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Disposable test strips with integrated reagent/blood separation layer

A one-time, isolation-layer technology that can be used in the determination/inspection of microorganisms, biological testing, instruments, etc., and can solve problems such as adverse effects on accuracy, increased cost, and reduced effective electrode area.

Inactive Publication Date: 2002-03-20
LIFESCAN SCOTLAND
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Second, the fragmentation of the screen-printed electrode means that the effective electrode area becomes smaller over time
), but this adds an extra step in the manufacturing process, increases cost, and often adversely affects other aspects such as accuracy

Method used

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  • Disposable test strips with integrated reagent/blood separation layer
  • Disposable test strips with integrated reagent/blood separation layer
  • Disposable test strips with integrated reagent/blood separation layer

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0052] A non-conductive formulation for the preparation of the monolithic reagent / blood separation layer 17 was prepared as follows. 100 mL of the aqueous phase was adjusted to pH 6 with 20 mM trisodium citrate in water by adding 0.1 M citric acid. Add 6g of hydroxyethyl cellulose (HEC), and homogenize and mix. The mixture was left overnight and allowed to air bubble to disperse before being used as a storage solution for the coating composition.

[0053] 2 grams of Cab-o-Sil silica and 0.1 grams of DowCorning antifoam compound were added gradually by hand to 50 grams of the HEC solution until 4 / 5 of the total was added. While homogenizing to mix, add the rest. The mixture was then cooled in the refrigerator for 10 minutes. Then 8 g of potassium hexacyanoferrate (III) was added and mixed until completely dissolved. Finally, 0.8 g of glucose oxidase preparation (250 units / mg) was added and mixed thoroughly until dissolved. The resulting formulation can be used for printing...

Embodiment 2

[0055]To prepare glucose test strips using the slurry formulation of Example 1, screen printing was performed in a series of patterns on a 330 micron polyester substrate (Melinex 329). The first step is to print the carbon pad. The polyester substrate was printed with EC2 carbon (Ercon) to form a 10 x 50 array of carbon pads on its surface. The printed substrate is then passed through a heated dryer, and may also be cured at a high temperature (eg, 70° C.) for 1-3 weeks.

[0056] Next, an array of silver / silver chloride connecting tracks and contacts was printed on the substrate with ERCON R-414 (DPM-68) 1.25 bioelectrode sensor coating material and dried. For each carbon pad in the array, a working rail and a reference rail are printed in contact with the carbon pad.

[0057] The dielectric layer was then printed with ERCON R488-B(HV)-B2 blue. The pattern imprinted with the dielectric layer covered nearly the entirety of each device, exposing only the contacts, the tip of ...

Embodiment 3

[0061] With the slurry of embodiment 1, the test strip manufactured in the manner of embodiment 2 is placed in the meter, and a voltage of 500mV is added for testing blood with different glucose concentrations and hematocrit between 40%-60%. sample. Figures 3A-3C shows the measured current versus glucose concentration after applying the voltage for 25 seconds, while Figure 4 is the slope of the glucose response plotted as a function of hematocrit. As can be seen, the results are very reproducible currents, essentially independent of hematocrit.

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PUM

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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 non-conductive integrated reagent / blood separation layer containing a filler, an enzyme effective to oxidize glucose, e.g., glucose oxidase, and a mediator effective to transfer electrons from the enzyme. The integrated layer formulation is printed over a conductive carbon element 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 element. 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

Background of the invention [0001] This application relates to disposable test strips for the electrochemical determination of blood analytes such as glucose and methods and compositions for making such test strips. [0002] Glucose monitoring is a measure of everyday life for diabetics, and the accuracy of this monitoring can pinpoint the difference between life and death. In order to adapt a normal lifestyle to the need for frequent monitoring of glucose levels, a number of glucose meters are available which allow a patient to measure glucose levels in only a small amount of blood. [0003] Many of these meters measure glucose electrochemically in a blood sample by using an enzyme, such as glucose oxidase, as part of a disposable, single-use electrode system to measure oxidation of blood glucose. Examples of such devices are disclosed in European Patent No. 0 127 958 and US Patent Nos. 5,141,868, 5,286,636 and 5,437,999, which are hereby incorporated by reference in the pre...

Claims

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Application Information

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IPC IPC(8): G01N33/48C12Q1/00C12Q1/54G01N27/26G01N27/30G01N27/327G01N27/416G01N33/483G01N33/487G01N33/50G01N33/66
CPCC12Q1/002C12Q1/004C12Q1/006G01N27/3272C12Q1/54G01N33/5002G01N27/3271
Inventor J·F·麦克阿莱D·斯科特G·霍尔M·阿尔瓦雷斯-伊卡萨E·V·普洛特金O·W·H·戴维斯
Owner LIFESCAN SCOTLAND
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