CN207020121U - A kind of synchronous multiple analyte sensing test-paper of sample introduction breach isolation current interference - Google Patents

A kind of synchronous multiple analyte sensing test-paper of sample introduction breach isolation current interference Download PDF

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Publication number
CN207020121U
CN207020121U CN201720593470.2U CN201720593470U CN207020121U CN 207020121 U CN207020121 U CN 207020121U CN 201720593470 U CN201720593470 U CN 201720593470U CN 207020121 U CN207020121 U CN 207020121U
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China
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sample introduction
insulating substrate
breach
paper
introduction breach
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梁明龙
李中
伍寿胜
崔晓斌
刘勤
廖姗
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GUILIN ZHONGHUI TECHNOLOGY DEVELOPMENT Co Ltd
GUILIN ROYALYZE MEDICAL INSTRUMENT CO Ltd
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GUILIN ZHONGHUI TECHNOLOGY DEVELOPMENT Co Ltd
GUILIN ROYALYZE MEDICAL INSTRUMENT CO Ltd
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Abstract

The utility model discloses a kind of synchronous multiple analyte sensing test-paper of sample introduction breach isolation current interference, including the first insulating substrate and the second insulating substrate and two separate detection architectures being arranged on the first insulating substrate and the second insulating substrate, first insulating substrate is provided with the first sample introduction breach, second insulating substrate is provided with the second sample introduction breach, and drain cell body is provided with the 3rd sample introduction breach;The shape and size of first sample introduction breach, the second sample introduction breach and the 3rd sample introduction breach are identical;First insulating substrate, drain cell body, the second insulating substrate sequential layer poststack, a stacking sample introduction breach is formed, the both sides end face of sample introduction breach depth direction is laminated, is the first injection port, the second injection port respectively.The test paper is by being laminated sample introduction breach, and electric current interferes between completely cutting off different analyte response systems, realizes that a piece of test paper single injected sampling accurately detects two or more projects.

Description

A kind of synchronous multiple analyte sensing test-paper of sample introduction breach isolation current interference
Technical field
The utility model belongs to the accurate detection technique field of bio-sensing, is related to a kind of sample introduction breach isolation current interference Synchronous multiple analyte sensing test-paper.
Background technology
In medical institutions and patient home, the test paper and analyzer produced according to bio-sensing electrochemical techniques can be fast The concentration value of the chemical markers such as speed detection blood sugar for human body, ketoboidies, glucose in urine, uric acid, cholesterol, triglycerides, hemoglobin.Only Need to gather micro blood or a small amount of urine specimen, suction bio-sensing electrochemistry test paper and linking parsing instrument, will soon obtain Obtain testing result." supporting test paper of blood glucose monitoring system and preparation method thereof " is introduced as disclosed in Publication No. CN1447113A, examination Paper mainly includes:One substrate, is printed on a working electrode on substrate, a reference electrode, is printed on grounding electrode on substrate, One end of substrate is printed on the wire connected with instrument is read, it is characterised in that working electrode and reference electrode are to be imprinted on base respectively The carbon coating formed on piece conductive silver layer, the biology enzyme of catalysis blood-glucose reaction is coated with working electrode, and it is a kind of The medium and binder of electron transmission can be carried out between enzymic catalytic reaction center and electrode, so forms a circuit loop. During sample-adding reaction, the height of concentration of glucose, produces correspondingly sized current signal in blood sample, is tested instrument detection and reads.
This single detection project test paper, often using once, obtain the testing result of a biochemical marker.User is such as Fruit needs to test two or more biochemical marker projects related to medical diagnosis on disease it is necessary to use the test paper of other detection projects instead And analyzer, not only need to repeat to take a blood sample, be also multiplied buying instrument and use cost.
At present, the existing two-parameter or multi parameter analysis instrument of in the market, can detect two or more using an analyzer Biochemical marker.Such as blood glucose, glucose in urine two-parametric analysis instrument, blood glucose, glucose in urine, uric acid, cholesterol multi parameter analysis instrument etc..These Instrument, it is by multiple biochemical marker current signal read functions, is integrated into an analyzer.By changing different detections Purpose test paper, complete different analyte Indexs measures.In order to avoid repeating to take a blood sample, most users increase acupuncture finger depth, Or finger blood-taking wound is firmly extruded, to obtain enough blood samples.This way, subcutaneous cell liquid is set to ooze out composition increasing Add, blood sample exposes aerial time lengthening, and reducing substances aoxidizes with the oxonium ion combination in air in blood sample, nothing Method ensures the uniformity and accuracy of testing result.
There is inventor's imagination, if two panels bio-sensing test paper electrode reaction area is superimposed relatively, common sample introduction mouth, so that it may To realize a piece of test paper while detect the purpose of two different analytes." have as disclosed in Publication No. CN102156154A The Dual chamber, multi-analyte test strip of comparative electrode " is introduced, and blood sample is further separated into two-chamber from test paper blood inlet siphon, and salt bridge is each From current signal is produced, turned by test paper seated connection, after tester is read, you can to obtain the detection knot of two different analytes Fruit.
But the patent has the defects of obvious, possibly purpose of design can not be realized in concrete practice.Because two-chamber Electrode common return, two-chamber lead blood groove and share blood inlet.During actual sample introduction, blood sample touches blood inlet under siphonage Into two-chamber, now blood inlet and the blood sample of residual in blood groove is led, if same root wire is by two-chamber turn on automatically, because of salt bridge Common return, in the case that salt bridge is connected by residual blood sample, independent two-chamber design mutually has been not present, and salt bridge is each Necessarily mutually mix, be superimposed, disturb or offset from caused current signal, the current signal that analyzer is read is two analytes Composite result, it is impossible to accurate and effective.
Utility model content
The purpose of this utility model is to provide a kind of more points of synchronization of sample introduction breach isolation current interference for the above situation Thing sensing test-paper is analysed, coordinates intelligent multi-parameter analyzer to use, examination of this synchronous multiple analyte sensing test-paper accurately to calculate Paper sample introduction breach, automatic issuable current interference between completely cutting off test paper double-reaction area difference analyte, can be solved related existing The defects of with the presence of technology, the hidden danger for avoiding different analyte electrodes from can turn on, making only can be with a piece of test paper single injected sampling The synchronous two or more projects of detection become a reality.
