TW552411B - Arbitrarily directional sampling sensor-strip, its preparation and use - Google Patents

Abstract

The present invention relates to a novel arbitrarily directional sampling sensor-strip, which comprising an insulating substrate, working and counter electrodes or working, counter, and reference electrodes formed from electrically conductive materials on the insulating substrate, an insulating layer, and a covering substrate. The present arbitrarily directional sampling sensor-strip is characterized by providing a sampling and determining space between the insulating and the covering substrates at the detecting end of the sensor-strip which will suck in sample solution base on the principle of capillary phenomenon Sample solution when contacted with any point around the detecting end of the sensor-strip will automatically be sucked into the above mentioned sampling and determining space to initiate an analysis. The sensor-strip of the present invention could be operated in a more convenient and easy sampling operation that make accurate analysis possible. The present invention also relates to a method for preparing the arbitrarily directional sampling sensor-strip and a use thereof.

Description

552411 V. Description of the invention d) Field of the invention The main feature of the present invention is that the material can be borrowed between the present invention and its application. BACKGROUND OF THE INVENTION Biochemical analyzers are used to test and test products, and then use the color before and after optical processing to read and read. Therefore, the surface of the test strip is often coated and touched for analysis and inspection. In addition, the dry biochemical products are composed of biochemical sensing components such as color interference. Materials, such as micro-organisms, enzymes, and anti-corrosion are novel and optional. The end of the test area of the test strip is inhaled by capillary phenomenon. The direction taking analyzer can be generally divided into three types: wet type and biochemical sensor. Transfer agents (usually color developers, etc.) are mixed. Reading devices such as colorimeters, or changes in absorbance. This requires more expensive equipment and is not specialized in hospitals and laboratories. Dry chemicals, enzymes, or resistance are greatly simplified compared to wet biochemical methods. However, the biochemical analysis method still requires the use of an analyzer. The test strip has some disadvantages. The test specimens are often made of biological elements, thin films. The biological elements have specialized biological cells, animal and plant cytokines or antibodies, and chemical reagents. The test specimens sampled from the direction, the insulating base material and the cover base form a space for the detection step. Samples of test strips are made by a biochemical analyzer with a wet biosynthesis system, and inspectors who perform chemical spectrophotometer measurements cannot type biochemical analytes, etc., directly analyze the analyzer, eliminating the dry biochemical separation principle for easy oxidation and discoloration. Need to go through the front components, as well as sexual identification, animal and plant groups, etc .; film, dry biochemical analyzer, and other reactions to read the anti-products often have to be operated and judged by the reagent connected to the test reagent analyzer Detection, this is vulnerable to inspection. The biomechanical and cellular elements of the sensor are usually 552411 V. Description of the invention (2) is a polymer material, which is used to fix the bioelement sensor, including various electrodes, ion-selective field effect interference 2; transmitter, piezoelectric device , Fiber optics, photoelectric camps, offering, + electricity, body, thermistor, etc. Among them, the hydrogen peroxide electrode is currently used: one of the sensors of the processor. Zhiguang Zhi's biochemical sensor uses the principle of these biochemical sensors as an example. It is based on a glucose oxidase-immobilized thin film ^ = sensing ^ surface ', and then made of platinum, gold, palladium, carbon and other conductive materials. : Etiquette: The electrode table is made of conductive materials such as silver / silver chloride,-, gold, handle, carbon, etc., and a polarizing potential is applied between the working electrode and the electrode / counter electrode, and the glucose is oxidized by glucose. The hydrogen peroxide produced by the reaction can be converted; it is oxidized to water 'and simultaneously releases electrons. Calculate the glucose concentration in the test article based on the electronic release, as described in "! ≫ 4,545,382. The enzyme-developed biochemical sensors that currently hold test articles for testing are mostly located on the surface of the test moon, and its use method is Drop the collected test substance on the test

The place where the test piece is accepted is as described in USP 5,120 420, USP 5'628,890, and USP 5,798,031. However, these biochemical sensors require a larger amount of specimens such as blood. Therefore, it will cause greater pain when sampling, and it is still inconvenient for patients who are not easy to sample, such as those in intensive care units. In addition, a 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 the Republic of China Patent Bulletin No. 416005 (Application No. 88119683). This type of biosensor can be tested with a small number of inspection items. However, inspection using these biosensors

