WO2005022139A1

WO2005022139A1 - An novel test strip, the method for its manufacture and the use thereof

Info

Publication number: WO2005022139A1
Application number: PCT/CN2003/000738
Authority: WO
Inventors: Jianyuan Chen
Original assignee: Jianyuan Chen
Priority date: 2003-09-03
Filing date: 2003-09-03
Publication date: 2005-03-10
Also published as: AU2003261594A1

Abstract

The invention relates to an novel test strip, which includes an insulating substrate, a measurement electrode and a counter electrode or a measurement electrode, a counter electrode and a reference electrode, a middle insulating layer and a cover substrate. The primary character of said strip is that between the insulating substrate and the cover substrate of the measurement area of said strip, there is a space into which the test sample can be sucked or injected by the capillary phenomenon and the like in order to fulfill testing process. The invention also relates to the method for its manufacture and the use thereof.

Description

Novel test strip, preparation method and application thereof

The present invention relates to a novel test strip, which is mainly characterized in that a space is provided between the insulating substrate and the cover substrate in the detection area of the test strip to complete the detection step by sucking or injecting the sample by capillary phenomenon.

The invention also relates to a novel test strip, which is characterized in that an opening is provided on a covering substrate corresponding to the working electrode and the counter electrode, or the detection site corresponding to the working electrode, the counter electrode and the reference electrode, and can be used for testing. Before using the test strip, a bioactive substance is applied through the countersink, so the user can select an appropriate bioactive ingredient according to the item to be detected.

The invention also relates to a method for preparing the above-mentioned test strip and its application. Background technique

Biochemical analyzers are generally divided into three types: wet biochemical analyzer, dry biochemical analyzer, and biochemical sensor. The traditional wet biochemical analyzer is to mix the test substance with a reagent (usually a developer or a fluorescer), perform a chemical reaction, and then use an optical interpretation device such as a colorimeter, spectrophotometer, or fluorometer to read Change the color or absorbance before and after the reaction. The samples measured in this way often need to be pre-processed, the required equipment is expensive, and non-professionals cannot operate and interpret them, so they are often used in hospitals and laboratories. The dry-type biochemical analyzer is coated with chemical reagents, enzymes, or antibodies on the surface of the test strip, and directly contacts the sample for analysis and detection. Compared with the wet-type biochemical analyzer, the reagent preparation step is omitted and the operation method is large. simplify. However, the detection principle of the dry biochemical analyzer is the same as that of the wet biochemical analysis method, which still needs to be tested by the color rendering principle. In addition, the dry biochemical analyzer still has some shortcomings such as the test strip is easy to oxidize and discolor, and it is susceptible to the color interference of the test product. Inspections often require pre-treatment.

Biochemical sensors are composed of biological elements, thin film elements, and sensors. Among them, biological elements are biological materials with specific identification capabilities, such as microbial cells, animal and plant cells, animal and plant tissues, organelles, Enzymes, antigens or antibodies, and chemical receptors, etc .; thin-film elements are usually high-molecular materials used to fix the biological elements and screen out interfering substances; sensors include various electrodes, ion-selective field-effect transistors, heat Thermistor, piezoelectric device, optical fiber, photoelectric tube, acoustic wave counter, image processor, etc. Among them, the hydrogen peroxide electrode is one of the sensors widely used in biochemical sensors.

The principle of these biochemical sensors is a biosensor that analyzes blood glucose as an example. The glucose oxidase-immobilized film is closely attached to the surface of a hydrogen peroxide electrode, and is composed of conductive materials such as platinum, gold, palladium, and carbon. the working electrode and the reference electrode replacement sheet made of a conductive material such as silver / silver chloride, platinum, gold, palladium, carbon, etc. ⁽² Rule 6) / A polarizing potential is applied between the counter electrodes, and hydrogen peroxide generated by the glucose oxidation reaction catalyzed by glucose oxidase can be oxidized to water near the surface of the working electrode and release electrons at the same time. The glucose concentration in the test substance can be deduced based on the electronic release amount, as described in USP. 4, 545, 382.

