TW202018291A - Electrochemical sensor strip and manufacturing method thereof - Google Patents

Abstract

An electrochemical sensing test sheet comprises a top plate, an electrode substrate and a flow channel plate. The electrode substrate includes a bottom plate and a reaction circuit disposed on a surface of the bottom plate. The flow channel plate includes a measuring circuit disposed on the surface of the flow channel plate, defines an opening and at least a at least one perforation, and is located between the top plate and the electrode substrate, so that the electrode substrate, the flow channel plate and the top plate define a flow channel corresponding to the opening. The measuring circuit is filled in the at least one perforation, and the measuring circuit is electrically connected to the reacting circuit through the at least one perforation.

Description

Electrochemical sensing test piece and manufacturing method thereof

The invention relates to an electrochemical sensing test piece and a manufacturing method thereof, in particular to an electrochemical sensing test piece where measurement circuits and reaction circuits are respectively located on different substrates.

Electrochemical Sensor Strip (Electrochemical Sensor Strip) has been maturely applied to the detection of various fluids, and its basic principle is to use a chemical reagent (Reagent) to make it with one of the analytes in a fluid to be tested Electrochemical action and produce an electrical output signal, which is related to the analyte of the fluid to be measured. Wherein, when the fluid to be measured is human blood and the analyte is blood glucose, then a glucose oxidase and other complexes can be used as chemical reagents.

FIG. 1 shows a schematic diagram of the appearance of a conventional electrochemical sensing test piece. Fig. 2 shows an exploded view of the electrochemical sensing test piece of Fig. 1. As shown in FIGS. 1 and 2, the electrochemical sensing test piece 100 is a blood glucose test piece, which includes an electrode substrate 110, a flow channel plate 120 and a top plate 130. The electrode substrate 110 includes a circuit layout 112 and a substrate 111, and it is formed by printing a circuit layout 112 on a substrate 111 by a printing technique, and the circuit layout 112 has a plurality of electrodes and circuits. The runner plate 120 defines an opening 122, which is formed by penetrating the upper and lower surfaces of the runner plate 120. In order to allow blood to flow more smoothly, an exhaust port 135 may be provided at the position of the top plate 130 corresponding to the opening 122 of the flow channel plate 120.

When manufacturing the electrochemical sensing test piece 100, the electrode substrate 110, the flow channel plate 120, and the top plate 130 need to be bonded together. The flow channel plate 120 is positioned between the electrode substrate 110 and the top plate 130, and the electrode substrate 110, the flow channel plate 120, and the top plate 130 together define a flow channel 150. The position of the flow channel 150 corresponds to the position of the opening 122 of the flow channel plate 120, and has an inlet 125 and an exhaust port 135. During operation, the user drops blood at the inlet 125, the blood enters the flow channel 150 from the inlet 125, and the blood flows in the flow channel 150 due to the capillary phenomenon, and the gas in the flow channel 150 is discharged from the exhaust port 135.

FIG. 3 shows a flowchart of a conventional manufacturing method of an electrochemical sensor test piece. As shown in FIG. 3, the manufacturing method of the conventional electrochemical sensor test piece includes the following steps. In step S01, an electrode substrate 110 is provided. The electrode substrate 110 includes a circuit layout 112 and a substrate 111, as shown in FIG. 3(a). In step S02, a first-class track board 120 is provided, as shown in FIG. 3(b). In step S03, a top plate 130 is provided, as shown in FIG. 3(c). In step S04, the flow channel plate 120 is attached to the electrode substrate 110 to form a laminated plate, as shown in FIG. 3(d). In step S05, a chemical agent (Reagent) is coated or sprayed on at least a part of the circuit layout 112 in the flow channel 150, as shown in FIG. 3(e). In step S06, the top plate 130 is attached to the laminated board prepared in step S04, more specifically, the top plate 130 is attached to the flow channel plate 120, as shown in FIG. 3(f). In step S07, the laminated board produced in step S06 is cut out to form an electrochemical sensing test piece 100, as shown in FIG. 3(g).

However, there is still room for further improvement of the electrochemical sensor test piece 100 according to the conventional technology between.

