CN1858592A - Test sheet - Google Patents
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- CN1858592A CN1858592A CN 200510069956 CN200510069956A CN1858592A CN 1858592 A CN1858592 A CN 1858592A CN 200510069956 CN200510069956 CN 200510069956 CN 200510069956 A CN200510069956 A CN 200510069956A CN 1858592 A CN1858592 A CN 1858592A
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- conservancy diversion
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Abstract
This invention provides a test plate for biochemical test including: a chip carrying electrodes, a reaction region, a diversion film, a cover plate and a separation film, in which the reaction region is coated with a reacting reagent and connected with the electrode, which outputs electric signals by the lead, the diversion film is set on the chip, part of which end-the reaction region is covered by the cover plate and part of the other end is covered by the separation film, part of the diversion film covered by the cover plate between the chip and the cover plate forms a reaction cavity and a separation cavity is formed by the diversion film covered by the separation film between the chip and the separation film, the two cavities are connected by a feeding channel, the being tested solution enters into the separation cavity via the separated reaction solution and enters into the reaction cavity via the feeding channel to be reacted with the reaction reagent in the reaction region under the reaction cavity.
Description
Technical field
The present invention relates to the electrochemical measurement field, particularly be used for a kind of test piece of biology, chemical measurement.
Background technology
Recent every studies show that, increasing of cholesterol is the cardiac trigger disease in the blood of human body, miocardial infarction, the main arch-criminal of angiocardiopathy.As high fat of blood is to cause hypertension and atherosclerotic important factor, and blood lipids index in the blood, mainly is meant the overall target of triglyceride and T-CHOL.Along with the variation of diet, habits and customs, working pressure etc., more and more by the patient that increasing of serum lipid concentrations causes angiocardiopathy, so people are necessary to carry out timely the test of cholesterol and triglyceride.Carry out in good time monitoring and understanding by cholesterol isoconcentration to self, with the cholesterol intake in keeping on a diet timely, or cholesterol accumulation in the reduction blood that strengthens physical training, guarantee healthy.
Present hospital tradition method for determination of cholesterol is still based on colorimetric and method for saponification, and these methods are promptly time-consuming, and price is high again and need specialized equipment and professional's operation, is difficult for popularizing with the personal user selftest monitoring of cholesterol is used.For the selftest monitoring that improves clinical detection efficiency and realize patient, just need a kind of energy easy, test the means of cholesterol concentration in the blood fast, so occurred cooperating the cholesterol concentration tester uses, the disposable test piece of cholesterol concentration fast on the market.Fig. 1 is the simple structure synoptic diagram of the test piece of existing two electrode structures, wherein 101,102,103,104 represent substrate, working electrode, contrast electrode and reaction reagent respectively, testing liquid and reaction reagent reaction, the electric signal that produces comes cholesterol detection concentration by described working electrode and contrast electrode collection according to electric signal.
Because the test process of conventional cholesterol is slow, for fast reaction speed, reduce the reaction time, usually in reaction reagent, add surfactant, the test piece and the supporting use of cholesterol test instrument of test cholesterol concentration just can obtain test result in general 2.5 minutes like this.But surfactant can have a negative impact to red blood cell, therefore can not carry out cholesterol with whole blood and measure.For this reason, erythrocytic filter membrane occurred filtering, but because the diffusion of reaction liquid, be dissolved in the reaction liquid after still having a spot of red blood cell destroyed, thereby caused measuring inaccurate, the diffusion that therefore how to prevent reaction reagent is still one problem to be solved.
In addition, test piece design commonly used is that testing liquid directly is added drop-wise to reaction zone, or from side direction sucting reaction district.For the mode that drips liquid, often control causes measuring error owing to be difficult to accurately to the amount of the liquid that drips, and exposed or also polluted easily and influence measurement result with the reaction zone of silk screen covering; Traditional sucks there is the exhaust effect difference again easily in liquid to the test piece of reaction zone problem from side direction.Therefore, how to overcome simultaneously that testing liquid non-quantitative, reaction zone easily pollute and the problem of venting quality difference, also have to be solved.
