Detection test piece with multiple electrochemical reaction blocks

Abstract

The invention discloses a detection test piece with multiple electrochemical reaction blocks, which is provided with a plurality of electrochemical reaction blocks which share one sampling channel and a structure capable of inhibiting medium substance diffusion and mutual interference in each reaction block, and comprises a plurality of detection electrodes, a first reaction region and a second reaction region, the detection electrode in the first reaction zone is used for measuring hematocrit ratio data of the analyte specimen, the detection electrode in the second reaction zone is used for reading reaction data generated by the analyte specimen and the electrochemical medium, and a detection instrument is provided for calculating the two kinds of data for data compensation, so that the concentration of the analyte is corrected, and the detection accuracy of the analyte specimen is improved. The problem of deviation of measurement data of a detection instrument caused by different hematocrit ratios of individuals is avoided, and a correct actual value of the analyte concentration is presented.

Description

Technical Field

[0001] The present invention relates to a test strip for detecting body fluids, and more particularly to a test strip having a plurality of electrochemical reaction blocks but sharing a sampling channel, and capable of inhibiting diffusion of medium substances in each reaction block and mutual interference. Background Art

[0002] In the test strips of the prior art, two test objects are placed in the same channel. When the liquid test object flows in, the electrochemical medium in the front reaction area will dissolve and then flow to the rear reaction area. After the liquid test object fills each reaction area, the electrochemical medium in the rear reaction area will diffuse to the front reaction area, thus causing mutual interference in measurement.

[0003] Later, improved products were introduced, such as Fig. 9 The electrochemical mediator is coated on the two bifurcated channels, but it still flows to other reaction areas when it is not dry. When the liquid sample fills each reaction area, the electrochemical mediators in both reaction areas will diffuse to other reaction areas, which still causes the problem of mutual interference in measurement.

[0004] In addition, the current analyte concentration test is interfered with by the difference in hematocrit ratio. For example, a high hematocrit ratio in an infant will cause the measured blood glucose value to be too low; a low hematocrit ratio in a hemodialysis patient will cause the measured blood glucose value to be too high. The difference in this numerical range is also affected by age, gender, diet, physiology, etc.

[0005] In clinical practice, the measurement of body fluids (such as blood) is performed using a large biochemical testing machine in a clinical biochemical laboratory. After centrifugation, plasma is obtained for testing to avoid interference with the test results caused by differences in the hematocrit ratio of whole blood. However, such instruments must be used in specific medical institutions, which limits the location of testing. When using a handheld testing instrument (biosensor) that is easy for individuals to use and a disposable body fluid test strip (strip), when doing whole blood sampling testing, due to individual differences in hematocrit ratio, it is easy to cause deviations in test data. Summary of the invention

[0006] In view of the problems existing in the prior art, the present invention provides a test strip with multiple electrochemical reaction blocks, which solves the problem in the prior art that when performing sample testing, after the liquid sample fills the reaction areas of the test strip, the electrochemical media in each reaction area will diffuse with each other, which easily causes mutual interference in measurement; and due to individual differences in hematocrit ratio, the existing handheld detection instrument combined with the test strip is prone to cause deviation in detection data during detection.

[0007] To solve the above problems, the present invention provides a test strip for a multi-electrochemical reaction block of a body fluid, comprising a substrate, the substrate comprising a first wire, a second wire, and a third wire, which are formed on the substrate in parallel and spaced from each other; a first contact electrode is provided at one end of the first wire, a first detection electrode is provided at the other end of the first wire, a second contact electrode is provided at one end of the second wire, and a second detection electrode is provided at the other end of the second wire; a third contact electrode is provided at one end of the third wire, and a third detection electrode is provided at the other end of the third wire; A first spacer layer, one side of which is provided with a hollowed-out first reaction zone and a second reaction zone; a second spacer layer, one side of which is provided with a hollowed-out flow guide groove, one side of which is provided with an inlet, the second spacer layer is combined with the top of the first spacer layer, and the flow guide groove is correspondingly connected to the first reaction zone and the second reaction zone; The first spacer layer is combined with the upper sides of the first wire, the second wire and the third wire, the first detection electrode and the third detection electrode extend into the first reaction area; the second detection electrode and the third detection electrode extend into the second reaction area and are coated with at least one layer of the first electrochemical medium, and the first reaction area and the second reaction area are not connected to each other; An upper cover layer, the upper cover layer comprising a first pore and a second pore, the upper cover layer is combined with the second spacer layer, the first pore is correspondingly connected to the first reaction zone and the guide groove, and the second pore is correspondingly connected to the second reaction zone and the guide groove; Portions of the first contact electrode, the second contact electrode and the third contact electrode located on one side of the substrate are exposed portions.

[0008] Furthermore, the shape of the guide groove corresponds to the first reaction zone and the second reaction zone. The guide groove includes a first groove extending from one side of the inlet and a second groove extending from the other side of the inlet. The first groove is correspondingly connected to the first reaction zone, the second groove is correspondingly connected to the second reaction zone, the first pore is correspondingly connected to the first groove and the first reaction zone, and the second pore is correspondingly connected to the second groove and the second reaction zone.