Realize that the technical scheme of the utility model purpose is as follows:
A kind of synchronous multiple analyte sensing test-paper of sample introduction breach isolation current interference, including the first insulating substrate and second Insulating substrate and the separate electrode detection system being arranged on the first insulating substrate and the second insulating substrate;It is described Detection architecture includes the drain cell body being arranged in the first insulating substrate and the second insulating substrate, and the drain cell body is provided with independent The first intake chute and the second intake chute, the first intake chute is provided with the first injection port, and the second intake chute is provided with the second injection port;
Unlike existing disclosed technology, first insulating substrate is provided with the first sample introduction breach, the second insulation base Piece is provided with the second sample introduction breach, and drain cell body is provided with the 3rd sample introduction breach;The first sample introduction breach, the second sample introduction breach and The shape and size of three sample introduction breach are identical;After first insulating substrate, drain cell body, the second insulating substrate sequential layer overlay are neat, A stacking sample introduction breach is formed, the both sides end face of sample introduction breach depth direction is laminated, is the first injection port, the second sample introduction respectively Mouthful;
Sample introduction gap opened width and the proportional constraint of vertical depth are laminated, volume capacity when sample is added dropwise according to analyte It is configured;Sample size is added dropwise generally between 1.5ul~30ul in blood or urine, and stacking sample introduction gap opened width is arranged to Between 0.5mm~5mm, vertical depth is arranged between 1mm~10mm;The utility model synchronization multiple analyte sensing test-paper is added dropwise Sample size 3ul~5ul, stacking sample introduction gap width may be configured as >=2mm, and vertical depth may be configured as >=5mm;Stacking sample introduction lacks Mouthful it is rectangle, U-shaped or V-arrangement.It is laminated the width of sample introduction breach and vertical depth is computed and practical proof, it can be ensured that detection During be laminated noresidue blood sample or urine examination thing between sample introduction breach, the injection port of breach both sides first, the second injection port, keep away Exempt from the possibility turned between different analyte electrodes by residual sample, ensure different analyte detecting electrodes each caused electric current Signal is interference-free.
The synchronous multiple analyte sensing test-paper for completely cutting off current interference by sample introduction breach, including
The first conductive film layer on the first insulating substrate, first conductive film layer first including mutually insulated are anti- Answer thing working electrode and the second reactant working electrode;
Film layer is reacted, the reaction film layer includes the first reaction film and the second reaction film, and the first reaction film is covered in first On reactant working electrode, the second reaction film is covered on the second reactant working electrode.
The drain cell body is arranged on the first conductive film layer, and the drain cell body is by the first reaction film and the second reaction film Separate in independent intake chute, intake chute body forms the first intake chute and the second intake chute, the first reaction film are arranged on first In intake chute, the second reaction film is arranged in the second intake chute, and the corresponding first reactant working electrode of the first intake chute, second leads The corresponding second reactant working electrode of liquid bath.
The first described intake chute is provided with first row gas port, and the second intake chute is provided with second exhaust port.
The back side of second insulating substrate is provided with the second conductive film layer, and the second conductive film layer includes the first reactant reference Electrode and the second reactant reference electrode;
Including hydrophilic membrane, the hydrophilic membrane includes the first hydrophilic film and the second hydrophilic film, and the first hydrophilic film is covered in On first reactant reference electrode, the second hydrophilic film is covered on the second reactant reference electrode;
The back side of second insulating substrate is amplexiformed with drain cell body, the first insulating substrate, and the first intake chute forms the first reaction Chamber, the second intake chute form the second reaction chamber, and drain cell body separates the first reaction film, the second reaction film in independent reaction chamber It is interior;First hydrophilic film is corresponding with the first reaction film, and the second hydrophilic film is corresponding with the second reaction film.
Including the 3rd conductive film layer, the 3rd conductive film layer is arranged on before the second insulating substrate, the 3rd conducting film Layer is respectively equipped with the first pin and second pin;
Second insulating substrate is provided with the first via hole, the second via hole, and the first via hole reacts the first pin and first Thing reference electrode forms electrical connection, and the second via hole makes second pin be electrically connected with the formation of the second reactant reference electrode.
Second insulating substrate and the second conductive film layer, which correspond at the first hydrophilic film, is provided with the first sample introduction observation window, the Two insulating substrates and the second conductive film layer, which correspond at the second hydrophilic film, is provided with the second sample introduction observation window.
The bottom of second insulating substrate is provided with substrate breach, the first reactant working electrode on the first insulating substrate Expose with the second reactant working electrode from substrate breach.
The synchronous multiple analyte sensing test-paper of described sample introduction breach isolation current interference, preparing synchronous detection blood sample Acetyl glucosaminidase, bile acid, glutamic-pyruvic transaminase, T-CHOL, the HDL courage of sheet or urine specimen are consolidated Alcohol, LDL-C, triglycerides, uric acid, glucose in urine, lactic acid, blood glucose, ketoboidies, hemoglobin or bilirubin are any Combination two or multinomial biochemical marker Test paper in application.
Described synchronous multiple analyte sensing test-paper, coordinate intelligent multi-parameter analyzer to use, can synchronously detect blood sample Acetyl glucosaminidase, bile acid, glutamic-pyruvic transaminase, T-CHOL, the HDL courage of sheet or urine specimen are consolidated Alcohol, LDL-C, triglycerides, uric acid, glucose in urine, lactic acid, blood glucose, ketoboidies, hemoglobin or bilirubin are any Two biochemical markers are combined, realize that a piece of test paper single injected sampling accurately detects two or more projects.
