing subject
US5708247A (en) * 1996-02-14 1998-01-13 Selfcare, Inc. Disposable glucose test strips, and methods and compositions for making same
US7112265B1 (en) * 1996-02-14 2006-09-26 Lifescan Scotland Limited Disposable test strips with integrated reagent/blood separation layer
US6241862B1 (en) * 1996-02-14 2001-06-05 Inverness Medical Technology, Inc. Disposable test strips with integrated reagent/blood separation layer
JP3370504B2 (en) * 1996-03-13 2003-01-27 松下電器産業株式会社 Biosensor
GB2322707B (en) * 1996-06-17 2000-07-12 Mercury Diagnostics Inc Electrochemical test device and related methods
JP3394262B2 (en) * 1997-02-06 2003-04-07 セラセンス、インク． Small volume in vitro analyte sensor
GB9711395D0 (en) 1997-06-04 1997-07-30 Environmental Sensors Ltd Improvements to electrodes for the measurement of analytes in small samples
US6764581B1 (en) * 1997-09-05 2004-07-20 Abbott Laboratories Electrode with thin working layer
US5906921A (en) * 1997-09-29 1999-05-25 Matsushita Electric Industrial Co., Ltd. Biosensor and method for quantitative measurement of a substrate using the same
US6036924A (en) 1997-12-04 2000-03-14 Hewlett-Packard Company Cassette of lancet cartridges for sampling blood
US8071384B2 (en) 1997-12-22 2011-12-06 Roche Diagnostics Operations, Inc. Control and calibration solutions and methods for their use
US7390667B2 (en) * 1997-12-22 2008-06-24 Roche Diagnostics Operations, Inc. System and method for analyte measurement using AC phase angle measurements
US7407811B2 (en) * 1997-12-22 2008-08-05 Roche Diagnostics Operations, Inc. System and method for analyte measurement using AC excitation
US6893552B1 (en) 1997-12-29 2005-05-17 Arrowhead Center, Inc. Microsensors for glucose and insulin monitoring
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
WO1999044507A1 (en) * 1998-03-06 1999-09-10 Spectrx, Inc. Integrated tissue poration, fluid harvesting and analysis device, and method therefor
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
US9066695B2 (en) * 1998-04-30 2015-06-30 Abbott Diabetes Care Inc. Analyte monitoring device and methods of use
US6949816B2 (en) 2003-04-21 2005-09-27 Motorola, Inc. Semiconductor component having first surface area for electrically coupling to a semiconductor chip and second surface area for electrically coupling to a substrate, and method of manufacturing same
US6175752B1 (en) * 1998-04-30 2001-01-16 Therasense, Inc. Analyte monitoring device and methods of use
US8974386B2 (en) 1998-04-30 2015-03-10 Abbott Diabetes Care Inc. Analyte monitoring device and methods of use
US8688188B2 (en) 1998-04-30 2014-04-01 Abbott Diabetes Care Inc. Analyte monitoring device and methods of use
US8346337B2 (en) 1998-04-30 2013-01-01 Abbott Diabetes Care Inc. Analyte monitoring device and methods of use
US8480580B2 (en) * 1998-04-30 2013-07-09 Abbott Diabetes Care Inc. Analyte monitoring device and methods of use
US8465425B2 (en) 1998-04-30 2013-06-18 Abbott Diabetes Care Inc. Analyte monitoring device and methods of use
GB2337122B (en) * 1998-05-08 2002-11-13 Medisense Inc Test strip
US6554798B1 (en) 1998-08-18 2003-04-29 Medtronic Minimed, Inc. External infusion device with remote programming, bolus estimator and/or vibration alarm capabilities
US6251260B1 (en) 1998-08-24 2001-06-26 Therasense, Inc. Potentiometric sensors for analytic determination
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
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
WO2000078992A2 (en) 1999-06-18 2000-12-28 Therasense, Inc. Mass transport limited in vivo analyte sensor
US7223364B1 (en) 1999-07-07 2007-05-29 3M Innovative Properties Company Detection article having fluid control film
US20050103624A1 (en) 1999-10-04 2005-05-19 Bhullar Raghbir S. Biosensor and method of making
US7073246B2 (en) 1999-10-04 2006-07-11 Roche Diagnostics Operations, Inc. Method of making a biosensor
US7276146B2 (en) * 2001-11-16 2007-10-02 Roche Diagnostics Operations, Inc. Electrodes, methods, apparatuses comprising micro-electrode arrays
US6645359B1 (en) * 2000-10-06 2003-11-11 Roche Diagnostics Corporation Biosensor
US6662439B1 (en) 1999-10-04 2003-12-16 Roche Diagnostics Corporation Laser defined features for patterned laminates and electrodes
US20060091006A1 (en) * 1999-11-04 2006-05-04 Yi Wang Analyte sensor with insertion monitor, and methods
US6616819B1 (en) 1999-11-04 2003-09-09 Therasense, Inc. Small volume in vitro analyte sensor and methods
US6627057B1 (en) 1999-12-23 2003-09-30 Roche Diagnostic Corporation Microsphere containing sensor
US6593394B1 (en) * 2000-01-03 2003-07-15 Prosperous Kingdom Limited Bioactive and osteoporotic bone cement
US6716577B1 (en) * 2000-02-02 2004-04-06 Lifescan, Inc. Electrochemical test strip for use in analyte determination
US6733655B1 (en) * 2000-03-08 2004-05-11 Oliver W. H. Davies Measurement of substances in liquids
DE60135583D1 (en) * 2000-03-28 2008-10-09 Diabetes Diagnostics Inc Timepiece with fast response glucose sensor
ES2252212T3 (en) * 2000-03-28 2006-05-16 Diabetes Diagnostics, Inc. MANUFACTURING PROCEDURE IN CONTINUOUS DISPOSABLE ELECTROCHEMICAL SENSOR.
US20020092612A1 (en) * 2000-03-28 2002-07-18 Davies Oliver William Hardwicke Rapid response glucose sensor
HUP0302819A2 (en) * 2000-08-29 2003-12-29 Nestle Sa Flexible container having flat walls
US6982027B2 (en) * 2000-10-27 2006-01-03 Arkray, Inc. Biosensor
US6540890B1 (en) * 2000-11-01 2003-04-01 Roche Diagnostics Corporation Biosensor
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
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
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
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
US7041468B2 (en) * 2001-04-02 2006-05-09 Therasense, Inc. Blood glucose tracking apparatus and methods
US7981056B2 (en) 2002-04-19 2011-07-19 Pelikan Technologies, Inc. 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
US9226699B2 (en) * 2002-04-19 2016-01-05 Sanofi-Aventis Deutschland Gmbh Body fluid sampling module with a continuous compression tissue interface surface
US7316700B2 (en) * 2001-06-12 2008-01-08 Pelikan Technologies, Inc. Self optimizing lancing device with adaptation means to temporal variations in cutaneous properties
US8337419B2 (en) 2002-04-19 2012-12-25 Sanofi-Aventis Deutschland Gmbh Tissue penetration device
US9795747B2 (en) 2010-06-02 2017-10-24 Sanofi-Aventis Deutschland Gmbh Methods and apparatus for lancet actuation
EP1404232B1 (en) 2001-06-12 2009-12-02 Pelikan Technologies Inc. Blood sampling apparatus and method
US9427532B2 (en) 2001-06-12 2016-08-30 Sanofi-Aventis Deutschland Gmbh Tissue penetration device
ES2357887T3 (en) 2001-06-12 2011-05-03 Pelikan Technologies Inc. APPARATUS FOR IMPROVING THE BLOOD OBTAINING SUCCESS RATE FROM A CAPILLARY PUNCTURE.
