TWI485399B - Method for making an electrochemical test strip - Google Patents

Description

Method for manufacturing electrochemical test piece

The present invention relates to a method for producing an electrochemical test piece, and more particularly to a method for producing an electrochemical test piece which reduces the occurrence of defective products.

Electrochemical Sensor Strips have been used to detect various substances in fluids. The basic principle is to use a reagent to produce one of the analytes in a fluid to be tested. Electrochemically to generate an electrical output signal that is related to the analyte to be measured. When the fluid to be tested is human blood and the analyte is blood sugar, a glucose enzyme and other complexes can be used as a chemical reagent.

Figure 1 shows a schematic view of the appearance of a conventional electrochemical test piece. Figure 2 shows an exploded view of the electrochemical test piece of Figure 1. As shown in FIGS. 1 and 2, the electrochemical test piece 100 is a blood glucose test piece including an electrode substrate 110, a flow path plate 120, and a top plate 130. The electrode substrate 110 includes a circuit layout 112 and a substrate 111, and 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 11a and 11c. The runner plate 120 defines an opening 122 that is formed through the upper surface above the runner plate 120. In order to allow blood to flow more smoothly, an opening 135 may be provided at the position of the opening 122 of the corresponding flow channel plate 120 of the top plate 130.

3A is a cross-sectional view and a plan view showing an electrode substrate in a step of a method of manufacturing a conventional electrochemical test piece, wherein the cross-sectional view is a cross section taken along line AA in plan view. Fig. 3B is a cross-sectional view and a plan view showing a substrate for a flow path in one step of a method of manufacturing a conventional electrochemical test piece. Fig. 3C is a plan view showing the bonding of the electrode substrate and the substrate for a flow path in one step of the method for producing a conventional electrochemical test piece. Fig. 3D is a cross-sectional view and a plan view showing a substrate for a top plate in one step of a method of manufacturing a conventional electrochemical test piece. As shown in FIGS. 3A to 3D, when the electrochemical test piece 100 is manufactured, the manufacturing method of the electrochemical test piece 100 of the prior art includes the following steps.

As shown in FIG. 3A, step S10: an electrode substrate 110 is provided. The electrode substrate 110 is fabricated by forming at least one circuit layout 112 on a substrate 111.

As shown in FIG. 3B, step S12: providing a first-class track substrate 128, and attaching the flow path plate 120 of the flow path substrate 128 to the electrode substrate 110, wherein the flow path plate 120 defines at least one for forming a flow. An opening 122 of the track 150; and an opening 123 to expose a portion of the circuit layout 112. More specifically, the flow path substrate 128 includes a first-order doping plate 120, an adhesive layer 129, and a release layer 127. The adhesive layer 129 is located between the flow channel substrate 128 and the release layer 127. When the flow channel plate 120 is to be attached to the electrode substrate 110, only the release layer 127 needs to be torn off, and the adhesive layer 129 can be transmitted. The flow channel plate 120 is attached to the electrode substrate 110.

As shown in FIG. 3C, in step S14, after a syringe is positioned over the opening 122 for forming the flow channel 150 by using a drip device, the glucose enzyme is dropped into the flow channel 150 through the syringe, and then dried. Thereby, glucose enzyme is formed on the electrode in the flow channel 150.

As shown in FIG. 3D, in step S16, a top substrate 138 is provided, and the top plate 130 of the top substrate 138 is attached to the flow channel plate 120 such that the flow channel plate 120 is located 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 collectively define a first-class track 150. The position of the flow path 150 corresponds to the position of the opening 122 of the flow path plate 120 and has an inlet 125 and an opening 135. More specifically, the top substrate 138 includes a top plate 130, an adhesive layer 139, and a release layer 137. The adhesive layer 139 is located between the top substrate 138 and the release layer 137. When the top plate 130 is to be attached to the flow channel plate 120, only the release layer 137 needs to be torn off, and the top plate can be passed through the adhesive layer 139. 130 is attached to the flow channel plate 120.

When the electrochemical test strip 100 is to be used, the user drops blood to the inlet 125, and the blood enters the flow path 150 from the inlet 125. The blood flows through the flow path 150 due to capillary action, and the gas in the flow path 150 passes from the opening 135. discharge.

However, according to the conventional manufacturing method, it is easy to cause the glucose enzyme to not overflow the entire flow path 150 or to overflow the flow path 150 due to being too full, or to easily overflow the flow path 150 due to the positioning deviation, and the like. The electrochemical test piece 100 produced has a low yield, and the use amount of a chemical reagent (Reagent) such as glucose enzyme is large, so there is room for further improvement.

