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Disposable test strips with integrated reagent/blood separation layer and forming method thereof

A disposable, isolation layer technology, applied in the direction of biochemical equipment and methods, microbial measurement/inspection, biological testing, etc., can solve the problems of increased cost, smaller effective electrode area, and adverse effects on accuracy

Inactive Publication Date: 2006-02-08
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 and forming method thereof
  • Disposable test strips with integrated reagent/blood separation layer and forming method thereof
  • Disposable test strips with integrated reagent/blood separation layer and forming method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0052] A non-conductive preparation for preparing the integral reagent / blood barrier layer 17 was prepared as follows. By adding 0.1 M citric acid, 100 ml of the aqueous phase of 20 mM trisodium citrate aqueous solution was adjusted to pH6. Add 6 g of hydroxyethyl cellulose (HEC), and homogenize and mix. The mixture was left overnight and allowed to bubble and dispersed, and then used as a storage solution for the coating composition.

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

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 (Melinex329). The first step is to print a carbon pad. The polyester substrate was printed with EC2 carbon (Ercon), and a 10×50 carbon pad array was formed on the surface. Then, the printed substrate is passed through a heating dryer, and can be cured at a high temperature (such as 70° C.) for 1-3 weeks.

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

[0057] The dielectric layer was then printed with ERCON R488-B(HV)-B2 blue. The pattern printed on the dielectric layer covers almost all of each device, only exposing the contacts, the head of the reference electrode a...

Embodiment 3

[0061] Put the test strip manufactured in the manner of Example 2 with the slurry of Example 1 in a measuring meter, and add a voltage of 500mV to test blood with different glucose concentrations and a hematocrit between 40% and 60%. sample. Figure 3A-3C Shows the relationship between the current measured 25 seconds after applying the voltage and the glucose concentration, and Figure 4 Is the slope of the glucose response plotted as a function of hematocrit. It can be seen that the result is that the reproducibility of the current is very good, basically independent of the 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 electrochemical determination of blood analytes such as glucose and methods and compositions for manufacturing such test strips. [0002] Glucose monitoring is a measurement in the daily life of diabetic patients. The accurate performance of this monitoring accurately indicates the difference between life and death. In order to adapt a normal lifestyle to the need for frequent monitoring of glucose levels, there are many types of glucose meters that allow patients to measure glucose levels with only a small amount of blood. [0003] Many of these meters use electrochemical methods to measure glucose in blood samples. They use enzymes (such as glucose oxidase) as part of a disposable, disposable electrode system to measure blood glucose oxidation. Examples of such devices are disclosed in European Patent No. 0 127 958 and U.S. Patent Nos. 5,141,868, 5,286,636, and 5,437,999, which are cited in...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): G01N27/26G01N33/48C12Q1/00C12Q1/54G01N27/30G01N27/327G01N27/416G01N33/483G01N33/487G01N33/50G01N33/66
CPCC12Q1/002C12Q1/004C12Q1/006G01N27/3272C12Q1/54G01N33/5002
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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