Most of the currently developed biochemical sensors are located on the surface of the test strip for the test specimens. The use method is to drop the collected test specimens on the test strips to receive the test specimens, such as USP 5, 120. , 420, USP 5, 628, 890, USP 5, 798, 031. However, these biochemical sensors require a larger amount of samples such as blood. Therefore, it will cause greater pain when sampling, and it has inconveniences for patients who are not easy to sample, such as those in intensive care units.

Another type of biosensor has been developed, in which a specific specimen inhalation site is provided on the test strip for detection of the specimen aspiration, as shown in Taiwan Patent Publication No. 416005 (application number 88119683). This type of biosensor can be used for detection with a small number of inspection items. However, when using these biosensors for testing, the sampling location, such as a finger, must be aligned with the specimen inhalation site in order to allow the sample to enter and fill the specimen-accepting space smoothly for testing purposes. Subjects, such as patients in the intensive care unit, still have inconveniences in their use.

In view of the aforementioned shortcomings of the conventional techniques, the inventors of the present invention have conducted extensive research on the shortcomings of current biosensor detection test strips, and thus completed the present invention.

Disclosure of invention

The invention relates to a novel test strip, which is mainly characterized in that the working electrode and the counter electrode of the test strip sampled in any direction and the insulating substrate and the covering of the detection area end of the electrode such as the working electrode, the counter electrode and the reference electrode are covered. There is a space between the substrates through which a fixed amount of sample can be sucked in by capillary phenomenon to complete the detection step.

The present invention also relates to a novel test strip, which is characterized in that an opening is provided on a portion of a covering substrate corresponding to the working electrode and the counter electrode, or corresponding to the working electrode, the counter electrode, and the reference electrode. Before the tablet is used, a bioactive substance is applied through the opening, so the user can select an appropriate bioactive ingredient according to the item to be detected, which can provide greater selectivity.

Accordingly, a first object of the present invention is to provide a novel detection test strip, which includes:

A plate-like insulating substrate;

A working electrode and a counter electrode, or a working electrode, a counter electrode, and a reference electrode, which are separated from each other and formed of a conductive material on the insulating substrate; a detection region and a connection region are respectively formed at two ends of the electrodes;

An intermediate insulating layer covering a part of the surface of the insulating substrate and the surfaces of the electrodes, wherein the intermediate insulating layer does not cover the detection area and the connection area of the electrodes;

Bioactive film covering the detection area; replacement page (Details Article 26) A plate-shaped covering substrate covering the above structure; and

There is a space where a capillary phenomenon can occur between the insulating substrate and the covering substrate at the ends of the detection areas of the electrodes, so that the sample can be drawn in by capillary phenomenon at any position around the end to complete the sampling step.

A second object of the present invention is to provide the above-mentioned detection test strip, which can be further provided with an opening on the covering substrate corresponding to the detection positions of the electrodes, and the size of the opening is such that a finger cannot touch the electrode detection However, the bioactive component can be guided to the electrode detection site by capillary action.

A third object of the present invention is to provide the above-mentioned detection test strip, which can be further provided with an opening on the covering substrate corresponding to the detection positions of the electrodes, and the size of the opening is such that a finger cannot touch the electrode detection However, the bioactive component can be guided to the electrode detection site by capillary action, and the working electrode detection site is provided with an opening corresponding to the covering substrate and an opening to help the capillary capillary phenomenon described above. Of active ingredients.