US7041068B2 (en) 2001-06-12 2006-05-09 Pelikan Technologies, Inc. Sampling module device and method
WO2002100460A2 (en) * 2001-06-12 2002-12-19 Pelikan Technologies, Inc. Electric lancet actuator
AU2002348683A1 (en) * 2001-06-12 2002-12-23 Pelikan Technologies, Inc. Method and apparatus for lancet launching device integrated onto a blood-sampling cartridge
US6767441B1 (en) 2001-07-31 2004-07-27 Nova Biomedical Corporation Biosensor with peroxidase enzyme
AT410223B (en) * 2001-08-09 2003-03-25 Adlassnig Alexander Mag Dr BIOSENSORS IN THICK FILM TECHNOLOGY
US6814844B2 (en) * 2001-08-29 2004-11-09 Roche Diagnostics Corporation Biosensor with code pattern
US8118991B2 (en) * 2001-09-04 2012-02-21 Stephen Eliot Zweig Apoenzyme reactivation electrochemical detection method and assay
US7166208B2 (en) * 2004-03-03 2007-01-23 Stephen Eliot Zweig Apoenzyme reactivation electrochemical detection method and assay
US7758744B2 (en) * 2001-10-05 2010-07-20 Stephen Eliot Zweig Dual glucose-turbidimetric analytical sensors
US6984307B2 (en) * 2001-10-05 2006-01-10 Stephen Eliot Zweig Dual glucose-hydroxybutyrate analytical sensors
US20030084027A1 (en) * 2001-10-12 2003-05-01 Neocore Inc. Control method for an extensible markup language file
US6997343B2 (en) * 2001-11-14 2006-02-14 Hypoguard Limited Sensor dispensing device
US20030116447A1 (en) 2001-11-16 2003-06-26 Surridge Nigel A. Electrodes, methods, apparatuses comprising micro-electrode arrays
DE60237463D1 (en) * 2001-11-16 2010-10-07 Roche Diagnostics Gmbh FLEXIBLE SENSOR AND MANUFACTURING PROCESS
US6723500B2 (en) 2001-12-05 2004-04-20 Lifescan, Inc. Test strips having reaction zones and channels defined by a thermally transferred hydrophobic barrier
US20030111357A1 (en) * 2001-12-13 2003-06-19 Black Murdo M. Test meter calibration
US6952604B2 (en) 2001-12-21 2005-10-04 Becton, Dickinson And Company Minimally-invasive system and method for monitoring analyte levels
US7004928B2 (en) 2002-02-08 2006-02-28 Rosedale Medical, Inc. Autonomous, ambulatory analyte monitor or drug delivery device
US20030212379A1 (en) * 2002-02-26 2003-11-13 Bylund Adam David Systems and methods for remotely controlling medication infusion and analyte monitoring
US20030169426A1 (en) * 2002-03-08 2003-09-11 Peterson Timothy A. Test member orientation
US20030186446A1 (en) 2002-04-02 2003-10-02 Jerry Pugh Test strip containers and methods of using the same
US7291117B2 (en) * 2002-04-19 2007-11-06 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
US7524293B2 (en) * 2002-04-19 2009-04-28 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
US7244265B2 (en) * 2002-04-19 2007-07-17 Pelikan Technologies, Inc. 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
US20070142748A1 (en) * 2002-04-19 2007-06-21 Ajay Deshmukh Tissue penetration device
US7892183B2 (en) * 2002-04-19 2011-02-22 Pelikan Technologies, Inc. Method and apparatus for body fluid sampling and analyte sensing
US8221334B2 (en) * 2002-04-19 2012-07-17 Sanofi-Aventis Deutschland Gmbh Method and apparatus for penetrating tissue
US6837976B2 (en) * 2002-04-19 2005-01-04 Nova Biomedical Corporation Disposable sensor with enhanced sample port inlet
US6942770B2 (en) 2002-04-19 2005-09-13 Nova Biomedical Corporation Disposable sub-microliter volume biosensor with enhanced sample inlet
US8702624B2 (en) * 2006-09-29 2014-04-22 Sanofi-Aventis Deutschland Gmbh Analyte measurement device with a single shot actuator
US7175642B2 (en) 2002-04-19 2007-02-13 Pelikan Technologies, Inc. Methods and apparatus for lancet actuation
US8784335B2 (en) * 2002-04-19 2014-07-22 Sanofi-Aventis Deutschland Gmbh Body fluid sampling device with a capacitive sensor
US7708701B2 (en) * 2002-04-19 2010-05-04 Pelikan Technologies, Inc. Method and apparatus for a multi-use body fluid sampling device
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
US8360992B2 (en) * 2002-04-19 2013-01-29 Sanofi-Aventis Deutschland Gmbh Method and apparatus for penetrating tissue
US7229458B2 (en) 2002-04-19 2007-06-12 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
US9795334B2 (en) * 2002-04-19 2017-10-24 Sanofi-Aventis Deutschland Gmbh Method and apparatus for penetrating tissue
US8372016B2 (en) 2002-04-19 2013-02-12 Sanofi-Aventis Deutschland Gmbh Method and apparatus for body fluid sampling and analyte sensing
US8579831B2 (en) 2002-04-19 2013-11-12 Sanofi-Aventis Deutschland Gmbh Method and apparatus for penetrating tissue
US7371247B2 (en) 2002-04-19 2008-05-13 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
US7331931B2 (en) * 2002-04-19 2008-02-19 Pelikan Technologies, Inc. Method and apparatus for penetrating tissue
US7674232B2 (en) 2002-04-19 2010-03-09 Pelikan Technologies, Inc. Method and apparatus for penetrating tissue
US7232451B2 (en) 2002-04-19 2007-06-19 Pelikan Technologies, Inc. Method and apparatus for penetrating tissue
US9248267B2 (en) 2002-04-19 2016-02-02 Sanofi-Aventis Deustchland Gmbh Tissue penetration device
US7410468B2 (en) * 2002-04-19 2008-08-12 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
US7491178B2 (en) 2002-04-19 2009-02-17 Pelikan Technologies, Inc. Method and apparatus for penetrating tissue
US7648468B2 (en) * 2002-04-19 2010-01-19 Pelikon Technologies, Inc. Method and apparatus for penetrating tissue
US9314194B2 (en) 2002-04-19 2016-04-19 Sanofi-Aventis Deutschland Gmbh Tissue penetration device
US20080112852A1 (en) * 2002-04-25 2008-05-15 Neel Gary T Test Strips and System for Measuring Analyte Levels in a Fluid Sample
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
US6743635B2 (en) * 2002-04-25 2004-06-01 Home Diagnostics, Inc. System and methods for blood glucose sensing
US7303726B2 (en) * 2002-05-09 2007-12-04 Lifescan, Inc. Minimal procedure analyte test system
US20040067481A1 (en) * 2002-06-12 2004-04-08 Leslie Leonard Thermal sensor for fluid detection
US7250095B2 (en) * 2002-07-11 2007-07-31 Hypoguard Limited Enzyme electrodes and method of manufacture