An object of an embodiment of the present invention is to provide an electrochemical sensing test piece and a method for manufacturing the same. The measurement circuit and the reaction circuit of the electrochemical sensing test piece are formed in different manufacturing steps. In one embodiment, the materials and manufacturing methods of the measurement circuit and the reaction circuit are also different.

According to an embodiment of the present invention, the electrochemical sensing test piece includes a top plate, an electrode substrate, and a flow channel plate. The electrode substrate includes a bottom plate and a reaction circuit disposed on the surface of the bottom plate. The flow channel plate includes a measuring circuit provided on the surface of the flow channel plate, defining an opening and at least one through hole, and is located between the top plate and the electrode substrate. The electrode substrate, the flow channel plate and the top plate define a pair The first-rate way that should be spoken. The measuring circuit is filled in the at least one through hole, and the measuring circuit is electrically connected to the reaction circuit through the at least one through hole.

In one embodiment, the reaction circuit is formed by peeling off a conductive film for reaction by a peeling technique, and the accuracy of a line edge of the reaction circuit is about ≦10 μm. Preferably, the stripping technique is a laser stripping technique.

In an embodiment, the material of the reaction circuit is different from the material of the measurement circuit. The measurement circuit includes a first measurement electrode and a second measurement electrode. The reaction circuit includes a first reaction electrode and A second reaction electrode, and the at least one through hole includes a first through hole And a second through hole. Wherein, the first reaction electrode and the second reaction electrode are respectively provided on the electrode substrate, the first measurement electrode and the second measurement electrode are respectively provided on the flow channel plate, and the first measurement electrode passes through the first penetration The perforation is electrically connected to the first reaction electrode, and the second measurement electrode is electrically connected to the second reaction electrode through the second through hole.

In one embodiment, the reaction circuit includes multiple lines, and each line is a straight line.

In one embodiment, the material of the reaction circuit is a precious metal, and the material of the measurement circuit is a conductive material different from the precious metal.

According to an embodiment of the invention, a method for manufacturing an electrochemical sensor test piece includes the following steps. An electrode substrate is provided. The electrode substrate includes a bottom plate and a reaction circuit disposed on the surface of the bottom plate. The flow channel plate is pasted on the electrode substrate. The flow channel plate defines an opening and at least one through hole. A measuring circuit is formed on the surface of the flow channel plate, and the measuring circuit is filled in the at least one through hole, so that the measuring circuit is electrically connected to the reaction circuit through the at least one through hole. A top plate is attached to the flow channel plate, whereby the flow channel plate is located between the top plate and the electrode substrate, and the electrode substrate, the flow channel plate, and the top plate define a flow path corresponding to the opening.

In one embodiment, the step of providing an electrode substrate includes the following steps. A conductive thin film for reaction is formed on a bottom plate. A part of the reaction conductive film is peeled off by a peeling technique to form the reaction circuit, wherein the peeling technique makes the accuracy of the edge of a line of the reaction circuit about ≦10 μm.

In one embodiment, the step of peeling the reaction conductive film with a peeling technique to form the reaction circuit includes the following steps: forming at least one spacer in the reaction conductive film, and the spacer It is a straight line, so that each line of the reaction circuit is a straight line.

In one embodiment, the stripping technique is a laser stripping technique.

In one embodiment, the manufacturing method of the electrochemical test strip further includes the following steps: forming a chemical reagent film in the flow channel, wherein the step of forming a chemical reagent film in the flow channel A measuring circuit is formed on the surface of the flow channel plate before the step, and after the top plate is attached to the flow channel plate.

According to an embodiment of the present invention, the measurement circuit and the reaction circuit are located on different substrates and the manufacturing steps are different. In one embodiment, the materials and manufacturing methods of the measurement circuit and the reaction circuit are also different. Therefore, The reaction circuit can use materials and peeling methods that have better measurement effects and higher manufacturing costs. In one embodiment, a stripping technique with a process tolerance range of about ≦10 μm that can produce the edge of the circuit can be used to form a reaction circuit, which can reduce the manufacturing cost without compromising measurement accuracy.