In addition, the preparation cost of test piece also is a factor must considering.
Summary of the invention
The object of the present invention is to provide a kind of test piece, not only technology is simple for it, cost is low, can fast, accurately detect the cholesterol concentration in the whole blood again, by plasma separation membrane with the separating plasma in the whole blood, and be sent to the fixing reaction chamber of sampling quantity through the water conservancy diversion film, utilize the size of working electrode and contrast electrode detection electric signal to realize the accurate test of cholesterol concentration.
For realizing described purpose, technical scheme of the present invention is:
A kind of test piece comprises: be loaded with the substrate of electrode, also comprise: reaction zone, water conservancy diversion film, cover plate and diffusion barrier; Wherein,
Described reaction zone is provided with reaction reagent, and contacts with described electrode, through lead output electric signal;
Described water conservancy diversion film is arranged on the substrate, and an end of this water conservancy diversion film is covered at least in part by described cover plate, and it covers described reaction zone; The other end of this water conservancy diversion film is covered at least in part by described diffusion barrier;
The water conservancy diversion membrane portions that is covered by cover plate between substrate and cover plate is formed with a reaction chamber;
The water conservancy diversion membrane portions that is covered by diffusion barrier between substrate and diffusion barrier is formed with a disengagement chamber;
The sample intake passage that is made of a water conservancy diversion film between described reaction chamber and the disengagement chamber connects, testing liquid separates through diffusion barrier, isolated reaction liquid enters disengagement chamber, and enters reaction chamber by described sample intake passage, reacts with reaction reagent in the reaction zone of reaction chamber below; The electric signal that described reaction produced is exported through lead by described electrode.
Described diffusion barrier is a plasma separation membrane, and described testing liquid is a blood, is blood plasma through the isolated reaction liquid of described plasma separation membrane.
Described diffusion barrier and cover plate closely are arranged in water conservancy diversion film top.
Described disengagement chamber, sample intake passage and reaction chamber are to be limited by substrate, cover plate, diffusion barrier and the two-sided marginal portion that all is provided with the water conservancy diversion film of gluing to form; The one side of described marginal portion with fix by gluing and described substrate, another side is fixed by gluing and described cover plate and diffusion barrier, the center section of the water conservancy diversion film of gluing is not formed with disengagement chamber, sample intake passage and reaction chamber.
Described substrate is glued by two layers of insulation material and forms.
Described water conservancy diversion film is the textile of plain film one class of wire mesh membrane, nonwoven fabrics or glass fibre.
Have a hole on the described cover plate, form the exhaust passage of described reaction chamber.
Described electrode comprises working electrode and contrast electrode.Described substrate is a strip.
Beneficial effect of the present invention is, the present invention is for providing a kind of clinically and the matching used test piece of tester, not only technology is simple, cost is low, can also realize the accurate detection of whole blood cholesterol concentration, for clinical diagnosis, daily detection, guidance treatment and blood lipid level generaI investigation provide easy, quick and cheap means, thereby help realizing to the effective monitoring of blood lipid level and the incidence of disease of control angiocardiopathy.
Description of drawings
Fig. 1 is the test piece structural representation of prior art;
Fig. 2 is the STRUCTURE DECOMPOSITION synoptic diagram of test piece of the present invention.
Embodiment
Below in conjunction with accompanying drawing the specific embodiment of the present invention is done detailed explanation.