According to an embodiment of the present invention, an electrochemical test piece for reducing the occurrence of defective products is provided. Production method. In one embodiment, a method of fabricating an electrochemical test strip that reduces crystallization is provided.

In an embodiment, a method for manufacturing an electrochemical test piece is provided, which comprises the following steps Step. An electrode substrate is provided, the electrode substrate comprising a circuit layout. The top plate of the first-class substrate is attached to the electrode substrate, wherein the flow plate defines at least one first opening for forming at least the first pass. A chemical reagent film is formed at the at least first pass by a spray method or a coating method. A top plate is attached to the flow channel plate such that the flow channel plate is located between the electrode substrate and the top plate, and the electrode substrate, the flow channel plate and the top plate collectively define the at least first channel.

In one embodiment, the substrate for the flow channel includes the flow channel plate, a first adhesive layer, and a first The release layer, wherein the first adhesive layer is located on the side of the flow channel, and the first release layer is located on the outer side of the first adhesive layer. The step of attaching the top plate to the flow channel plate further comprises: tearing the first release layer, and then bonding the top plate to the flow channel plate through the first adhesive layer.

In one embodiment, the chemical film is formed by a spray method or a coating method. Forming at least the first-class track, comprising, in a direction in which the at least one first opening is arranged, performing a spraying process to spray minute droplets of the chemical agent onto the at least first pass and the first release layer; Alternatively, a chemical reagent liquid is applied to the at least first pass and the first release layer. Preferably, when a chemical reagent film is formed at the at least first pass by a spray method, a plurality of spray processes are performed in the direction in which the at least one first opening is arranged.

In one embodiment, the substrate for the flow channel further includes a second adhesive layer and a second release layer. The second adhesive layer is located on the lower side of the flow channel plate, and the second release layer is located on the outer side of the second adhesive layer. The step of attaching the first-class track plate of the first-class substrate to the electrode substrate further comprises: tearing the second release layer, and then bonding the flow channel plate to the electrode substrate through the second adhesive layer.

In an embodiment, the flow channel plate is further defined to expose a portion of the circuit layout At least one second opening. In one embodiment, the chemical reagent is a glucose enzyme.

In one embodiment, the chemical film is formed by a spray method or a coating method. Forming at least the first-class track includes: providing a mask film on the flow channel plate, and exposing at least one first opening for forming the at least one of the first channels, concealing the flow outside the at least one first opening After the portion of the land plate, a chemical film is formed on the at least first pass and the mask by a spray method or a coating method. On the membrane. The step of attaching a top plate to the flow path plate comprises: removing the mask film and then bonding the top plate to the road plate.

The manufacturing method according to an embodiment of the present invention can be reduced because it is not a drip method. Less crystallization occurs. In addition, since the chemical phenomenon can be avoided by reducing the crystallization phenomenon, the liquid to be tested can dissolve the chemical reagent more quickly, and the detection accuracy is increased. In one embodiment, a chemical spray film or a coating method is used to form a chemical reagent film at the at least first pass, so that it is not necessary to accurately position the syringe and the flow channel opening as in the prior art.

100‧‧‧Electrochemical test piece

110‧‧‧Electrode substrate

111‧‧‧One substrate

112‧‧‧Circuit layout

120‧‧‧flow channel board

122‧‧‧ openings

123‧‧‧ openings

125‧‧‧ entrance

127‧‧‧Fractal layer

128‧‧‧Flower substrate

129‧‧ ‧ adhesive layer

130‧‧‧ top board

135‧‧‧ openings

137‧‧‧Fractal layer

138‧‧‧Top substrate

139‧‧‧Adhesive layer

150‧‧‧ flow path

157‧‧‧Glucose Enzyme Crystallization

510‧‧‧Electrode substrate

511‧‧‧Substrate

512‧‧‧Circuit layout

520‧‧‧flow channel board

522‧‧‧ openings

527‧‧‧Fractal layer

528‧‧‧Flower substrate

529‧‧ ‧ adhesive layer

530‧‧‧ top board

537‧‧‧Fractal layer

539‧‧‧Adhesive layer

540‧‧‧Glucosamine film

11a, 11c‧‧‧ electrodes

Figure 1 shows a schematic view of the appearance of a conventional electrochemical test piece.

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

3A is a cross-sectional view and a plan view showing an electrode substrate in a step of a method of manufacturing a conventional electrochemical test piece, wherein the cross-sectional view is a cross section taken along line AA in plan view.