It can be fixed on above-mentioned synchronous the first reactant of multiple analyte sensing test-paper working electrode and acetylglucosamine Glycosides enzyme, bile acid, glutamic-pyruvic transaminase, T-CHOL, HDL-C, LDL-C, glycerine three A kind of reaction reacted in the biochemical markers such as ester, uric acid, glucose in urine, lactic acid, blood glucose, ketoboidies, hemoglobin, bilirubin Film, it can fix on the second reactant working electrode and consolidate with acetyl glucosaminidase, bile acid, glutamic-pyruvic transaminase, total courage Alcohol, HDL-C, LDL-C, triglycerides, uric acid, glucose in urine, lactic acid, blood glucose, ketoboidies, blood The another kinds different from the first reactant working electrode test event in the biochemical markers such as Lactoferrin, bilirubin are reacted Reaction film, so as to realize single injected sampling, the synchronous purpose for detecting two or more analytes.
The intelligent multi parameter analysis instrument that multiple analyte sensing test-paper synchronous with the utility model is used cooperatively, its liquid crystal display The detection data result of multiple analytes can be shown;
The electrode signal processor that multiple analyte sensing test-paper synchronous with the utility model is used cooperatively, including multi-electrode examination Paper socket and four cores or eight core piece computing systems, the system can read four-way (containing) simultaneously to eight passage bio-sensings Current signal caused by electrochemistry test paper sample-adding reaction is more by intellectuality after being scaled corresponding biochemical marker concentration value Parameter analyzer shows result.
The synchronous multiple analyte sensing test-paper of sample introduction breach isolation current interference described in the utility model, when test paper is laminated When sample introduction breach contacts analyte blood sample or urine sample dropwise addition, under capillary siphonage, analyte blood sample or urine sample are by layer Folded sample introduction breach enters the first intake chute and the second intake chute, quilt by the first injection port, the second injection port automatic shunt respectively Analyte with the reagent reacting in the first reaction film and the second reaction film, while produces weak current respectively, passes through test paper seat electricity Pole is switched through, and by current signal input signal processor, the concentration value of analyte is calculated, then in multi parameter analysis instrument display screen Show result.
The reaction film of first reactant working electrode and the second reactant working electrode, which surveys material, to be entered according to function Row combination, such as, blood glucose and uric acid can be combined test glucose and uric acid, can also be T-CHOL and glycerine Three esters combine monitoring blood ester, can also be T-CHOL and HDL-C or low-density lipoprotein courage Sterol combines test cholesterol level monitoring cardiovascular function.
Compared with existing public technology, the utility model is provided with the first sample introduction breach on the first insulating substrate, second Insulating substrate is provided with the second sample introduction breach, and the 3rd sample introduction breach is provided with drain cell body, and the shape of sample introduction breach is identical, folds Stick on the stacking sample introduction breach for closing and forming test paper one end, be laminated sample introduction gap opened width and the proportional constraint of vertical depth, root It is configured according to analyte sample amount;Blood or urine specimen amount are generally between 1.5ul~30ul, sample introduction gap opened width It is arranged between 0.5mm~5mm, vertical depth is arranged between 1mm~10mm;Synchronization in a specific embodiment is more Analyte sensing test-paper, sample introduction gap width are preferably set to 1~3mm, and vertical depth is preferably set to 3~6mm;Sample introduction Breach is rectangle, U-shaped or V-arrangement.When blood sample or urine sample touch stacking sample introduction breach, the first sample introduction of stacking sample introduction breach both sides Mouthful, the second injection port will detect sample siphon and enter two detection zone intake chutes, after the completion of sample-adding, air pressure difference can be filled up rapidly Space between two injection ports, blood sample or urine will not be remained by being laminated between sample introduction breach and the first injection port, the second injection port Sample, ensure two different analytes circuit system will not UNICOM, " there is comparative electrode so as to avoid existing public technology Dual chamber, multi-analyte test strip " sets sample introduction breach because ignoring, and causes the blood sample that test paper injection port remains to be connected as wire The circuit system of two different analytes, the interference of electric current is produced, the degree of accuracy of test can not be ensured.
Synchronous multiple analyte sensing test-paper technique described in the utility model is simple, is adapted to batch production, does not increase substantially Product cost.Single injected sampling is only needed not only to be saved the time, raising is examined with regard to the testing results of two or more analytes can be obtained Disconnected efficiency, also avoids the mental burden brought to patient of repeatedly taking a blood sample.
Brief description of the drawings
Fig. 1 is the stereochemical structure signal of the synchronous multiple analyte sensing test-paper that sample introduction breach completely cuts off current interference in embodiment Figure;
Fig. 2 is the dimensional decomposition structure of the synchronous multiple analyte sensing test-paper that sample introduction breach completely cuts off current interference in embodiment Schematic diagram;
Fig. 3 is the dimensional decomposition structure diagram of multiple analyte sensing test-paper in comparative example;
Fig. 4 is the sample distribution figure of the synchronous multiple analyte sensing test-paper that sample introduction breach completely cuts off current interference in embodiment;
Fig. 5 is the sample distribution figure of synchronous multiple analyte sensing test-paper in comparative example.
In figure, conductive film layer 2-1. the first reactant works of 1. first the first sample introductions of insulating substrate 1-1. breach 2. first Make the second reactants of electrode 2-2. working electrode 3. and react the drain of the second reaction films of film layer 3-1. the first reaction film 3-2. 4. Sample introduction breach 4-2. the first injection port 4-3. the first intake chute 4-4. first row gas ports 4-5. second of cell body 4-1. the 3rd enter Hydrophilic membrane 5-1. the first hydrophilic film the second hydrophilic films of 5-2. of sample mouth 4-6. the second intake chute 4-7. second exhaust port 5. 6. second the first sample introductions of conductive film layer 6-1. the first reactant reference electrode 6-2. the second reactant reference electrode 6-3. are observed Insulating substrate 7-1. the second sample introduction breach the first via holes of the 7-2. 7-3. second of the second sample introductions of window 6-4. observation window 7. second Conductive film layer 8-1. the first pin 8-2. second pins 9. of via hole 7-4. substrates breach 8. the 3rd are laminated sample introduction breach.
Embodiment
In conjunction with the embodiments and accompanying drawing, the utility model is implemented to be described in further detail.Here, of the present utility model show Meaning property embodiment and its illustrate be used for explain the utility model.Modification that any person skilled in the art can easily do and Change is both contained in applying for a patent appended by this case in the range of right requirement.