In the novel test strip of the present invention, the method of forming the working electrode and the counter electrode, or the working electrode, the counter electrode and the reference electrode can be performed by a variety of conventional methods, as long as the above-mentioned various electrodes capable of providing a detection purpose can be formed. Yes, there are no special restrictions, including, for example: (1) a metal layer is plated on the conductive gel after printing a conductive paste on an insulating substrate; (2) a carbon paste is directly coated on the insulating substrate to make such electrodes; (3) depositing a metal layer directly on the insulating substrate; (4) applying a PC board technique to attaching a copper foil to an insulating substrate, etching into a predetermined pattern, and plating metal on the copper foil of the predetermined pattern; and (5) Apply metal foil to the insulating substrate by heating or applying adhesive.

The metal used is not limited in any way, as long as it is a metal that is stable under the measurement conditions of the test strip of the present invention that can be sampled in any direction. Examples are, for example, precious metals such as gold, platinum, palladium, rhodium and the like.

In the test specimen capable of sampling in any direction of the present invention, the space provided between the insulating base material and the covering base material for sucking the test product by capillary phenomenon can be obtained by using an insulating base material and a covering base material having sufficient hardness. This can be achieved by providing one or more small supports between the insulating substrate and the cover substrate. The one end of the premises where the test specimen is accommodated, that is, the end of the space capable of sucking the test specimen by capillary phenomenon, is hereinafter referred to as "the detection site of the test strip".

Since the test specimen of the present invention can be sampled in any direction, the sample is drawn into a fixed volume of space by capillary phenomenon, so the sample can be sampled in a fixed amount, so it can be used to measure the test items that must take a fixed amount of sample, such as It can measure the activity of liver function indicator enzymes GOT and GPT in blood.

Accordingly, the present invention also relates to a test strip that can sample a fixed amount in any direction.

In the novel test strip of the present invention, a bioactive film can be provided on the detection sites of the working electrode and the counter electrode, or the working electrode, the counter electrode, and the reference electrode. The bioactive film may cover a part or all of the conductive material on the detection sites of the electrodes, or a part of the insulating substrate that is not covered by the electrodes at the detection site end of the test strip. Or full replacement page (Article 26) It is also possible to fill the inspection accommodating space between the insulating substrate and the covering substrate at the detection end of the test strip.

In addition, based on consideration of operation and measurement characteristics, in the novel test strip of the present invention, the working electrode, the counter electrode, or the working electrode, the counter electrode, and the reference electrode, which are made of the conductive material, can be respectively composed of One or more layers of material. Different parts of the same electrode may be composed of different layers. Each layer of material may not be conductive. One part may be a non-conductive material such as an adhesive, but it is located on each of the two electrodes. The connection area between the terminal and the detection area is electrically conductive.

In the novel test strip of the present invention, the shape of the detection end may be any shape, and may be, for example, a triangle, a square, a polygon, an ellipse or a ring structure, or even an irregular shape. However, in terms of convenience, an elliptical or ring structure is preferred. The term "ring structure" means an equilateral polygonal configuration or a circular configuration with an angle of 108 ° or more.

In addition, if the novel test strip of the present invention has only a working electrode and a counter electrode, the counter electrode simultaneously functions as both a counter electrode and a reference electrode.

Furthermore, there may be one or more working electrodes in the novel test strip of the present invention, depending on the desired test items. For example, if two items such as blood glucose and blood lipid are to be detected, a test strip having two working electrodes can be made, and a bioactive film that can specifically identify blood glucose and blood lipid is used in the detection area of the two working electrodes, respectively. Two tests are performed simultaneously.

A fourth object of the present invention is a method for manufacturing a test strip, and the method includes:

(a) forming a working electrode and a counter electrode, or forming a working electrode, a counter electrode, and a reference electrode on a plate-shaped insulating substrate, wherein two ends of the electrodes form a detection area and a connection area, respectively;

(b) coating an insulating layer on the surface of a part of the source substrate and part of the electrodes, wherein the electrical insulating layer does not cover the detection sites and connection sites of the electrodes;

(c) Next, a plate-shaped cover substrate having a cover shape corresponding to the plate-shaped insulating substrate is formed thereon, and a capillary phenomenon can be sucked in between the insulating substrate and the cover substrate at the detection site end of the formed test strip. The space of the inspection product, that is, the inspection space for receiving the inspection product.