JP4283512B2 (en) * 2002-09-09 2009-06-24 アークレイ株式会社 Test tool and method of manufacturing the same
CA2499527A1 (en) * 2002-09-20 2004-04-01 Medinnov, Inc. An analyzer for the simultaneous enzymatic detection of closely related analytes
KR100485671B1 (en) * 2002-09-30 2005-04-27 주식회사 인포피아 A measuring instrument for biosensor
US9017544B2 (en) 2002-10-04 2015-04-28 Roche Diagnostics Operations, Inc. Determining blood glucose in a small volume sample receiving cavity and in a short time period
DK1552146T3 (en) * 2002-10-09 2011-08-15 Abbott Diabetes Care Inc Device for administering fluid, system and method
US7727181B2 (en) * 2002-10-09 2010-06-01 Abbott Diabetes Care Inc. Fluid delivery device with autocalibration
US7993108B2 (en) * 2002-10-09 2011-08-09 Abbott Diabetes Care Inc. Variable volume, shape memory actuated insulin dispensing pump
US7501053B2 (en) * 2002-10-23 2009-03-10 Abbott Laboratories Biosensor having improved hematocrit and oxygen biases
US20050049522A1 (en) * 2002-10-30 2005-03-03 Allen John J Method of lancing skin for the extraction of blood
US7381184B2 (en) 2002-11-05 2008-06-03 Abbott Diabetes Care Inc. Sensor inserter assembly
US7572237B2 (en) 2002-11-06 2009-08-11 Abbott Diabetes Care Inc. Automatic biological analyte testing meter with integrated lancing device and methods of use
US7842234B2 (en) * 2002-12-02 2010-11-30 Epocal Inc. Diagnostic devices incorporating fluidics and methods of manufacture
US7094330B2 (en) * 2002-12-02 2006-08-22 Epocal Inc. Heterogeneous membrane electrodes
US7767068B2 (en) * 2002-12-02 2010-08-03 Epocal Inc. Heterogeneous membrane electrodes
EP1578286A4 (en) * 2002-12-13 2009-01-14 Pelikan Technologies Inc Method and apparatus for measuring analytes
US7175897B2 (en) * 2002-12-17 2007-02-13 Avery Dennison Corporation Adhesive articles which contain at least one hydrophilic or hydrophobic layer, method for making and uses for same
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
US8574895B2 (en) 2002-12-30 2013-11-05 Sanofi-Aventis Deutschland Gmbh Method and apparatus using optical techniques to measure analyte levels
US7811231B2 (en) * 2002-12-31 2010-10-12 Abbott Diabetes Care Inc. Continuous glucose monitoring system and methods of use
US7264139B2 (en) * 2003-01-14 2007-09-04 Hypoguard Limited Sensor dispensing device
US20040163987A1 (en) 2003-02-25 2004-08-26 John Allen Automatically opening medical device package and method of manufacture
KR20050105100A (en) * 2003-03-06 2005-11-03 라이프스캔, 인코포레이티드 System and method for piecing dermal tissue
US7052652B2 (en) 2003-03-24 2006-05-30 Rosedale Medical, Inc. Analyte concentration detection devices and methods
US7473264B2 (en) * 2003-03-28 2009-01-06 Lifescan, Inc. Integrated lance and strip for analyte measurement
US20040193202A1 (en) * 2003-03-28 2004-09-30 Allen John J. Integrated lance and strip for analyte measurement
US20040193072A1 (en) * 2003-03-28 2004-09-30 Allen John J. Method of analyte measurement using integrated lance and strip
US7679407B2 (en) * 2003-04-28 2010-03-16 Abbott Diabetes Care Inc. Method and apparatus for providing peak detection circuitry for data communication systems
ES2347248T3 (en) 2003-05-30 2010-10-27 Pelikan Technologies Inc. PROCEDURE AND APPLIANCE FOR FLUID INJECTION.
US7850621B2 (en) 2003-06-06 2010-12-14 Pelikan Technologies, Inc. Method and apparatus for body fluid sampling and analyte sensing
US8066639B2 (en) 2003-06-10 2011-11-29 Abbott Diabetes Care Inc. Glucose measuring device for use in personal area network
WO2006001797A1 (en) 2004-06-14 2006-01-05 Pelikan Technologies, Inc. Low pain penetrating
US7718439B2 (en) 2003-06-20 2010-05-18 Roche Diagnostics Operations, Inc. System and method for coding information on a biosensor test strip
US7488601B2 (en) 2003-06-20 2009-02-10 Roche Diagnostic Operations, Inc. System and method for determining an abused sensor during analyte measurement
US7597793B2 (en) * 2003-06-20 2009-10-06 Roche Operations Ltd. System and method for analyte measurement employing maximum dosing time delay
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
US8058077B2 (en) 2003-06-20 2011-11-15 Roche Diagnostics Operations, Inc. Method for coding information on a biosensor test strip
US8679853B2 (en) * 2003-06-20 2014-03-25 Roche Diagnostics Operations, Inc. Biosensor with laser-sealed capillary space and method of making
US8206565B2 (en) 2003-06-20 2012-06-26 Roche Diagnostics Operation, Inc. System and method for coding information on a biosensor test strip
US7452457B2 (en) * 2003-06-20 2008-11-18 Roche Diagnostics Operations, Inc. System and method for analyte measurement using dose sufficiency electrodes
US8071030B2 (en) * 2003-06-20 2011-12-06 Roche Diagnostics Operations, Inc. Test strip with flared sample receiving chamber
US7645373B2 (en) * 2003-06-20 2010-01-12 Roche Diagnostic Operations, Inc. System and method for coding information on a biosensor test strip
PL1639354T3 (en) 2003-06-20 2018-11-30 F.Hoffmann-La Roche Ag Test strip with slot vent opening
US7645421B2 (en) 2003-06-20 2010-01-12 Roche Diagnostics Operations, Inc. System and method for coding information on a biosensor test strip
KR100611510B1 (en) * 2003-07-03 2006-08-11 주식회사 올메디쿠스 Electrochemical biosensor test strip and reagent for analyzing physiological sample including blood corpuscles
US7306641B2 (en) * 2003-09-12 2007-12-11 Hewlett-Packard Development Company, L.P. Integral fuel cartridge and filter
WO2005033659A2 (en) 2003-09-29 2005-04-14 Pelikan Technologies, Inc. Method and apparatus for an improved sample capture device
US9351680B2 (en) 2003-10-14 2016-05-31 Sanofi-Aventis Deutschland Gmbh Method and apparatus for a variable user interface
ES2285536T3 (en) * 2003-10-31 2007-11-16 Lifescan Scotland Ltd METHOD FOR REDUCING THE EFFECT OF A DIRECT INTERFERENCE CURRENT ON AN ELECTROCHEMICAL TEST STRIP.