552411 V. Description of the invention (3) At the time of measurement, the sample was smoothly entered into the sampling area, and the method of autonomous movement still has its inconvenience. DETAILED DESCRIPTION OF THE INVENTION The present invention has its main characteristics as the counter electrode, or the absolute fixed quantity inspection product at the end of the measurement area. Based on this, the present invention includes: a plate-shaped insulating substrate between the insulating base and the opposite electrode Two of them are covered in a part of the marginal layer, in which the connection area; the test is covered in the above-mentioned, for example, a finger, etc., which needs to be aligned with the inhalation site of the test object, and is filled with the test object receiving space for testing, For example, patients in intensive care units, etc. = place. These shortcomings of the conventional technology used in K, the inventor of this case has extensively studied the shortcomings of the test strip, and thus completed this = Shengmingguan a new type of test strip that can be sampled in any direction. There is a space between the working electrode of the test piece, the edge detection substrate of the electrodes such as the electrode, the counter electrode, and the reference electrode and the covering substrate, and the detection step can be completed by a capillary phenomenon. The invention relates to a test specimen that can be sampled in any direction. The working electricity, or working electrode, opposite electrode, and reference electrode formed of conductive material on the material are separated from each other; the ends form a detection area and a connection area; an insulating substrate The surface and the intermediate insulating layer of the surface of the electrode parts do not cover the bioactive film on the detection area and continuous measurement area of the electrodes; a plate-shaped covering substrate on the structure; and

Page 8 552411 V. Description of the invention (4) There is a space where capillary phenomenon can occur between the insulating substrate and the covering substrate at the end of the detection area of the electrodes, so it can be used at any position around the end by Capillary is drawn into the sample to complete the sampling procedure. In the test strip for sampling in any direction 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 it can form the above-mentioned various types that can provide detection purposes The electrodes are sufficient, and there are no special restrictions, including, for example: (〇 After printing a conductive paste on an insulating substrate, a metal layer is plated on the conductive paste; (2) These electrodes are coated directly with a carbon paste on the insulating substrate. (3) depositing a metal layer directly on an insulating substrate; (4) applying a PC board technology to a copper box on an insulating substrate, and carving into a predetermined pattern in the remainder of the copper pig on the predetermined pattern; and ( 5) Paste a metal box on the insulating substrate by heating or coating with adhesive. There is no restriction on the metal used, as long as it is stable under the measurement conditions of the test strip for sampling in any direction of the present invention, Yes. = For example, metals such as gold, platinum, palladium, rhodium, etc. ^ ^ In the test strip of the present invention that can be sampled in any direction, the capillary phenomenon provided between the material and the covering substrate is provided. The space of the inspection product: It can be achieved by using an insulating substrate and a covering substrate with sufficient hardness. This can be achieved by placing a or = support between the insulating substrate and the covering substrate. The setting One end of the premises where the test product is accommodated, and one end of the space where the test product is sucked in by the capillary phenomenon, is located at the test site of the later test strip. "This is called the test strip of the present invention, which can be sampled in any direction. Capillary

552411 V. Description of the invention (5) Phenomenon sucks and samples samples', so that, for example, blood can be measured. Based on this, this test strip. The detection electrodes of the present invention and the equivalent electrodes cover the above-mentioned electrical parts, and can also cover the covered insulating base and the detection end of the medium. In addition, based on the direction of sampling, the detection electrode and the opposite electrode may be divided into parts. The shape of the present invention may be an arbitrary shape or a ring structure at both ends of each electrode. , Or the working electricity is composed of one layer or the same number of layers. The connection area may be sticky and can be arbitrarily oriented. For example, it can even be irregularly inserted into a space of a fixed volume. The test items of the measuring products, the activity of the liver function indicators enzymes GOT, GPT, etc. in the liquid function are related to a test strip that can be sampled in any direction in a fixed amount, and can be sampled in any direction. , Or a bioactive plutonium is set on the working electrode, the counter electrode, and the reference electric part. The bioactive film may be a part of the conductive material on the detection part or all or part of the electrode on the detection part side of the test strip, or may be filled on the test strip. In consideration of the characteristics of the inspection material receiving place between the insulating substrate and the covering substrate, the electrodes, the opposite electrodes, and the multilayer materials composed of the conductive material of the present invention are not necessarily the same. Non-conductive materials such as agents, but in the test strips that are electrically conducting sampling between the detection areas, such as triangles, squares, polygons, etc. However, in terms of convenience, it can be used in any way, such as working electrodes, electrodes, etc. The difference in preparation of conductivity is a separate state. For the shape of the probe, ellipse,

