CN2748912Y - Disposable electrode type blood sugar test bar - Google Patents
Disposable electrode type blood sugar test bar Download PDFInfo
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- CN2748912Y CN2748912Y CN 200420091585 CN200420091585U CN2748912Y CN 2748912 Y CN2748912 Y CN 2748912Y CN 200420091585 CN200420091585 CN 200420091585 CN 200420091585 U CN200420091585 U CN 200420091585U CN 2748912 Y CN2748912 Y CN 2748912Y
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Abstract
The utility model discloses a disposable electrode type blood sugar test bar which can avoid the interference by substances in blood. Silver paste which is used for conducting electricity and carbon-coating which is used for making working electrode, auxiliary electrode, and reference electrode, are printed on a plastic substrate. The carbon layer for making working electrode and the carbon layer for making reference electrode are respectively printed with a layer of ferricyanic acid ferric membrane in a chemosynthetic way, forming a reference electrode and an intermediate membrane for the working electrode. A layer of whole agent containing glucose/blood separator is covered on the intermediate film of the working electrode, forming an electrode type blood sugar test bar. The test bar can eliminate easily oxidized substances existing in the blood with a great deal, can raise accuracy, and can raise test sensibility.
Description
Technical field
The utility model relates to and is used for the disposable electrode formula blood sugar strip that electrochemical process is measured whole blood sample glucose.
Background technology
In order to satisfy the needs of glucose level in the daily monitoring blood of diabetic, many kinds of glucose meter have appearred now.Many in these instrument with the glucose in the electrochemical process detection blood sample, wherein be no lack of the precedent of utilizing disposable electrode system to detect glucose in the blood.The example of this class device is disclosed in european patent number 0127958 and U.S. Patent number 5141868,5286362, in 52,886 36 and 5437999.
But all there is certain shortcoming in the electric pole type strip that these electrochemical tests use, and other electroactive materials that test result is subjected to exist in the sample usually influence.For avoiding this interference, to add electron mediator usually.The oxidizing potential of the representative mediator that adopts is all higher at present, a large amount of readily oxidizable substance such as ascorbic acid, Ammoniom-Acetate phenol and uric acid that exist in the blood, and they may be oxidized with the mediator of reduced form, thereby cause reading higher.Want to reduce and disturb, a kind of approach is exactly a screening mediator preferably, but this method is limited by the characteristic of glucose oxidase to a certain extent.Also have some manufacturers to attempt using auxiliary electrode to carry out background deduction and solve this problem, though effectively, increased extra measurement and relevant error, cause the mensuration precise decreasing.Background deduction also may cause excessive correction, because the redox efficient of chaff interference is also inequality on two electrodes.
The haemocyte that Electrochemical results also is subjected to exist in the sample usually disturbs; the sample of common high hematocrit can make the read-around ratio actual value low; and low hematocrit sample causes reading to be higher than actual value, thereby because haemocyte can be deposited on the transfer of electrode surface restriction electronics.Someone comes haemocyte component in the elimination blood by adding filter membrane (seeing U.S. Patent number 5658444), but usually measuring accuracy is brought adverse influence.
Summary of the invention
The purpose of this utility model just provides a kind of be subjected to chaff interference and haemocyte that is used for detecting blood sample glucose influences little, highly sensitive disposable electrode formula blood sugar strip.
This strip comprises: a substrate; Be printed in the conducting element on the substrate and place working electrode, auxiliary electrode and contrast electrode on the conducting element; Be used for forming between conducting element and the meter contact that circuit is connected; Serigraphy insulation slurries deposit insulation course; Place one deck Hexacyanoferrate iron decorative layer on the working electrode; Place the whole reagent/blood separation layer on three electrodes; Detect current potential and adopt reduction potential.
Working electrode on the substrate is to be printed on carbon electrode on the substrate with the silk screen technology, and contact conductor is the silver wire that is printed on the substrate, and joint is the carbon-coating that is printed on the substrate.Working electrode is to print one deck Hexacyanoferrate iron decorative layer on basal electrode, and chemical reaction on the substrate carbon electrode forms this tunic by the potassium ferricyanide and iron chloride.Contrast electrode is printed Hexacyanoferrate iron decorative layer with the silk screen technology and is formed on basal electrode.Whole reagent/blood separation layer is to be formed by the filter paper matrix of having adsorbed mix reagent (comprising glucose oxidase, stabilizing agent, damping fluid), comprises glucose oxidase at least, and polyvinyl alcohol (PVA) stabilizing agent, pH are 5.0 citrate buffer solution.