[0009] Furthermore, the substrate further includes a fourth wire and a fifth wire, which are formed on the substrate in a spaced manner and parallel to the first wire, the second wire and the third wire; a fourth contact electrode is provided at one end of the fourth wire, and a fourth detection electrode is provided at the other end of the fourth wire; a fifth contact electrode is provided at one end of the fifth wire, and a fifth detection electrode is provided at the other end of the fifth wire; A third reaction area and a fourth reaction area are hollowed out on one side of the first spacing layer. The third reaction area and the fourth reaction area are arranged parallel to and spaced between the first reaction area and the second reaction area. The fourth detection electrode and the third detection electrode extend into the third reaction area and are coated with a layer of a second electrochemical medium. The fifth detection electrode and the third detection electrode extend into the fourth reaction area and are coated with a layer of a third electrochemical medium. The third reaction area, the fourth reaction area, the first reaction area and the second reaction area are not connected to each other. The guide groove of the second spacer layer also includes a third groove and a fourth groove, the third groove and the fourth groove are formed between the first groove and the second groove, the third groove and the fourth groove are respectively connected to the inlet, the first groove and the second groove, the third groove is correspondingly connected to the third reaction zone, and the fourth groove is correspondingly connected to the fourth reaction zone; The upper cover layer further includes a third air hole and a fourth air hole, wherein the third air hole is connected to the third reaction zone and the third groove, and the fourth air hole is connected to the fourth reaction zone and the fourth groove; The portions of the fourth contact electrode and the fifth contact electrode located at one side of the substrate are exposed portions.

[0010] Furthermore, the first groove to the fourth groove and / or the first reaction zone to the fourth reaction zone are rectangular or polygonal.

[0011] Furthermore, the first reaction zone forms a first extension section on a side close to the introduction port, and the second reaction zone forms a second extension section on a side close to the introduction port.

[0012] Furthermore, the front end of the introduction port is shaped like a protruding, flat or concave structure.

[0013] Furthermore, a protruding structure is formed at the front end of the introduction port, the substrate forms a first sampling protrusion on one side of the introduction port, the first spacing layer forms a second sampling protrusion on one side of the introduction port, and the upper cover layer forms a third sampling protrusion on one side of the introduction port. The first sampling protrusion and the second sampling protrusion are stacked on the lower side of the introduction port, and the third sampling protrusion is on the upper side of the introduction port.

[0014] Furthermore, a concave structure is formed at the front end of the inlet, the substrate forms a first V-shaped sampling port on one side of the inlet, the first spacing layer forms a second V-shaped sampling port on one side of the inlet, and the upper cover layer forms a third V-shaped sampling port on one side of the inlet. The third V-shaped sampling port is on the upper side of the inlet, and the first V-shaped sampling port and the second V-shaped sampling port are stacked on the lower side of the inlet.

[0015] Furthermore, it is characterized in that: the first wire is an AC potential signal wire, the second wire, the third wire, the fourth wire and / or the fifth wire are DC circuit wires, and the first detection electrode and the third detection electrode of the AC potential signal inside the first reaction area are hematocrit detection points.

[0016] Furthermore, the first detection electrode and the third detection electrode of the AC potential signal inside the first reaction area are hematocrit detection points, and the detection test strip also includes a plurality of independent reaction areas, each coated with a different electrochemical mediator.

[0017] The beneficial effects of the present invention are: 1. The present invention has multiple electrochemical reaction blocks but shares a sampling channel, and can suppress the diffusion of media substances in each reaction block and the structure of mutual interference. The present invention is used to compensate for the interference caused by the difference in the hematocrit ratio of the analyte on the test results. In addition, the detection test strip with multiple electrochemical reaction blocks in the present invention can provide a detection instrument to read the hematocrit (Hct) data obtained in the first reaction area, and the uncorrected analyte concentration in the second reaction area, and then correct the analyte concentration detection data deviation according to the hematocrit ratio to present truly correct specimen analysis concentration data. At the same time, one test strip in the present invention can simultaneously detect multiple test items of the specimen.

[0018] 2. The thickness of the stack of the substrate, the first spacer layer and its first reaction zone, the second reaction zone, the second spacer layer and its flow guide groove, and the upper cover layer in the present invention forms a channel for sample siphoning and diversion from the inlet. The test strip of the present invention has multiple electrochemical reaction zones but shares a sampling channel, and can suppress the diffusion of media substances in each reaction zone and the structure of mutual interference. The sample can be injected into the first reaction zone and the second reaction zone through this channel and contact the detection electrode. The first reaction zone and the second reaction zone are not connected to each other, and the exposed parts of the first contact electrode, the second contact electrode and the third contact electrode are used to be electrically connected to the detection instrument (such as a blood glucose meter, etc.). The first reaction zone can provide the detection instrument (such as a blood glucose meter, etc.) with hematocrit data, which can avoid, for example, blood glucose electrochemical mediator enzymes from diffusing from another reaction zone, so that accurate hematocrit and second reaction zone analyte concentration detection data can be obtained, and the two data are used to compensate for the deviation correction of data to present truly correct sample analysis concentration data.