100‧‧‧Electrochemical test piece

110‧‧‧Electrode substrate

111‧‧‧One substrate

112‧‧‧ Circuit layout

120‧‧‧Runner board

122‧‧‧ opening

125‧‧‧ entrance

130‧‧‧Top plate

135‧‧‧Exhaust

150‧‧‧Flower

200‧‧‧Electrochemical sensing

210‧‧‧Electrode substrate

211‧‧‧Bottom plate

212‧‧‧Reaction circuit

212a‧‧‧ First line

212b‧‧‧Second line

212c‧‧‧ Third Line

212d‧‧‧ Fourth Line

213‧‧‧Space

220‧‧‧Runner board

221‧‧‧Measurement circuit

222‧‧‧ opening

223‧‧‧First through hole

224‧‧‧Second through hole

230‧‧‧Top plate

235‧‧‧Exhaust

241‧‧‧ First measuring electrode

242‧‧‧Second measuring electrode

250‧‧‧Flower

FIG. 1 is a schematic diagram showing the appearance of a conventional electrochemical sensor test piece.

FIG. 2 shows an exploded view of the electrochemical sensor test piece of FIG. 1.

FIG. 3 shows a flowchart of a conventional manufacturing method of an electrochemical sensor test piece.

FIG. 4 shows a flowchart of a method for manufacturing an electrochemical sensor test piece according to an embodiment of the invention.

FIG. 5 shows a top view of an electrode substrate according to an embodiment of the invention.

FIG. 6 shows a top view of a runner plate according to an embodiment of the invention.

FIG. 7 shows a top view of a laminated board in one step according to an embodiment of the invention.

FIG. 4 shows a flowchart of a method for manufacturing an electrochemical sensor test piece according to an embodiment of the invention. 4(a) to 4(g) are schematic diagrams showing steps of a method for manufacturing an electrochemical sensor test piece according to an embodiment of the invention. According to an embodiment of the present invention, the electrochemical sensing test piece can be manufactured using the following steps S02, S04, S06, S08, S10, S12, S14, and S16.

Step S02: An electrode substrate 210 is provided, and the electrode substrate 210 includes a bottom plate 211 and a reaction circuit 212 disposed on the surface of the bottom plate 211, as shown in FIG. 4(a). FIG. 5 shows a top view of an electrode substrate according to an embodiment of the invention. As shown in FIG. 5, in one embodiment, the reaction circuit 212 includes a plurality of lines and at least one space, and a space 213 is formed between two adjacent lines. In one embodiment, the multiple lines include a first line 212a and a second line 212b, and a space 213 is formed between the first line 212a and the second line 212b. In one embodiment, the multiple lines further include a third line 212c and a fourth line 212d, and a space 213 is formed between two adjacent lines.

In one embodiment, step S02 includes: a deposition step, forming a reactive conductive film on the bottom plate 211; and a peeling step, using a peeling technique to peel off a part of the reactive conductive film to form the reaction Circuit 212, wherein the stripping technique makes the accuracy of the edge of each line 212a-212b of the reaction circuit 212 approximately ≦10 μm. In one embodiment, after peeling off a part of the conductive film for reaction, the peeled portion is formed in at least one spacer 213 in the conductive film for reaction, and the spacer 213 is a straight line, so that the reaction circuit 212 Each line 212a-212b is a straight line. With this feature, the peeling step can be simplified, and the process time and cost can be reduced.

In one embodiment, the stripping technique is a laser stripping technique. The laser stripping method can be used to manufacture an electrode with a smaller line width. Compared with the conventional printing technology, the size of the electrochemical sensing test piece can be further reduced. In addition, when the circuit layout 112 made of carbon is formed by printing technology, an irregular edge similar to a sawtooth is formed on the side of one electrode of the circuit layout 112, however, this irregular edge will affect the measurement accuracy. The side of the reaction circuit 212 formed by the laser stripping method is less likely to produce a jagged side, so a more accurate measurement value can be obtained. More specifically, when an appropriate laser beam is used, the accuracy of the edge of each line 212a-212b of the reaction circuit 212 can be approximately ≦10 μm, and a more accurate measurement value can be obtained.

