TWM574235U - Electrochemical test sheet - Google Patents

Abstract

An electrochemical test sheet including an insulating substrate, an electrode system, a first insulating septum, and a second insulating septum is provided. The electrode system is disposed on the insulating substrate and includes a first electrode structure and a second electrode structure insulated from each other. The first insulating septum covers a part of the electrode system and has a notch at one end thereof. A part of the electrode system is exposed by the notch. The second insulating septum covers the first insulating septum. The notch of the first insulating septum, the insulating substrate, and the second insulating septum constitute a reaction region. The electrode system in the reaction region has a breaking region near a bottom of the notch.

Description

Electrochemical test strip

The novel creation is related to a test piece, and in particular to an electrochemical test piece.

With the advancement of medicine and the increasing awareness of modern people's health care concepts, self-test products (such as blood glucose meters, electronic ear thermometers, and electronic sphygmomanometers) that are fast, inexpensive, small, and do not require professional operation More attention has been paid. The use of electrochemical coupons has become a common technique in medical or biochemical testing. A conventional electrochemical test piece has at least two measuring electrodes (including a working electrode and a reference electrode), and after the liquid sample is injected into the reaction zone of the test piece, the measuring electrode is used to measure the electrical properties of the sample. However, such an electrode design structure cannot confirm whether the sample has completely covered the measuring electrode before performing the measurement.

At present, in a commercially available electrochemical test piece, a third electrode may be additionally added to the reaction zone, wherein the third electrode is disposed at the farthest from the sampling port in the reaction zone compared to the above two measuring electrodes. End. After injecting the sample, the third electrode can be used to detect whether the sample is properly covered by the current change between the most front end of the reaction zone and the last measuring electrode at the farthest end from the sampling port. electrode. Alternatively, at least four electrodes can be designed in the reaction zone. That is to say, in addition to the above two measuring electrodes, a third electrode and a fourth electrode are additionally added in the reaction zone, wherein the third electrode and the fourth electrode are disposed in the reaction zone in comparison with the two measuring electrodes. The farthest end of the sampling port. After the sample enters the reaction zone by capillary phenomenon, the liquid electrode is electrically conductive to make the third electrode and the fourth electrode electrically conduct, thereby confirming whether the sample covers the measuring electrode.

However, in order to confirm whether the sample appropriately covers the measuring electrode, the design of adding the third electrode or adding the third electrode and the fourth electrode is required to increase the accommodation space of the reaction zone. In addition, in order to ensure the accurate measurement of the biochemical value of the electrochemical test piece, a measuring electrode for measuring interference factors (for example, uric acid, blood oxygen, hematocrit value, etc.) is added to the reaction zone for calibration measurement. The value also needs to increase the accommodation space of the reaction zone, thereby forcing the user to provide more samples to the reaction zone, which is contrary to the current trend of reducing the volume of the sample provided.

In addition, some commercially available electrochemical test strips use a measuring electrode to detect the sample reaction amplitude or phase angle to calculate the sample capacity to confirm whether the sample covers the measuring electrode. Although there is no need to add additional electrodes in this way, however, since the sample contains many substances with electrical signal reaction, in the process of electrochemical concentration detection, the method of detecting amplitude or phase angle is easy to cause electron loss in the reaction zone, resulting in Concentration measurement error. Therefore, there is a need in the industry for an electrochemical test strip that does not require additional electrodes or that can reduce electrode settings while simultaneously achieving accurate identification of sample capacity.

The novel creation provides an electrochemical test piece, which can accurately identify whether the test sample reaches a sufficient capacity and appropriately cover the electrode without additionally adding other electrode structures.

The electrochemical test piece created by the novel comprises an insulating substrate, an electrode system, a first insulating spacer and a second insulating spacer. The electrode system is disposed on the insulating substrate, wherein the electrode system includes a first electrode structure and a second electrode structure, and the first electrode structure and the second electrode structure are insulated from each other. The first insulating spacer covers a portion of the electrode system, wherein the first insulating spacer has a recess at one end and a portion of the electrode system is exposed to the recess. The second insulating spacer covers the first insulating spacer, wherein the recess of the first insulating spacer forms a reaction zone with the insulating substrate and the second insulating spacer, wherein the electrode system in the reaction zone has a breaking area near the bottom of the recess.