[0019] 3. The present invention is a test strip with multiple electrochemical reaction blocks, wherein in addition to the first reaction zone as the detection electrode for hematocrit, there can also be multiple reaction zones, for example, three independent reaction zones, each coated with an electrochemical medium of total cholesterol, triglyceride, and high-density lipoprotein cholesterol, for measuring individual values, and the detection instrument calculates low-density lipoprotein cholesterol using a formula. Because the present invention avoids the interference of the diffusion of the medium, the instrument can obtain accurate total cholesterol, triglyceride, and high-density lipoprotein cholesterol values, so the low-density lipoprotein cholesterol value can be accurately calculated. BRIEF DESCRIPTION OF THE DRAWINGS

[0020] The present invention is further described in detail below with reference to the accompanying drawings and specific embodiments.

[0021] Figure 1 A schematic diagram of an embodiment of the present invention; Figure 2 For the present invention Figure 1 An exploded view of an embodiment; Figure 3 It is a schematic diagram of another embodiment of the present invention; Figure 4 For the present invention Figure 3 An exploded view of an embodiment; Figure 5 A schematic diagram of another different embodiment of the present invention; Figure 6 For the present invention Figure 5 An exploded view of an embodiment; Figure 7 A reference example of deviation values ​​of data obtained from a test piece in the prior art without data compensation; Figure 8 This is an application example of the more accurate value of the data obtained by the test piece of the present invention after data compensation; Fig. 9 The figure is an exploded view of a test strip in the prior art.

[0022] Description of Reference Numerals 1 substrate 10First conductor 101 first detection electrode 102 first contact electrode 11 Second wire 111 second detection electrode 112 second contact electrode 12Third wire 121 third detection electrode 122 third contact electrode 13 Fourth wire 131 fourth detection electrode 132 fourth contact electrode 14 Fifth Wire 141 fifth detection electrode 142 fifth contact electrode 15 First sampling flange 17 The first V-shaped sampling port 20 First spacer layer 201 First Reaction Zone 2011 First extension 202 Second reaction zone 2021 Second Extension 203 Third reaction zone 204 Fourth Reaction Zone 21 Second sampling flange 23 Second V-shaped sampling port 30 Second spacer layer 31 diversion groove 310 First Slot 311 Second Slot 313 Third Slot 314 Fourth Slot 33 Import port 331 protruding structure 333 concave structure 40 Upper cover 401 First Air Hole 402 Second Air Hole 403 Third air hole 404 Fourth air hole 41 Third sampling flange 43 The third V-shaped sampling port 51 first electrochemical mediator 52 second electrochemical mediator 53 A third electrochemical mediator. DETAILED DESCRIPTION

[0023] The preferred embodiment of the detection strip of the multi-electrochemical reaction block of the present invention is described in detail as follows with reference to the accompanying drawings. Figure 3 The detection strip of the multi-electrochemical reaction block of the present invention comprises: a substrate 1, a layer of conductive material such as carbon is combined on the substrate 1 to form a plurality of transmission wires, which are used to define: a first wire 10, a second wire 11, and a third wire 12, wherein the first wire 10, the second wire 11, and the third wire 12 are formed on the substrate 1 in parallel with each other at intervals; A first contact electrode 102 is provided at one end of the first wire 10, and a first detection electrode 101 is provided at the other end of the first wire 10; a second contact electrode 112 is provided at one end of the second wire 11, and a second detection electrode 111 is provided at the other end of the second wire 11; a third contact electrode 122 is provided at one end of the third wire 12, and a third detection electrode 121 is provided at the other end of the third wire 12; The first contact electrode 102, the second contact electrode 112 and the third contact electrode 122 are used to be electrically connected to a detection instrument (such as a blood glucose meter, etc.); In the embodiment, the first wire 10 is used as a hematocrit detection wire to measure the hematocrit (Hct). The first wire 10 is, for example, an AC potential signal wire, and the second wire 11 and the third wire 12 are, for example, DC potential signal wires. The second wire 11 can be used as a detection working wire for a first analyte, such as blood glucose concentration. A first spacer layer 20, one side of which is provided with a first reaction area 201 and a second reaction area 202 which are hollowed out. The first reaction area 201 and the second reaction area 202 defined by the hollowing out are not connected to each other in the embodiment; A second spacer layer 30, a hollow guide groove 31 is provided on one side of the second spacer layer 30, an inlet 33 is provided on one side of the guide groove 31, the second spacer layer 30 is combined on the top of the first spacer layer 20, and the guide groove 31 corresponds to the first reaction zone 201 and the second reaction zone 202; The first spacing layer 20 is combined on the upper side of the first wire 10, the second wire 11 and the third wire 12. The first detection electrode 101 and the third detection electrode 121 partially extend into the first reaction area 201. In the embodiment, the first wire 10 is used as an AC potential signal wire, wherein the first detection electrode 101 inside the first reaction area 201 and the third detection electrode 121 of the third wire 12 are used as hematocrit (Hct) detection points to measure the hematocrit (Hct). The first reaction area 201 does not need to be coated with an electrochemical medium; the second detection electrode 111 and the third detection electrode 121 partially extend into the second reaction area 202, and coated with at least one layer of first electrochemical mediator 51 (such as enzymes and other reaction reagents or electronic mediators, etc.), for detecting the concentration of the first analyte (such as blood sugar), the first reaction area 201 and the second reaction area 202 are not connected to each other, the first detection electrode 101 and the second detection electrode 111 are used as working electrodes, and the third detection electrode 121 is used as a reference electrode. The design area of ​​the reaction area of ​​the present invention can be reduced, and the various enzyme reaction reagents of the electrochemical mediator coated on the corresponding detection electrode and reference electrode on the upper side of the substrate 1 can be controlled to be appropriate, not too much, so that the biological reaction data of the specimen can be more accurate; An upper cover layer 40 includes a first pore 401 and a second pore 402. The upper cover layer 40 is combined on the second spacer layer 30. The first pore 401 corresponds to connecting the first reaction zone 201 and the guide groove 31, and the second pore 402 corresponds to connecting the second reaction zone 202 and the guide groove 31, thereby forming an exhaust channel function. The first pore 401 can generate a capillary siphon effect of airflow on the first reaction zone 201, the guide groove 31 and the inlet 33, and the second pore 402 can generate a capillary siphon effect of airflow on the second reaction zone 202, the guide groove 31 and the inlet 33.