US7655119B2 (en) 2003-10-31 2010-02-02 Lifescan Scotland Limited Meter for use in an improved method of reducing interferences in an electrochemical sensor using two different applied potentials
USD914881S1 (en) 2003-11-05 2021-03-30 Abbott Diabetes Care Inc. Analyte sensor electronic mount
EP1680175B1 (en) * 2003-11-06 2019-06-05 LifeScan, Inc. Drug delivery pen with event notification means
US7419573B2 (en) * 2003-11-06 2008-09-02 3M Innovative Properties Company Circuit for electrochemical sensor strip
US7822454B1 (en) * 2005-01-03 2010-10-26 Pelikan Technologies, Inc. Fluid sampling device with improved analyte detecting member configuration
US8668656B2 (en) 2003-12-31 2014-03-11 Sanofi-Aventis Deutschland Gmbh Method and apparatus for improving fluidic flow and sample capture
US20050150763A1 (en) * 2004-01-09 2005-07-14 Butters Colin W. Biosensor and method of manufacture
WO2005078118A1 (en) 2004-02-06 2005-08-25 Bayer Healthcare Llc Oxidizable species as an internal reference for biosensors and method of use
WO2005089103A2 (en) 2004-02-17 2005-09-29 Therasense, Inc. Method and system for providing data communication in continuous glucose monitoring and management system
US20050187525A1 (en) * 2004-02-19 2005-08-25 Hilgers Michael E. Devices and methods for extracting bodily fluid
US7807043B2 (en) * 2004-02-23 2010-10-05 Oakville Hong Kong Company Limited Microfluidic test device
WO2005114164A2 (en) 2004-05-14 2005-12-01 Bayer Healthcare Llc Voltammetric systems for assaying biological analytes
US8828203B2 (en) * 2004-05-20 2014-09-09 Sanofi-Aventis Deutschland Gmbh Printable hydrogels for biosensors
US7118667B2 (en) * 2004-06-02 2006-10-10 Jin Po Lee Biosensors having improved sample application and uses thereof
EP1765194A4 (en) 2004-06-03 2010-09-29 Pelikan Technologies Inc Method and apparatus for a fluid sampling device
US9775553B2 (en) * 2004-06-03 2017-10-03 Sanofi-Aventis Deutschland Gmbh Method and apparatus for a fluid sampling device
US7569126B2 (en) 2004-06-18 2009-08-04 Roche Diagnostics Operations, Inc. System and method for quality assurance of a biosensor test strip
US7556723B2 (en) * 2004-06-18 2009-07-07 Roche Diagnostics Operations, Inc. Electrode design for biosensor
US20050284757A1 (en) * 2004-06-29 2005-12-29 Allen John J Analyte measuring system which prevents the reuse of a test strip
US20050284773A1 (en) 2004-06-29 2005-12-29 Allen John J Method of preventing reuse in an analyte measuring system
BRPI0515340A (en) * 2004-09-20 2008-07-22 Bayer Heathcare Llc biological test tape
US7402616B2 (en) 2004-09-30 2008-07-22 Lifescan, Inc. Fusible conductive ink for use in manufacturing microfluidic analytical systems
MX2007004331A (en) * 2004-10-12 2007-06-05 Bayer Healthcare Llc Concentration determination in a diffusion barrier layer.
US10226207B2 (en) 2004-12-29 2019-03-12 Abbott Diabetes Care Inc. Sensor inserter having introducer
US9351669B2 (en) 2009-09-30 2016-05-31 Abbott Diabetes Care Inc. Interconnect for on-body analyte monitoring device
US20110060196A1 (en) * 2009-08-31 2011-03-10 Abbott Diabetes Care Inc. Flexible Mounting Unit and Cover for a Medical Device
US20110073475A1 (en) * 2009-08-29 2011-03-31 Abbott Diabetes Care Inc. Analyte Sensor
US7883464B2 (en) 2005-09-30 2011-02-08 Abbott Diabetes Care Inc. Integrated transmitter unit and sensor introducer mechanism and methods of use
US8333714B2 (en) 2006-09-10 2012-12-18 Abbott Diabetes Care Inc. Method and system for providing an integrated analyte sensor insertion device and data processing unit
US9743862B2 (en) 2011-03-31 2017-08-29 Abbott Diabetes Care Inc. Systems and methods for transcutaneously implanting medical devices
US20090105569A1 (en) 2006-04-28 2009-04-23 Abbott Diabetes Care, Inc. Introducer Assembly and Methods of Use
US8571624B2 (en) * 2004-12-29 2013-10-29 Abbott Diabetes Care Inc. Method and apparatus for mounting a data transmission device in a communication system
US7731657B2 (en) 2005-08-30 2010-06-08 Abbott Diabetes Care Inc. Analyte sensor introducer and methods of use
US9788771B2 (en) 2006-10-23 2017-10-17 Abbott Diabetes Care Inc. Variable speed sensor insertion devices and methods of use
US7697967B2 (en) 2005-12-28 2010-04-13 Abbott Diabetes Care Inc. Method and apparatus for providing analyte sensor insertion
US9398882B2 (en) * 2005-09-30 2016-07-26 Abbott Diabetes Care Inc. Method and apparatus for providing analyte sensor and data processing device
US9259175B2 (en) 2006-10-23 2016-02-16 Abbott Diabetes Care, Inc. Flexible patch for fluid delivery and monitoring body analytes
US8512243B2 (en) 2005-09-30 2013-08-20 Abbott Diabetes Care Inc. Integrated introducer and transmitter assembly and methods of use
US9572534B2 (en) 2010-06-29 2017-02-21 Abbott Diabetes Care Inc. Devices, systems and methods for on-skin or on-body mounting of medical devices
US20070027381A1 (en) * 2005-07-29 2007-02-01 Therasense, Inc. Inserter and methods of use
US20110054275A1 (en) * 2009-08-31 2011-03-03 Abbott Diabetes Care Inc. Mounting Unit Having a Sensor and Associated Circuitry
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
US20060166629A1 (en) * 2005-01-24 2006-07-27 Therasense, Inc. Method and apparatus for providing EMC Class-B compliant RF transmitter for data monitoring an detection systems
US20060184065A1 (en) * 2005-02-10 2006-08-17 Ajay Deshmukh Method and apparatus for storing an analyte sampling and measurement device
EP1859048B1 (en) * 2005-03-04 2014-06-18 Bayer HealthCare LLC Stabilizing the activity of pqq-dependent glucose dehydrogenase in electrochemical biosensors
CA2601441A1 (en) * 2005-03-21 2006-09-28 Abbott Diabetes Care Inc. Method and system for providing integrated medication infusion and analyte monitoring system
US20060216203A1 (en) * 2005-03-28 2006-09-28 Mds Sciex (Us) A Division Of Mds Pharma Services (Us) Inc. Multiwell sample plate with integrated impedance electrodes and connection scheme
US20060243591A1 (en) * 2005-04-28 2006-11-02 Plotkin Elliot V Electrochemical-based analytical test strip with hydrophilicity enhanced metal electrodes
US20060246214A1 (en) * 2005-04-28 2006-11-02 Plotkin Elliot V Method for manufacturing an electrochemical-based analytical test strip with hydrophilicity enhanced metal electrodes
US8112240B2 (en) * 2005-04-29 2012-02-07 Abbott Diabetes Care Inc. Method and apparatus for providing leak detection in data monitoring and management systems
US7768408B2 (en) * 2005-05-17 2010-08-03 Abbott Diabetes Care Inc. Method and system for providing data management in data monitoring system
US7620437B2 (en) 2005-06-03 2009-11-17 Abbott Diabetes Care Inc. Method and apparatus for providing rechargeable power in data monitoring and management systems
GB0511270D0 (en) 2005-06-03 2005-07-13 Hypoguard Ltd Test system
US7695600B2 (en) * 2005-06-03 2010-04-13 Hypoguard Limited Test system
US20060281187A1 (en) 2005-06-13 2006-12-14 Rosedale Medical, Inc. Analyte detection devices and methods with hematocrit/volume correction and feedback control