Step S04: providing a first-level runner plate 220 and punching the runner plate 220 so that the runner plate 220 defines an opening 222 and at least one through hole, as shown in FIG. 4(b). Figure 6 shows a real invention Top view of the runner plate of the embodiment. As shown in FIG. 6, at least one through hole includes a first through hole 223 and a second through hole 224. The first through hole 223, the second through hole 224, and the opening 222 are not in communication with each other, and the first through hole 223 and the second through hole 224 penetrate the entire thickness of the flow channel plate 220, that is, extend from the upper surface of the flow channel plate 220 to The lower surface, and the positions of the first through hole 223 and the second through hole 224 can expose the first line 212a and a second line 212b, respectively, preferably the diameters of the first through hole 223 and the second through hole 224 are located at The line widths of the first line 212a and a second line 212b are within.

Step S06: Paste the flow channel plate 220 on the electrode substrate 210 to form a laminated plate, as shown in FIG. 4(c).

Step S08: forming a measuring circuit 221 on a surface of the flow channel plate 220, and filling the measuring circuit 221 with the at least one through hole, so that the measuring circuit 221 is electrically connected to the reaction circuit 212 through the at least one through hole , As shown in Figure 4(d).

Step S10: Apply at least one chemical reagent (Reagent) for testing on the reaction circuit 212, as shown in FIG. 4(e). Preferably, the position of the opening 222 of the flow channel plate 220 corresponds to the position of the reaction circuit 212.

Step S12: affix a top plate 230 to the flow channel plate 220, whereby the flow channel plate 220 is located between the top plate 230 and the electrode substrate 210, and the electrode substrate 210, the flow channel plate 220 and the top plate 230 define the first-class corresponding to the opening 222 Road. An exhaust port 235 is formed on the top plate 230, as shown in FIG. 4(f).

Step S14: shape cutting the laminated board prepared in step S12 to form a plurality of electrochemical sensing test pieces 200, as shown in FIG. 4(g). The foregoing steps S10, S12, and S14 can be completed by those with ordinary knowledge in the art, and can use currently known or future-developed technologies, so they are omitted. Its related instructions.

According to the electrochemical sensing test piece 200 of one embodiment, the flow channel plate 220 is located between the top plate 230 and the electrode substrate 210, so that the electrode substrate 210, the flow channel plate 220 and the top plate 230 define a flow channel 250. The measurement circuit 221 is provided on the flow channel plate 220. The measurement circuit 221 is filled in the at least one through hole to electrically connect the reaction circuit 212. In one embodiment, the material of the reaction circuit 212 is different from the material of the measurement circuit 221. At least one chemical reagent is coated on the reaction circuit 212. In one embodiment, the chemical reagent is a glucose enzyme, a uric acid enzyme, a cholesterol enzyme, a ketone ketone enzyme or a heme enzyme.

7 shows a top view of the laminated board in step S08 according to an embodiment of the invention. As shown in FIG. 7, in the laminated board of step S08, in one embodiment, the reaction circuit 212 includes a first reaction electrode (circuit) 212a and a second reaction electrode (circuit) 212b, which are located at Bottom plate 211. The measuring circuit 221 includes a first measuring electrode 241 and a second measuring electrode 242 on the flow channel plate 220 and is suitable for coupling to an electrochemical sensing device. The first measurement electrode 241 is electrically connected to the first reaction electrode 212a through the first through hole 223, and the second measurement electrode 242 is electrically connected to the second reaction electrode 212b through the second through hole 224. When the top plate 230 covers the flow channel plate 220, at least a part of the first and second measuring electrodes 241 and 242 are exposed to be electrically connected to an electrochemical sensing test device. 4(f) again, an opening is further defined on the top plate 230 to serve as the exhaust port 235.

In addition, the present invention does not limit the formation method of the measuring circuit 221 or the material thereof, as long as it is a material that can conduct electricity. The measurement circuit 221 can use screen printing In this case, the material of the measurement circuit 221 may be graphite, silver paste, aluminum paste, or the like. In addition, the measurement circuit 221 can also be formed by vapor-deposited and electroplating, combined with etching, scribing, or other separation techniques. At this time, the material of the measurement circuit 221 can be Metals such as copper, titanium, nickel, gold, platinum, palladium, rhodium, ruthenium, or iridium. From the standpoint of ease of manufacturing and cost saving, it is preferable to use a printing technique to print graphite or conductive paste to form the measurement circuit 221. In one embodiment, the material of the reaction circuit 212 is different from the material of the measurement circuit 221. In an embodiment, the material of the reaction circuit 212 may be precious metals such as palladium (Palladium) and gold. In one embodiment, the material of the reaction circuit 212 can also be carbon, and it can be formed by printing.