In an embodiment of the present invention, the circuit breaker region is located in the first electrode structure.

In an embodiment of the present invention, the first electrode structure includes a front electrode segment and a rear electrode segment. The front electrode section includes a section of the first electrode structure that extends from the top of the recess to the open area. The rear electrode section includes a section in which the first electrode structure extends from the breaking zone to a portion near the bottom of the recess. The distance between the front electrode segment and the rear electrode segment is a first distance, and the minimum electrical distance between the front electrode segment and the second electrode structure is a second distance, the rear electrode segment and the second electrode The minimum electrical distance between the structures is a third distance, wherein the third distance is greater than the first distance and the third distance is greater than the second distance.

In an embodiment of the novel creation, the third distance is greater than or equal to the sum of the first distance and the second distance.

In an embodiment of the novel creation, the first distance is greater than the second distance.

In an embodiment of the novel creation, the first distance is greater than or equal to twice the second distance.

In an embodiment of the present invention, the first electrode structure is a reference electrode, and the second electrode structure is a working electrode.

In an embodiment of the present invention, the first electrode structure is a working electrode, and the second electrode structure is a reference electrode.

In an embodiment of the present invention, the second insulating spacer includes a vent hole, and the projection of the vent hole on the insulating substrate is located in the reaction area, wherein the projection of the vent hole on the electrode system partially overlaps with the breaking area or Completely overlapping.

In an embodiment of the present invention, the circuit breaker region includes a conductive material, a curing agent, or a combination thereof.

In an embodiment of the present invention, the conductive material includes an ionic compound, a conductive metal, a conjugated double bond polymer, or a combination thereof.

Based on the above, the novel creation can accurately identify whether the test sample reaches a sufficient capacity and appropriately by using the open circuit area design of the first electrode structure on the electrochemical test piece without additional additional electrode structure. Cover the electrode. That is to say, the electrochemical test piece created by the novel can effectively reduce the test failure without providing more test samples without increasing the accommodation space of the reaction zone of the electrochemical test piece. Probability and ensure the accuracy of subsequent measurements.

The above described features and advantages of the present invention will become more apparent and understood from the following description.

BRIEF DESCRIPTION OF THE DRAWINGS Fig. 1 is an exploded perspective view showing an electrochemical test piece according to an embodiment of the present invention, in which the positional contour of the electrochemical test piece is represented by a broken line in order to facilitate the understanding of the relative positions between the elements. 2 is a partial perspective schematic view of the electrochemical test strip of FIG. 1.

Referring to FIGS. 1 and 2 , the electrochemical test strip 100 of the present invention includes an insulating substrate 110 , an electrode system 120 , a first insulating spacer 130 , and a second insulating spacer 150 . In some embodiments, the insulating substrate 110 is electrically insulating, and the material thereof may include, for example, polyvinyl chloride (PVC), glass fiber, polyester, bakelite, polyethylene terephthalate (PET), polycarbonate. (PC), polypropylene (PP), polyethylene (PE), polystyrene (PS), ceramics or a combination thereof, but the novel creation is not limited thereto.

The electrode system 120 is disposed on the insulating substrate 110. The electrode system 120 includes a first electrode structure 122 and a second electrode structure 124. The first electrode structure 122 and the second electrode structure 124 are insulated from each other. In some embodiments, the first electrode structure 122 is, for example, a reference electrode, the second electrode structure 124 is, for example, a working electrode, and the first electrode structure 122 and the second electrode structure 124 constitute a measuring electrode group, but the novel creation is not limited to this. In other embodiments, electrode system 120 can include other electrodes, such as correction electrodes, functional electrodes, and the like. In some embodiments, the material of the electrode system 120 may be, for example, any conductive material such as carbon glue, silver glue, copper glue, carbon silver mixed glue or the like and combinations thereof, but the novel creation is not limited thereto.