Fig. 2 is the STRUCTURE DECOMPOSITION synoptic diagram of test piece of the present invention.As shown in Figure 2, test piece of the present invention comprises: be loaded with the substrate 201 of electrode, the reaction zone 205 that is loaded with reaction reagent 204, water conservancy diversion film 200, cover plate 206 and plasma separation membrane 207;
Wherein, substrate 201 can adopt any conventional insulating material with stabilizing mechanical performance to make, as nonconducting polymkeric substance (as polycarbonate, polyolefin, polyester etc.), resin or pottery etc., because substrate is the support chip as test piece, it should guarantee to have certain thickness and support strength thereof, in order to save cost, in the present embodiment, substrate is made of two layers of insulation material: the PET that the transparent polyvinyl chloride that 0.3mm is thick (PVC) base material and 0.125mm are thick (lid white paint), the two utilizes pressure sensitive adhesive bonding fixing.
On-chip electrode comprises a working electrode 202 and a contrast electrode 203; Electrode can adopt any conductive material, as palladium, platinum, gold, carbon etc., the preparation of electrode also can be adopted the kinds of processes means, as vacuum coating (vacuum evaporation, magnetron sputtering, ion beam depositing etc.), serigraphy, electron beam lithography etc., electrode is to adopt the magnetically controlled sputter method preparation in the present embodiment.
Described reaction zone 205 is fixed with reaction reagent 204, and this reaction zone is positioned at electrode surface and contacts with described electrode, and the electric signal that testing liquid and reaction reagent reaction are produced is exported through lead by described electrode.
Reaction reagent 204 is made up of enzyme, electronic medium, buffer reagent, cellulose etc.Adopt different enzymes according to the material that will detect is different, as be used for the cholesterol test and then adopt cholesterol esterase and cholesterol oxidase.Electronic medium promotes the biochemical reaction product at electrode surface generation electrochemical redox reaction, and transmits electronics between reactant and working electrode, and it can be iron hydrofining, ferrocene etc.Reaction reagent can directly be added drop-wise to reaction zone or be added to reaction zone by means such as machine injections, and reaction reagent forms reagent layer through drying or toasting drying.
For accuracy and the guard electrode that improves measurement; on the substrate 201 that is loaded with electrode, also be provided with one deck dielectric film 212; it partly covers insulating substrate 201 and electrode, and exposes reaction zone and be used to connect the measuring junction of the electrode of testing tool, as shown in Figure 2.Dielectric film can adopt the insulating material identical with substrate, is the PET film in the present embodiment.
Water conservancy diversion film 200 is arranged on the substrate, it is a mesh-like hydrophilic substance, it can be nonwoven fabrics, glass fibre membrane or wire mesh membrane, it in the present embodiment the uniform wire mesh membrane of silk screen of thick 0.12mm, adopt glue to be coated with or method of printing with described water conservancy diversion film edge double spread, one side is bonded on the substrate 201, and covers reaction zone and SI semi-insulation film 212; Another side and cover plate 206 and plasma separation membrane 207 are bonding, and promptly described water conservancy diversion film 200 is fixed between substrate and cover plate 206 and the plasma separation membrane 207 by the gluing 213 around it.
As shown in Figure 2, the top of water conservancy diversion film is compact arranged cover plate 206 and plasma separation membrane 207.One end of water conservancy diversion film 200 is covered by cover plate 206, and this end covers described reaction zone; The other end of water conservancy diversion film is covered by plasma separation membrane 207, and this end is positioned at dielectric film 212 tops.
Among the present invention, described cover plate 206 can be arbitrary insulating material of polymer, is the PET material of thickness 0.05mm herein; The insulation cover plate is used for fixing the reaction zone space, and the control sampling quantity improves the sample introduction precision, and also the protective reaction district avoids polluting simultaneously.On cover plate 206, has a hole 211, as the exhaust passage.
Plasma separation membrane 207 is used for filtering whole blood as carrying platform, and blood plasma is separated with red blood cell, and in the present embodiment, diffusion barrier is the filter paper of thickness 0.8mm, and in addition, its material can also be for porous membrane etc.