[0024] The lengths of the first spacer layer 20, the second spacer layer 30 and the upper cover layer 40 are shorter than the substrate 1. The first contact electrode 102, the second contact electrode 112 and the third contact electrode 122 located on one side of the substrate 1 are exposed portions, which are used to electrically connect to a detection instrument (such as a blood glucose meter, etc.).

[0025] Thus, the stacked thickness of the substrate 1, the first spacer layer 20 and its first reaction zone 201, the second reaction zone 202, the second spacer layer 30 and its guide groove 31, and the upper cover layer 40 forms a channel for siphoning and diverting the specimen from the inlet 33. The test strip of the present invention has multiple electrochemical reaction zones but only shares one sampling channel, and at the same time can suppress the diffusion of the medium substances in each reaction zone and the structure of mutual interference. The specimen can be injected into the first reaction zone 201 and the second reaction zone 202 through this channel and contact the detection electrode.

[0026] When performing the test, in the embodiment, for example, analyzing the blood sugar concentration, the first wire 10 is a hematocrit (Hct) detection wire, used to measure the hematocrit (Hct). In one embodiment, the first wire 10 is, for example, an AC potential signal wire, and the second wire 11 and the third wire 12 are, for example, DC potential signal wires; The first detection electrode 101 of the first wire 10 and the third detection electrode 121 of the third wire 12 of the AC potential signal in the inner part of the first reaction area 201 are used as detection points of the hematocrit to measure the hematocrit.

[0027] The second detection electrode 111 and the third detection electrode 121 inside the second reaction area 202 are coated with at least one layer of a first electrochemical medium 51 (such as various reaction reagents such as special enzymes for blood sugar detection) for a specific test item according to different test items; The specimen sample is, for example, blood. Each individual's blood has a different hematocrit. The user utilizes the inlet 33 of the test strip of the multi-electrochemical reaction block of the present invention to contact and collect the blood. Through the exhaust function of the first air hole 401 and the second air hole 402, the blood can be quickly and effectively capillary-siphoned into the guide groove 31 and the hematocrit detection point formed on the inner side of the first reaction zone 201 from the inlet 33 of the test strip of the multi-electrochemical reaction block. The first detection electrode 101 and the third detection electrode 121 contact the AC potential signal wire to measure the hematocrit, which can prevent the electrochemical mediator enzyme, such as blood sugar, from diffusing from another reaction zone, so that an accurate hematocrit can be obtained. The specimen blood is capillary-siphoned into the second reaction zone 202 to contact the first electrochemical mediator 51, the second detection electrode 111 and the third detection electrode 121, and a redox reaction is generated to generate an electronic signal. The above-mentioned multiple electrochemical reaction zones share a sampling channel, and the diffusion of the mediators in each reaction zone and the mutual interference can be suppressed.

[0028] Thus, the test strip of the multi-electrochemical reaction block is inserted into a detection instrument (such as a blood glucose meter), and the first contact electrode 102, the second contact electrode 112 and the third contact electrode 122 are respectively electrically connected to the detection instrument (such as a blood glucose meter) to generate corresponding electrical reactions to measure blood. For example, the first conductor 10 of the AC potential signal reads the AC potential signal of the blood sample in the first reaction area 201, and blood samples with different hematocrit ratios can be measured. The measured hematocrit ratio is read by the detection instrument (such as a blood glucose meter) to read the measured data, and at the same time, the blood sample (such as blood glucose) in the second reaction area 202 is read. After the special enzyme in contact with the first electrochemical medium 51 generates an oxidation-reduction reaction, a DC potential signal is generated to monitor the change of its current value or resistance value for detection, and the measured value is compensated by the hematocrit correction. By measuring the data difference of different hematocrit ratios, it is used as the basis for the correction of the analyte concentration measured by the detection instrument. The two data are compensated to present the true correct value (value / L Data), so that the detection instrument, such as a blood glucose meter, can obtain the final calibrated actual value (correct value) of blood glucose concentration after calibration. In some other embodiments, such as using circuit mechanisms of different designs, the detection method may include other changes, such as using current, capacitance, voltage, resistance or other electrical forms for measurement.