WO2007013915A1 (en) 2005-07-20 2007-02-01 Bayer Healthcare Llc Gated amperometry
JP5147702B2 (en) 2005-09-30 2013-02-20 インテュイティ メディカル インコーポレイテッド Fully integrated wearable or handheld monitor
US9521968B2 (en) * 2005-09-30 2016-12-20 Abbott Diabetes Care Inc. Analyte sensor retention mechanism and methods of use
US8801631B2 (en) 2005-09-30 2014-08-12 Intuity Medical, Inc. Devices and methods for facilitating fluid transport
CN101273266B (en) 2005-09-30 2012-08-22 拜尔健康护理有限责任公司 Gated voltammetry
US7756561B2 (en) 2005-09-30 2010-07-13 Abbott Diabetes Care Inc. Method and apparatus for providing rechargeable power in data monitoring and management systems
US20070191736A1 (en) * 2005-10-04 2007-08-16 Don Alden Method for loading penetrating members in a collection device
US20070276290A1 (en) * 2005-10-04 2007-11-29 Dirk Boecker Tissue Penetrating Apparatus
US7468125B2 (en) * 2005-10-17 2008-12-23 Lifescan, Inc. System and method of processing a current sample for calculating a glucose concentration
US8066866B2 (en) 2005-10-17 2011-11-29 Lifescan, Inc. Methods for measuring physiological fluids
US7583190B2 (en) 2005-10-31 2009-09-01 Abbott Diabetes Care Inc. Method and apparatus for providing data communication in data monitoring and management systems
US20090054747A1 (en) * 2005-10-31 2009-02-26 Abbott Diabetes Care, Inc. Method and system for providing analyte sensor tester isolation
US7766829B2 (en) 2005-11-04 2010-08-03 Abbott Diabetes Care Inc. Method and system for providing basal profile modification in analyte monitoring and management systems
ES2402578T3 (en) * 2005-11-14 2013-05-06 Bayer Healthcare, Llc Test sensor reagent that has cellulose polymers
US11298058B2 (en) 2005-12-28 2022-04-12 Abbott Diabetes Care Inc. Method and apparatus for providing analyte sensor insertion
CA2636034A1 (en) 2005-12-28 2007-10-25 Abbott Diabetes Care Inc. Medical device insertion
US20070158189A1 (en) * 2006-01-09 2007-07-12 Health & Life Co., Ltd Disposable biosensor
US8344966B2 (en) 2006-01-31 2013-01-01 Abbott Diabetes Care Inc. Method and system for providing a fault tolerant display unit in an electronic device
US7885698B2 (en) 2006-02-28 2011-02-08 Abbott Diabetes Care Inc. Method and system for providing continuous calibration of implantable analyte sensors
GB2436616A (en) 2006-03-29 2007-10-03 Inverness Medical Switzerland Assay device and method
US20070233051A1 (en) * 2006-03-31 2007-10-04 David Hohl Drug delivery systems and methods
US7738264B2 (en) * 2006-03-31 2010-06-15 Lifescan Scotland Ltd. Devices and methods for protecting handheld electronic devices from electrostatic discharge
US8226891B2 (en) 2006-03-31 2012-07-24 Abbott Diabetes Care Inc. Analyte monitoring devices and methods therefor
US7620438B2 (en) 2006-03-31 2009-11-17 Abbott Diabetes Care Inc. Method and system for powering an electronic device
US7593097B2 (en) * 2006-05-26 2009-09-22 Lifescan Scotland Limited Method for determining a test strip calibration code for use in a meter
US7474391B2 (en) * 2006-05-26 2009-01-06 Lifescan Scotland Limited Method for determining a test strip calibration code using a calibration strip
US7589828B2 (en) * 2006-05-26 2009-09-15 Lifescan Scotland Limited System for analyte determination that includes a permutative grey scale calibration pattern
US7586590B2 (en) * 2006-05-26 2009-09-08 Lifescan, Scotland, Ltd. Calibration code strip with permutative grey scale calibration pattern
US7474390B2 (en) * 2006-05-26 2009-01-06 Lifescan Scotland Limited Test strip with permutative grey scale calibration pattern
US20090054749A1 (en) * 2006-05-31 2009-02-26 Abbott Diabetes Care, Inc. Method and System for Providing Data Transmission in a Data Management System
US7920907B2 (en) * 2006-06-07 2011-04-05 Abbott Diabetes Care Inc. Analyte monitoring system and method
GB0616566D0 (en) * 2006-08-19 2006-09-27 Rolls Royce Plc An alloy and method of treating titanium aluminide
JP5395665B2 (en) 2006-09-22 2014-01-22 バイエル・ヘルスケア・エルエルシー Biosensor system with improved stability and hematocrit performance
EP2080022B1 (en) * 2006-10-05 2015-05-13 Lifescan Scotland Ltd Methods for determining an analyte concentration using signal processing algorithms
ATE534901T1 (en) * 2006-10-05 2011-12-15 Lifescan Scotland Ltd ELECTROCHEMICAL METHODS AND DEVICES FOR USE IN MEASURING ANALYTE CONCENTRATIONS WITH CORRECTED HEMATOCRIT
EP2437056B1 (en) 2006-10-05 2013-11-20 Lifescan Scotland Ltd Methods for determining the presence of a sufficient quantity of fluid sample on a test strip
US9046480B2 (en) 2006-10-05 2015-06-02 Lifescan Scotland Limited Method for determining hematocrit corrected analyte concentrations
WO2008040997A1 (en) * 2006-10-05 2008-04-10 Lifescan Scotland Limited A test strip comprising patterned electrodes
EP2679150B1 (en) 2006-10-24 2020-07-22 Ascensia Diabetes Care Holdings AG Transient decay amperometry
US20080124693A1 (en) * 2006-10-26 2008-05-29 Mcevoy Mary System for determining an analyte in a bodily fluid sample that includes a graphics-based step-by-step tutorial module
US20080164142A1 (en) 2006-10-27 2008-07-10 Manuel Alvarez-Icaza Surface treatment of carbon composite material to improve electrochemical properties
US8579853B2 (en) 2006-10-31 2013-11-12 Abbott Diabetes Care Inc. Infusion devices and methods
US20080119710A1 (en) * 2006-10-31 2008-05-22 Abbott Diabetes Care, Inc. Medical devices and methods of using the same
US8930203B2 (en) 2007-02-18 2015-01-06 Abbott Diabetes Care Inc. Multi-function analyte test device and methods therefor
US8732188B2 (en) * 2007-02-18 2014-05-20 Abbott Diabetes Care Inc. Method and system for providing contextual based medication dosage determination
US8123686B2 (en) 2007-03-01 2012-02-28 Abbott Diabetes Care Inc. Method and apparatus for providing rolling data in communication systems
US20080281179A1 (en) * 2007-05-08 2008-11-13 Abbott Diabetes Care, Inc. Analyte monitoring system and methods
US8665091B2 (en) * 2007-05-08 2014-03-04 Abbott Diabetes Care Inc. Method and device for determining elapsed sensor life
US8461985B2 (en) * 2007-05-08 2013-06-11 Abbott Diabetes Care Inc. Analyte monitoring system and methods
US7928850B2 (en) 2007-05-08 2011-04-19 Abbott Diabetes Care Inc. Analyte monitoring system and methods
US8456301B2 (en) 2007-05-08 2013-06-04 Abbott Diabetes Care Inc. Analyte monitoring system and methods
WO2008150917A1 (en) 2007-05-31 2008-12-11 Abbott Diabetes Care, Inc. Insertion devices and methods
CN101755043B (en) * 2007-07-23 2013-06-19 埃葛梅崔克斯股份有限公司 Electrochemical test strip
US7875461B2 (en) * 2007-07-24 2011-01-25 Lifescan Scotland Limited Test strip and connector
CN101802612B (en) * 2007-07-26 2016-08-10 埃葛梅崔克斯股份有限公司 Electrochemical analyte detection apparatus and method
WO2009026946A1 (en) * 2007-08-29 2009-03-05 Lifescan Scotland Limited A data management system and method
US7943022B2 (en) * 2007-09-04 2011-05-17 Lifescan, Inc. Analyte test strip with improved reagent deposition
EP2040079B1 (en) * 2007-09-19 2009-05-20 F. Hoffman-la Roche AG Marking method for marking rejects of test elements