The fifth object of the present invention is also a method for manufacturing a test strip, the method includes-

(a) forming a working electrode and a counter electrode, or a working electrode, a counter electrode, and a reference electrode with a conductive material on a plate-shaped insulating substrate, wherein the two ends of the electrodes are the electrode detection site and the occupation, respectively.

( _b ) applying an intermediate insulating layer thereon, wherein the intermediate insulating layer is not coated with the detection sites and contacts of the electrodes;

(c) Next, a plate-shaped covering substrate is provided with an opening at a position corresponding to the plate-shaped insulating substrate and corresponding to the electrode detection portions formed in step (a). The opening is for Inhalation of selected biologically active ingredients and replacement of the insulating base material and cover base on the electrode test site of the test strip (Detailed Article 26) The material provides the exit of the opening and the space for sucking in the test substance by capillary phenomenon.

In the manufacturing method of the fifth object of the present invention, the working electrode detection site formed in step (a) may be provided with an opening to provide another outlet for coating the bioactive ingredient through the opening of the covering substrate.

In the manufacturing methods of the present invention, the method of forming the working electrode and the counter electrode, or the working electrode, the counter electrode, and the reference electrode in step (a) can be performed by a variety of conventional methods, as long as it can form a detection electrode The above-mentioned various electrodes are sufficient, and are not particularly limited, and may include, for example: (1) a conductive paste is printed on a conductive substrate after a conductive paste is printed on the insulating substrate; (2) a carbon paste is directly coated on the insulating substrate (3) directly deposit a metal layer on an insulating substrate; (4) apply PC board technology to a copper foil on an insulating substrate, etch it into a predetermined pattern, and plate the copper foil on the predetermined pattern Metal; and (5) applying a metal foil or the like to the insulating substrate by heating or applying an adhesive.

The metal used is not limited as long as it is a metal that is stable under the measurement conditions of the novel test strip of the present invention. Examples are metals such as gold, platinum, palladium, rhodium and the like.

In the manufacturing methods of the present invention, after step (a) or (b), part or all of the detection areas of the working electrode and the counter electrode, or the working electrode, the counter electrode, and the reference electrode, and the detection area may also be detected. A part or all of the surface of the insulating substrate in the area not covered by the electrode is coated with a bioactive film. The bioactive film can also inhale the biological activity after the test strip of the present invention is completed, and before performing the detection operation, use the capillary phenomenon at the detection site end of the test strip or perform the capillary phenomenon through the openings provided thereon. The components can be used for sampling and subsequent testing by taking advantage of this capillary phenomenon after drying.

In the manufacturing method of the fourth object of the present invention, the space provided in the step (c) between the insulating substrate and the covering substrate can be sucked into the test article by capillary phenomenon, and the insulating substrate and the substrate having sufficient hardness can be used. This can be achieved by covering the substrate, or by placing one or more small supports between the insulating substrate and the covering substrate.

The novel test strip of the present invention can provide sampling space between the insulating substrate and the cover substrate at the end of the detection site, and can be sampled by capillary phenomenon at any position around the detection site, which is extremely convenient and easy to use. .

According to the manufacturing method of the fifth object of the present invention, the size of the opening is such that the finger cannot touch the working electrode but the bioactive component can be guided to the working electrode by capillary phenomenon.

The novel test strip prepared according to the fifth object of the present invention is provided with an opening in the test portion of the test strip, and the bioactive component can be coated by the opening before use. The selection of appropriate biologically active ingredients makes them more widely available.

The novel test strip of the present invention can be made into a plate-shaped biological test strip with simple operation and high safety, which mainly uses the electrochemical and other effects of the test substance during the biochemical reaction process to quickly detect the test substance. Category and quantification of its concentration are not affected by factors such as sample volume, sample pretreatment, and sample sampling habits, so the accuracy of the test results can be relatively improved.

