CN1858591A - Double parameter test strip - Google Patents

Double parameter test strip Download PDF

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Publication number
CN1858591A
CN1858591A CN 200510069955 CN200510069955A CN1858591A CN 1858591 A CN1858591 A CN 1858591A CN 200510069955 CN200510069955 CN 200510069955 CN 200510069955 A CN200510069955 A CN 200510069955A CN 1858591 A CN1858591 A CN 1858591A
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CN
China
Prior art keywords
reaction chamber
reaction
parameter
test strip
double
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.)
Pending
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CN 200510069955
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Chinese (zh)
Inventor
何伟
宗小林
李元光
吴家永
夏桂芳
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.)
BEIJING YICHENG BIOELECTRONIC TECHNOLOGY Co Ltd
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BEIJING YICHENG BIOELECTRONIC TECHNOLOGY Co Ltd
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Priority to CN 200510069955 priority Critical patent/CN1858591A/en
Publication of CN1858591A publication Critical patent/CN1858591A/en
Pending legal-status Critical Current

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Abstract

This invention relates to a double parameter test strip for testing two components in whole blood including: a chip carrying electrodes, in which, a first reaction chamber formed by an insulating cover board, said chip and a wall between them and a second reaction chamber formed by an insulation cover board, said chip and a wall between them are set on the chip, the first reaction chamber includes a vent hole and a feeding hole and a first parameter reaction reagent, the second reaction chamber includes a vent hole and a feeding hole and a second parameter reaction reagent and the two reaction chambers share a reference electrode.