The effect of Hexacyanoferrate iron decorative layer is to reduce and detects current potential, and adopts reduction potential as detecting current potential, fundamentally eliminates the influence of chaff interference; Substituting traditional silver/silver chloride reason with Hexacyanoferrate iron has two, and the former is than latter Geng Yi fast and stable on the one hand, and two can intensifier electrode and the compatibility of enzyme, the preservation life-span of prolongation strip; Whole reagent/blood separation layer is a matrix with dielectric filter paper, and the reagent that will be used for analysis measurement disperses thereon, and this separation layer can be isolated haemocyte and electrode surface, allows the solubility electroactive material to arrive electrode surface simultaneously.Among the embodiment of the present utility model, made glucose strip with whole reagent/blood separation layer, separation layer contains the surfactant that strengthens water wettability and the penetrating power of micromolecule, with the glucose oxidase of glucose response with keep the stable buffer medium that carries out of enzyme reaction.Experimental results show that this strip is not influenced by common interference thing and hematocrit substantially.
Reduce the essence approach that current potential is elimination or the influence of reduction chaff interference that detects, adopt Hexacyanoferrate iron to substitute traditional mediator in the utility model, its action principle has the transformation of essence, relating to analyte in the classic method is converted into the oxidation state of enzyme and goes back ortho states, the enzyme effect of oxygen or mediator and reductibility subsequently produces hydrogen peroxide or goes back the mediator of ortho states, mediator produces current signal in electrode surface generation electrooxidation then, this response has reflected enzyme and mediator, balance between enzyme and glucose and enzyme and the oxygen reaction, when having oxygen in the sample, enzyme that can go back ortho states is at first by oxygen rather than by the mediator oxidation, thereby signal is reduced.The oxidizing potential of mediator is generally all higher in addition, and the component of some easy oxidations can cause that signal is higher directly in the electrode surface reaction.The Hexacyanoferrate iron that the utility model uses is the compound that has high stability and hydrogen peroxide is had high catalytic reduction activity, the benefit that has two aspects like this at least: one, modification Hexacyanoferrate iron sensing membrane has changed the character of basal electrode later on, experiment showed, that the background current of multiple chaff interference such as ascorbic acid, Ammoniom-Acetate phenol and uric acid is not obvious even do not have; Owing to cancelled mediator, enzyme reaction and electrode reaction are separated in addition, thereby eliminate, and the detection thing is hydrogen peroxide that its reduction potential (is approximately 50mV vs.Fe/K because mediator is competed the influence that enzyme brought with oxygen
3Fe[CN]
6) be starkly lower than the oxidizing potential (being generally 500mV vs.Ag/AgCL) of mediator, thus the influence of interfering component eliminated greatly.
The use of dielectric whole reagent/blood separation layer is another important feature of the present utility model.Compare with at present known strip, the latter's printing slurries are funtion parts of electrode, and the haemocyte in the sample can directly interact with reagent layer.On the contrary, whole reagent/the blood separation layer that uses in the utility model is nonconducting, therefore not the part of electrode on function, electric charge can not take place between this layer and the electrode shift, and provide haemocyte and macromolecular compound to arrive the barrier of conducting element.
Electrode is covered has fully also overcome another source of error, test period, reagent can be from former deposition position sideways diffusion, if reagent layer is placed directly on the conducting element, the diffusion of these reagent changes and will exert an influence to analytic signal, and for example the diffusion difference that causes of temperature difference XOR device processes difference will show as the not reproducibility of signal.If yet reagent layer overlap on the electrode, it just can not work to signal from the sideways diffusion in hole.