At described substrate, cover plate, plasma separation membrane, and the part of described water conservancy diversion film edge double spread partly limits the not gluing of described water conservancy diversion film and formed a reaction chamber 209, a disengagement chamber 208, and the sample intake passage between described reaction chamber and the disengagement chamber 210.Wherein, described reaction chamber 209 is positioned at insulation cover plate below, promptly insulate between cover plate and the reaction zone, and described disengagement chamber 208 is positioned at the below of described plasma separation membrane, and the sample intake passage by a water conservancy diversion film between described disengagement chamber and the reaction chamber connects.Blood separates through the blood plasma diffusion barrier, and isolated blood plasma enters disengagement chamber, and enters reaction chamber through described sample intake passage, reacts with reaction reagent in the reaction zone of reaction chamber below; The electric signal that described reaction produced is exported through lead by working electrode and contrast electrode.Among the present invention, the effect of water conservancy diversion film is: both be used for water conservancy diversion blood plasma and arrived reaction zone, can prevent that again reacting test solution spreads back disengagement chamber.The present invention since with the water conservancy diversion film as reaction chamber and disengagement chamber, prevented that effectively the reactant in the reaction zone from spreading back disengagement chamber even diffusion barrier, blood sample is impacted avoiding.
As seen from Figure 2, because reaction chamber and disengagement chamber and described sample intake passage are partly limited by the gluing of described water conservancy diversion film, therefore size and the shape that can control reaction chamber, disengagement chamber by the area and the shape of change water conservancy diversion film gluing part, and the width of sample intake passage 210; By changing the thickness of described water conservancy diversion film, can change the cavity in two chambeies and the height of sample introduction sample intake passage in addition.Thus, the present invention has realized the accurate control of blood plasma reacting dose to be measured, thereby improves the precision of reaction.
According to the whole blood cholesterol test piece of said structure, utilize signal detecting and measuring apparatus to be connected with the electrode of test piece, just can detect cholesterol concentration in the whole blood:
Whole blood sample is added on the plasma separation membrane, haemocyte is trapped in the film, have only blood plasma to arrive disengagement chamber through plasma separation membrane, and because capillary action, blood plasma arrives the reaction chamber of test piece through sample intake passage 210, thereby enter the enzyme reaction district, lipoprotein wherein discharges cholesteryl ester through the reagent effect, together with small-amount free cholesteryl ester in the blood plasma and cholesterol esterase (CEH) reaction that is fixed on the test piece surface, hydrolysis generates cholesterol, oxidation takes place in the latter under cholesterol oxidase (CHOD) effect, the potassium ferricyanide is reduced, and produces Δ
4Cholestenone and potassium ferrocyanide.Signal detecting and measuring apparatus applies a constant operating voltage to test piece, makes potassium ferrocyanide be oxidized to the potassium ferricyanide, produces oxidation current, and the size of oxidation current is directly proportional with cholesterol concentration.Signal detecting and measuring apparatus writes down the size of oxidation current, and converses the concentration of cholesteryl ester, i.e. whole blood cholesterol concentration.Drip whole blood on the plasma separation membrane of test piece, detecting instrument just can obtain measurement result after 3 minutes, and is very quick and convenient.
The water conservancy diversion film 200 of cover plate double spread around substrate reaches limits the reaction chamber of the fixed in space with sample intake passage 210 and exhaust passage 211 that forms, and has controlled sample size, has improved the accuracy of measuring.For the better protection reaction zone, the hole on the cover plate, promptly the exhaust passage is positioned at the reaction zone oblique upper, and as far as possible little.
The water conservancy diversion film not only plays the effect of water conservancy diversion among the present invention, can also effectively prevent the enzyme reaction diffusion of reagents in disengagement chamber, can prevent that also the red blood cell of destroyed dissolving enters into reaction chamber in the plasma separation membrane.Therefore utilize test piece of the present invention, can be effectively, accurately cholesterol level is detected again fast, and test piece of the present invention is simple in structure, and cost is low again.