Description

A kind of double parameter test strip
Technical field
The present invention relates to a kind of biological detection device, relate in particular to a kind of double parameter test strip that is used for testing simultaneously two kinds of component contents of whole blood.
Background technology
In recent years, no matter still domestic abroad, the diabetic is more and more, and effective means in time controlling hyperglycaemia are exactly that the blood sugar concentration in the blood is often tested.In addition, the lactic acid content in the blood is the important indicator of judging such as sb.'s sickness becomes critical property such as miocardial infarction, ventricular fibrillation, septic shock, therefore also is necessary in time to carry out the mensuration of lactic acid content.
Often need in actual applications the concentration or the content of two kinds of compositions in the blood are detected, for example need simultaneously glucose in the whole blood and lactic acid content to be detected, perhaps need simultaneously the content of glucose in the blood and ketoboidies to be measured, because it is the main performance of the acute metabolism complication-diabetic ketoacidosis of diabetes that blood ketone body raises, the monitoring of the diabetic being carried out blood ketone body helps the early diagnosis diabetic ketoacidosis.
Yet the biochemical test bar to component content in the blood or concentration all can only detect a physiochemical indice at present, when the concentration of two kinds of compositions or content detect in need be to blood, can only measure respectively, so not only time-consuming, blood using amount is also more, and cost is also higher.
Summary of the invention
The object of the present invention is to provide a kind of double parameter test strip, it can realize that the concentration of two kinds of compositions in the whole blood or content measures simultaneously fast, provides the index of two kinds of compositions in the blood at short notice, for medical diagnosis provides multiple information fast, reduce testing cost, and improved efficient.
In order to realize described purpose, technical scheme of the present invention is:
A kind of double parameter test strip comprises: the substrate that is loaded with electrode; It is characterized in that: described substrate is provided with:
The first parameter testing part, be by an insulation cover plate, described substrate and between wall limit first reaction chamber that forms, this reaction chamber has a vent port at least, and a sample holes, and is provided with the first parameter reaction reagent;
The second parameter testing part, be by an insulation cover plate, described substrate and between wall limit second reaction chamber that forms, this reaction chamber has a vent port at least, and a sample holes, and is provided with the second parameter reaction reagent;
First working electrode contacts with the first parameter reaction reagent in first reaction chamber;
Second working electrode contacts with the second parameter reaction reagent in second reaction chamber;
Contrast electrode contacts with the first parameter reaction reagent and the second parameter reaction reagent;
Described first working electrode and described contrast electrode are exported the electric signal that electrochemical reaction produces in first reaction chamber;
Described second working electrode and described contrast electrode are exported the electric signal that electrochemical reaction produces in second reaction chamber.
The vent port of described first reaction chamber is positioned on the insulation cover plate of first reaction chamber top; The vent port of described second reaction chamber is positioned on the insulation cover plate of second reaction chamber top.
The sample holes of the sample holes of described first reaction chamber and second reaction chamber is positioned at the same side of described substrate one end.
Described first reaction chamber does not communicate with second reaction chamber.
Beneficial effect of the present invention is, double parameter test strip of the present invention, only need a whole blood just can finish two kinds of component contents in the blood simply, measure fast, and pass through the shared of contrast electrode, effectively reduce preparation cost and process complexity.Double parameter test strip of the present invention can be used for medical institutions' outpatient service, emergency treatment and clinical laboratory and carries out in-vitro diagnosis, can make things convenient for glucose and lactic acid concn in medical institutions' fast detecting blood samples of patients, and takes measures to carry out treatment work.
Description of drawings
Fig. 1 is the vertical view of double parameter test strip of the present invention;
Fig. 2 a is one of electrode structure synoptic diagram of double parameter test strip of the present invention;
Fig. 2 b is two of the electrode structure synoptic diagram of double parameter test strip of the present invention;
Fig. 2 c is three of the electrode structure synoptic diagram of double parameter test strip of the present invention;
Fig. 3 attempts for the side of double parameter test strip of the present invention;
Fig. 4 is a double parameter test strip right view shown in Figure 1.
Embodiment
With reference to the accompanying drawings, the specific embodiment of the present invention is described.
Fig. 1 is the decomposing schematic representation of double parameter test strip of the present invention.Fig. 2 a, Fig. 2 b and Fig. 2 c are the electrode structure synoptic diagram of double parameter test strip of the present invention, and Fig. 3 attempts for the side of double parameter test strip of the present invention; Fig. 4 is a double parameter test strip right view shown in Figure 1.As shown in the figure, double parameter test strip of the present invention comprises: one is loaded with substrate 101, insulation cover plate 102 and the insulation cover plate 103 of electrode; Described substrate 101 is provided with:
The first parameter testing part, be by insulation cover plate 102, described substrate 101 and between double faced adhesive tape or other wall 301 limit first reaction chamber that forms, this reaction chamber has a vent port 108 at least, and a sample holes 105, and is provided with the first parameter reaction reagent;
The second parameter testing part, be by insulation cover plate 103, described substrate 101 and between double faced adhesive tape or other wall 301 limit second reaction chamber that forms, this reaction chamber has a vent port 107 at least, and a sample holes 104, and is provided with the second parameter reaction reagent;
Do not communicate between described first reaction chamber and second reaction chamber.
Described substrate 101 is made by polymeric materials such as PVC, PET or PP, and described insulation cover plate 102 and 103 is the water wetted material of transparent insulation.The insulation cover plate 102 of described first reaction chamber and second reaction chamber top also can be replaced by a shared insulation cover plate with insulation cover plate 103.
