WO2021143730A1 - 用于多种指标检测的电化学测试条及其检测方法 - Google Patents

用于多种指标检测的电化学测试条及其检测方法 Download PDF

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WO2021143730A1
WO2021143730A1 PCT/CN2021/071526 CN2021071526W WO2021143730A1 WO 2021143730 A1 WO2021143730 A1 WO 2021143730A1 CN 2021071526 W CN2021071526 W CN 2021071526W WO 2021143730 A1 WO2021143730 A1 WO 2021143730A1
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biosensor
test strip
electrochemical test
sample
channel forming
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PCT/CN2021/071526
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English (en)
French (fr)
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孙玉龙
程艳
张莉
黄勇刚
施金良
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利多(香港)有限公司
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Priority to US18/003,383 priority Critical patent/US20240302312A1/en
Publication of WO2021143730A1 publication Critical patent/WO2021143730A1/zh

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    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N27/00—Investigating or analysing materials by the use of electric, electrochemical, or magnetic means
    • G01N27/26—Investigating or analysing materials by the use of electric, electrochemical, or magnetic means by investigating electrochemical variables; by using electrolysis or electrophoresis
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N27/00—Investigating or analysing materials by the use of electric, electrochemical, or magnetic means
    • G01N27/26—Investigating or analysing materials by the use of electric, electrochemical, or magnetic means by investigating electrochemical variables; by using electrolysis or electrophoresis
    • G01N27/28—Electrolytic cell components
    • G01N27/30—Electrodes, e.g. test electrodes; Half-cells
    • G01N27/327—Biochemical electrodes, e.g. electrical or mechanical details for in vitro measurements
    • G01N27/3275—Sensing specific biomolecules, e.g. nucleic acid strands, based on an electrode surface reaction
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N27/00—Investigating or analysing materials by the use of electric, electrochemical, or magnetic means
    • G01N27/26—Investigating or analysing materials by the use of electric, electrochemical, or magnetic means by investigating electrochemical variables; by using electrolysis or electrophoresis
    • G01N27/28—Electrolytic cell components
    • G01N27/30—Electrodes, e.g. test electrodes; Half-cells
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N27/00—Investigating or analysing materials by the use of electric, electrochemical, or magnetic means
    • G01N27/26—Investigating or analysing materials by the use of electric, electrochemical, or magnetic means by investigating electrochemical variables; by using electrolysis or electrophoresis
    • G01N27/28—Electrolytic cell components
    • G01N27/30—Electrodes, e.g. test electrodes; Half-cells
    • G01N27/307—Disposable laminated or multilayered electrodes
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N27/00—Investigating or analysing materials by the use of electric, electrochemical, or magnetic means
    • G01N27/26—Investigating or analysing materials by the use of electric, electrochemical, or magnetic means by investigating electrochemical variables; by using electrolysis or electrophoresis
    • G01N27/28—Electrolytic cell components
    • G01N27/30—Electrodes, e.g. test electrodes; Half-cells
    • G01N27/327—Biochemical electrodes, e.g. electrical or mechanical details for in vitro measurements
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N27/00—Investigating or analysing materials by the use of electric, electrochemical, or magnetic means
    • G01N27/26—Investigating or analysing materials by the use of electric, electrochemical, or magnetic means by investigating electrochemical variables; by using electrolysis or electrophoresis
    • G01N27/28—Electrolytic cell components
    • G01N27/30—Electrodes, e.g. test electrodes; Half-cells
    • G01N27/327—Biochemical electrodes, e.g. electrical or mechanical details for in vitro measurements
    • G01N27/3271—Amperometric enzyme electrodes for analytes in body fluids, e.g. glucose in blood
    • G01N27/3272—Test elements therefor, i.e. disposable laminated substrates with electrodes, reagent and channels
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N27/00—Investigating or analysing materials by the use of electric, electrochemical, or magnetic means
    • G01N27/26—Investigating or analysing materials by the use of electric, electrochemical, or magnetic means by investigating electrochemical variables; by using electrolysis or electrophoresis
    • G01N27/416—Systems
    • G01N27/4161—Systems measuring the voltage and using a constant current supply, e.g. chronopotentiometry

Definitions

  • the invention relates to an electrochemical test strip for detecting multiple indexes in blood and other samples and a detection method thereof, and belongs to the technical field of electroanalytical chemistry detection.
  • Electrochemical test strips with electrode systems have been widely used for rapid detection of biological samples, such as the detection of various physiological indicators such as glucose, cholesterol, and blood ketones in blood samples.
  • the basic structure of an electrochemical test strip includes an insulating substrate, an electrode system on the insulating substrate, a channel forming layer and an upper cover.
  • the electrode system includes at least a working electrode and a counter electrode, and the reaction reagent is covered on at least one working electrode.
  • the detection sample passes through the channel forming area on the channel forming layer to react with the reaction reagent and generate a detectable signal.
  • the analyzer connected to the electrochemical test strip obtains the detection result based on the signal.
  • the existing electrochemical test strips can only detect a single sample index. To detect multiple indicators, different electrochemical test strips can only be used to detect different physiological indicators. To complete the detection of multiple physiological indicators, the patient must collect multiple blood samples. Multiple sampling not only brings pain to the patient, but also takes a long time for detection, and the detection steps are cumbersome.
  • Chronic kidney disease and the end-stage renal disease caused by it is a group of common chronic progressive diseases that seriously threaten human life and health. It has the characteristics of high prevalence, high fatality rate, high medical and health expenditure, and low awareness rate.
  • renal function indicators in patients with chronic kidney disease, it is often necessary to obtain three physiological indicators of blood creatinine, urea and uric acid at the same time. The detection of these three indicators can effectively detect the prevalence of kidney disease in patients, and make corresponding judgments, which can be used as a basis for further treatment options.
  • the kidney function index tests on the market are mainly single test kits applied to large-scale biochemical analyzers, which are expensive, take a long test time, and test procedures are cumbersome, and are not suitable for popularization in township and community health centers.
  • Electrochemical test strips can be applied to portable testing instruments for testing. They have the characteristics of small size, anti-interference, low price and disposable disposables, which provide convenience for testing operations.
  • the present invention provides an electrochemical test strip for detecting multiple indicators, including a first biosensor, the first biosensor including an insulating substrate, a first electrode system arranged on the insulating substrate, a first channel forming layer, and The first upper cover layer, the first channel forming layer is provided with a first channel forming area, the first channel forming area is located on the electrode of the first electrode system, and further includes a second biosensor, and the second biosensor includes insulation The substrate, the second electrode system, the second channel forming layer and the second upper cover layer arranged on the insulating substrate, the second channel forming layer is provided with a second channel forming area, the second channel forming area is located in the second electrode system Above the electrode; the first biosensor and the second biosensor are located on the front and back of the electrochemical test strip, and the electrical connection end of the first biosensor and the electrical connection end of the second biosensor are located on the electrochemical test strip The same end; the sample inlet of the electrochemical test strip is respectively connected with the first channel forming area of the first bio
  • the first electrode system includes an electrode system for measuring the first index and an electrode system for measuring the second index.
  • the second electrode system includes an electrode system for measuring the third index.
  • the second electrode system further includes an electrode system for measuring the fourth index.
  • the electrode system for measuring the first index and the electrode system for measuring the second index are respectively located on both sides of the sample inlet.
  • the electrode system for measuring the third index and the electrode system for measuring the fourth index are respectively located on both sides of the sample inlet.
  • first biosensor and the second biosensor share an insulating substrate, or the first biosensor and the second biosensor each include an insulating substrate.
  • a first reaction region forming layer is provided between the insulating substrate of the first biosensor and the first channel forming layer, and/or a second reaction region forming layer is provided between the insulating substrate of the second biosensor and the second channel forming layer Area cambium.
  • sample inlet includes a gap in the first upper cover layer and a gap in the second upper cover layer.
  • the notch of the first upper cover layer and the notch of the second upper cover layer are located on the same side of the electrochemical test strip and aligned in position, and the notch of the first upper cover layer is larger than the notch of the second upper cover layer.
  • the electrochemical test strip is also provided with an identifier for distinguishing the front and back of the electrochemical test strip.
  • the identifier is a conductive automatic start contact, which is provided on at least one of the insulating substrate of the first biosensor and the insulating substrate of the second biosensor.
  • the marker is a colored insulating material
  • the insulating substrate of the first biosensor faces the side of the first channel forming layer
  • the side of the insulating substrate of the second biosensor facing the second channel forming layer are made of materials of different colors.
  • the first upper cover layer and the second upper cover layer are opaque, the first upper cover The cover layer and the second upper cover layer are made of materials of different colors.
  • the electrochemical test strip is used to determine at least two indicators of glucose, cholesterol, hemoglobin, glycosylated hemoglobin, uric acid, urea, creatinine, bilirubin, ketone bodies, HCT, and pH.
  • a method for detecting multiple indexes includes providing the electrochemical test strip of the present invention.
  • the present invention also provides an electrochemical test strip for detecting renal function indicators, including a first biosensor, the first biosensor including an insulating substrate, a first electrode system arranged on the insulating substrate, and a first channel forming layer And the first upper cover layer, the first channel forming layer is provided with a first channel forming area, the first channel forming area is located on the electrode of the first electrode system, and is characterized in that it further includes a second biosensor, the first The second biosensor includes an insulating substrate, a second electrode system, a second channel forming layer, and a second upper cover arranged on the insulating substrate. A second channel forming area is provided on the second channel forming layer, and the second channel forming area is located on the second channel forming layer.
  • the electrode of the two-electrode system On the electrode of the two-electrode system; it also includes a sample inlet in fluid communication with the first channel forming area of the first biosensor and the second channel forming area of the second biosensor; the first biosensor and the second biosensor
  • the sensors are respectively located on the front and back of the electrochemical test strip; the first biosensor is used to determine two indicators in urea, creatinine or uric acid, and the second biosensor is used to determine the third indicator remaining in urea, creatinine or uric acid.
  • the first electrode system includes an electrode system for measuring urea and an electrode system for measuring creatinine.
  • the second electrode system includes an electrode system for measuring uric acid.
  • potentiometric method is used to measure urea.
  • the current method is used to measure creatinine or uric acid.
  • the electrode system for measuring urea and the electrode system for measuring creatinine are respectively located on both sides of the injection port.
  • the second electrode system further includes an electrode system for measuring HCT.
  • the first channel formation is divided into two parts, the first part of the first channel formation area is located on the electrode system for measuring creatinine, the second part of the first channel formation area is located on the electrode system for measuring urea, and the first channel forms The width of the first part of the zone is greater than the width of the second part of the first channel forming zone.
  • a first reaction region forming layer is provided between the insulating substrate of the first biosensor and the first channel forming layer, and/or a second reaction region forming layer is provided between the insulating substrate of the second biosensor and the second channel forming layer Area cambium.
  • a method for detecting renal function indexes includes providing the electrochemical test strip according to the present invention.
  • the present invention also provides an electrochemical test strip, including a first biosensor, the first biosensor including an insulating substrate, a first electrode system disposed on the insulating substrate, and a first channel forming layer, on the first channel forming layer A first channel forming area is provided, the first channel forming area is located above the electrodes of the first electrode system, and the sample injection port is in liquid communication with the first channel forming area, characterized in that the first electrode system includes a first electrode system for measuring An electrode system for an index and an electrode system for measuring a second index, the electrode system for measuring the first index and an electrode system for measuring the second index are respectively located on both sides of the sample inlet.
  • the first biosensor is provided with a hydrophilic element, and the hydrophilic element is located at or near the shunt point of the first biosensor.
  • hydrophilic element is located below the first channel forming area.
  • the first electrode system includes an electrode system for measuring a first index and an electrode system for measuring a second index
  • the hydrophilic element is located between the electrode system for measuring the first index and the electrode system for measuring the second index. between.
  • a hydrophobic insulating region is provided between the hydrophilic element of the first biosensor and the first electrode system.
  • the second biosensor includes an insulating substrate, a second electrode system, a second channel forming layer, and a second upper cover provided on the insulating substrate, and the second channel forming layer is provided with The second channel forming area is located above the electrodes of the second electrode system; the first biosensor and the second biosensor are respectively located on the front and back of the electrochemical test strip.
  • first biosensor and the second biosensor share an insulating substrate, or the first biosensor and the second biosensor each include an insulating substrate.
  • the second biosensor is provided with a hydrophilic element, and the hydrophilic element is located at or near the shunt point of the second biosensor.
  • the second electrode system includes an electrode system for measuring the third index and an electrode system for measuring the fourth index, and the hydrophilic element is located between the electrode system for measuring the third index and the electrode system for measuring the fourth index. between.
  • a hydrophobic insulating region is provided between the hydrophilic element of the second biosensor and the second electrode system.
  • the present invention also provides an electrochemical test strip for detecting multiple indicators in a sample, which includes a sample inlet and a first biosensor.
  • the first biosensor includes an insulating substrate, a first electrode system arranged on the insulating substrate, and a first biosensor.
  • a channel forming layer and a first upper cover layer the first channel forming layer is provided with a first channel forming area, the first channel forming area is located on the electrode of the first electrode system, and is characterized in that it further includes a second biosensor ,
  • the second biosensor includes an insulating substrate, a second electrode system, a second channel forming layer and a second upper cover arranged on the insulating substrate, a second channel forming area is provided on the second channel forming layer, and the second channel
  • the formation area is located on the electrodes of the second electrode system; the first biosensor and the second biosensor are respectively located on the front and back of the electrochemical test strip.
  • the sample injection port includes a gap provided on the insulating substrate of the first biosensor and the insulating substrate of the second biosensor, a gap provided on the first channel forming layer and communicating with the first channel forming area, The notch provided on the second channel forming layer and connected to the second channel forming area, the notch provided on the first upper cover layer and the second upper cover layer; the insulating substrate of the first biosensor, the first channel forming layer The notch on the first upper cover layer and the insulating substrate of the second biosensor, the second channel forming layer and the notch on the second upper cover layer are located on the same side of the electrochemical test strip and aligned in position.
  • the notch on the first upper cover layer is larger than the notch on the second upper cover layer.
  • sample inlet includes a first sample inlet on the first biosensor and a second sample inlet on the second biosensor.
  • the first sample inlet and the second sample inlet are located on the electrochemical test strip. The same side or opposite sides.
  • a first reaction area forming layer is provided between the insulating substrate of the first biosensor and the first channel forming layer, and a second reaction area forming layer is provided between the insulating substrate of the second biosensor and the second channel forming layer .
  • first reaction area forming layer is provided with a gap corresponding to the gap of the first channel forming layer
  • second reaction area forming layer is provided with a gap corresponding to the gap of the second channel forming layer
  • the beneficial effects of the present invention adopts the electrochemical test strip to be assembled by two biosensors to realize the electrode arrangement on the front and back sides, so that a single electrochemical test strip can be used to detect multiple indicators.
  • the sample inlet adopts a notch design.
  • the size of the notch in the first upper cover layer in the first biosensor is larger than the size of the notch in the second upper cover layer in the second biosensor, which is beneficial to the sample in the second biosensor.