The first insulating spacer 130 covers a portion of the electrode system 120, wherein the first insulating spacer 130 has a recess 132 at one end and a portion of the electrode system 120 is exposed to the recess 132. In some embodiments, the first insulating spacer 130 covers a portion of the electrode system 120 such that a portion of the first electrode structure 122 and a portion of the second electrode structure 124 are exposed to the recess 132. In some embodiments, the material of the first insulating spacer 130 may include, for example, a PVC insulating tape, a PET insulating tape, a thermal drying type insulating varnish or an ultraviolet drying type insulating varnish, but the novel creation is not limited thereto.

The second insulating spacer 150 covers the first insulating spacer 130, wherein the notch 132 of the first insulating spacer 130 and the insulating substrate 110 and the second insulating spacer 150 constitute a reaction area 140, and the reaction area 140 can be used to accommodate a liquid sample. The reaction zone 140 has a sampling port 141 near the top of the recess 132 for liquid sample injection. When the liquid sample is injected from the sampling port 141 of the reaction zone 140, the electrodes in the electrode system are sequentially contacted. In some embodiments, the electrode system 120 is adjacent to the sampling port 141 and the end not covered by the first insulating spacer 130 is located in the reaction zone 140, and the other end of the electrode system 120 away from the sampling port 141 is used for the measuring instrument 10 ( As shown in Figure 3) connected.

In some embodiments, the material of the second insulating spacer 150 may be, for example, a transparent or translucent material to facilitate observation of whether the reaction zone 140 has been filled with the sample, and to avoid detection when the sample is not filled. The result of the measurement is wrong, but the novel creation is not limited to this. In other embodiments, the second insulating spacer 150 can include, for example, a transparent viewing zone 152, and the projection of the transparent viewing zone 152 on the insulating substrate 110 partially overlaps or completely overlaps the reaction zone 140, thereby being designed to facilitate viewing of the reaction. Whether the zone 140 has been filled with the sample. In some embodiments, the second insulating spacer 150 may be coated with a hydrophilic spacer near the surface 150a of the reaction zone 140 to enhance the capillary action of the inner wall surface of the reaction zone 140, and to introduce the sample into the reaction zone more quickly and efficiently. 140. In some embodiments, the second insulating spacer 150 includes a vent 154 that is disposed corresponding to the recess 132, the vent 154 being configured to enhance capillary action to vent gas within the reaction zone 140. In some embodiments, the projection of the vent 154 on the insulating substrate 110 is located within the reaction zone 140. In other embodiments, the vent 154 is disposed adjacent the bottom of the recess 132, but the novel creation is not limited thereto. In the present creation, the shape of the vent 154 is not limited. For example, the shape of the vent 154 may be, for example, a circle, an ellipse, a rectangle, a diamond, or the like, but the novel creation is not limited thereto.

In some embodiments, the electrochemical test strip may include, for example, an identification unit (not shown) that may be disposed, for example, on the side of the connection of the upper surface electrode system of the second insulating spacer 150 to the gauge. In other embodiments, the identification unit may be disposed, for example, on one end of the substrate 110 on which the electrode system 120 is relatively far from the sampling port 141, and the identification unit and the electrode system 120 do not interfere with each other. In some embodiments, the identification unit can include, for example, a plurality of electrical components. The electrical component can be a variety of electrically conductive electrical components, such as electrical components having electrical characteristics of the passive component. In some embodiments, the electrical component can be, for example, a resistor. The material of the electrical component can be the same as, for example, the electrode system 120. The method of forming the electrical component can be, for example, screen printing, imprinting, and heat. Thermal transfer printing, spin coating, ink-jet printing, laser ablation, deposition, electroposition, screen printing Screen-printing) and other technologies. However, in other embodiments, the electrical components included in the identification unit may be, for example, resistors, capacitors, inductors, integrated circuits, and/or combinations thereof, but the novel creation is not limited thereto. When the electrochemical test piece is placed in the measuring instrument, the measuring instrument can detect the position and quantity of each electrical component on the identification unit, thereby discriminating the type of the electrochemical test piece, and then adopting the corresponding correction parameter or mode. Make measurements. In other words, the number and position of the plurality of electrical components determine the identification code of the electrochemical test strip, so that the measuring instrument can discriminate the electrochemical test strip accordingly. However, the novel creation does not limit the number, shape or arrangement of the electrical components included in the identification unit. In addition, the novel creation does not limit the setting position or working mode of the identification unit, as long as the identification unit allows the measuring instrument to read the identification code.