The insulating base material and the covering base material used in the test sample of the present invention that can be sampled in any direction need to replace the page (Article 26 of the detailed rules) It has electrical insulation properties, and the materials used to make the insulating substrate and the covering substrate may be the same or different. Examples include, but are not limited to, polyvinyl chloride (PVC), glass fiber boards (such as FR-4), polyester sulphone, bakelite, polyethylene terephthalate (PET) boards, glass Plate, ceramic plate (such as CEM-1), etc.

The two ends of the working electrode in the test strip that can be sampled in any direction of the present invention are a detection area and a connection area, respectively. The detection area is used to detect the electrochemical effect of the sample during a chemical or biochemical reaction, and the connection area is It is used to connect a sensing device; and the detection area of the counter electrode and the reference electrode, if any, is provided at the same end as the detection area of the working electrode, and is used to cooperate with the working electrode to detect the electrochemical effect of the test object. The contact area of the reference electrode is similar to the working electrode connection area for connecting the sensing device.

The purpose of the insulating layer used in the novel test strip of the present invention is to prevent the test object from touching the conductive material outside the detection area of the electrode, thereby preventing short circuits to improve the detection quality, and to ensure that these electrodes perform a detection reaction with a fixed surface area. This ensures the correctness of the test. Suitable materials include, but are not limited to, high molecular materials such as polyvinyl chloride (PVC), polypropylene (PP), polyvinyl acetate (PVA), and epoxy resin.

The metal layer used in the novel test strip of the present invention can use (but is not limited to) any one or more of heavy metals such as gold, platinum, palladium, rhodium, silver, etc., the purpose of which is to conduct electrons and provide a place for detection operations And / or environment.

The bioactive film used in the novel test strip of the present invention may include, but is not limited to, immobilized or unimmobilized enzymes, antigens, antibodies, receptor proteins, small organs, microbial cells, animal and plant cells, animals and plants Tissues and chemical receptors have biorecognition capabilities.

When a support is provided between the insulating base material and the cover base material used in the novel test strip of the present invention, the height and number thereof are not particularly limited, as long as the space required for the capillary phenomenon is provided between the two base materials and does not hinder The height and number of the sample inhalation and filling the sample acceptance space can be sufficient.

As for the range of samples that can be detected by the novel test strip of the present invention, it can include (but is not limited to) whole blood, serum, plasma, fermentation broth, food, waste water, etc., and can be used with various sensing devices for single-function or multi-function detection. The application range is quite wide and has a wide range of industrial applicability.

When the novel test strip of the present invention is applied, it cooperates with the detection device to read the response signal. As the detection device system is not the main object of the present invention, only the block diagram of FIG. 6 is used to briefly explain its function principle and function. As shown in FIG. 6, when the test specimen capable of sampling in any direction of the present invention picks up a test object and connects the connection area between the working electrode and the counter electrode / reference electrode of the test specimen capable of sampling in any direction to the sensing device After the corresponding electrode is connected to the area, the electrochemical or other effects on the electrode caused by the chemical or biochemical reaction process performed by the test object are processed by the sensing circuit, and then input to the central processing unit via a class / digital converter (A / D) ( MPP), the operator can obtain the content data of the specific component in the test product on the display. Alternatively page ⁽² Rule 6) The novel test strip of the present invention is described in more detail in conjunction with the drawings as follows. This embodiment only lists an example in which the detection end of the test strip has a circular configuration, and the electrodes are manufactured by using PC board technology on an insulating substrate. After the copper foil is pasted on the material, the copper foil is etched into a predetermined pattern by etching and then plated with metal; however, the detection end may also have other configurations, including a triangle, a square, or a polygon, and the like The electrode manufacturing method can also be made using other methods described herein. Accordingly, the specific examples provided by the present invention are only used to illustrate the present invention, rather than to limit the scope of the present invention. Those skilled in the art can make various modifications and changes through the disclosure of the present invention. The scope disclosed in the theory and examples in the description of the invention and its extended derivatives all belong to the scope of the present invention. Brief description of the drawings