  • the load on the second insulating substrate facilitates the rapid flow of the sample into the inside of the electrochemical test strip.
  • Both ends of each electrode used for detecting creatinine, urea and uric acid can be provided with diffusion components that assist the diffusion of the reaction reagent, which helps the reaction reagent to diffuse more uniformly in the corresponding pair of reaction areas.
  • a sample-filled electrode made of carbon ink which can be used to detect whether the sample flowing to the first electrode system or the second electrode system is sufficient, It can also function as a diffusion component.
  • measuring one HCT test can simultaneously realize the HCT correction of the measured values of the three analytes creatinine, uric acid and urea, and finally realize the completion of creatinine, Uric acid, urea, HCT and other indicators are tested, and the test results are accurate.
  • Fig. 1 is an exploded view of the first biosensor of the first electrochemical test strip, and the first insulating substrate is not provided with a notch.
  • Fig. 2 is a schematic diagram of the first biosensor in Fig. 1 when assembled together.
  • Fig. 3 is an exploded view of the second biosensor of the first type of electrochemical test strip, and the second insulating substrate is not provided with notches.
  • Fig. 4 is a schematic diagram of the second biosensor in Fig. 3 when assembled together.
  • Figure 5 is an exploded view of the second electrochemical test strip.
  • Fig. 6 is a schematic diagram of the electrochemical test strip in Fig. 5 when assembled together.
  • Fig. 7 is a schematic side view of an electrochemical test strip.
  • the first biosensor and the second biosensor do not share the same insulating substrate.
  • Fig. 8 is a schematic side view of an electrochemical test strip.
  • the first biosensor and the second biosensor share the same insulating substrate.
  • Fig. 9 is an exploded view of the first biosensor of the third electrochemical test strip, and a notch is provided on one side of the first insulating substrate.
  • Fig. 10 is an exploded view of the second biosensor of the third type of electrochemical test strip, and a notch is provided on one side of the second insulating substrate.
  • FIG 11. (a) is a schematic diagram of the first biosensor in Figure 9 assembled together, (b) is a schematic diagram of the second biosensor in Figure 10 assembled together, located on the side of the first upper cover The size of the notch is larger than the notch located on one side of the second upper cover layer.
  • Figure 12 (a) is a schematic diagram of the first biosensor in Figure 9 when assembled, (b) compared to Figure 11b, the difference is that the size of the notch on the side of the first upper cover is equal to that on the second upper cover The gap on one side of the layer.
  • FIG. 13 An exploded view of the first biosensor of the fourth electrochemical test strip, (b) is a schematic diagram of the first biosensor in (a) when assembled together.
  • Figure 14 Schematic diagram of the first biosensor containing hydrophilic elements when assembled together.
  • Figure 15 Schematic diagram of a second biosensor containing hydrophilic elements when assembled together.
  • FIG. 1 Schematic diagram of the second biosensor with auto-turn on contacts assembled together.
  • the electrochemical test strip 200 includes a first biosensor 100 and a second biosensor 101, and the first biosensor 100 and the second biosensor 101 are not shared The same insulating substrate.
  • the first biosensor 100 has a first electrical connection end 7 and the second biosensor 101 has a second electrical connection end 13.
  • the electrochemical test strip 200 is located at the same end of the electrochemical test strip 200 through the first electrical connection end 7 and the second electrical connection end 13 and can be connected to the electrical connector of the detection instrument.
  • the sample inlet of the electrochemical test strip 200 includes a first sample inlet 601 on the side of the first biosensor 100 and a second sample inlet 602 on the side of the second biosensor 101.
  • the first biosensor 100 is sequentially provided with a first insulating substrate 1, a first electrode system disposed on the first insulating substrate 1, a first reaction region forming layer 3, a first channel forming layer 4 and a first upper cover layer 5.
  • the first insulating substrate 1, the first reaction region forming layer 3, the first channel forming layer 4 and the first upper cover layer 5 are all made of insulating materials.
  • the first electrode system includes a first index reference electrode 21, a first index working electrode 22, a second index working electrode 23, a second index counter electrode 24, and a conductive first contact 79 located at the first electrical connection terminal 7.
  • the first index reference electrode 21, the first index working electrode 22, the second index working electrode 23, and the second index counter electrode 24 are located on both sides of the first sample adding port 601.
  • the first reaction region forming layer 3 covers the first electrode system.
  • the first reaction area forming layer 3 has three separated reaction areas: a first reaction area 42, a second reaction area 41, and a third reaction area 43.
  • the shape of these reaction areas can be selected from rectangular, elliptical, and circular. , Corner-cut rectangle and other geometric shapes.
  • the second reaction area 41 contains a first index first reaction reagent
  • the first reaction area 42 contains a first index second reaction reagent
  • the third reaction area 43 contains a second index reaction reagent.
  • the third reaction area 43 at least partially exposes the second indicator working electrode 23 and the second indicator counter electrode 24, the second reaction area 41 at least partially exposes the first indicator reference electrode 21, and the first reaction area 42 at least partially exposes the first indicator working electrode. ⁇ 22 ⁇ Electrode 22.
  • the first channel forming layer 4 is provided on the first reaction region forming layer 3, the first channel forming layer 4 has a first channel forming area 55, a notch 62 is provided on one side of the first channel forming layer 4, and the notch 62 It communicates with the first passage forming area 55.
  • the first channel forming area 55 is located in the middle area of the first channel forming layer 4, and the notch 62 is located in the middle part of one side of the first channel forming layer 4.
  • the notch 62 divides the first passage forming area 55 into two parts. After the sample is added from the first sample injection port 601, the sample enters the first biosensor 100.
  • the sample When the sample enters the first channel formation layer 4 through the gap 62, the sample is shunted and a part of the sample flows into the first channel formation area 55 The first part of the sample, another part of the sample flows into the second part of the first channel formation zone 55.
  • the sample flowing into the first part of the first channel forming zone 55 passes through the third reaction zone 43 and finally flows to the second index working electrode 23 and the second index counter electrode 24, and the sample flowing into the second part of the first channel forming zone 55 passes through the first The second reaction area 41 and the first reaction area 42 finally flow to the first index reference electrode 21 and the first index working electrode 22.
  • the first portion of the first channel forming area 55 at least partially exposes the third reaction area 43.
  • the second portion of the first channel forming area 55 at least partially exposes the second reaction area 41 and the first reaction area 42.
  • the width of the first portion of the first channel forming region 55 may be smaller than, equal to, or greater than the width of the second portion of the first channel forming region 55. For example, when the detected first indicator is urea and the detected second indicator is creatinine, the width of the first portion of the first channel forming area 55 is greater than the width of the second portion of the first channel forming area 55, and the third reaction The area 43 is all exposed.
  • the advantage of this is that when the concentration of creatinine and other indicators in the sample is detected by the amperometric method, the detected current signal is related to the area of the third reaction area 43.
  • the third reaction area 43 is first When the first part of the channel forming area 55 is fully exposed, the third reaction area 43 is an effective area, which can generate effective signals, which can reduce the amount of reaction reagents; when the concentration of indicators such as urea in the sample is detected by the potential method, the detection The obtained potential signal has little correlation with the areas of the second reaction region 41 and the first reaction region 42. Therefore, reducing the width of the second portion of the first channel forming region 55 can reduce the amount of sample.
  • the first upper cap layer 5 is disposed on the first channel forming layer 4.
  • the first upper cover layer 5 forms a first sample channel together with the first channel forming region 55, the second reaction region 41, the first reaction region 42 and the third reaction region 43.
  • the first upper cover layer 5 is provided with a first air hole 51 and a second air hole 52 for discharging the air in the first sample channel during sample application.
  • the first air hole 51 is located above the first part of the first passage forming area 55 and communicates with the first part of the first passage forming area 55 on the air path.
  • the second air hole 52 is located above the second part of the first passage forming area 55 and communicates with the second part of the first passage forming area 55 on the air path.
  • the second biosensor 101 is sequentially provided with a second insulating substrate 8, a second electrode system disposed on the second insulating substrate 8, a second reaction region forming layer 10, a second channel forming layer 11 and a second upper cover layer 12.
  • the second insulating substrate 8, the second reaction region forming layer 10, the second channel forming layer 11, and the second upper cover layer 12 are all made of insulating materials.
  • the second electrode system includes a third index counter electrode 29, a third index working electrode 30, a conductive fifth contact 86 and a sixth contact 84 located at the second electrical connection end 13, and a third index counter electrode 29 and The fifth conductive trace 91 connecting the fifth contact 86 together and the sixth conductive trace 89 connecting the third index working electrode 30 and the sixth contact 84 together. More conductive traces or contacts can also be provided on the second insulating substrate 8 as required.
  • the second reaction region forming layer 10 covers the second electrode system.
  • the second reaction area forming layer 10 has a fourth reaction area 46, and the shape of the fourth reaction area 46 can be selected from geometric shapes such as a rectangle, an ellipse, a circle, and a corner-cut rectangle.
  • the fourth reaction area 46 contains a third index reaction reagent.
  • the fourth reaction area 46 is partially exposed on the third index counter electrode 29 and the third index working electrode 30.
  • the second channel forming layer 11 is provided on the second reaction region forming layer 10, the second channel forming layer 11 has a second channel forming area 56, a notch 66 is provided on one side of the second channel forming layer 11, the notch 66 It communicates with one end or the middle part of the second passage forming area 56.
  • the second upper cap layer 12 is disposed on the second channel forming layer 11.
  • the second upper cap layer 12 forms a second sample channel together with the second channel forming region 56 and the fourth reaction region 46.
  • the second upper cover layer 12 contains third pores 53.
  • the second sample channel is used to provide samples to the third index counter electrode 29 and the third index working electrode 30, dissolve the reaction reagents in the fourth reaction area 46, and react, thereby generating electrical signals.
  • the third air hole 53 is located above the second sample channel, communicates with the second sample channel on the air path, and is used to discharge the air in the second sample channel during sample loading.
  • a notch 61 is provided on one side of the first upper cover layer 5
  • a notch 62 is provided on one side of the first channel forming layer 4
  • a notch 63 is provided on one side of the first reaction region forming layer 3 .
  • the first insulating substrate 1 is not provided with a notch.
  • the notch 61, the notch 62, and the notch 63 are provided on the same side of the first biosensor 100, and are aligned in position.
  • the “alignment” mentioned in this article means that when two gaps are aligned, if the size (ie size and/or shape) of the two gaps is the same, the projection area of one gap and the other gap completely overlaps If the sizes of the two gaps are not the same, one of the gaps is located inside the projection area of the other gap.
  • a notch 65 is provided on one side of the second upper cover layer 12, a notch 66 is provided on one side of the second channel forming layer 11, and a notch 67 is provided on one side of the second reaction region forming layer 10 .
  • the second insulating substrate 8 is not provided with notches.
  • the notch 65, the notch 66, and the notch 67 are provided on the same side of the second biosensor 101, and are aligned in position.
  • the first sample injection port 601 and the second sample injection port 602 do not form a whole.
  • the first sample injection port 601 and the second sample injection port 602 are located on the same side of the electrochemical test strip 200 and are aligned in position.
  • the first sample inlet 601 and the second sample inlet 602 can also be located on the same side of the electrochemical test strip 200, but they are not aligned in position.
  • the first sample inlet 601 and the second sample inlet 602 can also be Located on different sides of the electrochemical test strip 200.
  • the sample flows into the first biosensor 100 and enters the first channel forming area 55 through the gap 61 and the gap 62.
  • the notch 62 divides the first channel forming region 55 into two parts. Therefore, the sample entering the first channel forming region 55 is divided into two parts, a part of the sample flows into the first part of the first channel forming region 55, and the other part of the sample flows into the first part.
  • the channel forms the second part of the area 55.
  • the sample flowing into the first part of the first channel forming zone 55 passes through the third reaction zone 43 and finally flows to the second index working electrode 23 and the second index counter electrode 24, and the sample flowing into the second part of the first channel forming zone 55 passes through the first
  • the second reaction area 41 and the first reaction area 42 finally flow to the first index reference electrode 21 and the first index working electrode 22.
  • the sample is added through the second sample inlet 602
  • the sample flows into the second biosensor 101, and enters the second channel forming area 56 through the gap 65 and the gap 66, and the sample flowing into the second indicator channel forming area 56 passes through the fourth reaction area 46 , And finally flow to the third index counter electrode 29 and the third index working electrode 30.
  • the first indicator reference electrode 21 and the first indicator working electrode 22 are used to detect the first indicator in the sample
  • the second indicator working electrode 23 and the second indicator counter electrode 24 are used to detect The second index in the sample
  • the third index counter electrode 29 and the third index working electrode 30 are used to detect the third index in the sample.
  • the first, second and third indicators can be the levels of analytes such as glucose, cholesterol, hemoglobin, glycosylated hemoglobin, uric acid, urea, creatinine, bilirubin and ketone bodies in the sample, or the physical and chemical properties of the sample , Such as pH value and HCT, etc., but also whether the sample volume is sufficient.
  • electrochemical parameters such as current, potential, electricity, conductance and resistance generated after the sample is added can be detected as needed, and then the level or presence or absence of different indicators to be measured can be determined according to the detected electrochemical parameters.
  • the second reaction zone 41 contains a first index first reaction reagent
  • the first reaction zone 42 contains a first index second reaction reagent
  • the third reaction zone 43 contains a second index reaction reagent
  • the fourth reaction zone 46 contains a third index reaction.
  • Reagents can be added to the corresponding reaction area respectively by spotting or screen printing.
  • the present invention combines spotting and solution screen printing methods to add these four reaction reagents to the corresponding four reaction areas respectively.
  • the first index reference electrode 21 and the first index working electrode 22 are used to detect urea in the sample by the electric potential measurement method, and the second index working electrode 23 and the second index counter electrode 24 are detected in the sample by the current measurement method.
  • Creatinine, the third index counter electrode 29 and the third index working electrode 30 detect uric acid in the sample by amperometric method.
  • the first indicator and the first reaction reagent contain a buffer, such as PBS; a polymer binder, such as methyl cellulose; a surfactant, such as Triton X-100; and urease.
  • the first indicator and the second reaction reagent contain buffers, such as PBS; polymer binders, such as methyl cellulose; surfactants, such as Triton X-100; electron mediators, such as ruthenium compounds (such as hexaammonium trichloride) Ruthenium), potassium ferricyanide or potassium ferrocyanide.
  • buffers such as PBS
  • polymer binders such as methyl cellulose
  • surfactants such as Triton X-100
  • electron mediators such as ruthenium compounds (such as hexaammonium trichloride) Ruthenium), potassium ferricyanide or potassium ferrocyanide.
  • the second indicator reaction reagent contains buffers, such as PBS; polymer binders, such as methyl cellulose; stabilizers, such as sucrose; surfactants, such as Triton X-100; creatinase, creatinase , Sarcosine oxidase; electron mediators, such as ruthenium compounds, potassium ferricyanide or potassium ferrocyanide.