The described test piece specification of present embodiment is: independent packaging test piece 70mm * 40mm, and test piece weight is every independent packaging of 1.2g/; The composition of every test piece is as follows:
Cholesterol oxidase 〉=0.8IU,
Cholesterol esterase 〉=2IU,
The potassium ferricyanide: 0.1mg,
Other salt: 64%.
Whole blood cholesterol of the present invention test piece, with the supporting use of cholesterol test instrument (the yin, yang electrode of test piece is connected with testing tool), after adding blood sample on the plasma separation membrane of test piece, (preferably blood sample is full of the blood separation membrane of test piece), just can show test results after 180 seconds, according to the present invention, only need 30 μ l whole bloods just can finish cholesterol detection.
Whole blood cholesterol of the present invention test piece and the supporting use of whole blood cholesterol test instrument, the precision of repeated measuring results meets the requirement of table 1.
Table 1. whole blood cholesterol test sheet measuring repeatability
| Test specification | Precision |
| ＜200mg/dl (or 5.18mmol/L) | SD＜15mg/dl (or 0.39mmol/L) |
| ≥200mg/dl | CV＜7.5％ |
Test piece of the present invention to the linear responding range of whole blood cholesterol is: 100mg/dl～400mg/dl.And described test piece greater than 0.98, has very high accuracy to the linearly dependent coefficient of the test of whole blood cholesterol and standard method test value.
In addition, in the test piece preparation process, to the whole blood cholesterol test piece of different lot numbers, its difference between batch is not more than 15%.
In addition, utilize the test piece of structure of the present invention, can also finish the test of other composition in the whole blood, for example test the triglyceride in the whole blood, at this moment, only need the reaction enzymes of described test piece reaction zone is replaced with lipase, glycerokinase, GPO, and with the supporting use of corresponding triglyceride testing tool, just can finish the test of triglyceride easily and fast, accurately.
In sum, the present invention is for providing a kind of clinically and the matching used cholesterol test piece of cholesterol test instrument, not only technology is simple, cost is low, can also realize quick, convenient, the detection accurately of whole blood cholesterol concentration, for clinical diagnosis, daily detection, guidance treatment and blood lipid level generaI investigation provide easy, quick and cheap means, thereby help realizing to the effective monitoring of blood lipid level and the incidence of disease of control angiocardiopathy.
Above embodiment only is used to illustrate the present invention, but not is used to limit the present invention.
Claims (9)
1. test piece comprises: be loaded with the substrate of electrode, it is characterized in that, also comprise: reaction zone, water conservancy diversion film, cover plate and diffusion barrier; Wherein,
Described reaction zone is provided with reaction reagent, and contacts with described electrode, through lead output electric signal;
Described water conservancy diversion film is arranged on the substrate, and an end of this water conservancy diversion film is covered at least in part by described cover plate, and it covers described reaction zone; This water conservancy diversion film other end is covered at least in part by described diffusion barrier;
The water conservancy diversion membrane portions that is covered by cover plate between substrate and cover plate is formed with a reaction chamber;
The water conservancy diversion membrane portions that is covered by diffusion barrier between substrate and diffusion barrier is formed with a disengagement chamber;
The sample intake passage that is made of a water conservancy diversion film between described reaction chamber and the disengagement chamber connects, testing liquid separates through diffusion barrier, isolated reaction liquid enters disengagement chamber, and enters reaction chamber by described sample intake passage, reacts with reaction reagent in the reaction zone of reaction chamber below; The electric signal that described reaction produced is exported through lead by described electrode.
2. test piece according to claim 1 is characterized in that, described diffusion barrier is a plasma separation membrane, and described testing liquid is a blood, is blood plasma through the isolated reaction liquid of described plasma separation membrane.
3. test piece according to claim 1 is characterized in that, described diffusion barrier and cover plate closely are arranged in water conservancy diversion film top.