1a to 1c are schematic structural diagrams of a specific example of the test strip of the present invention, wherein FIG. 1a shows a schematic view of a plate-shaped insulating substrate of the test strip of the present invention, and a working electrode and an opposite electrode have been provided thereon; FIG. 1b is An overview of the intermediate insulating layer provided in the test strip of the present invention; FIG. Lc is a schematic view of a plate-shaped covering substrate of the test strip of the present invention;

2 is a cross-sectional view of the test strip of the present invention taken along line A-A after completion;

3 is a cross-sectional view of the test strip of the present invention after completion along line B-B;

4a to 4c respectively show the composition of each layer forming another specific example of the test strip of the present invention, in which an opening 61 is provided in the cover substrate of FIG. 4c corresponding to the working electrode and the opposite electrode detection portion; and

FIGS. 5a to 5c respectively show the structure of each layer forming yet another specific example of the test strip of the present invention. An opening 23 is also provided at the working electrode detection position shown in FIG. 5a corresponding to the opening. Is a capillary action outlet; and the covering substrate shown in FIG. 5c is provided with an opening 61 corresponding to the working electrode and the opposite electrode detection portion; and

FIG. 6 is a system block diagram of a biosensor device for detecting a test piece according to the present invention. Wherein the figure number:

1 Plate-shaped insulating substrate

11 ring configuration

2 Working electrode

21 Working electrode detection area

22 working electrode connection area

23 working electrode opening

3 counter electrode

31 counter electrode detection area

32 Opposition electrode connection area replacement page (Details Article 26) 4 Insulation

5 support

6 Plate-shaped covering substrate

61 Covering substrate countersinks

7 metal layer

8 Bioactive film The best way to realize the present invention

Example 1

The manufacturing process of the test specimen that can be sampled in any direction according to the present invention will be described only with reference to the drawings. The description only exemplifies that the detection part of the detection test piece has a ring configuration, but the detection test sample that can be sampled in any direction of the present invention is not limited to the detection part having a ring configuration.

Please refer to FIG. La first. The test specimen for sampling in any direction of the present invention includes a plate-shaped insulating substrate 1 having a ring-shaped configuration 11 at one end; two plate-shaped insulating substrates are formed on the plate-shaped insulating substrate. Working electrode 2 and counter electrode 3 which are not in contact with each other, the working electrode 2 has a detection region 21 at the end of the ring-shaped configuration 11 of the insulating substrate 1 and a working electrode connection region 22 at the opposite end, and the counter electrode 3 The insulating substrate 1 has a detection region 31 at its end and a counter electrode connection region 32 at its opposite end.

Then, a metal layer 7 (refer to FIG. 2) is plated on the working electrode and the counter electrode, and then a bioactive film 8 (refer to FIG. 2) is coated on the detection area 21 and the detection area 31 of the corresponding electrode of the working electrode. .

Next, please refer to FIG. 1b, which is an insulating layer 4 coated on the insulating substrate 1 and the working electrode 2 and the counter electrode 3, but including the detection area 21 of the working electrode and the detection area 31 of the counter electrode. The other parts of the annular configuration 11 and the connection region 22 including the working electrode and the connection region 32 of the counter electrode are not coated, that is, the detection regions 21 and 31 and the connection regions 22 and 32 are exposed.

In FIG. 2, the metal layer 7 can also be plated after the insulating layer 4 is coated and only plated on the detection areas 21 and 31.

Next, a plurality of small supports are formed around the ring-shaped configuration portion 11 of the plate-shaped insulating substrate 1. Finally, please refer to FIG. 1c, which is a plate-shaped covering substrate 6 showing the test strip of the present invention. Test strip for sampling in any direction.

For a cross-sectional view of the test piece of the present invention that can be sampled in any direction at the test site, see FIG. 2. The sample is spread on the bioactive film 8 after being inhaled.