  • buffers such as PBS
  • polymer binders such as methyl cellulose
  • stabilizers such as sucrose
  • surfactants such as Triton X-100
  • creatinase, creatinase , Sarcosine oxidase
  • electron mediators such as ruthenium compounds, potassium ferricyanide or potassium ferrocyanide.
  • the third indicator reaction reagent contains buffers, such as PBS; polymer binders, such as methyl cellulose; stabilizers, such as trehalose; surfactants, such as Triton X-100; electron mediators, such as Ruthenium compound, potassium ferricyanide or potassium ferrocyanide.
  • buffers such as PBS
  • polymer binders such as methyl cellulose
  • stabilizers such as trehalose
  • surfactants such as Triton X-100
  • electron mediators such as Ruthenium compound, potassium ferricyanide or potassium ferrocyanide.
  • the first index first reaction reagent for detecting urea, the first index second reaction reagent and the second index reaction reagent for detecting creatinine can be added to the second reaction area 41 and the first reaction respectively by means of solution dots.
  • a third indicator reaction reagent for detecting uric acid is added to the fourth reaction area 46 by screen printing.
  • This method can be divided into 5 processes: the screen printing process, the first kcal solution fixing process, the second kcal solution fixing process, the covering process and the cutting process.
  • each electrode in the first electrode system formed on the first insulating substrate 1 by screen printing silver ink, and the first electrode formed on the first insulating substrate 1 by screen printing carbon ink For each conductive trace and contact in the system, as to whether to print the electrode or the conductive trace and contact first, there is no special order requirement, and it can also be done at the same time.
  • Each electrode in the second electrode system is formed on the second insulating substrate 8 by screen printing silver ink, and each conductive trace in the second electrode system is formed on the second insulating substrate 8 by screen printing carbon ink.
  • the contacts as to whether to print the electrodes first, or to print the conductive traces and contacts first, there is no special order requirement, and they can also be performed at the same time. In addition, as to whether to print the first electrode system first or the second electrode system first, there is no special order requirement, and it can also be done at the same time.
  • the first reaction area forming layer 3 covering the first electrode system and the second reaction area forming layer 10 covering the second electrode system are respectively formed by screen printing the insulating carbon ink, whether in the first electrode system Also in the second electrode system, each electrode is formed by screen printing silver ink, and each conductive trace and contact is formed by screen printing carbon ink.
  • the first index, first reaction reagent, and second index which are used to detect the first index, are placed on the first insulating substrate 1 and the first reaction region forming layer 3 that have been screen-printed.
  • a reaction reagent solution and a second index reaction reagent solution for detecting the second index are fixed on the second reaction area 41, the first reaction area 42 and the third reaction area 43 of the reaction area forming layer 3, respectively.
  • the first channel forming layer 4 is attached to the first reaction area forming layer 3, and the width of the third reaction area formed is 1.0 ⁇ 3.0mm, and the width of the second reaction area 41 and the first reaction area 42 is 0.5 ⁇ 2.0mm , And then cover the first upper cover layer 5 on the first channel forming layer 4, and then perform rolling to make the first channel forming layer 4 and the first upper cover layer 5 fit tightly, completing the production of electrochemical test kcal .
  • a hydrophobic insulating material such as an insulating ink
  • the first reaction area 42, the second reaction area 41, and the third reaction area 43 are cut out on the first reaction area forming layer 3; it can also be used for screen printing, the first insulating substrate 1 and the second insulating substrate Part of the area of 8 is not printed with insulating material, so that the second reaction area 41, the first reaction area 42, and the third reaction area 43 are separated on the first reaction area forming layer 3, and the second reaction area A fourth reaction area 46 is generated on the formation layer 10.
  • a solution fixing step is performed on the printed second electrode system and the second reaction area forming layer 10, and the second index reaction reagent solution for detecting the third index is fixed on the second
  • the reaction area is formed on the fourth reaction area 46 of the layer 10.
  • the second channel forming layer 11 is pasted on the second reaction region forming layer 10, and the width of the fourth reaction region 46 formed is 1.0-3.0 mm, and then the second upper cover layer 12 is covered on the second channel forming layer 11 Then, rolling is performed to make the second channel forming layer 11 and the second upper cover layer 12 fit tightly to complete the production of the second large card.
  • a hydrophobic insulating material such as an insulating ink
  • the second insulating substrate 8 can be formed by laser cutting or the like.
  • the fourth reaction area 46 is cut out on the reaction area forming layer 10; it is also possible that during screen printing, some areas of the second insulating substrate 8 are not printed with insulating material, so that a fourth reaction is generated on the second reaction area forming layer 10 Area 46.
  • the first insulating substrate 1 of the first card and the second insulating substrate 8 of the second card are pasted together with an adhesive such as double-sided tape, and then rolling is performed to make the first card and the second insulating substrate 8
  • the second card is tightly attached to form an electrochemical test card.
  • the electrochemical test kcal is cut into many electrochemical test strips.
  • first reaction region forming layer 3 and the second reaction region forming layer 10 can be selected as a double-sided tape or a single-sided tape, so that the first reaction region forming layer 3 and the second reaction region forming layer 10 are adhered to the first insulating layer.
  • first reaction area forming layer 3 or the second reaction area forming layer 10 can also be supported by a plastic sheet, and then coated with a pressure-sensitive adhesive or photopolymer on one side. Under the action, the photosensitive polymer is bonded to the insulating substrate.
  • an electrochemical test strip is used to detect multiple indicators in the sample.
  • the difference from the first embodiment is as shown in Figure 1, Figure 2, Figure 5 and Figure 6.
  • the first electrode system also includes a pair of electrodes for detecting whether the added sample is sufficient: a first sample filling electrode 25 and a second sample filling electrode 26, and the first reaction region forming layer 3 also has a first exposure hole 44 And second exposure hole 45.
  • the first index reference electrode 21, the first index working electrode 22, the second index working electrode 23, and the second index counter electrode 24 are located between the first sample filling electrode 25 and the second sample filling electrode 26, and the first sample
  • the filling electrode 25 and the second sample filling electrode 26 are connected to the seventh contact 78 and the eighth contact 75 provided at the first electrical connection terminal 7 through the seventh conductive trace 81 and the eighth conductive trace 71, respectively.
  • the distance between the first sample filling electrode 25 and the first electrical connection terminal 7 is the shortest, and the distance between the second sample filling electrode 26 and the first electrical connection terminal 7 is the farthest.
  • the positions of the first sample filling electrode 25 and the second sample filling electrode 26 can also be adjusted so that the distance between the second sample filling electrode 26 and the first electrical connection terminal 7 is the shortest, and the first sample filling electrode 25 is away from the first electrical connection. End 7 is the farthest.
  • the first sample filling electrode 25 and the second sample filling electrode 26 are made of conductive materials, and can be formed on the first insulating substrate by screen printing.
  • the sample When the sample is added through the first sample injection port 601, the sample is divided into two at the first biosensor 100 and flows in two opposite directions: a part of the sample flows to the first electrical connection end 7 and flows to the first index reference The electrode 21 and the first index working electrode 22; another part of the sample flows in the opposite direction and flows to the second index working electrode 23 and the second index counter electrode 24.
  • the sample it can be judged that the flow to the first index reference electrode 21 and the first index reference electrode 21 and the first index reference electrode 21 and the first index reference electrode 21 and the first index reference electrode 21 can be judged by detecting the electrical signals such as current, voltage, or impedance between the first sample filling electrode 25 and the second sample filling electrode 26. It is indicated whether the sample of the working electrode 22 and the sample flowing to the second index working electrode 23 and the second index counter electrode 24 are sufficient.
  • the first exposure hole 44 at least partially exposes the first sample-filled electrode 25, and the second exposure hole 45 at least partially exposes the second sample-filled electrode 26.
  • the first exposure hole 44 communicates with the first air hole 51 provided on the first biosensor 100 on the air path, thereby facilitating the flow of the sample to the second index working electrode 23 and the second index counter electrode 24.
  • the second exposure hole 45 communicates with the second gas hole 52 provided on the first biosensor 100 on the gas path, thereby facilitating the flow of the sample to the first index reference electrode 21 and the first index working electrode 22.
  • the first portion of the first channel forming region 55 at least partially exposes the third reaction region 43 and the first exposure hole 44.
  • the second portion of the first channel forming region 55 at least partially exposes the second reaction area 41, the first reaction area 42 and the second exposure hole 45.
  • the third reaction area 43 and the first exposure hole 44 may be combined into one.
  • the second reaction zone 41 and the first reaction zone 42 may also be combined into one, or only one of the two may remain.
  • an electrochemical test strip is used to detect multiple indicators in the sample.
  • the second electrode system is also provided with A third sample filling electrode 27 for detecting whether the added sample is sufficient; the second reaction region forming layer 10 has a third exposure hole 47.
  • the third sample filling electrode 27 is connected to the ninth contact 85 through the ninth conductive trace 90.
  • the distance between the third sample filling electrode 27 and the second electrical connection end 13 is smaller than the distance between the third index counter electrode 29 and the third index working electrode 30 and the second electrical connection end 13.
  • the third exposure hole 47 at least partially exposes the third sample filling electrode 27.
  • the third exposure hole 47 communicates on the air path with the third air hole 53 provided on the second biosensor 101 on the air path.
  • the sample flows into the second biosensor 101, and the flow can be judged by detecting the signal between the third sample filling electrode 27 and the third index counter electrode 29 or the third index working electrode 30
  • the third index is whether the samples of the electrode 29 and the third index working electrode 30 are sufficient.
  • an electrochemical test strip is used to detect multiple indicators in the sample.
  • the difference from the first embodiment is that the second biosensor
  • the two-electrode system is also provided with a pair of dedicated HCT electrodes 28 for detecting the indicators in the sample: HCT to correct the test differences caused by the HCT of the blood sample; the gap 66 provided on one side of the second channel cambium 11 It communicates with the middle portion of the second channel forming region 56; the second reaction region forming layer 10 has a fourth exposure hole 48, a fifth exposure hole 49, and a sixth exposure hole 50; the second upper cap layer 12 contains a third air hole 53 And the fourth air hole 54.
  • one of the HCT electrodes is connected to the tenth contact 83 through the tenth conductive trace 88, and the other HCT electrode is connected to the eleventh contact through the eleventh conductive trace 92.
  • Points 87 are connected together.
  • a pair of dedicated HCT electrodes 28, a third index counter electrode 29 and a third index working electrode 30 are located on both sides of the second sample inlet 602.
  • a pair of dedicated HCT electrodes 28, the third index counter electrode 29 and the third index working electrode 30 can also be located on the same side of the second sample injection port 602, at this time, they are arranged on one side of the second channel forming layer 11.
  • the notch 66 is connected to one end of the second channel forming area 56 and, of course, can also be connected to the middle part of the second channel forming area 56.
  • the fourth exposure hole 48 and the fifth exposure hole 49 each at least partially expose one of the pair of HCT electrodes 28.
  • the distance between the sixth exposure hole 50 and the second electrical connection terminal 13 is the largest, followed by the fifth exposure hole 49, and the distance between the fourth exposure hole 48 and the back electrical connection terminal 13 is the smallest.
  • the sixth exposure hole 50 is located near the third exposure hole 49 and exposes a part of the insulating area of the second insulating substrate 8.
  • the purpose of providing the sixth exposure hole 50 is that the sixth exposure hole 50 communicates with the fourth gas hole 54 provided on the second biosensor 101 in the gas path, so as to promote the sample to fully cover the pair of HCT electrodes 28.
  • the fifth exposure hole 49 and the sixth exposure hole 50 are preferably The middle area of each HCT electrode 28 is individually exposed.
  • the fifth exposure hole can be ensured The area of the HCT electrode exposed by 49 and the sixth exposure hole 50 remains unchanged, thereby ensuring that the electrical signals generated by different batches of electrochemical biosensors 200 remain consistent.
  • the fourth exposure hole 48, the fifth exposure hole 49, and the sixth exposure hole 50 may be partially merged together.
  • the fourth exposure hole 48 and the fifth exposure hole 49 may be merged together, and the fifth exposure hole 49 and the sixth exposure hole 49 may be merged together.
  • the exposure holes 50 can also be merged together, and even the fourth exposure hole 48, the fifth exposure hole 49, and the sixth exposure hole 50 can be merged together.
  • the fourth exposure hole 48, the fifth exposure hole 49, and the sixth exposure hole The hole 50 may also be merged with the fourth reaction zone 46.
  • the gap 66 communicates with the middle part of the second channel forming area 56, which divides the second channel forming area 56 into two parts. Therefore, when the sample is added from the second sample injection port 602, the sample enters the second channel through the gap 66.
  • the sample is divided, one part flows into the first part of the second channel forming region 56, and the other part flows into the second part of the second channel forming region 56.
  • the sample flowing into the first part of the second channel forming area 56 flows through the fourth exposing hole 48 and the fifth exposing hole 49 and finally flows to the pair of HCT electrodes 28 for detecting the HCT value of the sample, and flows into the second part of the second channel forming zone 56.
  • Part of the sample passes through the fourth reaction area 46 and finally flows to the third index counter electrode 29 and the third index working electrode 30 for detecting the third index.
  • the fourth air hole 54 is located above the first part of the second channel forming region 56 and communicates with the first part of the second channel forming region 56 and the sixth exposure hole 50 on the air path, and is used to discharge the second sample channel when sample is added. air.
  • the third air hole 53 is located above the second part of the second channel forming area 56 and communicates with the second part of the second channel forming area 56 on the air path, and is used to discharge the air in the second sample channel during sample injection.
  • the electrochemical test strip of this embodiment can measure four indicators: the first indicator (such as urea) is measured by the first indicator reference electrode 21 and the first indicator working electrode 22 located in the first biosensor 100; the second indicator ( For example, creatinine) is measured by the second index working electrode 23 and the second index counter electrode 24 located in the first biosensor 100; the third index (such as uric acid) is measured by the third index counter electrode 29 and the second index located in the second biosensor 101 The third index is measured by the working electrode 30; HCT is measured by a pair of HCT electrodes 28 located in the second biosensor 101.
  • the layout of the electrodes used to detect the four indicators of urea, creatinine, urea and HCT in the first biosensor 100 and the second biosensor 101 can also be adjusted as needed.
  • the electrodes used to detect three of the indicators can be adjusted. At the same time, it is located in the first biosensor 100 or the second biosensor 101, and the electrode for detecting the remaining one index is located in the second biosensor 101 or the first biosensor 100.
  • the pair of HCT electrodes 28 in this embodiment can also be replaced with a pair of electrodes for detecting analytes such as glucose in the sample.
  • an electrochemical test strip is used to detect multiple indicators in the sample.
  • the difference from the first embodiment is that, as shown in FIG. 8, the first biosensor 100 and the second The biosensor 101 shares the same insulating substrate, that is, the first insulating substrate 1, which can reduce the thickness and manufacturing cost of the electrochemical biosensor 200.
  • the first electrode system is completed on the front and back sides of the first insulating substrate 1 respectively.