For easy to detect, the sample holes of first reaction chamber and second reaction chamber all is positioned at the same side of described substrate end, as shown in Figure 1.The vent port 108 of first reaction chamber is positioned on the insulation cover plate 102 of first reaction chamber top; The vent port 107 of second reaction chamber is positioned on the insulation cover plate 103 of second reaction chamber top.
Be respectively arranged with a working electrode and a contrast electrode in each reaction chamber; Blood to be measured, as puncture the blood sample that finger obtains by blood taking needle, can be without heparin tube, and finger is contacted with strip adopt, make blood enter two reaction chambers through two sample holes, react respectively with the reaction reagent of described two reaction chambers, the electric signal that reaction produces is exported through lead by described working electrode and contrast electrode.In order to save cost and simpler for the preparation that makes electrode, the shared contrast electrode of two reaction chambers that described substrate and two insulation cover plates form is shown in Fig. 2 a, Fig. 2 b and Fig. 2 c.
The first parameter reaction reagent in first working electrode 201 and first reaction chamber contacts; The second parameter reaction reagent in second working electrode 203 and second reaction chamber contacts; Contrast electrode 202 contacts with the first parameter reaction reagent and the second parameter reaction reagent.
The shape of shared contrast electrode 202 can be done different variations, and for example described contrast electrode can be designed as L shaped, also can be prepared as T shape etc.
204 is connection terminal among the figure, is used to connect the input instrument.Described electrode can adopt any conductive material, and as preparations such as palladium, platinum, gold, carbon, the preparation technology of described electrode also can have multiple choices, as vacuum coating (vacuum evaporation, magnetron sputtering, ion beam depositing etc.), serigraphy etc.In order to protect described electrode, be loaded with on the substrate of electrode can part dielectric films 106 such as covering one deck PET.
Described vent port is positioned on the insulation cover plate of described reaction chamber top, and be positioned at a side relative of insulation cover plate with sample holes, this is in order to make whole blood sample be covered with reaction chamber by capillary action, with the test error of avoiding test volume fixedly not cause, in addition, according to the structure of double parameter test strip of the present invention, the liquid that can not of two reaction chambers influences each other, and has promptly suppressed influencing each other between two kinds of composition measurements to greatest extent.
According to the structure of double parameter test strip of the present invention, when just can realize in the whole blood glucose and lactic acid content, measure fast:
Can in first reaction chamber of double parameter test strip of the present invention, be fixed with glucose oxidase, the potassium ferricyanide and other salt, be fixed with Lactate Oxidase, the potassium ferricyanide and other salt in second reaction chamber.That is, every double parameter test strip contains following composition:
Glucose oxidase 〉=0.3IU, Lactate Oxidase 〉=0.2IU, the potassium ferricyanide: 0.12mg, other salt: 65%.
Glucose in the blood and glucose oxidase (GOD) that is fixed on the strip surface and potassium ferricyanide reaction produce gluconic acid and potassium ferrocyanide.Signal detecting and measuring apparatus applies a constant operating voltage to test-strips, makes potassium ferrocyanide be oxidized to the potassium ferricyanide, produces oxidation current, and the size of oxidation current is directly proportional with concentration of glucose.Signal detecting and measuring apparatus writes down the size of oxidation current, and converses the concentration of glucose.
In addition, the lactic acid in the blood and Lactate Oxidase (LAO) that is fixed on the strip surface and potassium ferricyanide reaction produce pyruvic acid and potassium ferrocyanide.Signal detecting and measuring apparatus applies a constant operating voltage to test-strips, makes potassium ferrocyanide be oxidized to the potassium ferricyanide, produces oxidation current, and the size of oxidation current is directly proportional with lactic acid concn.The size of signal detecting and measuring apparatus record oxidation current, and converse concentration of lactic acid.
The measurement range of double parameter test strip of the present invention is: full blood glucose, 40mg/dL~500mg/dL (2.2mmol/L~27.8mmol/L); Full blood lactic, 1mM-15mM.
For full blood glucose-lactic acid double parameter test strip measuring repeatability, wherein, the precision of full blood glucose repeated measuring results should meet the requirement of table 1, and the precision of full blood lactic repeated measuring results should meet the requirement of table 2.
Table 1 full blood glucose measuring repeatability
Test specification Precision
<5.5mmol/L (<100mg/dL) SD<0.42mmol/L (<7.7mg/dL)
≥5.5mmol/L (≥100mg/dL) CV<7.5%
Table 2 full blood lactic measuring repeatability
Test specification Precision
<2.0mmol/L SD<0.15mmol/L
≥2.0mmol/L CV<7.5%
The difference between batch of different lot number full blood glucoses-lactic acid double parameter test strip is not more than 15%.
In addition, test fast when can also realize in the whole blood glucose and blood ketone body concentration according to double parameter test strip of the present invention, only need the reagent of test lactic acid content in full blood glucose-lactic acid double parameter test strip as mentioned above to replace with the reagent of measuring blood ketone body concentration, promptly replace with the reaction reagent of the beta-hydroxybutyric dehydrogenase, diaphorase, the potassium ferricyanide and other salt that contain certain proportioning.
When glucose in carrying out whole blood-blood entire body was measured, the precision of full blood glucose repeated measuring results still met the requirement of table 1, and the precision of blood ketone body repeated measuring results meets the requirement of table 3.
Table 3 blood ketone body instrument and blood ketone body strip measuring repeatability
Test specification Precision
<0.6mmol/L SD<0.06mmol/L
≥0.6mmol/L CV<7.5%
In sum, double parameter test strip of the present invention, only need a whole blood just can finish two kinds of component contents in the blood simply, measure fast, and pass through the shared of contrast electrode, effectively reduce preparation cost and process complexity.
Double parameter test strip of the present invention can be used for medical institutions' outpatient service, emergency treatment and clinical laboratory and carries out in-vitro diagnosis, can make things convenient for glucose and lactic acid concn in medical institutions' fast detecting blood samples of patients, and takes measures to carry out treatment work.
Above embodiment only is used to illustrate the present invention, but not is used to limit the present invention.