The substrate that is used to make the utility model strip can be for any non-conductive, the material of stable in properties.Suitable material has mylar, Polyvinylchloride and polycarbonate; Substrate, any conductive material can be used in lead and contact, comprises silver, gold, platinum, carbon, and the preferred conductive carbon of working electrode, model have Carbon Electrode423 (Acheson Colloids) and ERC1, ERC2 (Ercon Inc.).Contrast electrode needs fast hydrating, and can also stablize fast enough, so that moment produces the required stable potential of working electrode.Conventional silver-silver chloride contrast electrode can not be enough fast stable.In the utility model, used the Hexacyanoferrate iron contrast electrode of response fast and stable.Constructed third electrode in addition, in order to the compensate for background electric current or as the counter electrode of traditional three-electrode system, electrode material is identical with working electrode.
Whole reagent/blood separation layer is a matrix by the filter paper in suitable aperture, and drying is made behind absorption glucose oxidase solution and the buffering agent.Control the pH value of reaction zone by buffering agent, the pH value maintains on 5 the level, because when this pH value, the reactivity of glucose oxidase is the highest, helps improving the sensitivity of analysis in the utility model.
Can eliminate a large amount of readily oxidizable substances that exist in the blood when the utility model detects blood sugar, improve accuracy; And the sensitivity of mensuration is improved.
Description of drawings
Fig. 1 is basal electrode figure of the present utility model.
Fig. 2 be strip structural drawing of the present utility model (2A, 2B).
2A is a vertical view.
2B is a side view.
Fig. 3 be the utility model strip process drawing (3A, 3B, 3C, 3D).
Fig. 4 be the electric current that records under three kinds of hematocrit levels and concentration of glucose graph of a relation (4A1,4A2,4A3,4B).
The electric current that Fig. 5 records under three kinds of chaff interference levels for the utility model and the graph of a relation of concentration of glucose.
The electric current that Fig. 6 records under the different temperatures level for the utility model and the graph of a relation of concentration of glucose.
Fig. 7 is the graph of a relation of the utility model electric current and concentration of glucose.
Embodiment
Embodiment
Fig. 1, Fig. 2 and shown in Figure 3, on substrate 10 with the silk screen technology print basal electrode 11,12,13, their nationality leads 14 are connected with measurement instrument with electrically conductive pin 15.Cover one deck dielectric film 21 then thereon, a part and the joint 15 of conducting element 11,12,13 are exposed, on 12 and 13, modify Hexacyanoferrate iron decorative layer 22 and 23 subsequently respectively, at last dielectric whole reagent/blood separation layer 20 is added on the window, makes it to cover fully three electrodes.When being connected with measurement instrument, glucose in the blood infiltrates on the internal layer electrode together with reaction medium through whole reagent/blood separation layer 20, and generate hydrogen peroxide with glucose oxidase generation selectivity catalytic reaction in its vicinity, then hydrogen peroxide is formed and detects electric current by Hexacyanoferrate iron sensing membrane catalytic reduction.
Thick polyester film (the Valox of substrate 10 preferred 500 μ m
TM), the first step is a depositing silver rail 14 on substrate, at the end of silver-colored rail conductive carbon (Carbon Electrode 423, Acheson Colloids Co.) goes out carbon pad 11,12,13 (being basal electrode) by the silk screen technology print, joint 15 and earth connection point 16, then deposit insulation course 21 with silk screen technology print insulation slurries, this insulation course contains three windows 11,12,13.Chemogenic deposit Hexacyanoferrate iron decorative layer on window 12 and 13 then, deposit fluid are formed and are seen the following form 1.
Table 1 chemical sinking effusion is formed
| Composition | Content |
| KCl(1.0mol/L) FeCl 3(0.004mol/L) K 4Fe[Fe(CN) 6](0.004mol/L) | 5ml 50ml 50ml |
Cover the whole reagent/blood separation layer 20 of one deck subsequently, and make its four edges extend across insulation course.Separation layer is a matrix with quick filter paper (the about 25 μ m in aperture), and the effect of matrix is that sample is transmitted uniformly by reaction zone, and limits the collecting region of sample, the suitable agent of use table 2 composed as follows.