In some embodiments, the inventive electrochemical test strip further includes a reaction layer 142, wherein the reaction layer 142 is located within the reaction zone 140 and covers at least a portion of the first electrode structure 122. The reaction layer 142 is, for example, used for electrochemical reaction with a liquid sample or for generating a specificity for identifying a biological signal. In some embodiments, the reaction layer 142 covers at least the electrode position in the reaction zone 140, and may also cover the non-electrode position in the reaction zone 140 for electrochemical reaction or specificity to identify the biological signal. . The reaction layer 142 may cover at least a portion of the first electrode structure 122 of the reaction region 140 and a portion of the second electrode structure 124, and is limited to not block the sampling port. In general, the area of the reaction layer 142 is smaller than the area of the reaction zone 140, as long as the reaction layer 142 can chemically react with the liquid sample, the shape of the novel is not limited.

In some embodiments, the reaction layer 142 includes, for example, a conductive medium, an active material, a buffer, a protective agent, or a combination thereof, but the novel creation is not limited thereto. In some embodiments, the electrically conductive medium can be used, for example, to receive electrons generated by the reaction of a sample (eg, blood, urine, saliva, etc.) and conduct the electrons through the electrode system 120 to the biometric instrument. In some embodiments, the electrically conductive medium can include, for example, potassium ferricyanide, potassium hexacyanoferrate (II) trihydrate, ruthenium (RU), ferrocene, sodium dithionite (sodium). Dithionite), nicotinamide adenine dinucleotide (NAD+), nicotinamide adenine dinucleotide phosphate (NADP+), thiamin pyrophosphate (TPP) ), coenzyme A (HSCoA), flavin adenine dinucleotide (FAD), or a combination thereof. In some embodiments, the active substance is, for example, an enzyme (eg, glucose oxidase), an antigen, an antibody, a microbial cell, an animal or plant cell, an animal or plant tissue, or a combination thereof, which is immobilized or not immobilized, or may have other The component of biological recognition ability. In some embodiments, the buffer is, for example, a phosphate buffer. In some embodiments, the protective agent includes, for example, a protein, dextrin, dextran, amino acid, or a combination thereof, but the novel creation is not limited thereto.

Referring to FIG. 2, in the embodiment, the first electrode structure 122 and the second electrode structure 124 are disposed in the reaction region 140, wherein the first electrode structure 122 is, for example, a reference electrode, and the second electrode structure 124 is, for example, a working electrode. The following embodiments will be described by way of example, but the novel creation is not limited thereto. That is, in other embodiments, the first electrode structure 122 can also be, for example, a working electrode, and the second electrode structure 124 is, for example, a reference electrode. During the measurement, the measuring device 10 applies a voltage difference between the electrodes to cause the sample in the reaction zone 140 to chemically react with the reaction layer 142 and convert the chemical energy into electrical energy, and then perform concentration analysis by the measuring instrument 10. However, this novel creation does not limit the configuration of the electrodes. In general, it is only necessary to arrange the electrodes as described above in the electrode system 120, and the electrodes are insulated from each other before being in contact with the liquid sample, and the electrode system 120 can be connected to the measuring instrument 10 after being in contact with the liquid sample. Forming an electrical loop is sufficient to implement.