Fig. 3B is a cross-sectional view and a plan view showing a substrate for a flow path in one step of a method of manufacturing a conventional electrochemical test piece.

Fig. 3C is a plan view showing the bonding of the electrode substrate and the substrate for a flow path in one step of the method for producing a conventional electrochemical test piece.

Fig. 3D is a cross-sectional view and a plan view showing a substrate for a top plate in one step of a method of manufacturing a conventional electrochemical test piece.

4A is a cross-sectional view and a plan view showing an electrode substrate in a step of a method of manufacturing an electrochemical test piece according to an embodiment of the present invention, wherein the cross-sectional view is a cross-sectional view taken along line AA in plan view.

4B is a cross-sectional view and a plan view showing a substrate for a flow path in one step of a method of manufacturing an electrochemical test piece according to an embodiment of the present invention.

Fig. 4C is a plan view showing the bonding of the electrode substrate and the substrate for a flow path in one step of the method for producing an electrochemical test piece according to an embodiment of the present invention.

4D is a cross-sectional view and a plan view showing a substrate for a top plate in one step of a method of manufacturing an electrochemical test piece according to an embodiment of the present invention.

Figure 5 shows an electrochemical test piece prepared according to the prior art, which shows after drying the glucose enzyme intention.

4A is a cross-sectional view and a plan view showing an electrode substrate in a step of a method of manufacturing an electrochemical test piece according to an embodiment of the present invention, wherein the cross-sectional view is a cross-sectional view taken along line AA in plan view. 4B is a cross-sectional view and a plan view showing a substrate for a flow path in one step of a method of manufacturing an electrochemical test piece according to an embodiment of the present invention. Fig. 4C is a plan view showing the bonding of the electrode substrate and the substrate for a flow path in one step of the method for producing an electrochemical test piece according to an embodiment of the present invention. 4D is a cross-sectional view and a plan view showing a substrate for a top plate in one step of a method of manufacturing an electrochemical test piece according to an embodiment of the present invention. As shown in FIGS. 4A to 4D, when the electrochemical test piece 100 is manufactured, the method for producing an electrochemical test piece according to the first embodiment of the present invention comprises the following steps.

As shown in FIG. 4A, step S20: an electrode substrate 510 is provided. The electrode substrate 510 is fabricated by forming at least one circuit layout 512 on a substrate 511.

As shown in FIG. 4B, step S22: providing a first-class substrate 528, and attaching a flow channel plate 520 of the substrate 528 to the electrode substrate 510, wherein the flow channel plate 520 defines at least one for forming a flow. An opening 522 of the track 150; and an opening 523 to expose a portion of the circuit layout 512. More specifically, the flow path substrate 528 includes a first-order doping plate 520, two-layer adhesive layers 529 and 539, and two-layered release layers 527 and 537. The two adhesive layers 529 and 539 are respectively located on both sides of the flow channel plate 520, and the two release layers 527 and 537 are respectively attached to the outer sides of the two adhesive layers 529 and 539. When the flow channel plate 520 is to be attached to the electrode substrate 510, the lowermost release layer 537 can be torn, and the flow channel plate 520 can be attached to the electrode substrate 510 through the adhesive layer 539. And the uppermost release layer 527 is retained.

As shown in FIG. 4C, step S24: above the opening 522 defined by the flow channel substrate 528 for forming the flow channel 150, the glucose enzyme film 540 is formed on the flow channel 150 by a spraying method or a coating method. On the uppermost release layer 527. Further, in the present embodiment, although glucose enzyme is used as the chemical reagent, the present invention is not limited thereto, and in other examples, uric acid enzyme, cholesterol enzyme, ketone ketone body enzyme or heme enzyme may be used. As a chemical reagent.

As shown in FIG. 4D, step S26: tearing off the uppermost release layer 527 of the flow channel substrate 528 to provide a top plate substrate, and the top plate substrate may be only a top plate 530, and the top plate The 530 is adhered to the flow channel plate 520 through the adhesive layer 529, so that the flow channel plate 520 is located on the electrode substrate 510 and the top plate 530. Between the electrode substrate 510, the flow channel plate 520, and the top plate 530, a first-class track 150 is defined. The position of the flow path 150 corresponds to the position of the opening 522 of the flow path plate 520 and has an inlet 125 and an opening 135.