Reference picture 1, Fig. 2, a kind of synchronous multiple analyte sensing test-paper of sample introduction breach isolation current interference, including first is exhausted The insulating substrate 7 of edge substrate 1 and second and be arranged on the first insulating substrate 1 and the second insulating substrate 7 two are independently of each other Detection architecture, the detection architecture includes being arranged on drain cell body 4 in the first insulating substrate 1 and the second insulating substrate 7, institute State drain cell body 4 and be provided with the first injection port provided with the first independent intake chute 4-3 and the second intake chute 4-6, the first intake chute 4-3 4-2, the second intake chute 4-6 are provided with the second injection port 4-5;
First insulating substrate 1 is provided with the first sample introduction breach 1-1, the second insulating substrate 7 is provided with the second sample introduction breach 7- 1st, drain cell body 4 is provided with the 3rd sample introduction breach 4-1, the first sample introduction breach 1-1, the second sample introduction breach 7-1 and the 3rd sample introduction Breach 4-1 shape and size are identical, the first insulating substrate 1, drain cell body 4, the sequential layer poststack of the second insulating substrate 7, form one Individual stacking sample introduction breach 9, the stacking sample introduction breach 9 are connected with the first injection port 4-2, the second injection port 4-5.Pass through this layer Folded sample introduction breach 9, during test, after sample leaves the first injection port 4-2, the second injection port 4-5, there will not be sample carryover to exist Injection port, so as to avoid turning on two detecting systems, current interference will not be produced.
The A/F of sample introduction breach 9 and the proportional constraint of vertical depth are laminated, is configured according to analyte sample amount, blood Generally between 1.5ul~30ul, the A/F of stacking sample introduction breach 9 is arranged to 0.5mm~5mm, hung down for liquid or urine specimen amount Straight depth is arranged to 1mm~10mm, and the width of the present embodiment stacking sample introduction breach 9 is 2mm, depth 5mm.
The described synchronous multiple analyte sensing test-paper with sample introduction breach isolation current interference, including
The first conductive film layer 2 on the first insulating substrate 1, first conductive film layer 2 include the of mutually insulated One reactant working electrode 2-1 and the second reactant working electrode 2-2;
Film layer 3 is reacted, the reaction film layer 3 includes the first reaction film 3-1 and the second reaction film 3-2, the first reaction film 3-1 It is covered on the first reactant working electrode 2-1, the second reaction film 3-2 is covered on the second reactant working electrode 2-2.
The reaction film layer 3 includes at least one electron mediator, at least one and enzyme of detected material qualitative response, in addition to Buffer solution, adhesive and surfactant;
Sample solution can pass through it is described reaction film layer 3 after, into covered with reaction film layer 3 electrochemical electrode reaction zone, Reacted with electron mediator or electron mediator and oxidoreducing enzyme.
The drain cell body 4 is arranged on the first conductive film layer 2, and the drain cell body 4 is by the first reaction film 3-1 and second Reaction film 3-2 separates in independent intake chute, and drain cell body 4 forms the first intake chute 4-3 and the second intake chute 4-6, and first Reaction film 3-1 is arranged in the first intake chute 4-3, and the second reaction film 3-2 is arranged in the second intake chute 4-6, the first intake chute The corresponding corresponding second reactant working electrode 2-2 of first reactant working electrode 2-1, the second intake chute 4-6 of 4-3;First drain Groove 4-3 is provided with the second injection port 4-5 provided with the first injection port 4-2, the second intake chute 4-6.
The first described intake chute 4-3 is provided with second exhaust port 4-7 provided with first row gas port 4-4, the second intake chute 4-6.
The back side of second insulating substrate 7 is provided with the second conductive film layer 6, and the second conductive film layer 6 includes the first reactant Reference electrode 6-1 and the second reactant reference electrode 6-2;
Including hydrophilic membrane 5, the hydrophilic membrane 5 includes the first hydrophilic film 5-1 and the second hydrophilic film 5-2, and first is hydrophilic Film 5-1 is covered on the first reactant reference electrode 6-1, and the second hydrophilic film 5-2 is covered in the second reactant reference electrode 6-2 On, hydrophilic membrane plays a part of accelerating sample suction;
The back side of second insulating substrate 7 is amplexiformed with drain cell body 4, the first insulating substrate 1, and the first intake chute 4-3 forms the One reaction chamber, the second intake chute 4-6 form the second reaction chamber, and drain cell body 4 divides the first reaction film 3-1, the second reaction film 3-2 It is interposed between in independent reaction chamber;First hydrophilic film 5-1 is corresponding with the first reaction film 3-1, the reactions of the second hydrophilic film 5-2 and second Film 3-2 is corresponding.
Including the 3rd conductive film layer 8, the 3rd conductive film layer 8 is arranged on before the second insulating substrate 7, and the 3rd is conductive Film layer 8 is respectively equipped with the first pin 8-1 and second pin 8-2;
Second insulating substrate 7, which is provided with the first via hole 7-2, the second via hole 7-3, the first via hole 7-2, makes the first pin 8-1 is formed with the first reactant reference electrode 6-1 and electrically connected, and the second via hole 7-3 joins second pin 8-2 and the second reactant Formed and electrically connected than electrode 6-2.First pin 8-1, second pin 8-2 are realized with the test paper connector of detecting instrument and electrically connected.
The conductive film layer 6 of second insulating substrate 7 and second, which corresponds at the first hydrophilic film 5-1, is provided with the observation of the first sample introduction Window 6-3, the second insulating substrate 7 and the second conductive film layer 6, which correspond at the second hydrophilic film 5-2, is provided with the second sample introduction observation window 6-4, Whether observation sample reaches observation window position when sample introduction observation window is used to test.
The bottom of second insulating substrate 7 is provided with substrate breach 7-4, the first reactant work on the first insulating substrate 1 Make electrode 2-1 and the second reactant working electrode 2-2 exposes from substrate breach 7-4.