In the novel creation, the electrode system 120 in the reaction zone 140 has a break zone 125 near the bottom of the recess 132. In some embodiments, the first electrode structure 122 in the reaction zone 140 has a circuit breaker region 125 near the bottom of the recess 132. That is, the circuit breaker region 125 is, for example, located in the first electrode structure 122, but the present invention is not limited thereto. In detail, the first electrode structure 122 includes a front electrode section 122a and a rear electrode section 122b, wherein the front electrode section 122a includes a section of the first electrode structure 122 extending from the top of the recess 132 to the open area 125, The electrode section 122b includes a section in which the first electrode structure 122 extends from the breaking zone 125 to near the bottom of the recess 132. That is, the first electrode structure 122 is divided into two sections of the front electrode section 122a and the rear electrode section 122b by the design of the breaking zone 125, before the liquid sample is not filled with the reaction zone 140 and covers the breaking zone 125. The front electrode section 122a is a section closer to the sampling port 141 of the reaction zone 140 and insulated from the measuring instrument 10, and the rear electrode section 122b is a section connected to the measuring instrument 10. When the liquid sample fills the reaction zone 140 and covers the front electrode section 122a and the back electrode section 122b of the first electrode structure 122, the liquid sample will cause the second electrode structure 124, the front electrode section 122a of the first electrode structure 122 And the rear electrode section 122b is simultaneously turned on. In addition, since the breaking zone 125 is disposed in the reaction zone 140 near the bottom of the recess 132, it can be determined whether the liquid sample has covered the entire reaction zone 140. For example, the method of viewing may be, for example, applying power between the second electrode structure 124 and the back electrode section 122b of the first electrode structure 122, and observing its electrical change. In the general case, the front electrode segment 122a and the rear electrode segment 122b of the first electrode structure 122 cannot be electrically connected to the first electrode structure 122 and the second electrode structure 124 before the liquid sample completely covers the circuit breaker region 125. The electrical changes of the first electrode structure 122 and the second electrode structure 124 can then be examined to determine if the sample is full of the reaction zone 140 near the bottom of the recess 132 and overlying the second electrode structure 124. It is worth mentioning that the novel creation does not limit the setting position of the breaking zone 125, and only needs to be located in the reaction zone 140 closer to the bottom (endmost end) of the notch 132 than the other electrodes and can be covered by the sample. In a preferred embodiment, the circuit breaker region 125 can be disposed, for example, below the vent 154. In other words, the projection of the vent 154 on the electrode system 120 partially overlaps or completely overlaps the circuit breaker region 125. In a specific embodiment, when the circuit breaker region 125 is located at the first electrode structure 122, the projection of the vent hole 154 on the first electrode structure 122 partially overlaps or completely overlaps the circuit breaker region 125. In a more preferred embodiment, a small portion of the open circuit region 125 is covered by the first insulating spacer 130, but the novel creation is not limited thereto.

After confirming that the sample properly covers the reaction zone 140, an electrical measurement between the first electrode structure 122 and the second electrode structure 124 can be performed, primarily to measure oxidation in the sample and reaction layer 142 in reaction zone 140. The change in current produced by the electrochemical action of the reductase, whereby the change in biochemical significance is analyzed by the change in current. It is worth mentioning that this new creation does not limit the measurement steps. In some embodiments, the meter 10 confirms that the first electrode structure 122 and the second electrode structure 124 are turned on and can be powered off and allowed to stand for a specific time, and then receive the reaction electrons through the second electrode structure 124. In other embodiments, after the meter 10 confirms that the first electrode structure 122 and the second electrode structure 124 are turned on, the concentration measurement procedure can also be performed immediately.

Under normal conditions, the second electrode structure 124 is an electrode that oxidizes with the sample and the reaction layer 142, and the first electrode structure 122 is an electrode that undergoes a reduction reaction with the sample and the reaction layer 142. Theoretically, the second electrode structure 124 is The impedance of the first electrode structure 122 must be a known fixed value. However, in the case where the reducing ability of the first electrode structure 122 is ensured to be greater than the redox ability of the active material of the reaction layer 142 and the sample, the impedance of the first electrode structure 122 may allow a certain range of impedance difference, and the impedance difference does not Affect the accuracy of concentration measurement. Therefore, although the difference in impedance of each liquid sample causes the reduction reaction effect of the first electrode structure 122, it does not affect the accuracy of concentration measurement of the novel creation.