4. test piece according to claim 1 is characterized in that, described disengagement chamber, sample intake passage and reaction chamber are to be limited by substrate, cover plate, diffusion barrier and the two-sided marginal portion that all is provided with the water conservancy diversion film of gluing to form; The one side of described marginal portion is fixed by gluing and described substrate, and another side is fixed by gluing and described cover plate and diffusion barrier, and the center section of the water conservancy diversion film of gluing is not formed with disengagement chamber, sample intake passage and reaction chamber.
5. test piece according to claim 1 is characterized in that, described substrate is glued by two layers of insulation material and forms.
6. test piece according to claim 1 is characterized in that, described water conservancy diversion film is the plain film of wire mesh membrane, nonwoven fabrics or glass fibre.
7. test piece according to claim 1 is characterized in that, has a hole on the described cover plate, forms the exhaust passage of described reaction chamber.
8. test piece according to claim 1 is characterized in that described electrode comprises working electrode and contrast electrode.
9. test piece according to claim 1 is characterized in that, described substrate is a strip.
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| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN 200510069956 CN1858592A (en) | 2005-04-30 | 2005-04-30 | Test sheet |
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| CN 200510069956 CN1858592A (en) | 2005-04-30 | 2005-04-30 | Test sheet |
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Cited By (6)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN102353707A (en) * | 2011-07-08 | 2012-02-15 | 无锡市金坤生物工程有限公司 | Cholesterol molecule blotting membrane sensing electrode and use of the cholesterol molecule blotting membrane sensing electrode in waste oil detection |
| CN102928468A (en) * | 2012-09-14 | 2013-02-13 | 北京体育大学 | Whole blood urea biosensing test paper |
| CN104569088A (en) * | 2014-12-25 | 2015-04-29 | 北京怡成生物电子技术股份有限公司 | Test paper strip for blood detection by electrochemical process and production method of test paper strip |
| CN105092662A (en) * | 2014-05-20 | 2015-11-25 | 光宏精密股份有限公司 | Electrochemical sensing test piece and making method thereof |
| CN106483175A (en) * | 2016-12-22 | 2017-03-08 | 山东理工大学 | A kind of palm rapid detector for antibiotic residue based on Internet of Things |
| CN104597100B (en) * | 2014-07-24 | 2021-11-05 | 南京工业大学 | Method for detecting triglyceride in serum |
-
2005
- 2005-04-30 CN CN 200510069956 patent/CN1858592A/en active Pending
Cited By (9)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN102353707A (en) * | 2011-07-08 | 2012-02-15 | 无锡市金坤生物工程有限公司 | Cholesterol molecule blotting membrane sensing electrode and use of the cholesterol molecule blotting membrane sensing electrode in waste oil detection |
| CN102353707B (en) * | 2011-07-08 | 2014-02-12 | 无锡市金坤生物工程有限公司 | Cholesterol molecule blotting membrane sensing electrode and use of cholesterol molecule blotting membrane sensing electrode in waste oil detection |
| CN102928468A (en) * | 2012-09-14 | 2013-02-13 | 北京体育大学 | Whole blood urea biosensing test paper |
| CN105092662A (en) * | 2014-05-20 | 2015-11-25 | 光宏精密股份有限公司 | Electrochemical sensing test piece and making method thereof |
| CN104597100B (en) * | 2014-07-24 | 2021-11-05 | 南京工业大学 | Method for detecting triglyceride in serum |
| CN104569088A (en) * | 2014-12-25 | 2015-04-29 | 北京怡成生物电子技术股份有限公司 | Test paper strip for blood detection by electrochemical process and production method of test paper strip |
| CN104569088B (en) * | 2014-12-25 | 2017-06-13 | 北京怡成生物电子技术股份有限公司 | Electrochemical process blood testing test strips and its manufacture method |
| CN106483175A (en) * | 2016-12-22 | 2017-03-08 | 山东理工大学 | A kind of palm rapid detector for antibiotic residue based on Internet of Things |
| CN106483175B (en) * | 2016-12-22 | 2019-06-11 | 山东理工大学 | A kind of palm rapid detector for antibiotic residue based on Internet of Things |
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