This synchronous multiple analyte sensing test-paper, preparing the acetamido glucose of synchronous detection blood sample or urine specimen Glycosidase, bile acid, glutamic-pyruvic transaminase, T-CHOL, HDL-C, LDL-C, glycerine Three esters, uric acid, glucose in urine, lactic acid, blood glucose, ketoboidies, hemoglobin, two or multinomial biochemical marker quality testing of bilirubin any combination Application in test paper.
Described synchronous multiple analyte sensing test-paper, coordinate intelligent multi-parameter analyzer to use, can synchronously detect blood sample Acetyl glucosaminidase, bile acid, glutamic-pyruvic transaminase, T-CHOL, the HDL courage of sheet or urine specimen are consolidated Any group of alcohol, LDL-C, triglycerides, uric acid, glucose in urine, lactic acid, blood glucose, ketoboidies, hemoglobin, bilirubin Two biochemical markers are closed, realize that a piece of test paper single injected sampling accurately detects two or more projects.
Described insulating substrate herein, i.e. the first insulating substrate 1 and the second insulating substrate 7, mean with straight table Face and the thin-layer tablet of electrical insulation characteristics.It is preferred that the insulating substrate is selected from following formed group:Polyvinyl chloride (PVC) piece, glass Glass fibre plate (FR-4), polyester, bakelite piece, PET (PET) piece, makrolon (PC) piece, polypropylene (PP) piece, polyethylene (PE) piece, polyamide (PA) piece, polystyrene (PS) piece, sheet glass and potsherd (CEM-I).This example One insulating substrate 1 and the second insulating substrate 7 are PC or PET sheet, thickness 0.10-0.45mm.
Described conductive film layer herein, including the first conductive film layer 2, the second conductive film layer 6, the 3rd conductive film layer 8, it is The layer that conducts can be played by referring to, and can be separation and the electrode not being in contact mutually, serve as working electrode and reference electrode or Function only as the conductive structure of electrical connection.According to a preferred embodiment of the present utility model, electrode one end forms work electricity respectively Pole and reference electrode and be connected with electrochemical electrode reaction zone, and the other end then forms the joint of working electrode and reference electrode, The detection means that electrical effect can be produced in electrochemical reaction with detection sample is connected.It is preferred that the material of the electrode system can From the conductive slurry-like material of suitable screen painting, such as, but not limited to carbon paste, gold size, elargol, carbon silver epoxy glue, volatility Graphite or copper glue or its combination (such as printing carbon paste again after first printing elargol with wire mark), or the conduction of other any suitable screen paintings Property slurry material.
Described reaction film layer 3 herein, means positioned at above-mentioned electrochemical electrode reaction zone, containing being reacted with measured matter Biological reagent.Reaction film layer 3 includes the enzyme reacted with measured matter and a kind of electron transfer mediator, while also containing buffering The composite thin layer of liquid, adhesive and surfactant, or reaction film layer 3 include the electron transmission with measured matter reaction Amboceptor, while the composite thin layer also containing buffer solution, adhesive and surfactant.It is preferred that the composite can print After coating or the mode being added dropwise add to the conversion zone, dried at 50-70 DEG C.
Described oxidoreducing enzyme herein, redox reaction can be produced with the mark to be measured in sample by meaning Enzyme.It is different and different depending on the mark to be detected using enzyme class.For example, during uric acid concentration to be detected, it is selected Enzyme be urate oxidase, during concentration of glucose to be detected, selected enzyme is glucose oxidase, and T-CHOL to be detected is dense When spending, selected enzyme is cholesterol oxidase, cholesterol esterase, can select peroxidase if needed, pass through selection Suitable enzyme, triglycerides, HDL-C, LDL-C, lactic acid or Gu Bingzhuan can be detected The biochemical markers such as ammonia enzyme.
Described electron mediator herein, mean can with after substance reaction caused by the effect of foregoing oxidoreducing enzyme, Itself can be by oxidation state reduction into reducing condition material.The electron transfer mediator can be the potassium ferricyanide, ferrocene and Its derivative, the complex compound of ruthenium or benzoquinone compound, potassium ferrocyanide.According to one of the present utility model preferably specific implementation Example, the electron mediator can be the potassium ferricyanide.It is preferred that the content of the electron mediator is 3% (W/W) to 20% (W/W).
Described buffer solution, adhesive and surfactant herein, mean and may help to oxidoreducing enzyme and electron mediator The material being attached to after drying on insulating substrate, or redox material can be protected.The buffer solution be phosphate buffer, One kind in the group that MES buffer solutions, citrate buffer solution form;Described adhesive is fine using starch, dextrin, gelatin, ethoxy Tie up the one or more in element, carboxymethyl cellulose, sodium alginate;The surfactant is TritonX-100, TW-20.
Described hydrophilic membrane 5 herein, refers to the cured layer containing water wetted material in slurries;Water wetted material can be bent The surfactants such as La Tong -100, lauryl sodium sulfate, Tween-20, aerosol;Thickener can also be contained in hydrophilic layer, It is such as one or two kinds of in carboxymethyl cellulose, hydroxyethyl cellulose, hydroxypropyl cellulose, sodium alginate etc..Hydrophilic slurries It can be added drop-wise on substrate by using hydrojet machine or be coated to by printing technology on substrate.