In the present embodiment, the distance between the front electrode section 122a and the rear electrode section 122b is the first distance D1, and the minimum electrical distance between the front electrode section 122a and the second electrode structure 124 is The second distance D2, the minimum electrical distance between the back electrode section 122b and the second electrode structure 124 is the third distance D3. Specifically, according to Kirchhoff's current law (KCL), when the liquid sample completely fills the reaction zone 140, the liquid collides with the front electrode section 122a and the rear electrode section 122b of the first electrode structure 122. . In some embodiments, the third distance D3 is greater than the first distance D1, and the third distance D3 is greater than the second distance D2. In other embodiments, the third distance D3 is greater than or equal to the sum of the first distance D1 and the second distance D2, but the novel creation is not limited thereto. In a preferred embodiment, the first distance D1 is greater than the second distance D2 to ensure that the front electrode section 122a of the first electrode structure 122 performs optimally. In a more preferred embodiment, the first distance D1 is greater than or equal to twice the second distance D2, but the novel creation is not limited thereto. However, the novel creation does not particularly limit the proportional relationship between the first distance D1, the second distance D2, and the third distance D3, as long as the first electrode structure 122 can simultaneously achieve both the measured concentration and the confirmation that the liquid sample is completely filled. The function of the area 140 is sufficient.

It is worth mentioning that, in some cases, due to insufficient liquid sample injected into the reaction zone 140 by the user, the liquid sample fails to completely fill the reaction zone 140, but is caused by the hydrophilicity and capillary effect of the reaction zone 140. The liquid sample covers only the second electrode structure 124 and the back electrode section 122b of the first electrode structure 122 without bonding the front electrode section 122a of the first electrode structure to the back electrode section 122b; or in other cases The sample covers only the open region 125 and the second electrode structure 124 of the first electrode structure 122, and does not cover the portion of the first electrode structure 122 that is close to the sampling port 141. In the case where the two samples are insufficient, since the reaction layer 142 is incompletely dissolved, the reaction signal will be smaller than the normal range threshold, so the measuring instrument 10 only needs to check whether the first electrode structure 122 and the second electrode structure 124 are turned on. By judging the response signal threshold, it is known whether the sample completely fills the reaction zone 140. Furthermore, since the first electrode structure 122 of the present invention has a design of the circuit breaker region 125 near the bottom of the recess 132 in the reaction zone 140, the liquid sample can be completely covered in the reaction zone under the normal signal threshold. 140.

In some embodiments, the open circuit region 125 of the present invention created in the first electrode structure 122 may include, for example, a conductive substance, a curing agent, or a combination thereof, but the novel creation is not limited thereto.

In some embodiments, a conductive material can be used to increase the effect of liquid collation between the front electrode section 122a and the back electrode section 122b of the first electrode structure 122. In some embodiments, the electrically conductive material is, for example, dried, which may, for example, comprise an ionic compound, a conductive metal, a conjugated double bond polymer, or a combination thereof, although the novel creation is not limited thereto. In some embodiments, the ionic compound includes, for example, an acetic acid polymer, an ethanoic acid polymer, a hydrogen chloride polymer, a sulfuric acid polymer, a nitric acid polymer, Carbonic acid polymer, sodium bicarbonate polymer, calcium hydroxide polymer, sodium hydroxide polymer, ammonia polymer, magnesium hydroxide Hydroxide) polymer, sodium carbonate polymer, sodium chloride polymer, potassium nitrate polymer, copper (copper(II) sulfate) polymer, zinc sulfate a polymer, a potassium chloride polymer or a combination thereof. In some embodiments, the conductive metal includes, for example, gold powder, silver powder, copper powder, platinum powder, iron powder, or a combination thereof. In some embodiments, the conjugated double bond polymer includes, for example, polyaniline, polyacetylene, polyphenylvinylene, poly-p-phenylene, polypyrrole, Polythiophene or a combination thereof, but the novel creation is not limited thereto. In some embodiments, the electrically conductive material can also be, for example, a silver oxide.