[0029] See also Figure 1 , Figure 2, an embodiment of a test strip of a multi-electrochemical reaction block of the present invention, wherein the shape of the guide groove 31 corresponds to the first reaction zone 201 and the second reaction zone 202, the guide groove 31 extends from one side of the introduction port 33 to form a first groove 310 and extends from the other side of the introduction port 33 to form a second groove 311, the first groove 310 is correspondingly connected to the first reaction zone 201, the second groove 311 is correspondingly connected to the second reaction zone 202, the first groove 310 and the second groove 311 are connected to each other through the introduction port 33, the first pore 401 is correspondingly connected to the first groove 310 and the first reaction zone 201, and the second pore 402 is correspondingly connected to the second groove 311 and the second reaction zone 202. The above configuration may include other changes, such as the first groove 310 and the second groove 311 are respectively connected to different introduction ports, using different connecting channels.

[0030] See also Figure 1 , Figure 2 , an embodiment of a test strip of multiple electrochemical reaction blocks of the present invention, wherein the first reaction zone 201 forms a first extension section 2011 on one side of the guide inlet 33, and the second reaction zone 202 forms a second extension section 2021 on one side of the guide inlet 33, whereby the first reaction zone 201 and the second reaction zone 202 can be further approached to the guide inlet 33, so that a small amount of specimen sample can be siphoned into the first reaction zone 201 and the second reaction zone 202 more quickly and efficiently.

[0031] See also Figure 3 , Figure 4 Some embodiments of the detection strip of multiple electrochemical reaction blocks of the present invention are the same as the aforementioned embodiments, wherein, in addition to the detection electrode for hematocrit in the first reaction zone 201, some examples of the expanded application of this embodiment may have multiple independent reaction zones. For example, there are three independent reaction zones, each coated with an electrochemical medium such as total cholesterol, triglyceride, and high-density lipoprotein cholesterol, to measure the values ​​of different detection items of a specimen (analyte), and the detection instrument can calculate low-density lipoprotein cholesterol using a formula; the detection strip of multiple electrochemical reaction blocks, wherein the first detection electrode of the AC potential signal inside the first reaction zone and the third detection electrode are hematocrit detection points, and the detection strip also includes multiple independent reaction zones, each coated with a different electrochemical medium, to measure the values ​​of different detection items of a specimen (analyte).

[0032] The substrate 1 further includes a fourth wire 13 and a fifth wire 14, which are formed on the substrate 1 in a spaced manner parallel to the first wire 10, the second wire 11 and the third wire 12; the fourth wire 13 and the fifth wire 14 are, for example, DC circuit wires, one end of the fourth wire 13 is provided with a fourth contact electrode 132, and the other end of the fourth wire 13 is provided with a fourth detection electrode 131; one end of the fifth wire 14 is provided with a fifth contact electrode 142, and the other end of the fifth wire 14 is provided with a fifth detection electrode 141, the first wire can be an AC potential signal wire, and the second wire, the third wire, the fourth wire or / and the fifth wire can be a DC circuit wire; A third reaction zone 203 and a fourth reaction zone 204 are provided on one side of the first spacer layer 20, and are spaced and parallel between the first reaction zone 201 and the second reaction zone 202; the fourth detection electrode 131 and the third detection electrode 121 extend into the third reaction zone 203, and are coated with at least one layer of a second electrochemical mediator 52 (e.g., a total cholesterol reaction reagent, etc.); the fifth detection electrode 141 and the third detection electrode 121 extend into the fourth reaction zone 204, and are coated with at least one layer of a third electrochemical mediator 53 (e.g., a high-density cholesterol reaction reagent, etc.); and the second detection electrode 111 inside the second reaction zone 202 and the third detection electrode 121 are coated with at least one layer of a first electrochemical mediator 51 (triglyceride), and the third reaction zone 203, the fourth reaction zone 204, the first reaction zone 201 and the second reaction zone 202 are not connected to each other.

[0033] The guide groove 31 of the second spacer layer 30 also includes a third groove 313 and a fourth groove 314. The third groove 313 and the fourth groove 314 are formed between the first groove 310 and the second groove 311. The third groove 313 and the fourth groove 314 are connected to the introduction port 33, the first groove 310 and the second groove 311 respectively. The second spacer layer 30 is combined on the top of the first spacer layer 20. The first groove 310 is correspondingly connected to the first reaction zone 20, the second groove 311 is correspondingly connected to the second reaction zone 202, the third groove 313 is correspondingly connected to the third reaction zone 203, and the fourth groove 314 is correspondingly connected to the fourth reaction zone 204. In this way, a trace amount of body fluid sampling specimen can be easily siphoned into each reaction zone through each groove to improve the detection accuracy.