The reagent of the whole reagent/blood separation layer of table 2 is formed
| Composition | Content |
| Potassium citrate (0.1mol/L) citric acid (0.1mol/L) polyvinyl alcohol (PVA) (PVA) glucose oxidase (GODx 250U/mg) | 11.8mL 8.2mL 1g 280mg |
Strip is placed on the meter, the voltage that between contrast electrode and working electrode, adds 50mV, test the blood sample that different concentration of glucose and hematocrit change between 40%～60%, Fig. 4 A is the response mapping of glucose under different hematocrits, Fig. 4 B is the mapping of glucose responding slope to hematocrit. the reappearance of electric current is fine as can be seen, and is irrelevant with hematocrit basically.
Strip is placed on the meter, the voltage that between contrast electrode and working electrode, adds 50mV, test the relation of different concentration of glucose and three kinds of chaff interference levels (ratio of chaff interference total amount such as ascorbic acid, Ammoniom-Acetate phenol and uric acid and glucose content) blood sample, Fig. 5 is the mapping of glucose responding slope to the chaff interference level.The reappearance of electric current is fine as can be seen, and is irrelevant with the chaff interference level basically.
At two kinds of different sample temperatures, promptly 37 ℃ and 20 ℃, 50mV voltage is measured down strip, and Fig. 5 has shown the electric current that records behind the making alive 30s and the relation of concentration of glucose.As shown in Figure 6, the slope of two lines basic identical (37 ℃ time, in the time of 20 ℃), prove strip in environment temperature in the physiological temp scope, its behavior does not rely on temperature basically.Tracing it to its cause may be that the use of separation layer makes blood analyte enter electrode surface bigger resistance is arranged, and electrode reaction is by diffusion control, rather than dynamics Controlling.
Strip is placed on the meter, add the voltage of 50mV between contrast electrode and working electrode, test the relation of the blood sample of different concentration of glucose, Fig. 7 has shown the electric current that records behind the making alive 30s and the relation of concentration of glucose.
Claims (5)
1. disposable electrode formula blood sugar strip, comprise substrate (10), basal electrode (11), (12), (13), lead (14), contact (15), ground wire (16) and insulation course (21) is characterized in that basal electrode (11), (12), (13) on the substrate (10) are used separately as auxiliary electrode, working electrode and contrast electrode; Lead (14), contact (15) and ground wire (16) are used for forming circuit between basal electrode (11), (12), (13) and the meter and are connected; Basal electrode (12), (13) are gone up and are modified Hexacyanoferrate iron decorative layer (22), (23); Serigraphy insulation slurries deposit insulation course (21), and auxiliary electrode, working electrode, contrast electrode, contact (15) and ground wire (16) are exposed; Cover whole reagent/blood separation layer (20) on auxiliary electrode, working electrode and the contrast electrode.
2. as claims 1 described strip, it is characterized in that basal electrode (11), (12), (13) on the described substrate (10) are to be printed on carbon-coating on the substrate with the silk screen technology, lead (14) is the silver layer that is printed on the substrate (10), and contact (15) and ground wire (16) are the carbon-coatings that is printed on the substrate (10).
3. as claims 1 described strip, it is characterized in that described working electrode is to go up with the silk screen technology at basal electrode (12) to print Hexacyanoferrate iron decorative layer (22), this tunic is gone up chemical reaction by the potassium ferricyanide and iron chloride at basal electrode (12) and is formed.
4. as claims 1 described strip, it is characterized in that described contrast electrode is to go up with the silk screen technology at basal electrode (13) to print Hexacyanoferrate iron decorative layer (23), this tunic is that the potassium ferricyanide and iron chloride are gone up chemical reaction formation at basal electrode (13).