BRPI0820721A2 (en) 2007-12-10 2015-06-16 Bayer Healthcare Llc Reagents and methods for detecting analytes
WO2009076302A1 (en) 2007-12-10 2009-06-18 Bayer Healthcare Llc Control markers for auto-detection of control solution and methods of use
CA2707300C (en) 2007-12-10 2017-09-26 Bayer Healthcare Llc Rapid-read gated amperometry
ES2664574T3 (en) * 2007-12-10 2018-04-20 Ascensia Diabetes Care Holdings Ag Reactive compositions of porous particles, devices and methods for biosensors
DE102008005065A1 (en) * 2008-01-18 2009-07-30 Cellasys Gmbh Reference electrode for electro-chemical measurements by sensor chip, is made of biocompatible material e.g. precious metal or precious metal alloy, where electrode is formed on substrate, and is planar
WO2009093840A2 (en) 2008-01-22 2009-07-30 Industry Foundation Of Chonnam National University Method and apparatus for estimating features of target materials by using kinetic change information
IL197532A0 (en) * 2008-03-21 2009-12-24 Lifescan Scotland Ltd Analyte testing method and system
US9386944B2 (en) 2008-04-11 2016-07-12 Sanofi-Aventis Deutschland Gmbh Method and apparatus for analyte detecting device
US9833183B2 (en) 2008-05-30 2017-12-05 Intuity Medical, Inc. Body fluid sampling device—sampling site interface
JP5642066B2 (en) 2008-06-06 2014-12-17 インテュイティ メディカル インコーポレイテッド Method and apparatus for performing an assay to determine the presence or concentration of an analyte contained in a sample of body fluid
WO2009148626A1 (en) 2008-06-06 2009-12-10 Intuity Medical, Inc. Medical diagnostic devices and methods
US7922985B2 (en) 2008-06-24 2011-04-12 Lifescan, Inc. Analyte test strip for accepting diverse sample volumes
US8187658B2 (en) 2008-06-24 2012-05-29 Lifescan, Inc. Method of manufacturing analyte test strip for accepting diverse sample volumes
US8178313B2 (en) 2008-06-24 2012-05-15 Lifescan, Inc. Method for determining an analyte in a bodily fluid
JP5405916B2 (en) * 2008-06-24 2014-02-05 パナソニック株式会社 Biosensor, method for manufacturing the same, and detection system including the same
US20100000905A1 (en) * 2008-07-03 2010-01-07 Abbott Diabetes Care, Inc. Strip vial and cap
EP3435077A1 (en) 2008-07-10 2019-01-30 Ascensia Diabetes Care Holdings AG Systems and methods including amperometric and voltammetric duty cycles
US8475732B2 (en) 2010-10-26 2013-07-02 Abbott Diabetes Care Inc. Analyte measurement devices and systems, and components and methods related thereto
US7896703B2 (en) * 2008-07-17 2011-03-01 Abbott Diabetes Care Inc. Strip connectors for measurement devices
US7946866B2 (en) * 2008-08-28 2011-05-24 Abbott Diabetes Care Inc. Apparatus for preventing electrical shock in devices
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 "
AU2009309458B2 (en) * 2008-10-27 2015-02-26 Lifescan Scotland Limited Methods and devices for mitigating ESD events
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
US20100187132A1 (en) * 2008-12-29 2010-07-29 Don Alden Determination of the real electrochemical surface areas of screen printed electrodes
US8103456B2 (en) 2009-01-29 2012-01-24 Abbott Diabetes Care Inc. Method and device for early signal attenuation detection using blood glucose measurements
US8560082B2 (en) 2009-01-30 2013-10-15 Abbott Diabetes Care Inc. Computerized determination of insulin pump therapy parameters using real time and retrospective data processing
US20100198196A1 (en) * 2009-01-30 2010-08-05 Abbott Diabetes Care, Inc. Therapy Delivery Device Programming Tool
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
US20100198034A1 (en) 2009-02-03 2010-08-05 Abbott Diabetes Care Inc. Compact On-Body Physiological Monitoring Devices and Methods Thereof
US20100213057A1 (en) * 2009-02-26 2010-08-26 Benjamin Feldman Self-Powered Analyte Sensor
EP2228658A1 (en) 2009-03-13 2010-09-15 Roche Diagnostics GmbH Method for producing an analytical consumable
US20100268053A1 (en) * 2009-04-15 2010-10-21 Abbott Diabetes Care Inc. Method and Device for Detecting USB Cable Connection
US20100270152A1 (en) 2009-04-24 2010-10-28 Lifescan Scotland Limited Enzymatic reagent ink
US8025788B2 (en) 2009-04-24 2011-09-27 Lifescan Scotland Limited Method for manufacturing an enzymatic reagent ink
US20100273249A1 (en) 2009-04-24 2010-10-28 Lifescan Scotland Limited Analytical test strips
WO2010127050A1 (en) * 2009-04-28 2010-11-04 Abbott Diabetes Care Inc. Error detection in critical repeating data in a wireless sensor system
US8467972B2 (en) * 2009-04-28 2013-06-18 Abbott Diabetes Care Inc. Closed loop blood glucose control algorithm analysis
WO2010138856A1 (en) 2009-05-29 2010-12-02 Abbott Diabetes Care Inc. Medical device antenna systems having external antenna configurations
US8173008B2 (en) * 2009-06-24 2012-05-08 Lifescan, Inc. Method for determining an analyte in a bodily fluid sample using an analyte test strip with combination electrode contact and meter identification feature
US20100326824A1 (en) 2009-06-24 2010-12-30 Lifescan, Inc. Analyte test strip with combination electrode contact and meter identification feature
US8798934B2 (en) 2009-07-23 2014-08-05 Abbott Diabetes Care Inc. Real time management of data relating to physiological control of glucose levels
US20110048972A1 (en) * 2009-08-31 2011-03-03 Lifescan Scotland Limited Multi-analyte test strip with shared counter/reference electrode and inline electrode configuration
US9314195B2 (en) 2009-08-31 2016-04-19 Abbott Diabetes Care Inc. Analyte signal processing device and methods
US20110106126A1 (en) * 2009-08-31 2011-05-05 Michael Love Inserter device including rotor subassembly
US8993331B2 (en) 2009-08-31 2015-03-31 Abbott Diabetes Care Inc. Analyte monitoring system and methods for managing power and noise
US20110057671A1 (en) * 2009-09-04 2011-03-10 Lifescan Scotland, Ltd. Methods, system and device to identify a type of test strip
CA2772738C (en) 2009-09-04 2019-01-15 Lifescan Scotland Limited Analyte measurement method and system
WO2011041449A1 (en) * 2009-09-29 2011-04-07 Abbott Diabetes Care Inc. Sensor inserter having introducer
US9320461B2 (en) 2009-09-29 2016-04-26 Abbott Diabetes Care Inc. Method and apparatus for providing notification function in analyte monitoring systems
US8545693B2 (en) * 2009-09-29 2013-10-01 Lifescan Scotland Limited Analyte measurment method and system
US20110079522A1 (en) 2009-10-02 2011-04-07 Lifescan Scotland Limited Multi-analyte test strip with inline working electrodes and shared opposing counter/reference electrode
WO2011044386A1 (en) * 2009-10-07 2011-04-14 Abbott Diabetes Care Inc. Sensor inserter assembly having rotatable trigger
US8632664B2 (en) * 2009-10-27 2014-01-21 Lifescan Scotland Limited Test meter for use with a dual chamber, multi-analyte test strip with opposing electrodes
US8323467B2 (en) 2009-10-27 2012-12-04 Lifescan Scotland Limited Dual chamber, multi-analyte test strip with opposing electrodes
EP2506768B1 (en) 2009-11-30 2016-07-06 Intuity Medical, Inc. Calibration material delivery devices and methods