In the present invention, the detection items of the electrochemical sensor sheet 200 are not limited, as long as the detection items can be detected by applying the electrochemical principle method, for example, including cardiovascular disease blood lipid detection, total cholesterol (T-Cholesterol) detection, high Detection of high-density lipoprotein cholesterol (HDL-C), low-density lipoprotein cholesterol (LDL-C), triglyceride (TG), LDH and CK related to myocardial congestion -MB, CPK, GOT and other tests, Uric acid test related to gout index, GOT and GPT test related to liver function, etc. Moreover, one of the benefits of multi-function detection is that it can exclude non-specific interactions.

In one embodiment, when the electrochemical sensing test piece 200 is operated, the electrochemical sensing test device forms a voltage difference between the first and second reaction electrodes 212a and 212b through the measuring electrodes 241 and 242. The device reuses these voltage differences to measure a measurement of a sample such as blood Magnitude.

According to an embodiment of the present invention, the materials of the measurement circuit 221 and the reaction circuit 212 are different, and are formed using different steps. With such a design, the function of the measurement circuit 221 can be simplified to transfer the electrical signal from the reaction circuit 212 to the electrochemical sensing device, so that a more cost-effective conductive material such as copper or graphite can be used. In addition, the reaction circuit 212 uses a material with a better measurement effect, such as gold, so that the use of gold can be reduced and the manufacturing cost can be reduced. The reaction circuit 212 can use the bottom plate 211 with a smaller area. In this way, the area of the reaction conductive film is smaller, and the amount of precious metals such as gold can be reduced. 4(a) and 4(b), the length of the bottom plate 211 is less than the length of the flow channel plate 220, preferably the length of the bottom plate 211 is less than a quarter of the length of the flow channel plate 220. In addition, when the laser stripping technique is used to remove unnecessary parts, a smaller amount can also be removed, reducing waste. In addition, in order to save manufacturing time, the reaction circuit 212 may adopt a simple pattern. Preferably, the spacing portion 213 is a straight line, so that each line 212a-212b of the reaction circuit 212 is a straight line, thereby simplifying the manufacturing process and reducing the manufacturing cost.

In one embodiment, after the metal thin film is formed on the substrate, laser etching metal technology is used to etch and define the electrode pattern by laser. The disadvantage is that the metal is wasted, and the laser etching time will increase with the complexity of the pattern. However, the circuit of the electrode substrate according to the present invention is relatively simple, and only one or more elongated spacers need to be formed, so the manufacturing time is shorter. The comparison between laser engraving technology and traditional ink technology can refer to the table below. Laser engraving is less likely to have ink spillage and less broken lines, and the accuracy (process tolerance) of the edge of the line can be made to be about 2μm. Therefore, the accuracy of the measured blood glucose value will be higher than the accuracy measured by the ink printing technology degree.

In addition, different laser rays will have different accuracy effects, different wavelengths of laser rays, and the accuracy of the edge of the line made using it, as shown in Table 3 below. Preferably, ultraviolet (UV) or excimer ultraviolet (Excimer UV) is used, so that the accuracy (process tolerance) of the edge of the circuit produced is about ≦10 μm.

It should be understood that the present invention does not limit the manufacturing method of the reaction circuit, as long as the accuracy (process tolerance) of the edge of the formed line is about ≦10 μm, the following techniques can also be used manufacture. In one embodiment, a semiconductor yellow light process technology is used, which requires a negative film or a photomask to define the electrode pattern. In one embodiment, a technique of electroless gold plating is used, more specifically, a metallization primer is formed on a region of the substrate where a circuit layout is to be formed by printing technology, in which a metal layer is formed on the metallization primer, thereby This circuit layout is formed. According to these techniques, the accuracy (process tolerance) of the edge of the reaction circuit can be approximately ≦10 μm.