Fig. 5 shows a schematic view of an electrochemical test piece prepared according to the prior art, which dries glucose enzyme. As shown in FIG. 5, a phenomenon of glucose enzyme crystals 157 is formed on the side edge of the flow path 150. This crystallization phenomenon is caused by excessive or uneven distribution of glucose enzymes. When the electrochemical test piece 100 is used for the blood sugar test, the glucose crystals are not easily dissolved in the blood, which causes a measurement deviation. Therefore, due to the fact that the conventional technology may not be full of glucose enzymes or the cloth is too full, it is necessary to perform visual or automatic optical inspection at the time of manufacture, and pick out the electrochemical test pieces 100 which are excessively crystallized, thus causing a yield deviation. Low and wasteful hours. In addition, since the crystallization phenomenon is caused by too much glucose enzyme, the conventional method of dropping, in addition to causing a low yield, additionally wastes glucose enzyme, resulting in high manufacturing costs. According to the prior art, in order to accurately drip the glucose enzyme into the flow channel 150, it is necessary to reuse the positioning function of the drip device to accurately position the syringe above the flow channel 150, which increases manufacturing man-hours and troubles. .

In view of the above disadvantages, in the manufacturing method according to an embodiment of the present invention, the glucose enzyme film 540 is formed on the flow path 150 and the uppermost release layer 527 by a spray method or a coating method without using a drip method. Various implementation details will be further described below with respect to step S24. According to the spraying method, very minute droplets are sprayed into the flow path 150, so that the glucose enzyme is not excessively distributed or unevenly distributed, and the occurrence of crystallization can be reduced. Further, it is also possible to spray back and forth several times over the flow path substrate 528 in the direction in which the openings 522 of the plurality of flow paths 150 are arranged. Since the spray method produces tiny droplets every time, after the glucose enzyme is sprayed, the glucose enzyme liquid is easily dried and is not easily crystallized. Therefore, the glucose enzyme film 540 is formed by multiple spraying methods, except for In addition to the quantitative coating thickness, it is also possible to avoid wasting glucose enzymes. Further, according to the present embodiment, since the spraying is performed back and forth along the direction in which the openings 522 of the plurality of flow paths 150 are arranged, it is possible to accurately position the head over the flow path 150 without being able to accurately reduce the manufacturing difficulty.

In an embodiment, the nozzle can also be positioned above the flow channel 150 by using a positioning method, and then sprayed. This can reduce the waste of glucose enzyme by spraying the glucose enzyme at a position where the flow path 150 is not formed.

In an embodiment, the coating tool such as a doctor blade or a brush may also be used to apply glucose. The enzyme is applied to the flow path 150 and the uppermost release layer 527. In one embodiment, the glucose enzyme can also be applied to the flow channel 150 and the uppermost release layer 527 by a printing technique.

The method of manufacturing the electrochemical test piece 100 according to the second embodiment of the present invention comprises the following steps.

Step S30: An electrode substrate 510 is provided. The electrode substrate 510 is fabricated by forming at least one circuit layout 512 on a substrate 511.

Step S32: providing a first-class doping plate 520, and attaching the flow channel plate 520 to the electrode substrate 510, wherein the flow channel plate 520 defines at least one opening 522 for forming the flow channel 150; and a portion for exposing the circuit layout 512 The opening 523.

Step S34: A mask film is disposed on the flow channel plate 520 to expose the opening 522 for forming the flow channel 150, and the portion of the flow channel plate 520 outside the openings 522 is concealed, and then the flow channel plate 520 is disposed. A glucose enzyme film 540 is formed on the flow path 150 and on the mask film by a spray method or a coating method to define an opening 522 for forming the flow path 150.

Step S36: After removing the mask film, a top plate 530 is attached to the flow channel plate 520, so that the flow channel plate 520 is located between the electrode substrate 510 and the top plate 530, and the electrode substrate 510, the flow channel plate 520, and The top plate 530 collectively defines a first-class track 150. The position of the flow path 150 corresponds to the position of the opening 522 of the flow path plate 520 and has an inlet 125 and an opening 135.

In addition, in an embodiment, the order of forming a chemical reagent film on a part of the circuit layout 512 by a spray method or a coating method may not be limited. For example, a chemical may be formed on the circuit layout 512 first. After the reagent film, the flow path plate 520 is attached. More specifically, it is explained below. The method of manufacturing the electrochemical test piece 100 according to the third embodiment of the present invention comprises the following steps.

Step S40: providing an electrode substrate 510, the electrode substrate 510 includes a circuit layout 512; Step S42: forming a chemical reagent film on a portion of the circuit layout 512 by a spray method or a coating method; Step S44: using the first-class circuit The top plate 520 of the substrate 528 is attached to the electrode substrate 510, wherein the flow plate 520 defines at least one opening 522 for forming at least the first pass 150; and step S46: attaching a top plate 530 to the flow plate 520 The flow channel plate 520 is located between the electrode substrate 510 and the top plate 530, and the electrode substrate 510, the flow channel plate 520, and the top plate 530 are common. The at least one of the first lanes 150 is defined, wherein the portion of the circuit layout 512 is located within the flow channel 150.