Page 10 552411 V. Description of the invention (6) It is preferably an oval or ring structure. Invited + 丨 丨 is also 1 08. The term "plasma-like structure with multiple readings or above" means the angle, and the present invention may have any two? Or circular configurations. When used as an electrode and an opposite electrode, the phase needle: f, if the test piece is only It has both a working electrode and a reference electrode: the machine: the counter electrode is provided as a relative electric power at the same time. In addition, the tuneable electrode of the present invention may be-or multiple: This item depends on the blood glucose measurement item. For example, 'if the electrode is tested for fat, it can be made into a test piece with two working wide poles, and the biological n region that can specifically identify blood glucose and blood lipid in the two jobs The biological active film of the blood 1 is called and the two tests are performed at the same time. The present invention also relates to the method of making sounds that can be used: The method for making test strips sampled in the direction of the heart, which should (:): a : A working electrode and a counter electrode are formed on an insulating substrate, or a working electrode, a counter electrode, and a reference electrode are formed on both ends of the electrode to form a detection area and a connection area, respectively. The surface :: wherein The electrical insulation layer does not cover the detection parts of these electrodes and the cover insulation edge cover ()). Its upper shape corresponds to the plate shape of the plate-shaped insulating substrate. The insulating substrate and the covering substrate at the detection site end are formed between the insulating substrate and the covering substrate, which can be sucked by the capillary phenomenon to form the inspection material receiving space. Second, also in the manufacturing method of the present invention, the working electrode in step (a) is formed opposite to the working electrode.

Page 11 552411 V. Description of the invention (7) The method of electrode, or working electrode, counter electrode and reference electrode can be performed by a variety of conventional methods, as long as it can form the above-mentioned various electrodes that can provide detection purposes, there is no special limitation. It can include, for example :) printing a conductive paste on an insulating substrate and plating a metal layer on the conductive paste; (2) directly coating the insulating substrate with a carbon paste to make such electrodes; (3) on an insulating substrate Directly deposit a metal layer; (4) apply PC board technology to two copper boxes on an insulating substrate, etch into a predetermined pattern, and plate metal on the copper foil of the predetermined pattern; and (5) apply heat to the insulating substrate Or apply an adhesive and apply gold foil. When the metal layer is used, there is no restriction on the metal used, as long as the metal is stable under the measurement conditions of the test piece that can be sampled in any direction during the month of the issue. Examples are metals such as gold, flip, handle, money, and the like. In the production method of the present invention, after step (3) or (10), a bioactive film may be coated on one or all of the surfaces of the working electrode, the working electrode, the counter electrode, and the reference electrode. The Γ is a test strip of the invention that can be sampled in any direction. Ϊ́ϊ 仃: Before using the active ingredient of the mammoth at the detection part of the test strip, it can be borrowed into the lamp after drying. UO sampling and subsequent testing. In the inter-material manufacturing method, step (c) of the insulating substrate and the covering substrate can be sucked into the space of the inspection product by capillary phenomenon, and the insulation material with sufficient hardness can be used by JL. One or more small branches are arranged between the insulating substrate and the covering substrate.

552411 V. Description of the invention (8). The insulating base of the present invention is convenient and easy in the surroundings of the measurement site. The present invention is simple and safe. It is based on the biochemical reaction product category and quantifies the sampling habits. The detection part can be used in this test device as a kind of operation using the test product to quickly detect the test, the accurate insulating base material of the test product, and for example (but polyester maple glycol ester is used as the electrode to connect the two test product test areas. The combined working electricity of the electrodes and the reference electrical connection sense the material and covering substrate of the present invention that can be taken in any direction. The materials used for the substrate must be the same without limitation. Polyethylene (PVC), glass (polyester su1 phone) ) 'Electrical (PET) plate, glass plate, ceramic plate (The ends of the invention can be taken in any direction are the detection area and the connection area, which are used to connect the sensing device during a chemical or biochemical reaction; and the phase detection area is set In the contact area where the working electrode electrode has an electrochemical effect on the test electrode, the test piece can be sampled in any direction as the working electrode, because of the capillary phenomenon, because of the space for receiving the test product between and the covering substrate, Sampling and testing. Test strips that can be sampled in any direction, and plate-shaped biological test strips with high manufacturability are mainly electrochemical and other effects that occur during the process, and can be concentrated quickly. It is not affected by the volume and quality of the test sample, so it can relatively improve the edge characteristics used in the test sample of the test result sample, and the manufacturing is absolutely different. Examples include glass fiber board (such as FR-4), The test area of a test piece such as a wooden board, ethyl terephthalate (CEM-1), etc., the detection area is used for electrochemical effects, etc., and the same end of the test area connected with the counter electrode and the existing reference is used for matching. Detection, and the opposite electrode connection area area is used for