The preparation method of the synchronous multiple analyte sensing test-paper of above-mentioned sample introduction breach isolation current interference, including following step Suddenly:
1) the first sample introduction breach 1-1 is processed on the first insulating substrate 1;Second is processed on the second insulating substrate 7 Sample introduction breach 7-1, the first via hole 7-2, the second via hole 7-3 and substrate breach 7-4;
2) the first conductive film layer 2 is printed on the first insulating substrate 1, is put into 70-90 DEG C of baking oven and dries 50-70min, shape Into the first reactant working electrode 2-1 and the second reactant working electrode 2-2;
3) the first reaction film 3-1 is sprayed on the first reactant working electrode 2-1, then sprayed the second reaction film 3-2 It is coated onto on the second reactant working electrode 2-2, then dries 10-30min for 40-60 DEG C, it is standby;
4) the drain cell body 4 with the 3rd sample introduction breach 4-1 is pasted on the first insulating substrate 1, the 3rd sample introduction breach 4-1 aligns with the first sample introduction breach 1-1;
5) the 3rd conductive film layer 8 and the second conductive film layer 6, the 3rd conducting film are printed respectively on the two sides of the second insulating substrate 7 Layer 8 forms the first pin 8-1 and second pin 8-2;Second conductive film layer 6 forms the first reactant reference electrode 6-1 and second Reactant reference electrode 6-2;
6) hydrophilic slurries are sprayed on the first reactant reference electrode 6-1 and the second reactant reference electrode 6-2 respectively; The hydrophilic slurries on hydrophilic slurries and the second reactant reference electrode 6-2 on first reactant reference electrode 6-1 are identical, then 40-60 DEG C of drying 10-30min, forms the first hydrophilic film 5-1 and the second hydrophilic film 5-2;
7) the first hydrophilic film 5-1 will be fixed, the second hydrophilic film 5-2 the second insulating substrate 7 pastes drain cell body 4 and On first insulating substrate 1, the first via hole 7-2 makes the first pin 8-1 be electrically connected with the first reactant reference electrode 6-1 formation, Second via hole 7-3 makes second pin 8-2 be electrically connected with the second reactant reference electrode 6-2 formation;Second sample introduction breach 7-1 with First sample introduction breach 1-1, the 3rd sample introduction breach 4-1 align, and form stacking sample introduction breach 9.
In step 1) the first sample introduction breach 1-1 and the second sample introduction breach 7-1 are processed using laser cutting machine or punch press;The The thickness of one insulating substrate 1 is 0.20-0.30mm, preferably 0.25mm.
First conductive film layer 2 is printed using screen printing technique in step 2), by silk-screen printing by conductive carbon ink the Finely dispersed ink thin layer is spread on one insulating substrate 1PET plastic substrates, conductive carbon ink comes from Acheson companies of the U.S..
The first reaction film 3-1 enzyme liquids are sprayed on the first reactant working electrode 2-1 by spraying enzyme machine in step 3), led to Spray enzyme machine is crossed to spray to the second reaction film 3-2 enzyme liquids on the second reactant working electrode 2-2.
By spraying, hydrophilic slurries are sprayed to the first reactant reference electrode 6-1 by enzyme machine and the second reactant is joined in step 6) Than on electrode 6-2.
Following examples are not intended as to restriction of the present utility model to be better understood from the utility model.
Embodiment 1:
The present embodiment provides a preparation reality for being used to detect glucose in blood and T-CHOL multiple analyte sensing test-paper Example is applied, the synchronous multiple analyte sensing test-paper preparation side of current interference is completely cut off so as to illustrate the utility model by sample introduction breach Method, the preparation method comprise the following steps:
1) the first sample introduction breach 1-1 is processed on the first insulating substrate 1;Second is processed on the second insulating substrate 7 Sample introduction breach 7-1, the first via hole 7-2, the second via hole 7-3 and substrate breach 7-4;
2) the first conductive film layer 2 is printed on the first insulating substrate 1, is put into 80 DEG C of baking ovens and dries 60min, forms first Reactant working electrode 2-1 and the second reactant working electrode 2-2;
3) the first reaction film 3-1 enzyme liquids i.e. blood glucose enzyme liquid reacted with glucose in blood is sprayed into the first reactant work Make on electrode 2-1, be then that T-CHOL enzyme liquid sprays to by the second reaction film 3-2 enzyme liquids reacted with T-CHOL in blood On second reactant working electrode 2-2, then 20min is dried for 50 DEG C, it is standby, take each component and its weight hundred of blood glucose enzyme liquid Ratio is divided to be shown in Table 1:
Table 1
Material Weight (w/v)
Glucose oxidase 1%
The potassium ferricyanide 18%
Carboxymethyl cellulose 2%
Trehalose 2%
Kaliumphosphate buffer (pH=8.0) 77%
The each component and its percentage by weight of taken T-CHOL enzyme liquid are shown in Table 2:
Table 2
Material Weight (w/v)
Cholesterol oxidase 2%
Cholesterol esterase 1%
Citrate buffer solution (pH=6.0) 83.5%
The potassium ferricyanide 12%
Sodium alginate 1.5%
4) the drain cell body 4 with the 3rd sample introduction breach 4-1 is pasted on the first insulating substrate 1, the 3rd sample introduction breach 4-1 aligns with the first sample introduction breach 1-1;
5) the 3rd conductive film layer 8 and the second conductive film layer 6, the 3rd conducting film are printed respectively on the two sides of the second insulating substrate 7 Layer 8 forms the first pin 8-1 and second pin 8-2;Second conductive film layer 6 forms the first reactant reference electrode 6-1 and second Reactant reference electrode 6-2;
6) hydrophilic slurries are sprayed on the first reactant reference electrode 6-1, it is anti-that hydrophilic slurries then are sprayed into second Answer on thing reference electrode 6-2;On hydrophilic slurries and the second reactant reference electrode 6-2 on first reactant reference electrode 6-1 Hydrophilic slurries it is identical;Then 50 DEG C of drying 20min, form the first hydrophilic film 5-1 and the second hydrophilic film 5-2;
Take hydrophilic on the hydrophilic slurries and the second reactant reference electrode 6-2 on the first reactant reference electrode 6-1 The each component and its percentage by weight of slurries are shown in Table 3:
Table 3
Material Weight (w/v)
Lauryl sodium sulfate 0.8%
Gasify silica 1%
Citrate buffer solution (pH=6.6) 92.2%
The potassium ferricyanide 5%
Sodium alginate 1.0%
7) the first hydrophilic film 5-1 will be fixed, the second hydrophilic film 5-2 the second insulating substrate 7 pastes drain cell body 4 and On first insulating substrate 1, the first via hole 7-2 makes the first pin 8-1 be electrically connected with the first reactant reference electrode 6-1 formation, Second via hole 7-3 makes second pin 8-2 be electrically connected with the second reactant reference electrode 6-2 formation;Second sample introduction breach 7-1 with First sample introduction breach 1-1, the 3rd sample introduction breach 4-1 align, and form stacking sample introduction breach 9;
8) the upper lid for being printed on house mark is pasted (not shown in accompanying drawing) on the second insulating substrate 7, being fabricated to has Sample introduction breach completely cuts off the synchronous multiple analyte sensing test-paper of current interference.