  • the printing of the first reaction area forming layer and the second electrode system and the second reaction area forming layer are performed as in the first embodiment, so as to prepare the electrochemical test strip in this embodiment.
  • an electrochemical test strip is used to detect multiple indicators in the sample.
  • the difference from the first embodiment is that, as shown in FIGS. 5 and 12, the first biosensor 100 Above, a notch 64 is also provided on one side of the first insulating substrate 1.
  • the notch 64, the notch 61, the notch 62, and the notch 63 are provided on the same side of the first biosensor 100, and are aligned in position to form the first sample addition.
  • Port 601; on the second biosensor 101, a notch 68 is also provided on one side of the second insulating substrate 8.
  • the notch 68 and the notch 65, the notch 66, and the notch 67 are provided on the same side of the second biosensor 101, and in position Align and form the second injection port 602 together.
  • the first sample inlet 601 and the second sample inlet 602 together constitute the sample inlet 6 of the electrochemical test strip.
  • the size of the notch 65 and the size of the notch 61 are the same.
  • an electrochemical test strip is used to detect multiple indicators in the sample.
  • the difference from the sixth embodiment is that, as shown in FIGS. 5 and 9-11, the gap 65
  • the size is smaller than the size of the notch 61, which facilitates the loading of the sample on the second biosensor 101 (especially the second upper cover layer 12), which facilitates the rapid flow of the sample into the first biosensor 100 and the second sensor 101.
  • the size of the notch 65 can also be smaller than the size of the notch 61.
  • the first upper cover layer 5 and the first insulating substrate 1 may not be provided with notches, or only the first upper cover layer 5 or the first insulating substrate 1 may be provided with notches, or Both the upper cover layer 5 and the first insulating substrate 1 are provided with notches.
  • both the second insulating substrate 8 and the second upper cover layer 12 may not be provided with notches, or only the second insulating substrate 8 or the second upper cover layer 12 may be provided with notches, or the second insulating substrate Both the 8 and the second upper cover layer 12 are provided with notches.
  • an electrochemical test strip is used to detect multiple indicators in the sample.
  • the first biosensor 100 A plurality of diffusion components are arranged on the first insulating substrate 1 of the first index, wherein a diffusion assembly 33 is arranged on both sides of the first index reference electrode 21, and a diffusion assembly 33 is arranged on one side of the first index working electrode 22.
  • the other side of the index working electrode 22 is the first sample filling electrode 25.
  • the first sample-filled electrode 25 is made of conductive ink, so that the first sample-filled electrode 25 can also serve as a diffusion component.
  • the purpose of arranging a plurality of diffusion components on the front insulating substrate 1 is to add the first index first reaction reagent solution to the second reaction area 41 and to add the first index second reaction reagent solution to the first reaction area 42. Promote the rapid and uniform diffusion of these reaction reagent solutions on these reaction areas.
  • the first reaction area 42 covers at least a part of each diffusion component provided on both sides or one side of the first index reference electrode 21.
  • At least one diffusion component can be provided on one or both sides of the second index working electrode 23 and the second index counter electrode 24 as required.
  • at least one diffusion component may be provided on one or both sides of the third index counter electrode 29 and the third index working electrode 30 on the second insulating substrate 8. Since the third sample filling electrode 27 is located on the side of the third index counter electrode 29, when the third sample filling electrode 27 is made of conductive ink, the third sample filling electrode 27 can also act as a diffusion component.
  • an electrochemical test strip is used to detect multiple indicators in the sample.
  • the electrochemical test strip further includes the first sample filling electrode 25, the second sample filling electrode 26, the first exposure hole 44 and the second exposure hole 45 in the second embodiment.
  • a notch 64 is also provided on one side of the first insulating substrate 1 and a notch 68 is also provided on one side of the second insulating substrate 8.
  • the size of the notch 65 is smaller than the size of the notch 61.
  • the first portion of the second channel forming region 56 at least partially exposes the fourth reaction area 46 and the third exposure hole 47.
  • the second portion of the second channel forming region 56 at least partially exposes the fourth exposure hole 48, the fifth exposure hole 49 and the sixth exposure hole 50.
  • the gap 66 divides the second channel forming area 56 into two parts, and the second sample channel is also divided into two parts accordingly.
  • the first part of the second sample channel is used to provide samples to a pair of HCT electrodes 28 and can be used to detect the HCT of the sample. Value; the second part of the second sample channel is used to provide samples to the third indicator counter electrode 29 and the third indicator working electrode 30, dissolve the reaction reagents in the fourth reaction area 46, and react, thereby generating electrical signals.
  • the fourth air hole 54 is located above the first part of the second sample channel, communicates with the first part of the second sample channel and the sixth exposure hole 50 on the air path, and is used to discharge the gas in the first part of the second sample channel during sample loading.
  • Air The third air hole 53 is located above the second part of the second sample channel, communicates with the second part of the second sample channel and the third exposure hole 47 on the air path, and is used to discharge the second part of the second sample channel during sample loading. Part of the air.
  • an electrochemical test strip is used to detect multiple indicators in the sample.
  • the electrochemical test strip also contains Hydrophilic element.
  • the sample flows to the first channel forming area, the sample will split, and the location where the split occurs is the split point.
  • the second index working electrode 23 the second index counter electrode 24 and the first sample filling electrode 26
  • a part of the sample flows to the first index reference electrode 21, the first index working electrode 22 and
  • the second sample filling electrode 25 is provided with a first hydrophilic element 31 and a second hydrophilic element 32 located at or near the sample shunt point on the first insulating substrate 1.
  • the first hydrophilic element 31 and the second hydrophilic element 32 can be Made of hydrophilic material.
  • the second index working electrode 23, the second index counter electrode 24 and the first index reference electrode 21, the first index working electrode 22 are located on both sides of the sample shunt point, and the second index working electrode 23, the second index counter electrode 24 and The distance between the first index reference electrode 21 and the first index working electrode 22 from the sample shunt point is greater than the distance between the first hydrophilic element 31 and the second hydrophilic element 32 from the sample shunt point.
  • first hydrophilic element 31 and the second hydrophilic element 32 Between the first hydrophilic element 31 and the second hydrophilic element 32, the first hydrophilic element 31 and the second index working electrode 23 or the second index counter electrode 24, and the second hydrophilic element 32 and the second index counter electrode 24 Or the second index working electrodes 23 are separated by hydrophobic insulating regions. This design can avoid mutual interference between samples after shunting. At the same time, the first hydrophilic element 31 and the second hydrophilic element 32 are designed with This helps the sample to flow into the third reaction area 43, the second reaction area 41, and the first reaction area 42 of the first biosensor 100 and the exposed electrodes more quickly. More hydrophilic elements can also be provided, or only one hydrophilic element can be provided.
  • the second biosensor 101 when the sample flows on the second insulating substrate 8, the sample will be shunted, a part of the sample flows to a pair of HCT electrodes 28, and a part of the sample flows to the third index counter electrode 29, the third index works
  • the electrode 30 and the third sample filling electrode 27, preferably, as shown in FIG. 15, can also be provided with corresponding one or more hydrophilic elements, such as two hydrophilic elements, at or near the sample shunt point of the back insulating substrate 8.
  • the third hydrophilic element 34 and the fourth hydrophilic element 35, the materials and positions of the third hydrophilic element 34 and the fourth hydrophilic element 35 are set with the first hydrophilic element 31 and the second hydrophilic element 31 and the second on the first insulating substrate 1.
  • the hydrophilic element 32 is similar.
  • an electrochemical test strip is used to detect multiple indicators in the sample.
  • the difference from the first embodiment is that, as shown in FIG. 16, on the second insulating substrate 8 A conductive automatic start contact 93 is also provided.
  • the automatic start contact 93 is located at the second electrical connection end 13.
  • the automatic start contact 93 can be connected to the tester.
  • a closed circuit is formed between the instruments, so that the testing instrument is automatically turned on; when the electrochemical test strip is inserted in the reverse direction, the automatic start contact 93 cannot form a closed circuit with the testing instrument, and the testing instrument cannot be automatically turned on. Therefore, the electrochemical test strip cannot be tested.
  • setting the automatic start contact 93 can help the testing instrument identify the front and back of the electrochemical test strip, prevent incorrect insertion, and prevent the insertion of other unmatched electrochemical test strips. It is also possible to provide an automatic starting contact located at the first electrical connection terminal 7 on the first insulating substrate 1, or at the same time to set one such automatic starting contact on each of the first insulating substrate 1 and the second insulating substrate 8, only when When the electrochemical test strip is used in conjunction with the matching detection instrument, the detection instrument can be automatically turned on.
  • the same point as the first embodiment is that the first upper cover layer and the second upper cover layer are both transparent, so that even after the electrochemical test strip is assembled, The colors of the first insulating substrate 1 and the second insulating substrate 8 can also be observed.
  • the first insulating substrate 1 and the second insulating substrate 8 can be made of insulating materials of different colors. In this way, the front and back sides of the electrochemical test strip can be distinguished by observing the colors of the first insulating substrate 1 and the second insulating substrate 8, that is, the first biosensor 100 and the second biosensor 101 can be distinguished, thereby preventing the electrochemical test
  • the strip is inserted into the detection instrument in the reverse direction.
  • the first upper cover layer and the second upper cover layer can also be opaque.
  • the first upper cover layer and the second upper cover layer can be made of insulating materials of different colors.
  • the colors of the layer and the second upper cover layer distinguish the front and back of the electrochemical test strip, that is, the first biosensor and the second biosensor can be distinguished, so as to prevent the electrochemical test strip from being inserted into the detection instrument in reverse.
  • each electrode system is made of any conductive material, such as carbon film, gold, silver, tin oxide/gold, platinum, other noble metals or their oxides.
  • the surface of the first upper cover layer facing the first channel forming layer and the surface of the second upper cover layer facing the second channel forming layer are coated with a layer of hydrophilic material.
  • the hydrophilic component is made of hydrophilic material.
  • the hydrophilic material mentioned in the present invention can be selected from starch, polysaccharides, cellulose molecules, polyacrylic acid, polyacrylamide, polyvinyl alcohol, polyurethane, polyphthalamide and carbon ink.
  • the hydrophilic component is preferably a carbon ink.
  • the electrochemical test strip is provided with markers for distinguishing the front and back sides of the electrochemical test strip.
  • the markers are conductive automatic start contacts, colored insulating materials, text, letters, and graphics.
  • the electrochemical test strip of the present invention can also be used to detect two or more indicators in a sample, and the two or more indicators are selected from glucose, cholesterol, hemoglobin, glycosylated hemoglobin, uric acid, Urea, creatinine, bilirubin, ketone bodies, HCT and pH, etc.
  • the first biosensor can detect an electrode system for blood sugar and an electrode system for detecting urea
  • the first biosensor can detect an electrode system for cholesterol and an electrode system for detecting ketone bodies.
  • the electrochemical test strip uses the first index reference electrode 21 and the first index working electrode 22 to detect urea in the sample by the potentiometric method, and the second index working electrode 23 And the second index pair electrode 24 detects the creatinine in the sample by the amperometric method, and the third index pair electrode 29 and the third index working electrode 30 detect the uric acid in the sample by the amperometric method.
  • the first indicator and first reaction reagent contained in the second reaction area 41 of the first reaction area forming layer 3 includes 0.05-0.5M PBS (pH 5.8-8.0), methylcellulose 0.1-10% (w/ w), Triton X-100 0.1% ⁇ 1.0%(v/v), urease (2280 ⁇ 8712U/mL), the first reaction zone 42 of the first reaction zone forming layer 3 contains the first indicator and the second reaction reagent includes 0.05-0.5M PBS(pH 5.8 ⁇ 8.0), methylcellulose 0.1 ⁇ 10%(w/w), Triton X-100 0.1% ⁇ 1.0%(v/v), ruthenium compound, potassium ferricyanide or sub Potassium ferricyanide 1.0 to 4.5% (w/w).
  • the second index reaction reagent contained in the third reaction area 43 of the first reaction area forming layer 3 includes 0.05-0.5M PBS (pH 5.8-8.0), polymer binder such as methylcellulose 0.1-10 %(W/w), sucrose 0.25% ⁇ 1%(w/w), Triton X-100 0.1% ⁇ 1%(v/v), creatinase (500 ⁇ 5000U/mL), creatinase (500 ⁇ 5000U/mL), sarcosine oxidase (500-5000U/mL), ruthenium compound, potassium ferricyanide or potassium ferrocyanide 1.0-4.5% (w/w).
  • PBS pH 5.8-8.0
  • polymer binder such as methylcellulose 0.1-10 %(W/w), sucrose 0.25% ⁇ 1%(w/w), Triton X-100 0.1% ⁇ 1%(v/v)
  • creatinase 500 ⁇ 5000U/mL
  • creatinase 500 ⁇ 5000U/mL
  • the third index reaction reagent contained in the fourth reaction area 46 of the second reaction area forming layer 3 includes 0.05-0.5M PBS (pH 5.8-8.0), polymer binder such as methylcellulose 0.1-10 %(W/w), trehalose 0.25% ⁇ 1%(w/w), Triton X-100 0.1% ⁇ 1.0%(v/v), ruthenium compound, potassium ferricyanide or potassium ferrocyanide 2.0 ⁇ 10% (w/w).
  • the electrochemical test strip in Example 1 was used to detect the levels of urea, creatinine and uric acid in clinical blood samples.
  • the first biosensor 100 and the second biosensor 101 are assembled together, after the sample is added through the sample inlet 6, a part of the sample flows into the first biosensor 100 and enters the first channel forming area 55 through the gap 61 and the gap 62. 62 divides the first channel forming area 55 into two parts. Therefore, at this time, the sample entering the first channel forming area 55 is divided, a part of the sample flows into the first part of the first channel forming area 55, and the other part of the sample flows into the first channel. The second part of the area 55 is formed.
  • the sample flowing into the first part of the first channel forming zone 55 passes through the third reaction zone 43 and finally flows to the second index working electrode 23 and the second index counter electrode 24, and the sample flowing into the second part of the first channel forming zone 55 passes through the first The second reaction area 41 and the first reaction area 42 finally flow to the first index reference electrode 21 and the first index working electrode 22.
  • the part of the sample that flows into the second biosensor 101 enters the second channel forming area 56 through the gap 65 and the gap 66.
  • the gap 66 divides the second channel forming area 56 into two parts, and a part of the sample that flows into the second channel forming area 56 It flows into the first part of the second passage forming area 56, and the other part flows into the second part of the second passage forming area 56.
  • the sample flowing into the first part of the second channel forming zone 56 passes through the fourth exposure hole 48 and the fifth exposing hole 49 and finally flows to the pair of HCT electrodes 28, and the sample flowing into the second part of the second channel forming zone 56 passes through the fourth reaction.
  • the area 46 finally flows to the third index counter electrode 29 and the third index working electrode 30.
  • the electrochemical test strip Before the test, the electrochemical test strip will be inserted into the electrical connector of a testing instrument, and the first biosensor and the second biosensor of the electrochemical test strip will be electrically connected to the electrical connector of the testing instrument. However, after adding the sample for a period of time, the urea, creatinine and uric acid in the sample were detected.