In some embodiments, a curing agent can be used to ensure that the conductive material does not affect the conductive effect due to dissolution of the liquid sample. In some embodiments, the curing agent includes, for example, a natural polymer, a synthetic polymer, or a combination thereof. In some embodiments, the natural polymer includes, for example, a fiber polymer, a starch paste, dextran, albumin, or a combination thereof. The fiber polymer includes, for example, hydroxypropyl methyl cellulose (HPMC), hydroxypropyl cellulose (HPC), hydroxyethyl cellulose (HEC), microcrystalline cellulose (microcrystalline cellulose). , MCC). Starch pastes include, for example, dextrin, cyclodextrin, pregelatinized starch, carboxymethyl starch sodium, hydroxypropy starch, carboxymethyl cellulose. Cellulose), crosslinked carboxymethy cellulose sodium, low substituted hydroxypropyl cellulose. In some embodiments, the synthetic polymer includes, for example, polyvinylpyrrolidone (PVP), polyethylene glycol (PEG), polyvinyl alcohol (PVA), or a combination thereof, but the novel creation is not limited thereto.

It should be noted that the novel creation does not limit the composition relationship between the conductive material disposed in the open region 125 of the first electrode structure 122 and the reaction layer 142, as long as the conductive material does not affect the electrochemical reaction between the reaction layer 142 and the sample. can. In some embodiments, the conductive material disposed in the open region 125 of the first electrode structure 122 may have the same composition as the reactive layer 142. In other embodiments, the conductive material disposed in the open region 125 of the first electrode structure 122 may have a different composition than the reactive layer 142.

3 is a block diagram showing the connection of the electrochemical test strip of FIG. 1 to a biometric instrument. Referring to FIG. 2 and FIG. 3 , a portion of the electrode system 120 is exposed at one end of the electrode system 120 away from the reaction zone 140 (or the sampling port 141 ) for electrically connecting to the measuring instrument 10 to be connected to the measuring instrument 10 . Form an electrical circuit. In some embodiments, the meter 10 includes a connector 11, a computing unit 12, an analog to digital converter (ADC) 13, a processor 14, a display 15, and a power supply unit 16, wherein the connector 11 is for For external connection, the calculation unit 12 is for converting the concentration. In a specific embodiment, after the sample enters the reaction zone 140 of the electrochemical test strip 100, the sample will overlie a portion of the electrode system 120. When the power supply unit 16 of the measuring instrument 10 applies an electrical signal to the electrode system 120, the sample and the electrical signal generate corresponding reaction signals and are transmitted through the connector 11 to the computing unit 12 of the measuring instrument 10. Then, the reaction signal is converted by the calculation unit 12 and output to the analog-to-digital converter 13 to obtain a digitalized reaction signal, which is further processed by the processor 14 for further processing and/or via the display 15 The measurement results are displayed.

4A is a schematic perspective view of an electrochemical test strip according to an embodiment of the present invention. 4B is a schematic perspective view of an electrochemical test strip of another embodiment of the present invention. In FIG. 4A, the electrode system 120 is a comb-shaped finger electrode, and the first electrode structure 122 forms a circuit breaker region 125 at the extreme end of the reaction zone 140, thereby detecting that the liquid sample fills the reaction zone 140. In FIG. 4B, the electrode system 120 may additionally include a correction electrode 126 for calibration and a functional electrode for non-concentration measurement, in addition to the concentration electrode 121 (first electrode structure 122 / second electrode structure 124) for measuring the concentration described above. 128. It should be noted that, as long as the arrangement order or arrangement of the electrode structures in the reaction zone 140 is as described above, and the electrode structures are insulated from each other, the novel creation does not limit the arrangement of the electrode structures on the biological test paper 100. Mode and shape of reaction zone 140.

In summary, the novel creation can accurately identify whether the test sample reaches a sufficient capacity by designing a circuit breaker region of the first electrode structure on the electrochemical test piece without additional additional electrode structure. Cover the electrode appropriately. That is to say, the electrochemical test piece created by the novel can effectively reduce the test failure without providing more test samples without increasing the accommodation space of the reaction zone of the electrochemical test piece. Probability and ensure the accuracy of subsequent measurements.