[0034] The upper cover layer 40 also includes a third pore 403 and a fourth pore 404. The upper cover layer 40 is combined on the second spacer layer 30. The first pore 401 corresponds to connecting the first reaction zone 201 and the first groove 310, the second pore 402 corresponds to connecting the second reaction zone 202 and the second groove 311, the third pore 403 corresponds to connecting the third reaction zone 203 and the third groove 313, and the fourth pore 404 corresponds to the fourth reaction zone 204 and the third groove 314, so as to form an exhaust channel between the third reaction zone 203 and the third groove 313, and an exhaust channel between the fourth reaction zone 204 and the fourth groove 314; the portions of the fourth contact electrode 131 and the fifth contact electrode 142 on one side of the substrate 1 are exposed portions.

[0035] Thereby, the stacked thickness of the substrate 1, the first spacer layer 20 and its first reaction zone 201, the second reaction zone 202, the third reaction zone 203, and the fourth reaction zone 204, the second spacer layer 30 and its guide groove 31, and the upper cover layer 40 form a channel for siphoning and diverting the sample from the inlet 33. The sample (can be injected into the first reaction zone 201, the second reaction zone 202, the third reaction zone 203 and the fourth reaction zone 204 through this channel and contact the detection electrode, and the first electrochemical medium 51 (such as triglycerides), the second electrochemical medium 52 (such as total cholesterol reaction reagent, etc.); the third electrochemical medium 53 (such as high-density cholesterol reaction reagent, etc.)), the above-mentioned multiple electrochemical reaction zones share a sampling channel, but the diffusion of the medium substances in each reaction zone and the mutual interference can be suppressed.

[0036] The exposed portions of the first contact electrode 102, the second contact electrode 112, the third contact electrode 122 and the fourth contact electrode 131 on one side of the substrate 1 are used to be electrically connected to a detection instrument (such as a blood glucose meter, etc.). In this way, the detection electrodes in the first reaction area 201 are used to measure the blood cell volume ratio data measured by each value, and the measurement data of the second reaction area 202, the third reaction area 203 and the fourth reaction area 204. The detection instrument can use a formula to calculate low-density cholesterol to implement another detection item.

[0037] In some embodiments of the test strip of multiple electrochemical reaction blocks of the present invention, the first groove 310 to the fourth groove 314 and / or the first reaction area 201 to the fourth reaction area 204 include any of rectangular, square, circular, elliptical, polygonal or irregular shapes.

[0038] The test strip with multiple electrochemical reaction blocks of the present invention can provide a detection instrument (such as a blood glucose meter, etc.) to directly read the blood cell volume ratio data of the specimen and the reaction data generated by the specimen and the electrochemical medium (reaction reagent). The two data are used for data compensation to correct the analyte concentration (such as blood glucose), avoid the problem of inaccurate detection data caused by the deviation of the blood cell volume ratio of different individuals, and present the correct actual value of the analyte concentration.

[0039] Among them, the first reaction area 201, the second reaction area 202, the third reaction area 203 and the fourth reaction area 204 are not connected to each other, and the design area of ​​the reaction area can be reduced. It is combined with the corresponding detection electrode on the upper side of the substrate 1, and the various enzyme reaction reagents of the electrochemical medium coated on the detection electrode can be controlled in appropriate amounts, not too much, so that the biological reaction data of the specimen can be more accurate. Because the present invention avoids the interference of medium diffusion, the instrument can obtain accurate total cholesterol, triglyceride, and high-density lipoprotein cholesterol values, and the detection instrument uses a formula to calculate the accurate low-density lipoprotein cholesterol value.

[0040] In some other embodiments, for example, by using circuit mechanisms of different designs such as more working wires, the detected liquid analysis concentration items can be increased, such as any one of high-density cholesterol HDLC, hemoglobin HI, triglycerides TG, ketone bodies Keto body, UA. The detection test strip of the multi-electrochemical reaction blocks of the present invention can enable the detection instrument to detect multiple items at the same time, so as to shorten the detection time and improve the detection efficiency.

[0041] In some embodiments of the test strip of the multi-electrochemical reaction block of the present invention, the front end of the introduction port 33 can be a protruding, concave or flat structure, and the upper and lower sides of the front end of the introduction port 33 can be, for example, a flat, protruding or concave structure to assist the introduction port 33 in more effectively contacting and guiding the collected specimen sample.

[0042] See also Figures 1 to 4In some embodiments, the upper and lower sides of the front end of the introduction port 33 are shaped as a protruding structure 331, the substrate 1 forms a first sampling protrusion 15 on one side of the introduction port 33, the first spacing layer 20 forms a second sampling protrusion 21 on one side of the introduction port 33, and the upper cover layer 40 forms a third sampling protrusion 41 on one side of the introduction port 33. The front end of the test strip introduction port 33 of the multi-electrochemical reaction block is formed as a protruding structure 331. When sampling, the third sampling protrusion 41 forming the protruding points is on the upper side of the introduction port 33, and the first sampling protrusion 15 and the second sampling protrusion 21 are stacked on the lower side of the introduction port 33, so as to accurately and quickly assist the test strip to contact a small amount of sample for sampling, so as to accurately transfer a small amount of sample to the introduction port 33, siphon to the guide groove 31 and enter the first reaction zone 201 or the second reaction zone 202 or the third reaction zone 203, so as to quickly and effectively sample the sample, so as to provide the sensing device with correct detection data.