FIG. 3 is a cross-sectional view of the bioassay test strip of the present invention taken along the line BB of FIG. 1; a replacement page can be seen from FIG. 3 (Article 26 of the detailed rules) The test strip of the present invention has an insulating layer 4 between the working electrode 2 and the counter electrode 3 in the non-detection area and the covering substrate 6 for insulation.

The test specimen capable of sampling in any direction of the present invention can be sampled in any direction on the periphery because of the space between the covering substrate and the insulating substrate at the detection end for capillaries to occur, which is equivalent in clinical and domestic use. Convenience and deep industrial utilization.

Example 2

4a, the novel test strip of the present invention includes a plate-shaped insulating substrate 1 having a ring-shaped configuration 11 at one end; two non-contacting plates are formed on the plate-shaped insulating substrate. Working electrode 2 and counter electrode 3, the working electrode 2 has a working electrode detection site 21 at the end of the ring-shaped configuration 11 of the insulating substrate 1, and a working electrode connection region 22 at the opposite end, and the counter electrode 3 is The ring-shaped structure 11 of the insulating substrate 1 has a counter electrode detection portion 31 at an end and a counter electrode connection region 32 at an opposite end.

A metal layer 7 is then plated on the working electrode and the counter electrode (see FIG. 2).

Next, please refer to FIG. 4b, which shows the insulating layer 4 coated on the insulating substrate, but the ring configuration 11 including the working electrode detection portion 21 and the counter electrode detection portion 31, and the working electrode connection region 22 and the counter electrode The other end of the connection region 32 is not coated, that is, the detection sites 21 and 31 of the electrodes and the electrode connection regions 22 and 32 are exposed.

The metal layer 7 can also be plated after the insulating layer 4 is applied and only plated on the electrode detection portions 21 and 31.

Next, a plurality of small supports are formed around the annular structure portion 11 of the plate-shaped insulating substrate 1

5 o

Finally, referring to FIG. 4c, a plate-shaped covering substrate 6 is shown, wherein the detection portion of the covering substrate is provided with an opening 61 for coating the bioactive component, so that the improved testing strip of the present invention is completed.

After the completion of the improved test strip of the present invention, the bioactive ingredient can be sucked and spread on the metal layer 7 through the opening provided in the covering substrate before use.

Another specific example of the improved test strip of the present invention is shown in Figs. 5a to 5c. The manufacturing of each layer is shown in Figs. 4a to 4c, but the difference is that an opening 23 is provided on the working electrode detection site in Fig. 5a. It can correspond to the opening 61 on the covering electrode in FIG. 5C and can be used as an outlet for inhaling activity to the working electrode through the opening 61 before use.

Since the improved test strip of the present invention is provided with an opening in the detection end of the plate-shaped biosensor and a space for capillary phenomenon is provided between the insulating substrate and the covering substrate, it can be detected as desired before use. A suitable biologically active component is selected for the target object, and the inhaled through the opening is attached to the electrode detection site, and various components can be measured in various ways, which is quite convenient and deeply industrially applicable. Replacement page (Article 26) The above description of the present invention is not intended to limit the present invention, and the scope of the present invention will be defined by the scope of patent application described later.

Replacement page (Article 26)

Claims

Rights and requirements, a test strip that can be sampled in any direction, including:

A plate-like insulating substrate;

Separate working electrodes and opposing electrodes formed of a conductive material on the insulating substrate; two ends of the electrodes respectively form a detection region and a connection region;

An intermediate insulating layer covering part of the surface of the insulating substrate and part of the surfaces of the electrodes, and the intermediate insulating layer does not cover the detection area and the connection area of the electrodes;

A plate-shaped covering substrate covering the above structure; and

There is a space where a capillary phenomenon can occur between the insulating substrate and the covering substrate at the ends of the detection areas of the electrodes, so that the sample can be sucked into the sample at any position around the end to complete the sampling step.