Comparative example 1:
The synchronous multiple analyte sensing test-paper of this comparative example, as shown in figure 3, there is sample introduction breach isolation electricity with embodiment 1 The synchronous multiple analyte sensing test-paper disturbed that drains off is compared, and the synchronous multiple analyte sensing test-paper of comparative example 1 lacks the first sample introduction and lacked Mouth 1-1, the second sample introduction breach 7-1, the stacking sample introduction breach 9 of the 3rd sample introduction breach 4-1 compositions, other structures and the phase of embodiment 1 Together.
Embodiment 2:
The synchronous multiple analyte with sample introduction breach isolation current interference that the present embodiment is prepared using embodiment 1 senses examination The synchronous multiple analyte sensing test-paper of paper and comparative example 1 tests blood sample.
Fresh venous blood is gathered, adjustment packed cell volume ratio is 40%, two blood samples is prepared, with YSI2300 glucose Analyzer tests blood sugar concentration, with Biochemical Analyzer and multiple star Long March T-CHOL biochemical reagents box test T-CHOL.Will be real The synchronous multiple analyte sensing test-paper test with sample introduction breach isolation current interference of the preparation of example 1 is applied, is placed in supporting multi-parameter Apply 300mV operating voltages in analyzer and in working electrode and reference electrode both ends;The blood sample of preparation is taken, sampling is added to and lacks Mouthful, blood leads the μ L samples of sample groove automatic sucking about 3 by siphon, and reagent reacting forms electricity into reaction zone and enzyme reaction film Stream, on multi parameter analysis instrument can quick detection go out blood glucose, cholesterol concentration, and show the blood that inspection is measured in display screen simultaneously Sugar, cholesterol result, result is recorded, the results are shown in Table 4, table 5.
The test paper of 4 embodiment of table 1 and the test paper of comparative example 1 test blood sugar effects
The test paper of 5 embodiment of table 1 and the test paper of comparative example 1 test T-CHOL result
From table 4, table 5 as can be seen that the synchronous multiple analyte with sample introduction breach isolation current interference prepared by embodiment 1 Sensing test-paper tests blood glucose and T-CHOL repeatability is more preferable than the synchronous multiple analyte sensing test-paper of comparative example 1, and test value is more Close to reference method test value.Analyze test value to find, there is many abnormal higher numerical value, therefore CV in the test value of comparative example 1 Value is very high.
In order to analyze reason, this patent researcher measures the first reactant work to abnormal higher test paper using universal meter Make electrode 2-1 and the second reactant reference electrode 6-2 resistance, find the higher test paper of all exceptions, the first reactant work electricity Pole 2-1 and the second reactant reference electrode 6-2 resistance only have 2k Ω or so, illustrate two reaction system that should be independent short circuits UNICOM, as shown in figure 5, being sample distribution scope in dotted line frame, it can be seen that at the first injection port 4-2, the second injection port 4-5 It is UNICOM.
This patent researcher measures the first reactant working electrode 2-1 to all test paper of embodiment 1 using universal meter With the second reactant reference electrode 6-2 resistance, all first reactant working electrode 2-1 and the second reactant reference electrode are found 6-2 resistance more than 100m Ω, illustrate two should independent reaction system there is no short-circuit UNICOM.That is, by First insulating substrate 1, drain cell body 4, the first sample introduction breach 1-1, the 3rd sample introduction breach 4- are set respectively on the second insulating substrate 7 The 1 and second sample introduction breach 7-1, three notch geometries are identical, the stacking sample introduction breach 9 formed when stacked together, during test, when After sample leaves the first injection port 4-2, the second injection port 4-5, there will not be sample carryover in injection port, be done so as to completely cut off electric current Disturb, as shown in figure 4, dotted line frame in be sample distribution scope, it can be seen that be at the first injection port 4-2, the second injection port 4-5 by It is laminated the cut-off of sample introduction breach 9.
Embodiment 3:
The detectable substance combination for illustrating the synchronous multiple analyte sensing test-paper with sample introduction breach isolation current interference should With.
Synchronous multiple analyte sensing test-paper manufactured in the present embodiment with sample introduction breach isolation current interference, except first T-CHOL is fixed by printing process on reactant working electrode 2-1 and detects enzyme slurry, is led on the second reactant working electrode 2-2 Cross printing process and fix triglycerides detection enzyme slurry, it is other same as Example 1.As shown in figure 4, it is sample distribution in dotted line frame Scope, it can be seen that the cut-off of sample introduction breach 9 is stacked at the first injection port 4-2, the second injection port 4-5.
The each component and its percentage by weight of taken triglycerides detection enzyme slurry are shown in Table 6:
Table 6
Material Weight (w/v)
Lipoprotein lipase 1%
Glycerokinase 2%
GPO 1
Carboxymethyl cellulose 4%
The potassium ferricyanide 14%
Kaliumphosphate buffer (pH=7.0) 78%
The each component and its percentage by weight of taken T-CHOL enzyme liquid are shown in Table 7:
Table 7
Material Weight (w/v)
Cholesterol oxidase 2%
The potassium ferricyanide 12%
Hydroxyethyl cellulose 4%
Cholesterol esterase 1%
Citrate buffer solution (pH=6.0) 81%
Fresh venous blood is gathered, adjustment packed cell volume ratio is 40%, prepares two blood samples, with Biochemical Analyzer and again Star Long March T-CHOL, triglycerides biochemical reagents box test T-CHOL, triglycerides respectively.Tool prepared by embodiment 3 There is the synchronous multiple analyte sensing test-paper test of sample introduction breach isolation current interference, be placed in supporting multi parameter analysis instrument and in work Make electrode and reference electrode both ends apply 300mV operating voltages;The blood sample of preparation is taken, stacking sample introduction breach 9 is added to, tests total courage Sterol, triglyceride concentration, result is recorded, the results are shown in Table 8, table 9.