[0043] See also Figure 5 to Figure 6 , an embodiment of the detection strip of the multi-electrochemical reaction block of the present invention, wherein the upper and lower sides of the front end of the introduction port 33 are shaped as a concave structure 333, the substrate 1 forms a first V-shaped sampling port 17 on one side of the introduction port 33, the first spacing layer 20 forms a second V-shaped sampling port 23 on one side of the introduction port 33, and the upper cover layer 40 forms a third V-shaped sampling port 43 on one side of the introduction port 33, whereby the upper and lower sides of the front end of the introduction port 33 of the detection strip of the multi-electrochemical reaction block are shaped as a concave structure 333, and when sampling, the third V-shaped sampling port 43 forming the concave points is on the upper side of the introduction port 33; The first V-shaped sampling port 17 and the second V-shaped sampling port 23 are stacked on the lower side of the introduction port 33, whereby the front end of the test strip introduction port 33 of the multi-electrochemical reaction block is formed into a protruding structure 331, which is used to accurately and quickly assist the test strip to contact a small amount of sample, so as to accurately transfer a small amount of sample to the introduction port 33, siphon it to the guide groove 31 and enter the first reaction zone 201, the second reaction zone 202, and the third reaction zone 203. The concave structure may include any one of U-shaped, V-shaped or rectangular, which can quickly and effectively sample the sample to provide the sensing device with correct detection data.

[0044] In some application examples of the present invention, in an electrochemical test strip, the hematocrit HCT is calculated using the AC measurement value, and the DC part is compensated accordingly using the HCT value calculated accordingly.

[0045] See also Figure 7In the prior art test piece, when the actual HCT is 60, for example, the AC values ​​are (7828, 8503, 8364), so the measured HCT is (52, 65, 62). The correct DC compensation should be based on HCT=60. However, since the measured HCT is (52, 65, 62), the DC compensation is based on HCT=(52, 65, 62), which has a considerable error from the expected correct value. The same result is obtained when the HCT is other values.

[0046] Figure 8 In the detection example of the detection strip of the multi-electrochemical reaction block of the present invention, when the actual HCT is 60, the AC values ​​are (1520, 1522, 1523, 1528), so the measured HCT is converted to (59.5, 60, 60, 61), and the DC part compensation is based on HCT = (59.5, 60, 60, 61). The result is close to the compensation required for HCT = 60, and the compensation is only slightly different from that based on HCT = 60. The same result is obtained when HCT is other values.

[0047] The test strip of the present invention is formed by coating different test reagents, such as enzymes, chemical substances, etc., on the detection electrodes of the wires in other designed reaction areas of the test strip specimen, and has multiple electrochemical media with multiple reaction areas. Various body fluid specimens such as blood and urine are sampled in these reaction areas and combined with a detection instrument to measure their concentration and other detection data, for example, to detect blood sugar, blood lipids, cholesterol, uric acid, hemoglobin, triglycerides, ketone bodies, glyceric acid or lactic acid.

[0048] In some embodiments of the present invention, the substrate or the spacer layer is, for example, an insulating material selected from one or a mixture of two or more of polyamide, polyester, polycarbonate, polyethylene terephthalate or polyvinyl chloride.

[0049] The material of the circuit conductors is selected from one of gold, silver, palladium, platinum, carbon, bio-carbon, silver paste, silver / silver chloride paste, or a mixture of two or more materials to have good electrical conductivity. The carbon or bio-carbon is formed by printing carbon ink on a substrate using screen printing, or the above-mentioned metal material, such as silver paste, is coated on a substrate and then laser engraved to form multiple conductors. The material and the method of forming the test piece are not limited to this.

[0050] The above is only a specific description of a feasible embodiment of the present invention, and is not intended to limit the scope of the present invention. All equivalent changes and modifications made according to the scope of the present invention are covered by the scope of the present invention, and the embodiments that do not change the essence of the present invention also belong to the scope of the present invention.

Claims

1. A test strip for detecting multiple electrochemical reaction blocks, characterized in that: include: A substrate, comprising: a first conductive line, a second conductive line, and a third conductive line, which are formed on the substrate in parallel and spaced apart from each other; A first contact electrode is provided at one end of the first wire, and a first detection electrode is provided at the other end thereof; A second contact electrode is disposed at one end of the second wire, and a second detection electrode is disposed at the other end thereof; A third contact electrode is provided at one end of the third wire, and a third detection electrode is provided at the other end thereof; A first spacer layer, one side of which is provided with a first reaction area and a second reaction area which are hollowed out; A second spacer layer, one side of which is provided with a hollowed-out guide groove, one side of which is provided with an inlet, the second spacer layer is combined above the first spacer layer, and the guide groove is correspondingly connected to the first reaction zone and the second reaction zone; The first spacing layer is combined with the first wire, the second wire and the third wire, the first detection electrode and the third detection electrode extend into the first reaction area; the second detection electrode and the third detection electrode extend into the second reaction area and are coated with a layer of a first electrochemical medium, and the first reaction area and the second reaction area are not connected to each other; An upper cover layer, the upper cover layer comprising a first pore and a second pore, the upper cover layer is combined with the second spacer layer, the first pore is correspondingly connected to the first reaction zone and the guide groove, and the second pore is correspondingly connected to the second reaction zone and the guide groove; Portions of the first contact electrode, the second contact electrode and the third contact electrode located on one side of the substrate are exposed portions.