5. as claims 1 described strip, it is characterized in that described whole reagent/blood separation layer (20) is to be formed by the filter paper matrix of adsorbing mix reagent, comprise glucose oxidase at least, polyvinyl alcohol (PVA) stabilizing agent, pH are 5.0 citrate buffer solution.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN 200420091585 CN2748912Y (en) | 2004-09-07 | 2004-09-07 | Disposable electrode type blood sugar test bar |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN 200420091585 CN2748912Y (en) | 2004-09-07 | 2004-09-07 | Disposable electrode type blood sugar test bar |
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| Publication Number | Publication Date |
|---|---|
| CN2748912Y true CN2748912Y (en) | 2005-12-28 |
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| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN 200420091585 Expired - Fee Related CN2748912Y (en) | 2004-09-07 | 2004-09-07 | Disposable electrode type blood sugar test bar |
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| Country | Link |
|---|---|
| CN (1) | CN2748912Y (en) |
Cited By (9)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101315345B (en) * | 2008-07-15 | 2011-09-28 | 四川大学 | Production method for Modified electrode for detecting grape-sugar concentration in non-enzyme condition |
| CN102338765A (en) * | 2010-12-23 | 2012-02-01 | 深圳大学 | Blood sugar testing paper |
| CN104950020A (en) * | 2014-03-26 | 2015-09-30 | 无锡市申瑞生物制品有限公司 | Abandoning type electrochemical sensor for detecting iodide ions and manufacturing method of abandoning type electrochemical sensor |
| CN104968798A (en) * | 2013-01-31 | 2015-10-07 | 生命扫描苏格兰有限公司 | Electrochemical-based analytical test strip with soluble acidic material coating |
| CN105353130A (en) * | 2015-11-06 | 2016-02-24 | 邢丽丽 | Automatic tester applied to intelligent electric meter production line |
| US9518951B2 (en) | 2013-12-06 | 2016-12-13 | Changsha Sinocare Inc. | Disposable test sensor with improved sampling entrance |
| CN109613078A (en) * | 2018-12-12 | 2019-04-12 | 广州万孚生物技术股份有限公司 | Anti-interference electrochemical test sensors and preparation method thereof |
| CN110320241A (en) * | 2019-07-28 | 2019-10-11 | 北京怡成生物电子技术股份有限公司 | The recognition methods of target strip and system |
| US10571425B2 (en) | 2013-05-09 | 2020-02-25 | Changsha Sinocare Inc. | Disposable test sensor with improved sampling entrance |
-
2004
- 2004-09-07 CN CN 200420091585 patent/CN2748912Y/en not_active Expired - Fee Related
Cited By (11)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101315345B (en) * | 2008-07-15 | 2011-09-28 | 四川大学 | Production method for Modified electrode for detecting grape-sugar concentration in non-enzyme condition |
| CN102338765A (en) * | 2010-12-23 | 2012-02-01 | 深圳大学 | Blood sugar testing paper |
| CN104968798A (en) * | 2013-01-31 | 2015-10-07 | 生命扫描苏格兰有限公司 | Electrochemical-based analytical test strip with soluble acidic material coating |
| US10571425B2 (en) | 2013-05-09 | 2020-02-25 | Changsha Sinocare Inc. | Disposable test sensor with improved sampling entrance |
| US9518951B2 (en) | 2013-12-06 | 2016-12-13 | Changsha Sinocare Inc. | Disposable test sensor with improved sampling entrance |
| US10088444B2 (en) | 2013-12-06 | 2018-10-02 | Changsha Sinocare Inc. | Disposable test sensor with improved sampling entrance |
| CN104950020A (en) * | 2014-03-26 | 2015-09-30 | 无锡市申瑞生物制品有限公司 | Abandoning type electrochemical sensor for detecting iodide ions and manufacturing method of abandoning type electrochemical sensor |
| CN105353130A (en) * | 2015-11-06 | 2016-02-24 | 邢丽丽 | Automatic tester applied to intelligent electric meter production line |
| CN109613078A (en) * | 2018-12-12 | 2019-04-12 | 广州万孚生物技术股份有限公司 | Anti-interference electrochemical test sensors and preparation method thereof |
| CN109613078B (en) * | 2018-12-12 | 2024-03-15 | 广州万孚生物技术股份有限公司 | Anti-interference electrochemical detection sensor and manufacturing method thereof |
| CN110320241A (en) * | 2019-07-28 | 2019-10-11 | 北京怡成生物电子技术股份有限公司 | The recognition methods of target strip and system |
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Legal Events
| Date | Code | Title | Description |
|---|---|---|---|
| C14 | Grant of patent or utility model | ||
| GR01 | Patent grant | ||
| C19 | Lapse of patent right due to non-payment of the annual fee | ||
| CF01 | Termination of patent right due to non-payment of annual fee |