The embodiment 3 of table 8 has the synchronous multiple analyte sensing test-paper test triglycerides of sample introduction breach isolation current interference As a result
The embodiment 3 of table 9 has the synchronous multiple analyte sensing test-paper test T-CHOL of sample introduction breach isolation current interference As a result
Table 8, the result of table 9 show that prepared by embodiment 3 has the synchronous multiple analyte biography of sample introduction breach isolation current interference Feel test paper test T-CHOL and triglycerides is reproducible, test value is close to reference method test value.Illustrate the utility model Synchronous multiple analyte sensing test-paper with sample introduction breach isolation current interference is in the first insulating substrate 1, drain cell body 4, second First sample introduction breach 1-1, the 3rd sample introduction breach 4-1 and the second sample introduction breach 7-1, three breach are set respectively on insulating substrate 7 Shape is identical, the stacking sample introduction breach 9 formed when stacked together, applies the test in different biochemical markers, can obtain Good test repeatability and the degree of accuracy.
Being only for example property of citing above, and it is non-limiting.It is any without departing from spirit and scope of the present utility model, and to it The equivalent modifications of progress and change, comprising but do not limit original paper described in the utility model embodiment with software or hardware or tough Body or its any combinations, are intended to be limited solely by interest field of the present utility model.

Claims (9)

1. a kind of synchronous multiple analyte sensing test-paper of sample introduction breach isolation current interference, including the first insulating substrate and second exhausted Edge substrate and two separate detection architectures being arranged on the first insulating substrate and the second insulating substrate, the inspection Survey system includes the drain cell body being arranged in the first insulating substrate and the second insulating substrate, and the drain cell body is provided with independent First intake chute and the second intake chute, the first intake chute are provided with the first injection port, and the second intake chute is provided with the second injection port;
Characterized in that, first insulating substrate is provided with the first sample introduction breach, the second insulating substrate is provided with the second sample introduction breach, Drain cell body is provided with the 3rd sample introduction breach;The first sample introduction breach, the second sample introduction breach and the 3rd sample introduction breach shape and Size is identical;First insulating substrate, drain cell body, the second insulating substrate sequential layer poststack, form a stacking sample introduction breach, layer The both sides end face of folded sample introduction breach depth direction, is the first injection port, the second injection port respectively.
2. the synchronous multiple analyte sensing test-paper of sample introduction breach isolation current interference according to claim 1, its feature exist In the stacking sample introduction gap opened width is 0.5mm~5mm, vertical depth is 1mm~10mm.
3. the synchronous multiple analyte sensing test-paper of sample introduction breach isolation current interference according to claim 1, its feature exist In the stacking sample introduction breach is rectangle, U-shaped or V-arrangement.
4. the synchronous multiple analyte sensing test-paper of sample introduction breach isolation current interference according to claim 1, its feature exist In, including
The first conductive film layer on the first insulating substrate, first conductive film layer include the first reactant of mutually insulated Working electrode and the second reactant working electrode;
Film layer is reacted, the reaction film layer includes the first reaction film and the second reaction film, and the first reaction film is covered in the first reaction On thing working electrode, the second reaction film is covered on the second reactant working electrode.
5. the synchronous multiple analyte sensing test-paper of sample introduction breach isolation current interference according to claim 4, its feature exist In the drain cell body is arranged on the first conductive film layer, and the drain cell body separates the first reaction film and the second reaction film In independent intake chute, intake chute body forms the first intake chute and the second intake chute, the first reaction film are arranged on the first drain In groove, the second reaction film is arranged in the second intake chute, the corresponding first reactant working electrode of the first intake chute, the second intake chute Corresponding second reactant working electrode.
6. the synchronous multiple analyte sensing test-paper of sample introduction breach isolation current interference according to claim 4, its feature exist In the back side of second insulating substrate is provided with the second conductive film layer, and the second conductive film layer includes the first reactant reference electrode With the second reactant reference electrode;
Including hydrophilic membrane, the hydrophilic membrane includes the first hydrophilic film and the second hydrophilic film, and the first hydrophilic film is covered in first On reactant reference electrode, the second hydrophilic film is covered on the second reactant reference electrode;
The back side of second insulating substrate is amplexiformed with drain cell body, the first insulating substrate, and the first intake chute forms the first reaction chamber, the Two intake chutes form the second reaction chamber, and drain cell body separates the first reaction film, the second reaction film in independent reaction chamber;The One hydrophilic film is corresponding with the first reaction film, and the second hydrophilic film is corresponding with the second reaction film.
7. the synchronous multiple analyte sensing test-paper of sample introduction breach isolation current interference according to claim 6, its feature exist In, including the 3rd conductive film layer, the 3rd conductive film layer be arranged on before the second insulating substrate, the 3rd conductive film layer difference Provided with the first pin and second pin;
Second insulating substrate is provided with the first via hole, the second via hole, and the first via hole joins the first pin and the first reactant Formed and electrically connected than electrode, the second via hole makes second pin be electrically connected with the formation of the second reactant reference electrode.
8. the synchronous multiple analyte sensing test-paper of sample introduction breach isolation current interference according to claim 6, its feature exist In second insulating substrate and the second conductive film layer, which correspond at the first hydrophilic film, is provided with the first sample introduction observation window, and second is exhausted Edge substrate and the second conductive film layer, which correspond at the second hydrophilic film, is provided with the second sample introduction observation window.
9. the synchronous multiple analyte sensing test-paper of sample introduction breach isolation current interference according to claim 6, its feature exist Substrate breach is provided with the bottom of, second insulating substrate, the first reactant working electrode and on the first insulating substrate Two reactant working electrodes expose from substrate breach.
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Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN106996951A (en) * 2017-05-25 2017-08-01 桂林乐尔医疗器械有限公司 A kind of synchronous multiple analyte sensing test-paper of sample introduction breach isolation current interference and its application

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN106996951A (en) * 2017-05-25 2017-08-01 桂林乐尔医疗器械有限公司 A kind of synchronous multiple analyte sensing test-paper of sample introduction breach isolation current interference and its application

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