2. The test strip for detecting multiple electrochemical reaction blocks according to claim 1, characterized in that: The shape of the guide groove corresponds to the first reaction zone and the second reaction zone. The guide groove includes a first groove extending from one side of the inlet and a second groove extending from the other side of the inlet. The first groove is correspondingly connected to the first reaction zone, the second groove is correspondingly connected to the second reaction zone, the first pore is correspondingly connected to the first groove and the first reaction zone, and the second pore is correspondingly connected to the second groove and the second reaction zone.

3. The detection strip of multiple electrochemical reaction blocks as claimed in claim 2, characterized in that: The substrate also includes a fourth wire and a fifth wire, which are formed on the substrate in a spaced manner and parallel to the first wire, the second wire and the third wire; a fourth contact electrode is provided at one end of the fourth wire, and a fourth detection electrode is provided at the other end of the fourth wire; a fifth contact electrode is provided at one end of the fifth wire, and a fifth detection electrode is provided at the other end of the fifth wire; A third reaction area and a fourth reaction area are hollowed out on one side of the first spacing layer. The third reaction area and the fourth reaction area are arranged parallel to and spaced between the first reaction area and the second reaction area. The fourth detection electrode and the third detection electrode extend into the third reaction area and are coated with a layer of a second electrochemical medium. The fifth detection electrode and the third detection electrode extend into the fourth reaction area and are coated with a layer of a third electrochemical medium. The third reaction area, the fourth reaction area, the first reaction area and the second reaction area are not connected to each other. The guide groove of the second spacer layer also includes a third groove and a fourth groove, the third groove and the fourth groove are formed between the first groove and the second groove, the third groove and the fourth groove are respectively connected to the inlet, the first groove and the second groove, the third groove is correspondingly connected to the third reaction zone, and the fourth groove is correspondingly connected to the fourth reaction zone; The upper cover layer further includes a third air hole and a fourth air hole, wherein the third air hole is connected to the third reaction zone and the third groove, and the fourth air hole is connected to the fourth reaction zone and the fourth groove; The portions of the fourth contact electrode and the fifth contact electrode located at one side of the substrate are exposed portions.

4. The test strip for detecting multiple electrochemical reaction blocks as claimed in claim 3, characterized in that: The first to fourth grooves and / or the first to fourth reaction zones are rectangular or polygonal.

5. The test strip for detecting multiple electrochemical reaction blocks according to claim 1, characterized in that: The first reaction zone forms a first extension section near the inlet, and the second reaction zone forms a second extension section near the inlet.

6. The test strip for detecting multiple electrochemical reaction blocks according to claim 1, characterized in that: The front end of the introduction port is in any of a protruding, flat or concave shape.

7. The test strip for detecting multiple electrochemical reaction blocks according to claim 6, characterized in that: A protruding structure is formed at the front end of the introduction port, a first sampling protrusion is formed on the substrate at one side of the introduction port, a second sampling protrusion is formed on the first spacing layer at one side of the introduction port, and a third sampling protrusion is formed on the upper cover layer at one side of the introduction port. The first sampling protrusion and the second sampling protrusion are stacked on the lower side of the introduction port, and the third sampling protrusion is on the upper side of the introduction port.

8. The test strip for detecting multiple electrochemical reaction blocks according to claim 6, characterized in that: A concave structure is formed at the front end of the introduction port, the substrate forms a first V-shaped sampling port on one side of the introduction port, the first spacing layer forms a second V-shaped sampling port on one side of the introduction port, and the upper cover layer forms a third V-shaped sampling port on one side of the introduction port. The third V-shaped sampling port is on the upper side of the introduction port, and the first V-shaped sampling port and the second V-shaped sampling port are stacked on the lower side of the introduction port.

9. The test strip for detecting multiple electrochemical reaction blocks according to claim 3 or 4, characterized in that: include: The first wire is an AC potential signal wire, the second wire, the third wire, the fourth wire and / or the fifth wire are DC circuit wires, and the first detection electrode and the third detection electrode of the AC potential signal inside the first reaction area are hematocrit detection points.

10. The test strip for detecting multiple electrochemical reaction blocks according to claim 9, characterized in that: The first detection electrode and the third detection electrode of the AC potential signal inside the first reaction area are hematocrit detection points. The detection test strip also includes a plurality of independent reaction areas, each coated with a different electrochemical medium.

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