According to the present embodiment, the conventional flow path substrate 128 and the top substrate 138 can be used without changing the flow path substrate 128 and the top substrate 138. However, an additional mask film is required. In contrast, according to the manufacturing method of the first embodiment, the structure of the conventional flow path substrate 128 and the top substrate 138 can be changed, and the uppermost release layer 527 of the flow path substrate 528 can be directly used. As a mask film, an additional mask film is not required, and the manufacturing process, man-hour, and materials can be reduced.

As described above, according to the method of manufacturing the electrochemical test piece 100 according to the embodiment of the present invention, since the drip method is not employed, the occurrence of the crystallization phenomenon can be reduced. In addition, because of the reduction of crystallization, the glucose enzyme can be not wasted, and the blood can dissolve the glucose enzyme more quickly, increasing the accuracy of detection. In one embodiment, a glucose method 540 is formed on the flow channel 150 by a spray method or a coating method. Therefore, the syringe and the flow channel 150 need not be accurately opened by the opening 522 as in the prior art. Positioning.

512‧‧‧Circuit layout

520‧‧‧flow channel board

Claims (10)

A method for manufacturing an electrochemical test piece, comprising: providing an electrode substrate, the electrode substrate comprising a circuit layout; and attaching a first-class track plate of a first-class substrate to the electrode substrate, wherein the flow channel plate defines Forming at least one first opening of at least one of the first channels; forming a chemical reagent film at the at least first pass by a spray method or a coating method; and attaching a top plate to the flow path plate to make the flow path The plate is located between the electrode substrate and the top plate, and the electrode substrate, the flow channel plate and the top plate collectively define the at least first channel. The method for manufacturing an electrochemical test strip according to claim 1, wherein the substrate for the flow channel comprises the flow channel plate, a first adhesive layer and a first release layer, wherein the first The adhesive layer is located on the side of the flow channel, and the first release layer is located on the outer side of the first adhesive layer, and the step of bonding the top plate to the flow path plate further comprises tearing the first After a release layer, the top plate is attached to the flow channel plate through the first adhesive layer. The method for producing an electrochemical test piece according to claim 2, wherein the step of forming a chemical reagent film at the at least first pass by a spray method or a coating method comprises, along the at least one a direction in which the first openings are arranged, a spraying process is performed to spray minute droplets of the chemical agent onto the at least first pass and the first release layer; or a chemical reagent liquid is applied to the at least first pass and the On the first release layer. The method for producing an electrochemical test piece according to claim 3, wherein when the chemical reagent film is formed at the at least first pass by the spray method, the at least one first opening is arranged. Direction, carry out most spray procedures. The method for manufacturing an electrochemical test strip according to claim 2, wherein the substrate for the flow channel further comprises a second adhesive layer and a second release layer, wherein the second adhesive layer is located The lower side of the flow channel plate, and the second release layer is located on the outer side surface of the second adhesive layer, and the step of attaching the first-class road plate of the first-class substrate to the electrode substrate further comprises tearing After the second release layer, the flow channel plate is adhered to the electrode substrate through the second adhesive layer. The method for producing an electrochemical test piece according to claim 1, wherein the flow path The board further defines at least one second opening that is useful to expose a portion of the circuit layout. The method for producing an electrochemical test piece according to claim 1, wherein the chemical agent is a glucose enzyme, a uric acid enzyme, a cholesterol enzyme, a ketone ketone body enzyme or a heme enzyme. The method for producing an electrochemical test piece according to claim 1, wherein the step of forming a chemical reagent film at the at least first pass by a spray method or a coating method comprises: at the flow Providing a mask film on the board, and exposing at least one first opening for forming the at least one of the first channels, concealing the portion of the flow channel plate other than the at least one first opening, and then using the spray method or the a coating method of forming the chemical reagent film on the at least the first pass and the mask film, and the step of attaching a top plate to the flow path plate, comprising: removing the mask film, and then removing the mask film The top plate is attached to the flow path plate. The method of fabricating an electrochemical test strip of claim 8, wherein the flow channel plate further defines at least one second opening for exposing a portion of the circuit layout. The method for producing an electrochemical test piece according to claim 8, wherein the chemical agent is a glucose enzyme, a uric acid enzyme, a cholesterol enzyme, a ketone ketone body enzyme or a heme enzyme.