USD924406S1 (en) 2010-02-01 2021-07-06 Abbott Diabetes Care Inc. Analyte sensor inserter
US20110210017A1 (en) * 2010-03-01 2011-09-01 Lai Rebecca Y Fabrication of electrochemical biosensors via click chemistry
CN102639185B (en) 2010-03-24 2015-02-04 雅培糖尿病护理公司 Medical device inserters and processes of inserting and using medical devices
GB201005357D0 (en) 2010-03-30 2010-05-12 Menai Medical Technologies Ltd Sampling plate
GB201005359D0 (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
US20130276521A1 (en) * 2010-05-09 2013-10-24 Labstyle Innovation Ltd. Fluids testing apparatus and methods of use
CN102243209A (en) * 2010-05-14 2011-11-16 湖南友能高新技术有限公司 Portable heavy metal chrome sensor, preparation process and detection method thereof
US8940141B2 (en) 2010-05-19 2015-01-27 Lifescan Scotland Limited Analytical test strip with an electrode having electrochemically active and inert areas of a predetermined size and distribution
US20110290668A1 (en) 2010-05-27 2011-12-01 Lifescan Scotland Limited Analytical test strip with crossroads exposed electrode configuration
US8239582B2 (en) 2010-05-27 2012-08-07 Cilag Gmbh International Hand-held test meter with disruption avoidance circuitry
CA2803797A1 (en) 2010-06-25 2011-12-29 Intuity Medical, Inc. Analyte monitoring methods and systems
US20110315564A1 (en) 2010-06-28 2011-12-29 Cilag Gmbh International Hand-held test meter with deep power conservation mode
US11064921B2 (en) 2010-06-29 2021-07-20 Abbott Diabetes Care Inc. Devices, systems and methods for on-skin or on-body mounting of medical devices
AU2011282711A1 (en) 2010-07-28 2013-01-10 Abbott Diabetes Care Inc. Analyte sensors having temperature independent membranes
US8409412B2 (en) * 2010-08-23 2013-04-02 Lifescan Scotland, Ltd. Enzymatic reagent inks for use in test strips having a predetermined calibration code
US20120048746A1 (en) 2010-08-30 2012-03-01 Cilag Gmbh International Analyte test strip with electrically distinguishable divided electrode
US20130229288A1 (en) 2010-11-15 2013-09-05 Lifescan Scotland Limited Server-side initiated communication with analyte meter-side completed data transfer
US9713440B2 (en) 2010-12-08 2017-07-25 Abbott Diabetes Care Inc. Modular analyte measurement systems, modular components thereof and related methods
US20120199498A1 (en) 2011-02-07 2012-08-09 Manuel Alvarez-Icaza Electrochemical-based analytical test strip with graded enzymatic reagent layer and related methods
US20130006536A1 (en) 2011-06-28 2013-01-03 Lifescan, Inc. Hand-held test meter with unpowered usb connection detection circuit
US20130002266A1 (en) 2011-06-28 2013-01-03 Lifescan, Inc. Hand-held test meter with electromagnetic interference detection circuit
WO2013016379A1 (en) 2011-07-27 2013-01-31 Agamatrix, Inc. Reagents for electrochemical test strips
WO2013020103A1 (en) 2011-08-03 2013-02-07 Intuity Medical, Inc. Devices and methods for body fluid sampling and analysis
US8580576B2 (en) 2011-08-04 2013-11-12 Cilag Gmbh International Method for bodily fluid sample transfer during analyte determination
US8475733B2 (en) 2011-08-04 2013-07-02 Cilag Gmbh International Hand-held test meter and analytical test strip cartridge assembly with desiccant vial
US8603309B2 (en) 2011-09-12 2013-12-10 Nova Biomedical Corporation Disposable sensor for electrochemical detection of hemoglobin
US20130084590A1 (en) 2011-09-30 2013-04-04 Lifescan Scotland Ltd. Analytical test strip with bodily fluid phase-shift measurement electrodes
US20130084591A1 (en) 2011-09-30 2013-04-04 Lifescan Scotland Ltd. Analytical test strip with isolated bodily fluid phase-shift and analyte determination sample chambers
US20130098775A1 (en) * 2011-10-20 2013-04-25 Nova Biomedical Corporation Glucose biosensor with improved shelf life
USD680454S1 (en) 2011-10-25 2013-04-23 Abbott Diabetes Care Inc. Analyte meter and strip port
AU2012335830B2 (en) 2011-11-07 2017-05-04 Abbott Diabetes Care Inc. Analyte monitoring device and methods
EP4344633A2 (en) 2011-12-11 2024-04-03 Abbott Diabetes Care, Inc. Analyte sensor methods
US9572922B2 (en) 2012-12-21 2017-02-21 Larry Leonard Inventive diabetic systems, tools, kits, and supplies for better diabetic living and mobility
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
US20130199942A1 (en) 2012-02-07 2013-08-08 Lifescan Scotland Limited Electrochemical-based analytical test strip with fill-speed configured reagent layer
US20130220835A1 (en) 2012-02-29 2013-08-29 Lifescan Scotland Limited Polymeric vdat nanoparticles for use in biosensors
US20130284609A1 (en) 2012-04-30 2013-10-31 Lifescan Scotland Limited Enzymatic electrochemical-based sensors with nad polymeric coenzyme
WO2013173499A2 (en) 2012-05-15 2013-11-21 Minor James M Diagnostic methods and devices for monitoring chronic glycemia
US11798685B2 (en) 2012-05-15 2023-10-24 James M. Minor Diagnostic methods and devices for controlling acute glycemia
US20130341207A1 (en) 2012-06-21 2013-12-26 Lifescan Scotland Limited Analytical test strip with capillary sample-receiving chambers separated by stop junctions
US9128038B2 (en) 2012-06-21 2015-09-08 Lifescan Scotland Limited Analytical test strip with capillary sample-receiving chambers separated by a physical barrier island
US8877023B2 (en) 2012-06-21 2014-11-04 Lifescan Scotland Limited Electrochemical-based analytical test strip with intersecting sample-receiving chambers
US9968306B2 (en) 2012-09-17 2018-05-15 Abbott Diabetes Care Inc. Methods and apparatuses for providing adverse condition notification with enhanced wireless communication range in analyte monitoring systems
TWI483848B (en) * 2012-09-24 2015-05-11 3M Innovative Properties Co Hydrophilic film, and preparation method and use thereof
CN103660404B (en) * 2012-09-24 2016-12-21 3M创新有限公司 Hydrophilic film, its preparation method and application
US9211087B2 (en) 2012-10-18 2015-12-15 Animas Corporation Self-contained hand-held test device for single-use
WO2014088492A1 (en) 2012-12-07 2014-06-12 Ascilion Ab A microfabricated sensor and a method of sensing the level of a component in bodily fluid
GB2509140B (en) * 2012-12-21 2015-12-30 Lifescan Scotland Ltd Analytical test strip with tiered capillary chamber
GB2510371B (en) * 2013-01-31 2016-01-06 Lifescan Scotland Ltd Electrochemical-based analytical test strip with soluble acidic material coating
US9157883B2 (en) 2013-03-07 2015-10-13 Lifescan Scotland Limited Methods and systems to determine fill direction and fill error in analyte measurements
US9623409B2 (en) 2013-03-11 2017-04-18 Cue Inc. Cartridges, kits, and methods for enhanced mixing for detection and quantification of analytes
US10545161B2 (en) 2013-03-11 2020-01-28 Cue Health Inc. Systems and methods for detection and quantification of analytes
KR102358124B1 (en) 2013-03-11 2022-02-08 큐 헬스 인코퍼레이티드 Systems and methods for detection and quantification of analytes
US9523653B2 (en) 2013-05-09 2016-12-20 Changsha Sinocare Inc. Disposable test sensor with improved sampling entrance