  • the urea in the sample reacts with the first index first reaction reagent and the first index second reaction reagent, and the potential signal generated between the first index reference electrode and the first index working electrode matches the sample
  • the urea concentration is proportional to the urea concentration, so the potentiometric method is used to measure the urea concentration.
  • the test time is 3s to 100s. This detection instrument can convert the detected potential signal into the corresponding urea concentration value.
  • the creatinine in the sample reacts with the second indicator reaction reagent, and the current signal generated after the voltage is applied is proportional to the creatinine concentration in the sample. Therefore, the ampere current method is used for measurement, and the test time is 3s-100s.
  • the detection instrument can convert the detected current signal into the corresponding creatinine concentration value. After the blood sample is added, the uric acid in the sample reacts with the third indicator reaction reagent, and the current signal generated after the voltage is applied is proportional to the uric acid concentration in the sample. Therefore, the ampere current method is used for measurement, and the test time is 2s-100s. The detection instrument can convert the detected current signal into the corresponding uric acid concentration value.
  • the electrochemical test strip also contains a pair of dedicated HCT electrodes, which can be used to measure the HCT value of blood samples, and the measured HCT value can be used to correct the measured urea, creatinine and uric acid concentrations at the same time, making the measurement results more accurate. accuracy.

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Abstract

用于多种指标检测的电化学测试条（200）及其检测方法，包括设有绝缘基板（1）、第一电极系统、第一通道形成层（4）、第一上盖层（5）的第一生物传感器（100），和设有绝缘基板（8）、第二电极系统、第二通道形成层（11）、第二上盖层（12）的第二生物传感器（101），第一生物传感器（100）和第二生物传感器（101）分别位于电化学测试条（200）的正反两面，电化学测试条（200）的加样口（6）分别与第一生物传感器（100）的第一通道形成区（55）和第二生物传感器（101）的第二通道形成区（56）连通。

Description

用于多种指标检测的电化学测试条及其检测方法 技术领域
本发明涉及用于检测血液等样品中多种指标的电化学测试条及其检测方法，属于电分析化学检测技术领域。
背景技术
带有电极系统的电化学测试条已被广泛运用于生物样本的快速检测，例如用于检测血液样本中的葡萄糖、胆固醇、血酮等各种生理指标。电化学测试条的基本结构包括一个绝缘基板，位于绝缘基板上的电极系统，通道形成层和上盖，电极系统至少包括工作电极和对电极，反应试剂覆盖在至少一个工作电极上。检测样品经过通道形成层上的通道形成区与反应试剂反应并产生可以可检测的信号。与电化学测试条连接的分析仪根据该信号，得出检测结果。
目前已有的电化学测试条只能检测单一的样品指标，若要检测多项指标，只能采用不同的电化学测试条分别对不同的生理指标进行检测。若要完成多个生理指标的检测，患者须采集多次血样。多次采样不仅给患者带来痛苦，还会花费较长的检测时间，且检测步骤繁琐。
慢性肾脏病及其引起的终末期肾病是一组严重威胁人类生命和健康的常见慢性进展性疾病，具有高患病率、高病死率、高医疗卫生支出，及低知晓率等特点。在慢性肾病患者的肾功能指标诊断中，常需要同时获得血液中肌酐、尿素和尿酸三种生理指标。通过这三种指标的检测可以有效地对检测患者肾病的患病程度，并做出相应的判断，作为进一步治疗方案的选择依据。目前，市场上的肾功能指标检测主要为应用于大型生化仪上的单项检测试剂盒，价格昂贵，测试时间较长，测试步骤繁琐，不适合在乡镇以及社区卫生院普及。
发明内容
针对现有技术检测不足，本发明提供了一种新型可用于检测多项样品指标的电化学测试条，克服现有技术中只能检测单一样品指标且多依附于大型生化仪检测的局限性。电化学测试条可应用于便携式检测仪器进行检测，具有体积小、抗干扰、价格低廉和一次性可抛弃等特点，为检验操作提供便利。
本发明提供一种用于多种指标检测的电化学测试条，包括第一生物传感器，所述第一生物传感器包括绝缘基板、设置在绝缘基板上的第一电极系统、第一通道形成层和第一上盖层，第一通道形成层上设有第一通道形成区，第一通道形成区位于第一电极系统的电极之上，还包括第二生物传感器，所述第二生物传感器包括绝缘基板，设置在绝缘基板上的第二电极系统、第二通道形成层和第二上盖层，第二通道形成层上设有第二通道形成区，第二通道形成区位于第二电极系统的电极之上；所述第一生物传感器和第二生物传感器分别位于电化学测试条的正面和反面，并且第一生物传感器的电连接端和第二生物传感器的电连接端位于电化学测试条的同一端；所述电化学测试条的加样口分别与第一生物传感器的第一通道形成区和第二生物传感器的第二通道形成区连通。
进一步地，第一电极系统包括用于测量第一指标的电极系统和用于测量第二指标的电极系统。
进一步地，第二电极系统包括用于测量第三指标的电极系统。
进一步地，第二电极系统还包括用于测量第四指标的电极系统。
进一步地，所述测量第一指标的电极系统和用于测量第二指标的电极系统分别位于加样口 的两侧。
进一步地，所述测量第三指标的电极系统和用于测量第四指标的电极系统分别位于加样口的两侧。
进一步地，第一生物传感器和第二生物传感器共用一个绝缘基板，或第一生物传感器和第二生物传感器分别包括一个绝缘基板。
进一步地，第一生物传感器的绝缘基板和第一通道形成层之间设有第一反应区域形成层，和/或第二生物传感器的绝缘基板和第二通道形成层之间设有第二反应区域形成层。
进一步地，所述加样口包括第一上盖层的缺口和第二上盖层的缺口。
进一步地，第一上盖层的缺口和第二上盖层的缺口位于电化学测试条的同一侧且在位置上对齐，第一上盖层的缺口比第二上盖层的缺口大。
进一步地，所述电化学测试条还设有一个区分电化学测试条正反面的标识物。
进一步地，所述标识物为可导电的自动开机触点，设于第一生物传感器的绝缘基板和第二生物传感器的绝缘基板中的至少一个。
进一步地，所述标识物为带颜色的绝缘材料，当所述第一上盖层和所述第一上盖层透明时，所述第一生物传感器的绝缘基板朝向第一通道形成层的一面和所述第二生物传感器的绝缘基板朝向第二通道形成层的一面由不同颜色的材料制成，当所述第一上盖层和所述第二上盖层不透明时，所述第一上盖层和所述第二上盖层由不同颜色的材料制成。
进一步地，所述电化学测试条用于测定中葡萄糖、胆固醇、血红蛋白、糖化血红蛋白、尿酸、尿素、肌酐、胆红素、酮体、HCT、pH值中的至少两项指标。
一种检测多种指标的方法，包括提供本发明所述的电化学测试条。
本发明还提供一种用于检测肾功能指标的电化学测试条，包括第一生物传感器，所述第一生物传感器包括绝缘基板、设置在绝缘基板上的第一电极系统、第一通道形成层和第一上盖层，第一通道形成层上设有第一通道形成区，第一通道形成区位于第一电极系统的电极之上，其特征在于，还包括第二生物传感器，所述第二生物传感器包括绝缘基板，设置在绝缘基板上的第二电极系统、第二通道形成层和第二上盖，第二通道形成层上设有第二通道形成区，第二通道形成区位于第二电极系统的电极之上；还包括分别与第一生物传感器的第一通道形成区和第二生物传感器的第二通道形成区液体连通的加样口；所述第一生物传感器和第二生物传感器分别位于电化学测试条的正面和反面；第一生物传感器用于测定尿素、肌酐或尿酸中的两个指标，第二生物传感器用于测定尿素、肌酐或尿酸中剩余的第三个指标。
进一步地，第一电极系统包括用于测量尿素的电极系统和用于测量肌酐的电极系统。
进一步地，第二电极系统包括用于测量尿酸的电极系统。
进一步地，采用电位法测量尿素。
进一步地，采用电流法测量肌酐或尿酸。
进一步地，用于测量尿素的电极系统和用于测量肌酐的电极系统分别位于加样口的两侧。
进一步地，第二电极系统还包括用于测量HCT的电极系统。
进一步地，第一通道形成区分为两个部分，第一通道形成区的第一部分位于测量肌酐的电极系统上，第一通道形成区的第二部分位于测量尿素的电极系统上，第一通道形成区的第一部分的宽度大于第一通道形成区的第二部分的宽度。
进一步地，第一生物传感器的绝缘基板和第一通道形成层之间设有第一反应区域形成层， 和/或第二生物传感器的绝缘基板和第二通道形成层之间设有第二反应区域形成层。
一种肾功能指标检测方法，包括提供本发明所述的电化学测试条。
本发明还提供一种电化学测试条，包括第一生物传感器，所述第一生物传感器包括绝缘基板、设置在绝缘基板上的第一电极系统和第一通道形成层，第一通道形成层上设有第一通道形成区，第一通道形成区位于第一电极系统的电极之上，加样口与第一通道形成区液体相通，其特征在于，所述第一电极系统包括用于测量第一指标的电极系统和用于测量第二指标的电极系统，所述测量第一指标的电极系统和用于测量第二指标的电极系统分别位于加样口的两侧。
进一步地，所述第一生物传感器设置有亲水元件，所述亲水元件位于第一生物传感器的分流点或其附近。
进一步地，所述的亲水元件位于第一通道形成区的下方。
进一步地，第一电极系统包括测量第一指标的电极系统和用于测量第二指标的电极系统，所述亲水元件位于测量第一指标的电极系统和用于测量第二指标的电极系统之间。
进一步地，第一生物传感器的亲水元件和第一电极系统之间设有疏水性的绝缘区域。
进一步地，还包括第二生物传感器，所述第二生物传感器包括绝缘基板，设置在绝缘基板上的第二电极系统、第二通道形成层和第二上盖，第二通道形成层上设有第二通道形成区，第二通道形成区位于第二电极系统的电极之上；所述第一生物传感器和第二生物传感器分别位于电化学测试条的正面和反面。
进一步地，第一生物传感器和第二生物传感器共用一个绝缘基板，或第一生物传感器和第二生物传感器分别包括一个绝缘基板。
进一步地，所述第二生物传感器设置有亲水元件，所述亲水元件位于第二生物传感器的分流点或其附近。
进一步地，第二电极系统包括测量第三指标的电极系统和用于测量第四指标的电极系统，所述亲水元件位于测量第三指标的电极系统和用于测量第四指标的电极系统之间。
进一步地，第二生物传感器的亲水元件和第二电极系统之间设有疏水性的绝缘区域。
本发明还提供一种检测样品中多种指标的电化学测试条，包括加样口和第一生物传感器，所述第一生物传感器包括绝缘基板、设置在绝缘基板上的第一电极系统、第一通道形成层和第一上盖层，第一通道形成层上设有第一通道形成区，第一通道形成区位于第一电极系统的电极之上，其特征在于，还包括第二生物传感器，所述第二生物传感器包括绝缘基板，设置在绝缘基板上的第二电极系统、第二通道形成层和第二上盖，第二通道形成层上设有第二通道形成区，第二通道形成区位于第二电极系统的电极之上；所述第一生物传感器和第二生物传感器分别位于电化学测试条的正面和反面。
进一步地，所述加样口包括设于第一生物传感器的绝缘基板和第二生物传感器的绝缘基板上的缺口、设于第一通道形成层上且与第一通道形成区相连通的缺口、设于第二通道形成层上且与第二通道形成区相连通的缺口、设于第一上盖层和第二上盖层上的缺口；第一生物传感器的绝缘基板、第一通道形成层和第一上盖层上的缺口和第二生物传感器的绝缘基板、第二通道形成层和第二上盖层上的缺口位于电化学测试条的同一侧且位置上对齐。
进一步地，第一上盖层上的缺口大于第二上盖层上的缺口。
进一步地，所述加样口包括位于第一生物传感器的第一加样口和位于第二生物传感器的第二加样口，第一加样口和第二加样口位于电化学测试条的同一侧或相反的两侧。
进一步地，第一生物传感器的绝缘基板和第一通道形成层之间设有第一反应区域形成层，第二生物传感器的绝缘基板和第二通道形成层之间设有第二反应区域形成层。
进一步地，所述第一反应区域形成层与第一通道形成层的缺口相对应处设置有缺口，第二反应区域形成层与第二通道形成层的缺口相对应处设置有缺口。