Although the present invention has been disclosed in the above embodiments, it is not intended to limit the novel creation, and any person skilled in the art can make some changes without departing from the spirit and scope of the novel creation. Retouching, the scope of protection of this new creation is subject to the definition of the scope of the patent application attached.

10‧‧‧Measuring instrument

11‧‧‧Connector

12‧‧‧Computation unit

13‧‧‧ Analog Digital Converter

14‧‧‧ Processor

15‧‧‧ display

16‧‧‧Power unit

100‧‧‧Electrochemical test strips

110‧‧‧Insert substrate

120‧‧‧Electrode system

121‧‧‧ concentration electrode

122‧‧‧First electrode structure

122a‧‧‧ front electrode section

122b‧‧‧Back electrode section

124‧‧‧Second electrode structure

125‧‧‧Disconnection area

126‧‧‧correction electrode

128‧‧‧ functional electrode

130‧‧‧First insulating spacer

132‧‧‧ Notch

140‧‧‧Reaction zone

141‧‧ ‧ sampling port

142‧‧‧Reaction layer

150‧‧‧Second insulation spacer

150a‧‧‧ surface

152‧‧‧ Transparent observation area

154‧‧‧Ventinel

D1, D2, D3‧‧‧ distance

BRIEF DESCRIPTION OF THE DRAWINGS Fig. 1 is an exploded perspective view showing an electrochemical test piece according to an embodiment of the present invention. 2 is a partial perspective schematic view of the electrochemical test strip of FIG. 1. 3 is a block diagram showing the connection of the electrochemical test strip of FIG. 1 to a biometric instrument. 4A is a schematic perspective view of an electrochemical test strip according to an embodiment of the present invention. 4B is a schematic perspective view of an electrochemical test strip of another embodiment of the present invention.

Claims (11)

An electrochemical test piece comprising: an insulating substrate; an electrode system disposed on the insulating substrate, wherein the electrode system comprises a first electrode structure and a second electrode structure, the first electrode structure and the second electrode The structures are insulated from each other; a first insulating spacer covering the electrode system, wherein the first insulating spacer has a recess at one end, a portion of the electrode system is exposed to the recess; and a second insulation a spacer covering the first insulating spacer, wherein the recess of the first insulating spacer forms a reaction zone with the insulating substrate and the second insulating spacer, wherein in the reaction zone The electrode system has a circuit breaking zone near the bottom of the recess. The electrochemical test strip of claim 1, wherein the circuit breaker region is located in the first electrode structure. The electrochemical test strip of claim 2, wherein the first electrode structure comprises: a front electrode section including the first electrode structure extending from a top of the recess to the open area a segment; and a rear electrode segment including a segment of the first electrode structure extending from the circuit breaker region to a bottom portion of the recess, wherein between the front electrode segment and the back electrode segment The distance between the circuit breaking zone is a first distance, and the minimum electrical distance between the front electrode segment and the second electrode structure is a second distance, and the rear electrode segment and the second electrode structure The minimum electrical distance between the three is a third distance, wherein the third distance is greater than the first distance, and the third distance is greater than the second distance. The electrochemical test strip of claim 3, wherein the third distance is greater than or equal to a sum of the first distance and the second distance. The electrochemical test strip of claim 3, wherein the first distance is greater than the second distance. The electrochemical test strip of claim 5, wherein the first distance is greater than or equal to twice the second distance. The electrochemical test strip of claim 2, wherein the first electrode structure is a reference electrode and the second electrode structure is a working electrode. The electrochemical test strip of claim 2, wherein the first electrode structure is a working electrode and the second electrode structure is a reference electrode. The electrochemical test strip of claim 1, wherein the second insulating spacer comprises a vent, and a projection of the vent on the insulating substrate is located in the reaction zone, wherein The projection of the vent on the electrode system partially overlaps or completely overlaps the break zone. The electrochemical test strip of claim 1, wherein the circuit breaker region comprises a conductive material, a curing agent, or a combination thereof. The electrochemical test strip of claim 10, wherein the conductive material comprises an ionic compound, a conductive metal, a conjugated double bond polymer, or a combination thereof.