US10371660B2 (en) 2013-05-17 2019-08-06 Lifescan Ip Holdings, Llc Accurate analyte measurements for electrochemical test strip based on multiple calibration parameters
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
JP2016522070A (en) 2013-06-21 2016-07-28 インテュイティ メディカル インコーポレイテッド Analyte monitoring system using audible feedback
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
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
USD745423S1 (en) 2014-05-12 2015-12-15 Cue Inc. Automated analyzer test cartridge and sample collection device for analyte detection
EP3152568B1 (en) 2014-06-07 2019-07-31 Ascilion AB A microfabricated sensor and a method of detecting a component in bodily fluid
US9453812B2 (en) 2014-06-24 2016-09-27 Lifescan Scotland Limited End-fill electrochemical-based analytical test strip with perpendicular intersecting sample-receiving chambers
KR101666978B1 (en) 2014-09-17 2016-10-24 주식회사 아이센스 Apparatus and Method for measuring concentration of Whole Blood Samples Using the same
US20160091450A1 (en) 2014-09-25 2016-03-31 Lifescan Scotland Limited Accurate analyte measurements for electrochemical test strip to determine analyte measurement time based on measured temperature, physical characteristic and estimated analyte value and their temperature compensated values
US20160091451A1 (en) 2014-09-25 2016-03-31 Lifescan Scotland Limited Accurate analyte measurements for electrochemical test strip to determine analyte measurement time based on measured temperature, physical characteristic and estimated analyte value
KR20170066446A (en) 2014-09-30 2017-06-14 쓰리엠 이노베이티브 프로퍼티즈 캄파니 Electrically conductive patterns with wide line-width and methods for producing same
US10213139B2 (en) 2015-05-14 2019-02-26 Abbott Diabetes Care Inc. Systems, devices, and methods for assembling an applicator and sensor control device
WO2016183493A1 (en) 2015-05-14 2016-11-17 Abbott Diabetes Care Inc. Compact medical device inserters and related systems and methods
CN117310193A (en) 2015-07-17 2023-12-29 克忧健康公司 Systems and methods for enhanced detection and analyte quantification
CN110461217B (en) 2017-01-23 2022-09-16 雅培糖尿病护理公司 Systems, devices, and methods for analyte sensor insertion
US11237161B2 (en) 2017-01-25 2022-02-01 Cue Health Inc. Systems and methods for enhanced detection and quantification of analytes
US20190094170A1 (en) 2017-09-22 2019-03-28 Cilag Gmbh International Analytical test strip with integrated electrical resistor
CZ2019228A3 (en) 2019-04-11 2020-06-17 Xglu S.R.O. Device for randomly measuring glycemia and its use
US11525799B1 (en) 2021-05-21 2022-12-13 PERSOWN, Inc. Electrochemical diagnostic system
CN114923965B (en) * 2022-03-18 2023-05-23 杭州微策生物技术股份有限公司 Integrated multi-index sensor and manufacturing method thereof

Family Cites Families (29)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4195129A (en) * 1975-11-26 1980-03-25 Kansai Paint Co., Ltd. Method for immobilizing enzymes and microbial cells
JPS5816696B2 (en) * 1978-07-10 1983-04-01 松下電器産業株式会社 enzyme electrode
JPS5816698B2 (en) * 1978-07-10 1983-04-01 松下電器産業株式会社 Enzyme electrode and its manufacturing method
JPS5816697B2 (en) * 1978-07-10 1983-04-01 松下電器産業株式会社 Enzyme electrode and its manufacturing method
JPS5512406A (en) * 1978-07-12 1980-01-29 Nippon Seiko Kk Method of compensating error in measuring circle or arc and meter with compensator
US4418148A (en) * 1981-11-05 1983-11-29 Miles Laboratories, Inc. Multilayer enzyme electrode membrane
CA1226036A (en) * 1983-05-05 1987-08-25 Irving J. Higgins Analytical equipment and sensor electrodes therefor
US4655880A (en) * 1983-08-01 1987-04-07 Case Western Reserve University Apparatus and method for sensing species, substances and substrates using oxidase
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
GB8526902D0 (en) * 1985-10-31 1985-12-04 Unilever Plc Electrochemical analysis
GB8619627D0 (en) * 1986-08-12 1986-09-24 Genetics Int Inc Electrochemical assay
US5128015A (en) * 1988-03-15 1992-07-07 Tall Oak Ventures Method and apparatus for amperometric diagnostic analysis
WO1989009397A1 (en) * 1988-03-31 1989-10-05 Matsushita Electric Industrial Co., Ltd. Biosensor and process for its production
GB8817421D0 (en) * 1988-07-21 1988-08-24 Medisense Inc Bioelectrochemical electrodes
GB8822738D0 (en) * 1988-09-28 1988-11-02 Medisense Inc Theophylline assay
US5264106A (en) * 1988-10-07 1993-11-23 Medisense, Inc. Enhanced amperometric sensor
US5262035A (en) * 1989-08-02 1993-11-16 E. Heller And Company Enzyme electrodes
DE69020908T2 (en) * 1989-12-15 1996-02-15 Boehringer Mannheim Corp REDOX MEDIATION REAGENT AND BIOSENSOR.
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
FR2673289B1 (en) * 1991-02-21 1994-06-17 Asulab Sa SENSOR FOR MEASURING THE QUANTITY OF A COMPONENT IN SOLUTION.
GB9309797D0 (en) * 1993-05-12 1993-06-23 Medisense Inc Electrochemical sensors
US5762770A (en) * 1994-02-21 1998-06-09 Boehringer Mannheim Corporation Electrochemical biosensor test strip
US5437999A (en) * 1994-02-22 1995-08-01 Boehringer Mannheim Corporation Electrochemical sensor
JP3061351B2 (en) * 1994-04-25 2000-07-10 松下電器産業株式会社 Method and apparatus for quantifying specific compounds
US5494562A (en) * 1994-06-27 1996-02-27 Ciba Corning Diagnostics Corp. Electrochemical sensors
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
JP2819260B2 (en) * 1995-07-11 1998-10-30 株式会社朋友メディカル Catheter extension tube
US5708247A (en) * 1996-02-14 1998-01-13 Selfcare, Inc. Disposable glucose test strips, and methods and compositions for making same

Also Published As

Publication number Publication date
AU715340B2 (en) 2000-01-20
ES2212077T3 (en) 2004-07-16
EP0880692B1 (en) 2004-01-07
EP0880692A1 (en) 1998-12-02
DK0880692T3 (en) 2004-05-17
ATE257595T1 (en) 2004-01-15
US5951836A (en) 1999-09-14
DE69727128T2 (en) 2004-11-11
AU2269297A (en) 1997-09-02
PT880692E (en) 2004-05-31
WO1997030344A1 (en) 1997-08-21
DE69727128D1 (en) 2004-02-12
CA2245941A1 (en) 1997-08-21
US5708247A (en) 1998-01-13

Similar Documents

Publication Publication Date Title
CA2245941C (en) Disposable test strips for determination of blood analytes, and methods and compositions for making same
AU763723B2 (en) Disposable test strips with integrated reagent/blood separation layer
US7112265B1 (en) Disposable test strips with integrated reagent/blood separation layer
JP3819936B2 (en) Electrochemical biosensor test strip
CA2644178C (en) Rapid response glucose sensor
JP5044655B2 (en) Reagent formulations using ruthenium hexamine as a transmitter for electrochemical test strips
JP5236824B2 (en) Stabilization of enzyme activity with electrochemical biosensors
US20030217918A1 (en) Rapid response glucose sensor
US20090050477A1 (en) Disposable sensor for liquid samples
EP0311377A2 (en) Sensor for measurement of a chemical species susceptible to dehydrogenation
JP2007024898A (en) Biosensor and production method thereof
JP2596017B2 (en) Biosensor
AU2006209265B2 (en) Rapid response glucose sensor
JPH0610662B2 (en) Biosensor

Legal Events

Date Code Title Description
EEER Examination request
MKEX Expiry

Effective date: 20170213