A test strip for sampling in any direction, including:

A plate-like insulating substrate;

Separate working electrodes, opposing electrodes, and reference electrodes formed of a conductive material on the insulating substrate; two ends of the electrodes respectively form a detection region and a connection region;

A plate-shaped covering substrate covering the above structure; and

7. The test strip for sampling in any direction according to claim 1 or 2, wherein an opening is provided on the covering substrate corresponding to the electrode detection portion, and the opening is sized so that a finger cannot touch the The electrode detection site can, however, lead the bioactive component to the electrode detection site by capillary action.

The test specimen for sampling in any direction according to claim 1 or 2, wherein the working electrode and the counter electrode, or the working electrode are formed by printing a conductive paste on an insulating substrate and plating a metal layer on the conductive paste. Opposite electrode and reference electrode.

7. The test specimen for sampling in any direction according to claim 1 or 2, wherein the working electrode and the counter electrode, or the working electrode, the counter electrode and the reference electrode are formed by directly coating a carbon paste on an insulating substrate.

7. The test specimen for sampling in any direction according to claim 1 or 2, wherein the working electrode and the counter electrode, or the working electrode, the counter electrode and the reference electrode are formed by directly depositing a metal layer on an insulating substrate. Replacement page (Article 26) The test specimen for sampling in any direction according to claim 1 or 2, wherein the copper foil is applied to an insulating substrate by applying a polycarbonate (PC) board technology, and the copper foil is etched into a predetermined pattern, wherein The copper foil of a predetermined pattern is plated with metal to form the working electrode and the counter electrode, or the working electrode, the counter electrode and the reference electrode.

The test specimen for sampling in any direction according to claim 1 or 2, wherein the working electrode and the counter electrode, or the working electrode, the counter electrode and the reference electrode are formed by attaching a metal foil to an insulating substrate.

The test specimen capable of sampling in any direction according to claim 1 or 2, wherein the specimen receiving space in the detection area further contains a material capable of causing the specimen to perform a specific reaction.

7. The improved test strip according to claim 3, wherein before the detection, the capillary action is used to inhale the bioactive component by covering the opening on the electrode detection site to form an electrode on the electrode detection site. Material that performs a specific reaction.

The test strip according to claim 9 or 10, wherein the material capable of causing the specimen to perform a specific reaction is a bioactive material.

7. The test strip according to claim 1 or 2, wherein one or more small supports are disposed between the insulating substrate and the cover substrate at the end of the detection area of the test strip.

A method for manufacturing test strips, the method includes:

(a) forming a working electrode and a counter electrode separated from each other on a plate-shaped insulating substrate, wherein two ends of the electrodes form a detection region and a connection region, respectively;

(b) applying an insulating layer thereon, wherein the electrically insulating layer does not cover the detection area and the connection area of the electrodes;

(c) Next, a plate-shaped covering substrate having a covering shape corresponding to the plate-shaped insulating substrate is provided, and a capillary phenomenon is provided between the insulating substrate and the covering substrate at the end of the detection area of the formed test strip. Inhale the space for the test article.

A method for manufacturing a test specimen that can be sampled in any direction. The method includes:

(a) forming a working electrode, a counter electrode, and a reference electrode separated from each other on a plate-shaped insulating substrate, wherein two ends of the electrodes form a detection region and a connection region, respectively;

8. The method according to claim 13 or 14, wherein step (c) further comprises providing an opening on the covering substrate corresponding to the electrode detection sites, and the opening is sized so that a finger cannot touch it. The electrode detection site can, however, guide the bioactive component to the electrode detection by capillary action.

Replacement page (Article 26) On the test site.

16. The manufacturing method according to claim 13 or 14, wherein after step (a) or (b) or (c), further performing the step of allowing the specimen acceptance space in the inspection area for detecting the test piece to contain A step of subjecting a test substance to a specific active biologically active ingredient.

Replacement page (Article 26)