本发明的有益效果：(1)本发明采用电化学测试条由两个生物传感器通过组装而成，实现正反两面的电极排布，从而可以利用单根电化学测试条检测多种指标。(2)加样口采用缺口设计，第一生物传感器中位于第一上盖层的缺口的尺寸大于第二生物传感器中第二上盖层的缺口的尺寸，有利于样品在第二生物传感器的第二绝缘基板上的承载，有利于样品快速流入电化学测试条内部。(3)用于检测肌酐、尿素和尿酸的每个电极的两端均可设置辅助反应试剂扩散的扩散组件，有助于反应试剂在相应对的反应区域中扩散更加均匀。(3)不论是在第一生物传感器，还是在第二生物传感器，有一个由碳油墨制成的样品填充电极，既可用于检测流到第一电极系统或第二电极系统的样品是否充足，还可发挥着扩散组件的功能。(4)在检测尿素、肌酐、尿酸和HCT这四种指标时，测量一次HCT测试可同时实现对三种分析物肌酐、尿酸和尿素测量值的HCT校正，最终实现较短时间内完成肌酐、尿酸、尿素和HCT等多种指标的检测，而且检测结果准确。
附图说明
图1为第一种电化学测试条的第一生物传感器的分解图，第一绝缘基板不设有缺口。
图2为图1中的第一生物传感器组装在一起时的示意图。
图3为第一种电化学测试条的第二生物传感器的分解图，第二绝缘基板不设有缺口。
图4为图3中的第二生物传感器组装在一起时的示意图。
图5为第二种电化学测试条的分解图。
图6为图5中的电化学测试条组装在一起时的示意图。
图7为电化学测试条侧面示意图，第一生物传感器和第二生物传感器不共用同一个绝缘基板。
图8为电化学测试条侧面示意图，第一生物传感器和第二生物传感器共用同一个绝缘基板。
图9为第三种电化学测试条的第一生物传感器的分解图，第一绝缘基板的一侧设有缺口。
图10为第三种电化学测试条的第二生物传感器的分解图，第二绝缘基板的一侧设有缺口。
图11.(a)为图9中的第一生物传感器组装在一起时的示意图，(b)为图10中的第二生物传感器组装在一起时的示意图，位于第一上盖层一侧的缺口尺寸大于位于第二上盖层一侧的缺口。
图12.(a)为图9中的第一生物传感器组装在一起时的示意图，(b)相比于图11b的差别在于位于第一上盖层一侧的缺口尺寸等于位于第二上盖层一侧的缺口。
图13.(a)第四种电化学测试条的第一生物传感器的分解图，(b)为(a)中的第一生物传感器组装在一起时的示意图。
图14.含有亲水元件的第一生物传感器组装在一起时的示意图。
图15.含有亲水元件的第二生物传感器组装在一起时的示意图。
图16.含有自动开机触点的第二生物传感器组装在一起时的示意图。
图17.尿素线性实验评估图。
图18.肌酐线性实验评估图。
图19.尿酸线性实验评估图。
具体实施方式
在本发明的第一个实施例中，如图1～7所示，电化学测试条200包括第一生物传感器100和第二生物传感器101，第一生物传感器100和第二生物传感器101不共用同一个绝缘基板。第一生物传感器100具有第一电连接端7和第二生物传感器101具有第二电连接端13。所述电化学测试条200通过第一电连接端7和第二电连接端13位于电化学测试条200的同一端，可与检测仪器的电连接器连接在一起。所述电化学测试条200的加样口包括一个位于第一生物传感器100侧面的第一加样口601和一个位于第二生物传感器101侧面的第二加样口602。
第一生物传感器100依次设有第一绝缘基板1、设置在第一绝缘基板1上的第一电极系统、第一反应区域形成层3、第一通道形成层4和第一上盖层5。第一绝缘基板1、第一反应区域形成层3、第一通道形成层4和第一上盖层5都是由绝缘材料制作成的。
第一电极系统包括第一指标参比电极21、第一指标工作电极22、第二指标工作电极23、第二指标对电极24、位于第一电连接端7的能够导电的第一触点79、第二触点77、第三触点76和第四触点80以及将第一指标参比电极21与第一触点79连接在一起的第一导电迹线74、将第一指标工作电极22与第二触点77连接在一起的第二导电迹线82、将第二指标工作电极23与第三触点76连接在一起的第三导电迹线72和将第二指标对电极24与第四触点80连接在一起的第四导电迹线73。第一指标参比电极21、第一指标工作电极22和第二指标工作电极23、第二指标对电极24位于第一加样口601的两边。
第一反应区域形成层3覆盖在第一电极系统上。第一反应区域形成层3具有三个分隔开的反应区域：第一反应区域42、第二反应区域41和第三反应区域43，这些反应区域的形状可选自矩形、椭圆形、圆形、切角矩形等几何形状。第二反应区域41含有第一指标第一反应试剂,第一反应区域42含有第一指标第二反应试剂，第三反应区域43含有第二指标反应试剂。第三反应区域43至少部分暴露第二指标工作电极23和第二指标对电极24，第二反应区域41至少部分暴露第一指标参比电极21，第一反应区域42至少部分暴露第一指标工作电极22。
第一通道形成层4设置在第一反应区域形成层3上，第一通道形成层4具有一个第一通道形成区55，一个缺口62设置在第一通道形成层4的一侧上，缺口62与第一通道形成区55相连通。优选地，第一通道形成区55位于第一通道形成层4的中间区域，缺口62位于第一通道形成层4的一侧的中间部分。缺口62将第一通道形成区55分为两个部分。当从第一加样口601加入样品后，样品进入第一生物传感器100，当样品通过缺口62进入第一通道形成层4中时，这时样品发生分流，一部分样品流入第一通道形成区55的第一部分，另一部分样品流入第一通道形成区55的第二部分。流入第一通道形成区55的第一部分的样品通过第三反应区域43最终流到第二指标工作电极23和第二指标对电极24，流入第一通道形成区55的第二部分的样品通过第二反应区域41和第一反应区域42最终流到第一指标参比电极21和第一指标工作电极22。
第一通道形成区55的第一部分至少部分暴露着第三反应区域43。第一通道形成区55的第二部分至少部分暴露着第二反应区域41和第一反应区域42。第一通道形成区55的第一部分的宽度可以小于、等于或大于第一通道形成区55的第二部分的宽度。例如，当检测的第一指标是尿素和检测的第二指标是肌酐时，第一通道形成区55的第一部分的宽度大于第一通道形成区55的第二部分的宽度，可将第三反应区域43全部暴露出来，这样做的好处在于：当用电流法检测样品中的肌酐等指标浓度时，检测到的电流信号与第三反应区域43的面积有关，当第三反应区 域43被第一通道形成区55的第一部分全部暴露时，第三反应区域43都是有效面积，都可产生有效信号，这样就可减少反应试剂用量；当用电势法检测样品中的尿素等指标浓度时，检测到的电势信号与第二反应区域41和第一反应区域42的面积相关性不大，因此，降低第一通道形成区55的第二部分的宽度可减少样品用量。
第一上盖层5设置在第一通道形成层4上。第一上盖层5与第一通道形成区55、第二反应区域41、第一反应区域42和第三反应区域43一起形成第一样品通道。
第一上盖层5设有第一气孔51和第二气孔52，用于加样时排出第一样品通道中的空气。第一气孔51位于第一通道形成区55的第一部分的上方，与第一通道形成区55的第一部分在气路上相连通。第二气孔52位于第一通道形成区55的第二部分的上方，与第一通道形成区55的第二部分在气路上相连通。
第二生物传感器101依次设有第二绝缘基板8、设置在第二绝缘基板8上的第二电极系统、第二反应区域形成层10、第二通道形成层11和第二上盖层12。第二绝缘基板8、第二反应区域形成层10、第二通道形成层11和第二上盖层12都是由绝缘材料制作成的。
第二电极系统包括第三指标对电极29、第三指标工作电极30、位于第二电连接端13的能够导电的第五触点86和第六触点84以及将第三指标对电极29与第五触点86连接在一起的第五导电迹线91和将第三指标工作电极30与第六触点84连接在一起的第六导电迹线89。还可根据需要在第二绝缘基板8上设置更多的导电迹线或触点。
第二反应区域形成层10覆盖在第二电极系统上。第二反应区域形成层10具有第四反应区域46，第四反应区域46的形状可选自矩形、椭圆形、圆形、切角矩形等几何形状。第四反应区域46含有第三指标反应试剂。优选地，第四反应区域46部分暴露在第三指标对电极29和第三指标工作电极30上。
第二通道形成层11设置在第二反应区域形成层10上，第二通道形成层11具有一个第二通道形成区56，一个缺口66设置在第二通道形成层11的一侧上，缺口66与第二通道形成区56的一端或中间部分相连通。当从第二加样口602加入样品后，样品进入第二生物传感器101，随后通过缺口66进入第二通道形成区56，最终流到第三指标对电极29和第三指标工作电极30。
第二上盖层12设置在第二通道形成层11上。第二上盖层12与第二通道形成区56和第四反应区域46一起形成第二样品通道。第二上盖层12含有第三气孔53。第二样品通道用于给第三指标对电极29和第三指标工作电极30和提供样品，溶解第四反应区域46中的反应试剂，并发生反应，从而产生电信号。第三气孔53位于第二样品通道的上方，与第二样品通道在气路上相连通，用于加样时排出第二样品通道中的空气。
在第一生物传感器100上，第一上盖层5的一侧设有缺口61，第一通道形成层4的一侧设有缺口62，第一反应区域形成层3的一侧设有缺口63。第一绝缘基板1未设有缺口。缺口61、缺口62和缺口63设于第一生物传感器100的同一侧，并且在位置上对齐。在本文中提到的“对齐”指的是，当两个缺口对齐时，如果这两个缺口的尺寸(即大小和/或形状)一致，其中的一个缺口与另一个缺口的投影区域完全重叠，如果这两个缺口的尺寸不一致，其中的一个缺口位于另一个缺口的投影区域的内部。当将第一生物传感器100的第一绝缘基板1、第一反应区域形成层3、第一通道形成层4和第一上盖层5组装在一起时，缺口61、缺口62和缺口63一起形成第一加样口601。在第二生物传感器101上，第二上盖层12的一侧设有缺口65，第二通道形成层11的一侧设有缺口66，第二反应区域形成层10的一侧设有缺口67。第二绝缘基板8未设 有缺口。缺口65、缺口66和缺口67设于第二生物传感器101的同一侧，并且在位置上对齐。当将第二生物传感器101的第二绝缘基板8、第二反应区域形成层10、第二通道形成层11和第二上盖层12组装在一起时，缺口65、缺口66和缺口67一起形成第二加样口602。由于第一绝缘基板1和第二绝缘基板8均未设置缺口，因此第一加样口601和第二加样口602并未构成一个整体。当将第一生物传感器100和第二生物传感器101组装在一起时，第一加样口601和第二加样口602位于电化学测试条200的同一侧，并且在位置上对齐。第一加样口601和第二加样口602也可位于电化学测试条200的同一侧，但在位置上并不对齐，此外，第一加样口601和第二加样口602也可位于电化学测试条200的不同侧面。
当第一生物传感器100和第二生物传感器101组装在一起时，通过第一加样口601加入样品后，样品流入第一生物传感器100，通过缺口61和缺口62进入第一通道形成区55，缺口62将第一通道形成区55分为两个部分，因此，这时进入第一通道形成区55的样品发生分流，一部分样品流入第一通道形成区55的第一部分，另一部分样品流入第一通道形成区55的第二部分。流入第一通道形成区55的第一部分的样品通过第三反应区域43最终流到第二指标工作电极23和第二指标对电极24，流入第一通道形成区55的第二部分的样品通过第二反应区域41和第一反应区域42最终流到第一指标参比电极21和第一指标工作电极22。通过第二加样口602加入样品后，样品流入第二生物传感器101，并通过缺口65和缺口66进入第二通道形成区56，流入第二指标通道形成区56的样品通过第四反应区域46，最终流到第三指标对电极29和第三指标工作电极30。
在本发明的电化学测试条中，第一指标参比电极21和第一指标工作电极22用于检测样品中的第一指标，第二指标工作电极23和第二指标对电极24用于检测样品中的第二指标，第三指标对电极29和第三指标工作电极30用于检测样品中的第三指标。第一指标、第二指标和第三指标可以是样品中葡萄糖、胆固醇、血红蛋白、糖化血红蛋白、尿酸、尿素、肌酐、胆红素和酮体等分析物的水平，也可以是样品的物理化学特性，比如pH值和HCT等，还可以是样品加样量是否充足。在检测时，可根据需要检测样品加入后产生的电流、电势、电量、电导和电阻等电化学参数，然后根据所检测的电化学参数，确定待测量的不同指标的水平或存在与否。
第二反应区域41含有第一指标第一反应试剂,第一反应区域42含有第一指标第二反应试剂，第三反应区域43含有第二指标反应试剂，第四反应区域46含有第三指标反应试剂。这四种反应试剂可通过点液或丝网印刷等方法分别添加到对应的反应区域上。本发明结合点液和溶液丝网印刷方法将这四种反应试剂分别添加到对应的四个反应区域上。
为了便于说明，这里以第一指标参比电极21和第一指标工作电极22通过电势测量法检测样品中的尿素，第二指标工作电极23和第二指标对电极24通过电流测量法检测样品中的肌酐，第三指标对电极29和第三指标工作电极30通过电流测量法检测样品中的尿酸。为了检测尿素，第一指标第一反应试剂含有缓冲剂，如PBS；聚合物粘合剂，如甲基纤维素；表面活性剂，如Triton X‐100；脲酶。第一指标第二反应试剂含有缓冲剂，如PBS；聚合物粘合剂，如甲基纤维素；表面活性剂，如Triton X‐100；电子传递体，如钌化合物(比如三氯化六铵合钌)、铁氰化钾或亚铁氰化钾。为了检测肌酐，第二指标反应试剂含有缓冲剂，如PBS；聚合物粘合剂，如甲基纤维素；稳定剂，如蔗糖；表面活性剂，如Triton X‐100；肌酐酶，肌酸酶，肌氨酸氧化酶；电子传递体，如钌化合物、铁氰化钾或亚铁氰化钾。为了检测尿酸，第三指标反应试剂含有缓冲剂，如PBS；聚合物粘合剂，如甲基纤维素；稳定剂，如海藻糖；表面活性剂，如Triton X-100；电 子传递体，如钌化合物、铁氰化钾或亚铁氰化钾。用于检测尿素的第一指标第一反应试剂、第一指标第二反应试剂和用于检测肌酐的第二指标反应试剂可通过溶液点液等方式分别添加到第二反应区域41、第一反应区域42和第三反应区域43上，用于检测尿酸的第三指标反应试剂通过丝网印刷方式添加到第四反应区域46上。
在制备本发明的电化学测试条的方法有很多种，这里选择其中的一种加以介绍。这种方法可分为5个工序：丝网印刷工序、第一大卡溶液固定工序、第二大卡溶液固定工序、套贴工序和切割工序。
在丝网印刷工序中，通过丝网印刷银油墨在第一绝缘基板1上形成的第一电极系统中的每个电极，通过丝网印刷碳油墨在第一绝缘基板1上形成的第一电极系统中的每个导电迹线和触点，至于是先印刷电极，还是先印刷导电迹线和触点，没有特别的顺序要求，也可同时进行。通过丝网印刷银油墨在第二绝缘基板8上形成第二电极系统中的每个电极，通过丝网印刷碳油墨在第二绝缘基板8上形成第二电极系统中的每个导电迹线和触点，至于是先印刷电极，还是先印刷导电迹线和触点，没有特别的顺序要求，也可同时进行。此外，至于是先印刷第一电极系统，还是先印刷第二电极系统，没有特别的顺序要求，也可同时进行。
然后通过丝网印刷绝缘碳油墨分别形成覆盖在第一电极系统上的第一反应区域形成层3和覆盖在第二电极系统上的第二反应区域形成层10，其中不论是在第一电极系统还是在第二电极系统中，每个电极是通过丝网印刷银油墨形成的，而每个导电迹线和触点是通过丝网印刷碳油墨形成的。