In summary, according to an embodiment of the present invention, the manufacturing steps of the measurement circuit 221 and the reaction circuit 212 can be different, and preferably the materials and manufacturing methods of the measurement circuit 221 and the reaction circuit 212 are also different. Therefore, The reaction circuit 212 can use materials and stripping methods that have better measurement effects and higher manufacturing costs. For example, gold is used as the material and the edge of the circuit is manufactured by the laser stripping method. The process tolerance range is about ≦10 μm, so that it can be used without Without compromising measurement accuracy, reduce manufacturing costs.

220‧‧‧Runner board

222‧‧‧ opening

223‧‧‧First through hole

224‧‧‧Second through hole

Claims (11)

An electrochemical sensor test piece, comprising: a top plate; an electrode substrate, including a bottom plate and a reaction circuit on the surface of the bottom plate; a flow channel plate, including a measuring circuit on the surface of the flow channel plate, An opening and at least one through hole are defined, and are located between the top plate and the electrode substrate. The electrode substrate, the flow channel plate, and the top plate define a flow path corresponding to the opening; wherein, the measurement circuit is filled in the at least consistent In the through hole, the measuring circuit is electrically connected to the reaction circuit through the at least one through hole. The electrochemical sensing test piece according to claim 1, wherein the reaction circuit is formed by peeling off a reaction conductive film by a peeling technique, and the accuracy range of an edge of a line of the reaction circuit is about ≦10μm. The electrochemical sensing test piece according to any one of claims 1 to 2, wherein the material of the reaction circuit is different from the material of the measurement circuit, and the measurement circuit includes a first measurement electrode and a second Measuring electrode, the reaction circuit includes a first reaction electrode and a second reaction electrode, the at least one through hole includes a first through hole and a second through hole, wherein the first reaction electrode and the second reaction electrode The first measurement electrode and the second measurement electrode are respectively provided on the flow channel plate, and the first measurement electrode is electrically connected to the first reaction electrode through the first through hole, the second The measurement electrode is electrically connected to the second reaction electrode through the second through hole. The electrochemical sensing test piece according to any one of claims 1 to 2, wherein the reaction circuit includes multiple Lines, and each line is a straight line. The electrochemical sensing test piece according to any one of claims 1 to 2, wherein the material of the reaction circuit is a precious metal, and the material of the measurement circuit is a conductive material different from the precious metal. The electrochemical sensing test piece according to claim 2, wherein the peeling technique is a laser peeling technique. A method for manufacturing an electrochemical test piece includes: providing an electrode substrate, the electrode substrate including a bottom plate and a reaction circuit disposed on the surface of the bottom plate; attaching the flow channel plate to the electrode substrate, the flow The channel plate defines an opening and at least one through hole; a measuring circuit is formed on the surface of the flow channel plate, and the measuring circuit is filled in the at least one through hole, so that the measuring circuit is electrically connected through the at least one through hole To the reaction circuit; and attaching a top plate to the flow channel plate, whereby the flow channel plate is located between the top plate and the electrode substrate, and the electrode substrate, the flow channel plate and the top plate are defined to correspond Opening first-rate. The method for manufacturing an electrochemical test piece according to claim 7, wherein the step of providing an electrode substrate comprises: forming a conductive film for reaction on a base plate; and using a peeling technique to part of the conductive film for reaction Stripping is performed to form the reaction circuit, wherein the stripping technique makes the accuracy of the edge of a line of the reaction circuit approximately ≦10 μm. The method for manufacturing an electrochemical test piece according to claim 8, wherein the step of peeling off the conductive film for reaction by a peeling technique to form the circuit for the reaction includes: At least one spacer is formed in the conductive thin film for reaction, and the spacer is straight, so that each line of the reaction circuit is straight. The method for manufacturing an electrochemical test piece according to any one of claims 8 to 9, wherein the peeling technique is a laser peeling technique. The method for manufacturing an electrochemical test piece according to claim 7, further comprising: forming a chemical reagent film in the flow channel, wherein the step of forming a chemical reagent film in the flow channel A measuring circuit is formed on the surface of the flow channel plate before the step, and after the top plate is attached to the flow channel plate.

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