Claims (4)

1. a double parameter test strip comprises: the substrate that is loaded with electrode; It is characterized in that: described substrate is provided with:
The first parameter testing part, be by an insulation cover plate, described substrate and between wall limit first reaction chamber that forms, this reaction chamber has a vent port at least, and a sample holes, and is provided with the first parameter reaction reagent;
The second parameter testing part, be by an insulation cover plate, described substrate and between wall limit second reaction chamber that forms, this reaction chamber has a vent port at least, and a sample holes, and is provided with the second parameter reaction reagent;
First working electrode contacts with the first parameter reaction reagent in first reaction chamber;
Second working electrode contacts with the second parameter reaction reagent in second reaction chamber;
Contrast electrode contacts with the first parameter reaction reagent and the second parameter reaction reagent;
Described first working electrode and described contrast electrode are exported the electric signal that electrochemical reaction produces in first reaction chamber;
Described second working electrode and described contrast electrode are exported the electric signal that electrochemical reaction produces in second reaction chamber.
2. double parameter test strip according to claim 1 is characterized in that: the vent port of described first reaction chamber is positioned on the insulation cover plate of first reaction chamber top; The vent port of described second reaction chamber is positioned on the insulation cover plate of second reaction chamber top.
3. double parameter test strip according to claim 1 is characterized in that: the sample holes of the sample holes of described first reaction chamber and second reaction chamber is positioned at the same side of described substrate one end.
4. double parameter test strip according to claim 1 is characterized in that: described first reaction chamber does not communicate with second reaction chamber.
CN 200510069955 2005-04-30 2005-04-30 Double parameter test strip Pending CN1858591A (en)

Priority Applications (1)

Application Number Priority Date Filing Date Title
CN 200510069955 CN1858591A (en) 2005-04-30 2005-04-30 Double parameter test strip

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Application Number Priority Date Filing Date Title
CN 200510069955 CN1858591A (en) 2005-04-30 2005-04-30 Double parameter test strip

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CN1858591A true CN1858591A (en) 2006-11-08

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Cited By (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN102033087A (en) * 2009-10-02 2011-04-27 生命扫描苏格兰有限公司 Multi-analyte test strip with inline working electrodes and shared opposing counter/reference electrode
EP2317315A1 (en) * 2009-10-27 2011-05-04 Lifescan Scotland Limited Dual chamber, multi-analyte test strip with opposing electrodes and body fluid test method using this strip
CN101661013B (en) * 2008-08-27 2013-04-17 华北电力科学研究院有限责任公司 Electrochemical measuring device
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
CN110554075A (en) * 2019-08-22 2019-12-10 北京怡成生物电子技术股份有限公司 Flexible electrode and preparation method thereof, enzyme sensor and preparation method thereof

Cited By (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN101661013B (en) * 2008-08-27 2013-04-17 华北电力科学研究院有限责任公司 Electrochemical measuring device
CN102033087A (en) * 2009-10-02 2011-04-27 生命扫描苏格兰有限公司 Multi-analyte test strip with inline working electrodes and shared opposing counter/reference electrode
EP2317315A1 (en) * 2009-10-27 2011-05-04 Lifescan Scotland Limited Dual chamber, multi-analyte test strip with opposing electrodes and body fluid test method using this strip
CN102156154A (en) * 2009-10-27 2011-08-17 生命扫描苏格兰有限公司 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
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
CN110554075A (en) * 2019-08-22 2019-12-10 北京怡成生物电子技术股份有限公司 Flexible electrode and preparation method thereof, enzyme sensor and preparation method thereof

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Open date: 20061108