在第一大卡溶液固定工序中，在完成丝网印刷的第一绝缘基板1和第一反应区域形成层3上将用于检测第一指标的第一指标第一反应试剂、第二指标第一反应试剂溶液和用于检测第二指标的第二指标反应试剂溶液分别固定在反应区域形成层3的第二反应区域41、第一反应区域42和第三反应区域43上。将第一通道形成层4贴在第一反应区域形成层3上，形成的第三反应区域的宽度为1.0～3.0mm，第二反应区域41和第一反应区域42的宽度为0.5～2.0mm，再将第一上盖层5覆盖在第一通道形成层4上，然后进行滚压以使第一通道形成层4和第一上盖层5贴合紧密，完成电化学测试大卡的生产。其中在丝网印刷第一反应区域形成层3时，可通过丝网印刷方法将疏水性的绝缘材料(如绝缘性的油墨)印在第一绝缘基板1上形成，然后通过激光切割等方式在第一反应区域形成层3上切出分隔开的第一反应区域42、第二反应区域41和第三反应区域43；也可在丝网印刷时，第一绝缘基板1和第二绝缘基板8的部分区域不印刷绝缘材料，从而使得在第一反应区域形成层3上产生分隔开的第二反应区域41、第一反应区域42和第三反应区域43，并且使得在第二反应区域形成层10上产生第四反应区域46。
在第二大卡溶液固定工序中，在完成印刷的第二电极系统和第二反应区域形成层10上进行溶液固定工序，将用于检测第三指标的第二指标反应试剂溶液固定在第二反应区域形成层10的第四反应区域46上。将第二通道形成层11贴在第二反应区域形成层10上，形成的第四反应区域46的宽度为1.0～3.0mm，再将第二上盖层12覆盖在第二通道形成层11上，然后进行滚压以使第二通道形成层11和第二上盖层12贴合紧密，完成第二大卡的生产。其中在丝网印刷第二反应区域形成层10时，可通过丝网印刷方法将疏水性的绝缘材料(如绝缘性的油墨)第二绝缘基板8上形成，然后通过激光切割等方式在第二反应区域形成层10上切出第四反应区域46；也可在丝网印刷时，第二绝缘基板8的部分区域不印刷绝缘材料，从而使得在第二反应区域形成层10上产生第四反应区域46。
在套贴工序中，通过双面胶等粘合剂将第一大卡的第一绝缘基板1与第二大卡的第二绝缘基板8粘贴在一起，然后进行滚压使第一大卡与第二大卡紧密贴合在一起，形成电化学测试大卡。在切割工序中，将电化学测试大卡切割成许多根电化学测试条。
此外，第一反应区域形成层3和第二反应区域形成层10可选为双面胶带或者单面胶带，从而将第一反应区域形成层3和第二反应区域形成层10粘在第一绝缘基板1和第二绝缘基板8上。此外，不论是第一反应区域形成层3，还是第二反应区域形成层10也可由塑料片材支撑，然后在它的一边包被上压敏型粘合剂或者光敏聚合物，其中在超声波的作用下，光敏聚合物结合到绝缘基板上。
在本发明的第二个实施例中，利用一种电化学测试条检测样品中多种指标，其与第一个实施例的差别在于，如图1、图2、图5和图6所示，第一电极系统还包括一对用于检测加入的样品是否充足的电极：第一样品填充电极25和第二样品填充电极26，以及第一反应区域形成层3还具有第一暴露孔44和第二暴露孔45。第一指标参比电极21、第一指标工作电极22、第二指标工作电极23和第二指标对电极24位于第一样品填充电极25和第二样品填充电极26之间，第一样品填充电极25和第二样品填充电极26分别通过第七导电迹线81和第八导电迹线71与设置在第一电连接端7的第七触点78和第八触点75连接在一起。第一样品填充电极25离第一电连接端7的距离最近，第二样品填充电极26离第一电连接端7的距离最远。也可调整第一样品填充电极25和第二样品填充电极26的位置，使得第二样品填充电极26离第一电连接端7的距离最近，第一样品填充电极25离第一电连接端7的距离最远。第一样品填充电极25和第二样品填充电极26由导电材料制成，可通过丝网印刷形成在第一绝缘基板上。
当通过第一加样口601加样时，样品在第一生物传感器100一分为二，向两个相反的方向流动：一部分样品向第一电连接端7流动，流到第一指标参比电极21和第一指标工作电极22；另一部分样品相反的方向流动，流到第二指标工作电极23和第二指标对电极24。当样品加入后，通过检测第一样品填充电极25和第二样品填充电极26之间的诸如电流、电压或阻抗之类的电信号就可以判断流到第一指标参比电极21和第一指标工作电极22的样品和流到第二指标工作电极23和第二指标对电极24的样品是否充足。
第一暴露孔44至少部分暴露第一样品填充电极25，第二暴露孔45至少部分暴露第二样品填充电极26。第一暴露孔44与设置在第一生物传感器100上的第一气孔51在气路上连通，从而促进样品流到第二指标工作电极23和第二指标对电极24。第二暴露孔45与设置在第一生物传感器100上的第二气孔52在气路上连通，从而促进样品流到第一指标参比电极21和第一指标工作电极22。第一通道形成区55的第一部分至少部分暴露着第三反应区域43和第一暴露孔44。第一通道形成区55的第二部分至少部分暴露着第二反应区域41、第一反应区域42和第二暴露孔45。当然，第三反应区域43和第一暴露孔44可以合二为一。此外，第二反应区域41和第一反应区域42也可合二为一，或者仅保留这两者中的一个。
在本发明的第三个实施例中，利用一种电化学测试条检测样品中多种指标，其与第一个实施例的差别在于，如图3～4所示，第二电极系统还设置一个用于检测加入的样品是否充足的第三样品填充电极27；第二反应区域形成层10具有第三暴露孔47。第三样品填充电极27通过第九导电迹线90与第九触点85连接在一起。第三样品填充电极27离第二电连接端13的距离小于第三指标对电极29和第三指标工作电极30离第二电连接端13的距离。第三暴露孔47至少部分暴露第三样品填充电极27。第三暴露孔47在气路上与设置在第二生物传感器101上的第三 气孔53在气路上连通。
当通过第二加样口602加入样品时，样品流入第二生物传感器101，可通过检测第三样品填充电极27与第三指标对电极29或第三指标工作电极30之间的信号判断流到第三指标对电极29和第三指标工作电极30的样品是否充足。
在本发明的第四个实施例中，如图3～5所示，利用一种电化学测试条检测样品中多种指标，其与第一个实施例的差别在于，第二生物传感器的第二电极系统还设置有一对专用的HCT电极28，用于检测样品中的指标：HCT，以校正由于血液样品HCT不同引起的测试差异；设置在第二通道形成层11的一侧上的缺口66与第二通道形成区56的中间部分相连通；第二反应区域形成层10具有第四暴露孔48、第五暴露孔49和第六暴露孔50；第二上盖层12含有第三气孔53和第四气孔54。在所述的一对HCT电极28中，其中的一个HCT电极通过第十导电迹线88与第十触点83连接在一起，另一个HCT电极通过第十一导电迹线92与第十一触点87连接在一起。一对专用的HCT电极28与第三指标对电极29和第三指标工作电极30位于第二加样口602的两边。当然，一对专用的HCT电极28与第三指标对电极29和第三指标工作电极30也可位于第二加样口602的同一边，这时设置在第二通道形成层11的一侧上的缺口66与第二通道形成区56的一端相连通，当然也可与第二通道形成区56的中间部分相连通。
第四暴露孔48和第五暴露孔49各自至少部分暴露一对HCT电极28中的一个。在这个三个暴露孔中，第六暴露孔50与第二电连接端13之间的距离最大，其次为第五暴露孔49，第四暴露孔48与背面电连接端13之间的距离最小。第六暴露孔50位于第三暴露孔49附近，暴露第二绝缘基板8的部分绝缘区域。设置第六暴露孔50的目的在于第六暴露孔50与设置在第二生物传感器101上的第四气孔54在气路上连通，从而促进样品充分覆盖一对HCT电极28。
在制造每个HCT电极28时，每个HCT电极28的中间区域的导电材料分布更为均匀，由此测量到的电信号也更好，因此第五暴露孔49和第六暴露孔50优选地各自暴露每个HCT电极28的中间区域，此外，在组装电化学生物传感器200时，即便第二反应区域形成层10和第二绝缘基板8之间发生相对偏移，也可确保第五暴露孔49和第六暴露孔50暴露的HCT电极面积保持不变，从而确保不同批次的电化学生物传感器200产生的电信号保持一致性。当然，第四暴露孔48、第五暴露孔49和第六暴露孔50可以部分合并在一起，比如第四暴露孔48和第五暴露孔49可以合并在一起，第五暴露孔49和第六暴露孔50也可以合并在一起，甚至第四暴露孔48、第五暴露孔49和第六暴露孔50也可以合并在一起，此外，第四暴露孔48、第五暴露孔49和第六暴露孔50也可与第四反应区域46合并在一起。
缺口66与第二通道形成区56的中间部分相连通，这将会第二通道形成区56分为两个部分，因此当从第二加样口602加入样品后，样品通过缺口66进入第二通道形成层11中时，样品发生分流，一部分流入第二通道形成区56的第一部分，另一部分流入第二通道形成区56的第二部分。流入第二通道形成区56的第一部分的样品通过第四暴露孔48和第五暴露孔49最终流到一对HCT电极28用于检测样品的HCT值，流入第二通道形成区56的第二部分的样品通过第四反应区域46最终流到第三指标对电极29和第三指标工作电极30用于检测第三指标。
第四气孔54位于第二通道形成区56的第一部分的上方，与第二通道形成区56的第一部分和第六暴露孔50在气路上相连通，用于加样时排出第二样品通道中的空气。第三气孔53位于第二通道形成区56的第二部分的上方，与第二通道形成区56的第二部分在气路上相连通，用于加样时排出第二样品通道中的空气。
本实施例的电化学测试条可测量四种指标：第一指标(比如尿素)，由位于第一生物传感器100的第一指标参比电极21和第一指标工作电极22测量；第二指标(比如肌酐)，由位于第一生物传感器100的第二指标工作电极23和第二指标对电极24测量；第三指标(比如尿酸)，由位于第二生物传感器101的第三指标对电极29和第三指标工作电极30测量；HCT，由位于第二生物传感器101的一对HCT电极28测量。这些用于检测尿素、肌酐、尿素和HCT这四种指标的电极在第一生物传感器100和第二生物传感器101的布局还可以根据需要加以调整，比如可让用于检测其中三种指标的电极同时位于第一生物传感器100或第二生物传感器101，让用于检测剩下的一种指标的电极位于第二生物传感器101或第一生物传感器100。此外，本实施例中的一对HCT电极28也可替换为一对检测样品中葡萄糖等分析物的电极。
在本发明的第五个实施例中，利用一种电化学测试条检测样品中多种指标，其与第一个实施例的差别在于，如图8所示，第一生物传感器100和第二生物传感器101共用同一个绝缘基板，即共用第一绝缘基板1，这样做可降低电化学生物传感器200的厚度和制造成本。此外，制备本实施例中的电化学测试条时，大体上如第一实施例中的相同，差别在于在丝网印刷工序中，在第一绝缘基板1的正面和背面分别完成第一电极系统、第一反应区域形成层以及第二电极系统和第二反应区域形成层的印刷。随后再按照第一实施例中的那样进行第一大卡溶液固定工序、第二大卡溶液固定工序、套贴工序和切割工序，从而制备出本实施例中的电化学测试条。
在本发明的第六个实施例中，利用一种电化学测试条检测样品中多种指标，其与第一个实施例的差别在于，如图5和12所示，在第一生物传感器100上，第一绝缘基板1的一侧也设置缺口64，缺口64与缺口61、缺口62和缺口63设于第一生物传感器100的同一侧，并且在位置上对齐，并一起构成第一加样口601；在第二生物传感器101上，第二绝缘基板8的一侧也设置缺口68，缺口68与缺口65、缺口66和缺口67设于第二生物传感器101的同一侧，并且在位置上对齐，并一起构成第二加样口602。第一加样口601和第二加样口602共同构成电化学测试条的加样口6。缺口65的尺寸和缺口61的尺寸相同。
在本发明的第七个实施例中，利用一种电化学测试条检测样品中多种指标，其与第六个实施例的差别在于，如图5和图9～11所示，缺口65的尺寸小于缺口61的尺寸，这有利于样品在第二生物传感器101(特别是第二上盖层12)上的承载，这有利于样品快速流进第一生物传感器100和第二传感器101。当然，缺口65的尺寸也可小于缺口61的尺寸。
当然，针对第一生物传感器100而言，第一上盖层5和第一绝缘基板1均可不设有缺口，或者仅第一上盖层5或第一绝缘基板1设有缺口，或者第一上盖层5和第一绝缘基板1都设有缺口。针对第二生物传感器101而言，第二绝缘基板8和第二上盖层12均可不有置缺口，或者仅第二绝缘基板8或第二上盖层12设有缺口，或者第二绝缘基板8和第二上盖层12都设有缺口。
在本发明的第八个实施例中，利用一种电化学测试条检测样品中多种指标，其与第二个实施例的差别在于，如图13～14所示，在第一生物传感器100的第一绝缘基板1上设置多个扩散组件，其中在第一指标参比电极21的两侧各设置一个扩散组件33，在第一指标工作电极22的一侧设置一个扩散组件33，第一指标工作电极22的另一侧为第一样品填充电极25。优选地，第一样品填充电极25由导电油墨制成，这样第一样品填充电极25还可充当扩散组件的作用。在正面绝缘基板1上设置多个扩散组件的目的在于当将第一指标第一反应试剂溶液添加第二反应区域41和将第一指标第二反应试剂溶液添加到第一反应区域42上时，促进这些反应试剂溶 液在这些反应区域上快速而又均匀地扩散。
也可根据需要仅在第一指标工作电极22和/或第一指标参比电极21的一侧放置至少一个扩散组件。第一反应区域42覆盖着设于第一指标参比电极21两侧或一侧的每个扩散组件的至少一部分。
类似地，也可根据需要在第二指标工作电极23和第二指标对电极24的一侧或两侧设置至少一个扩散组件。类似地，也可根据在第二绝缘基板8上的第三指标对电极29和第三指标工作电极30的一侧或两侧设置至少一个扩散组件。鉴于第三样品填充电极27位于第三指标对电极29的一侧，因此当第三样品填充电极27由导电油墨制成时，第三样品填充电极27也可充当扩散组件的作用。
在本发明的第九个实施例中，利用一种电化学测试条检测样品中多种指标，其与第一个实施例的差别在于，如图5所示，在第一个实施例的基础上，电化学测试条还包括第二个实施例中的第一样品填充电极25、第二样品填充电极26、第一暴露孔44和第二暴露孔45，第三个实施例中的第三样品填充电极27和第三暴露孔47，第四个实施例中的一对专用的HCT电极28、第四暴露孔48、第五暴露孔49和第六暴露孔50，第八个实施例中的辅助扩散组件；第一绝缘基板1的一侧也设置缺口64和第二绝缘基板8的一侧也设置缺口68，缺口65的尺寸小于缺口61的尺寸。第二通道形成区56的第一部分至少部分暴露着第四反应区域46和第三暴露孔47。第二通道形成区56的第二部分至少部分暴露着第四暴露孔48、第五暴露孔49和第六暴露孔50。
缺口66将第二通道形成区56分为两部分，第二样品通道也相应地分为两部分，第二样品通道的第一部分用于给一对HCT电极28提供样品，可用于检测样品的HCT值；第二样品通道的第二部分用于给第三指标对电极29和第三指标工作电极30提供样品，溶解第四反应区域46中的反应试剂，并发生反应，从而产生电信号。第四气孔54位于第二样品通道的第一部分的上方，与第二样品通道的第一部分和第六暴露孔50在气路上相连通，用于加样时排出第二样品通道的第一部分中的空气。第三气孔53位于第二样品通道的第二部分的上方，与第二样品通道的第二部分和第三暴露孔47在气路上相连通，用于加样时排出第二样品通道的第二部分中的空气。
在本发明的第十个实施例中，利用一种电化学测试条检测样品中多种指标，其与第八个实施例的差别在于，如图14和15所示，电化学测试条还含有亲水元件。当样品流到第一通道形成区上，样品会发生分流，发生分流的位置为分流点。在分流点处，一部分样品流向第二指标工作电极23、第二指标对电极24和第一样品填充电极26，还有一部分样品流向第一指标参比电极21、第一指标工作电极22和第二样品填充电极25，在第一绝缘基板1上设置位于样品分流点或附近的第一亲水元件31和第二亲水元件32，第一亲水元件31和第二亲水元件32可由亲水性材料制成。第二指标工作电极23、第二指标对电极24和第一指标参比电极21、第一指标工作电极22位于样品分流点的两边，并且第二指标工作电极23、第二指标对电极24和第一指标参比电极21、第一指标工作电极22距离样品分流点的距离大于第一亲水元件31和第二亲水元件32距离样品分流点的距离。第一亲水元件31和第二亲水元件32之间、第一亲水元件31与第二指标工作电极23或第二指标对电极24以及第二亲水元件32与第二指标对电极24或第二指标工作电极23之间均用疏水性的绝缘区域隔开，这样的设计可避免分流后的样品之间相互干扰，同时第一亲水元件31和第二亲水元件32的设计有助于样品更快速流入第一生物传感器100的第三反应区域43、第二反应区域41和第一反应区域42及其暴露的电极。也可设置更多个亲水元件，也可仅设置一个亲水元件。
就第二生物传感器101而言，当样品流到第二绝缘基板8上，样品会发生分流，一部分样品流向一对HCT电极28，还有一部分样品流向第三指标对电极29、第三指标工作电极30和第三样品填充电极27，优选地，如图15所示，也可在背面绝缘基板8的样品分流点或附近设置相应的一个或多个亲水元件，比如设置两个亲水元件：第三亲水元件34和第四亲水元件35，第三亲水元件34和第四亲水元件35的材料和位置设置与第一绝缘基板1上的第一亲水元件31和第二亲水元件32相类似。
在本发明的第十一个实施例中，利用一种电化学测试条检测样品中多种指标，其与第一个实施例的差别在于，如图16所示，在第二绝缘基板8上还设置可导电的自动开机触点93，自动开机触点93位于第二电连接端13，当电化学测试条以正确的方向插入检测仪器的电连接器时，自动开机触点93可与检测仪器之间形成一个闭合电路，从而让检测仪器自动开机；当电化学测试条反向插入时，自动开机触点93不能与检测仪器之间形成一个闭合电路，就不能让检测仪器自动开机，这样也就不能对电化学测试条进行检测，因此设置自动开机触点93可帮助检测仪器识别电化学测试条的正反面，防止插错，以及防止其他不配套的电化学测试条的插入。也可在第一绝缘基板1上设置一个位于第一电连接端7的自动开机触点，或者同时第一绝缘基板1和第二绝缘基板8上各设置一个这样的自动开机触点，只有当电化学测试条与之配套的检测仪器配套使用时，检测仪器才能自动开机。
在本发明的第十二个实施例中，其与第一个实施例的相同点在于第一上盖层和第二上盖层都是透明的，这样即便在电化学测试条组装完成后，也可以观察到第一绝缘基板1和第二绝缘基板8的颜色，其与第一个实施例的差别在于，可通过让第一绝缘基板1和第二绝缘基板8用不同颜色的绝缘材料制成，这样可通过观察第一绝缘基板1和第二绝缘基板8的颜色区分电化学测试条的正反面，也就是可以区分第一生物传感器100和第二生物传感器101，从而防止将电化学测试条反向插入到检测仪器中。第一上盖层和第二上盖层也可以是不透明的，这时可通过让第一上盖层和第二上盖层用不同颜色的绝缘材料制成，这样可通过观察第一上盖层和第二上盖层的颜色区分电化学测试条的正反面，也就是可以区分第一生物传感器和第二生物传感器，从而防止将电化学测试条反向插入到检测仪器中。
在本发明中，每一种电极系统由任何导电材料制成，如碳膜、金、银、锡氧化物/金、铂、其他的贵金属或它们的氧化物。第一上盖层面向第一通道形成层的表面和第二上盖层面向第二通道形成层的表面涂布上一层亲水性材料。亲水组件由亲水性材料制成。本发明所提及的亲水性材料可选自淀粉、多糖、纤维素类分子、聚丙烯酸、聚丙烯酞胺、聚乙烯醇、聚氨酷、聚酞胺和碳油墨。亲水组件优选为碳油墨。
在电化学测试条上设有用于区分电化学测试条的正反面的标识物，标识物为可导电的自动开机触点、带颜色的绝缘材料、文字、字母和图形等。可以合理推导的是，根据本发明的十二个实施例，可以将本发明的第二个实施例、第三个实施例、第四个实施例、第五个实施例、第六个实施例、第七个实施例、第八个实施例、第十个实施例、第十一个实施例和第十二个实施例中的至少一种与本发明的第一个实施例结合在一起。
根据测试需要，本发明的电化学测试条也可用于检测样品中的两种或两种以上的指标，所述两种或两种以上的指标选自葡萄糖、胆固醇、血红蛋白、糖化血红蛋白、尿酸、尿素、肌酐、胆红素、酮体、HCT和pH值等。比如，第一生物传感器可检测血糖的电极系统和检测尿素的电极系统，第一生物传感器可检测胆固醇的电极系统和检测酮体的电极系统。
实施例1 反应试剂
以第九实施例的电化学测试条为例进行说明，电化学测试条以第一指标参比电极21和第一指标工作电极22通过电势测量法检测样品中的尿素，第二指标工作电极23和第二指标对电极24通过电流测量法检测样品中的肌酐，第三指标对电极29和第三指标工作电极30通过电流测量法检测样品中的尿酸进行说明。
为了检测尿素，第一反应区域形成层3的第二反应区域41含有的第一指标第一反应试剂包括0.05～0.5M PBS(pH 5.8～8.0)，甲基纤维素0.1～10％(w/w)，Triton X-100 0.1％～1.0％(v/v)，脲酶(2280～8712U/mL)，第一反应区域形成层3的第一反应区域42含有的第一指标第二反应试剂包括0.05-0.5M PBS(pH 5.8～8.0),甲基纤维素0.1～10％(w/w)，Triton X-100 0.1％～1.0％(v/v)，钌化合物、铁氰化钾或亚铁氰化钾1.0～4.5％(w/w)。
为了检测肌酐，第一反应区域形成层3的第三反应区域43含有的第二指标反应试剂包括0.05～0.5M PBS(pH 5.8～8.0)，聚合物粘合剂如甲基纤维素0.1～10％(w/w)，蔗糖0.25％～1％(w/w)，Triton X-100 0.1％～1％(v/v)，肌酐酶(500～5000U/mL)，肌酸酶(500～5000U/mL)，肌氨酸氧化酶(500～5000U/mL)，钌化合物、铁氰化钾或亚铁氰化钾1.0～4.5％(w/w)。
为了检测尿酸，第二反应区域形成层3的第四反应区域46含有的第三指标反应试剂包括0.05～0.5M PBS(pH 5.8～8.0)，聚合物粘合剂如甲基纤维素0.1～10％(w/w)，海藻糖0.25％～1％(w/w)，Triton X-100 0.1％～1.0％(v/v)，钌化合物、铁氰化钾或亚铁氰化钾2.0～10％(w/w)。
实施例2 临床样品检测
以实施例1中的电化学测试条检测临床血液样品中的尿素、肌酐和尿酸水平。
当第一生物传感器100和第二生物传感器101组装在一起时，通过加样口6加入样品后，一部分样品流入第一生物传感器100，通过缺口61和缺口62进入第一通道形成区55，缺口62将第一通道形成区55分为两个部分，因此，这时进入第一通道形成区55的样品发生分流，一部分样品流入第一通道形成区55的第一部分，另一部分样品流入第一通道形成区55的第二部分。流入第一通道形成区55的第一部分的样品通过第三反应区域43最终流到第二指标工作电极23和第二指标对电极24，流入第一通道形成区55的第二部分的样品通过第二反应区域41和第一反应区域42最终流到第一指标参比电极21和第一指标工作电极22。流入第二生物传感器101的那一部分样品，通过缺口65和缺口66进入第二通道形成区56，缺口66将第二通道形成区56分为两个部分，流入第二通道形成区56的样品一部分流入第二通道形成区56的第一部分，另一部分流入第二通道形成区56的第二部分。流入第二通道形成区56的第一部分的样品通过第四暴露孔48和第五暴露孔49最终流到一对HCT电极28，流入第二通道形成区56的第二部分的样品通过第四反应区域46最终流到第三指标对电极29和第三指标工作电极30。
在测试之前，将让电化学测试条插入到一种检测仪器的电连接器中，让电化学测试条的第一生物传感器和第二生物传感器和这种检测仪器的电连接器进行电连接，然而在加入样品一段时间后，检测样品中的尿素、肌酐和尿酸。
加入血液样品后，样品中的尿素与第一指标第一反应试剂、第一指标第二反应试剂发生反应，第一指标参比电极和第一指标工作电极之间所产生的电势信号与样品中的尿素浓度成正比，因此采用电位法测量尿素浓度，测试时间为3s～100s，这种检测仪器可将检测到的电位信号转换为相应的尿素浓度值。加入血液样品后，样品中的肌酐与第二指标反应试剂发生反应，施加电压后产生的电流信号与样品中的肌酐浓度成正比，因此采用安培电流法测量，测试时间为3s～ 100s，这种检测仪器可将检测到的电流信号转换为相应的肌酐浓度值。加入血液样品后，样品中的尿酸与第三指标反应试剂发生反应，施加电压后产生的电流信号与样品中的尿酸浓度成正比，因此采用安培电流法测量，测试时间为2s～100s，这种检测仪器可将检测到的电流信号转换为相应的尿酸浓度值。
另外，电化学测试条还含有一对专用的HCT电极，可用于测量血液样品的HCT值，而且所测量的HCT值可同时用于对测量的尿素、肌酐和尿酸浓度进行校正，使得测量结果更准确性。
取临床血液样品，利用本发明的电化学测试条和利用迈瑞BS‐350E型全自动生化分析仪检测的血浆进行检测，尿素检测结果如表1和图17所示，肌酐检测结果如表2和图18所示，尿酸检测结果如表3和图19所示。
表1.尿素线性研究结果
Figure PCTCN2021071526-appb-000001
如表1和图17所示，尿素线性研究结果得出，线性相关系数R 2＝0.99549,R＝0.99774,线性方程斜率也均在0.90至1.10之间，表明肌酐在3～43mmol/L浓度范围内具较好的线性相关性，且在此浓度区间具有很好的检测准确度，与血浆尿素生化值的偏差均在10％以内。
表2.肌酐线性研究结果
Figure PCTCN2021071526-appb-000002
如表2和图18所示，肌酐线性研究结果得出，线性相关系数R 2＝0.99722,R＝0.99861,线性方程斜率也均在0.90至1.10之间,表明肌酐在35‐995μmol/L浓度范围内具较好的线性相关性，且在此浓度区间具有很好的检测准确度，与血浆肌酐生化值的偏差均在10％以内。
表3.尿酸线性研究结果
Figure PCTCN2021071526-appb-000003
如表3和图19所示，尿酸线性研究结果得出，线性相关系数R 2＝0.99939,R＝0.99969,线性方程斜率也均在0.90至1.10之间,表明尿酸在120～1313μmol/L浓度范围内具较好的线性相关性，且在此浓度区间具有很好的检测准确度，与血浆尿酸生化值的偏差均在10％以内。

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  1. 一种用于多种指标检测的电化学测试条，包括第一生物传感器，所述第一生物传感器包括绝缘基板、设置在绝缘基板上的第一电极系统、第一通道形成层和第一上盖层，第一通道形成层上设有第一通道形成区，第一通道形成区位于第一电极系统的电极之上，其特征在于，还包括第二生物传感器，所述第二生物传感器包括绝缘基板，设置在绝缘基板上的第二电极系统、第二通道形成层和第二上盖层，第二通道形成层上设有第二通道形成区，第二通道形成区位于第二电极系统的电极之上；所述第一生物传感器和第二生物传感器分别位于电化学测试条的正面和反面，并且第一生物传感器的电连接端和第二生物传感器的电连接端位于电化学测试条的同一端；所述电化学测试条的加样口分别与第一生物传感器的第一通道形成区和第二生物传感器的第二通道形成区连通。
  2. 根据权利要求1所述的电化学测试条，其特征在于，第一电极系统包括用于测量第一指标的电极系统和用于测量第二指标的电极系统。
  3. 根据权利要求2所述的电化学测试条，其特征在于，第二电极系统包括用于测量第三指标的电极系统。
  4. 根据权利要求3所述的电化学测试条，其特征在于，第二电极系统还包括用于测量第四指标的电极系统。
  5. 根据权利要求2所述的电化学测试条，其特征在于，所述测量第一指标的电极系统和用于测量第二指标的电极系统分别位于加样口的两侧。
  6. 根据权利要求4所述的电化学测试条，其特征在于，所述测量第三指标的电极系统和用于测量第四指标的电极系统分别位于加样口的两侧。
  7. 根据权利要求1至6之一所述的电化学测试条，其特征在于，第一生物传感器和第二生物传感器共用一个绝缘基板，或第一生物传感器和第二生物传感器分别包括一个绝缘基板。
  8. 根据权利要求1至6之一所述的电化学测试条，其特征在于，第一生物传感器的绝缘基板和第一通道形成层之间设有第一反应区域形成层，和/或第二生物传感器的绝缘基板和第二通道形成层之间设有第二反应区域形成层。
  9. 根据权利要求1至6之一所述的电化学测试条，其特征在于，所述加样口包括第一上盖层的缺口和第二上盖层的缺口。
  10. 根据权利要求9所述的电化学测试条，其特征在于，第一上盖层的缺口和第二上盖层的缺口位于电化学测试条的同一侧且在位置上对齐，第一上盖层的缺口比第二上盖层的缺口大。
  11. 根据权利要求1所述的电化学测试条，其特征在于，所述电化学测试条还设有一个区分电化学测试条正反面的标识物。
  12. 根据权利要求11所述的电化学测试条，其特征在于，所述标识物为可导电的自动开机触点，设于第一生物传感器的绝缘基板和第二生物传感器的绝缘基板中的至少一个。
  13. 根据权利要求1所述的电化学测试条，其特征在于，所述标识物为带颜色的绝缘材料，当所述第一上盖层和所述第一上盖层透明时，所述第一生物传感器的绝缘基板朝向第一通道形成层的一面和所述第二生物传感器的绝缘基板朝向第二通道形成层的一面由不同颜色的材料制成，当所述第一上盖层和所述第二上盖层不透明时，所述第一上盖层和所述第二上盖层由不同颜色的材料制成。
  14. 根据权利要求1至13之一所述的电化学测试条，其特征在于，所述电化学测试条用于测定中葡萄糖、胆固醇、血红蛋白、糖化血红蛋白、尿酸、尿素、肌酐、胆红素、酮体、HCT、pH值中的至少两项指标。
  15. 一种检测多种指标的方法，包括提供权利要求1至14之一所述的电化学测试条。
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