Page 13 552411 V. Description of the invention (9) --- Device. The purpose of the insulating layer used in the test strip for sampling in any direction according to 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 have a fixed surface area. The detection reaction is performed to ensure the accuracy of the detection. Suitable materials include, for example, but not limited to, high-molecular plastic materials such as polyvinyl chloride (PVC), polypropylene (PP), polyvinyl acetate (PVA), and epoxy resin. The metal layer used in the test strip for sampling in any direction 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 detection The place and / or environment in which it operates. The bioactive film used in the test strip for sampling in any direction 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 , Animal and plant tissues, and chemical receptors have biorecognition capabilities. When a support is provided between the insulating base material and the covering base material for the test specimen that can be sampled in any direction according to the present invention, its height and number are not specially defined, as long as a capillary phenomenon is required between the two base materials. The height and number of the space that does not prevent the inhalation of the sample and fill the space that the sample accepts.丨 As for the test strip that can be sampled in any direction according to the present invention, the range of testables can include (but is not limited to) whole blood, serum, plasma, fermentation broth, food, wastewater, etc., and can be used with various sensing devices for single function Or multifunctional detection, the application range is quite wide and it has a wide range of industrial applicability. b

Hsnser Page 14 552411 V. Description of the invention (10) The test strip for sampling in any direction is used in cooperation with ϊίίΐΓϊ: 讯 L. As for the detection device system, it is not a block diagram of the Si 2 of the present invention to briefly explain its working principle. As shown in FIG. 6, when the sample for sampling in any direction according to the present invention is sampled and the work of the sample for sampling in any direction is connected to the connection area of the reference electrode to the area of the biosensor device, the test is performed. The chemical or biochemical reaction performed by the product: over: the electrochemical and other effects occurring on the electrode, which are processed by the sensing circuit, and can be obtained on the display by the analog / digital converter (A / D) input to the central processing staff. Content of specific ingredients in the inspection product) :. The test strips of the present invention that can be sampled in any direction are more detailed with the diagrams. = The following is explained. The specific example only lists the test end of the test strips as circular dust, and the electrodes are manufactured using Pc. Plate technology is obtained by attaching sigma copper selenium on an insulating substrate, and then etching the copper foil into a predetermined pattern by etching, and then plating the metal; however, the detection end may also have other configurations, including a triangular, square, or Polygons, etc., and these electrodes can also be made using other methods described herein. Based on this, 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. &Amp; The skilled artisan may make various modifications and changes through the disclosure of the present invention. The scope of the theory and specific examples disclosed in the description and its extended derivative are all within the scope of the present invention. Specific Examples Only the drawings will be used to explain the manufacturing process of the test specimen that can be sampled in any direction according to the present invention. In this description, only the detection part of the test strip is exemplified. Page 15 552411

It is not limited to the detection configuration, but the test piece of the present invention which can sample in any direction has a ring configuration. Please refer to FIG. 1 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; and a plate-shaped insulating substrate is formed on the plate-shaped insulating substrate. Two working electrodes 2 and a counter electrode 3 which are not in contact with each other, the working electrode 2 has a detection area 21 at the end 11 of the ring-shaped configuration of the insulating substrate, and a working electrode connection area 22 at the opposite end, and the opposite electrode 3 has a detection region 31 at the end of the ring-shaped configuration of the insulating substrate 1 and an opposite electrode connection region 32 at the opposite end.

Then, a metal layer 7 (see FIG. 4) is plated on the working electrode and the counter electrode, and then a bioactive film 8 is coated on the detection area 21 and the detection area 31 of the counter electrode (see section 4). Figure). Secondly, please refer to FIG. 2, the insulating substrate 4 and the electrodes are coated with the insulating layer 4, but the annular configuration 11 including the detection region 21 of the working electrode and the detection region 31 of the counter electrode and the working electrode are included. The connection area 22 and the opposite end of the connection area 32 of the opposite electrode are excluded, that is, the detection areas 21 and 31 and the connection areas 22 and 32 are exposed. In the fourth figure, 'the metal layer 7 can also be plated after the insulating layer 4 is coated and only on the detection areas 21 and 31.

Next, a plurality of small supports 5 are formed around the ring-shaped configuration portion 11 of the plate-shaped insulating substrate 1. Finally, please refer to FIG. 3, covering a plate-shaped covering substrate 6, so that the test strip of the present invention can be sampled in any direction. After the completion of the present invention, the test piece that can be sampled in any direction is in the detection section.

Page 16 552411 V. Description of the invention (12) ----: Please see Figure 4 for the section ®. After being absorbed, the intermediate test product is spread on the bioactive film 8. Invented the test strip that can be sampled in any direction. Because there is a space for capillary phenomenon between the test material and the insulating substrate, the sample can be sampled in any number of directions. It is used in clinical and domestic applications. It has considerable convenience and deep industrial applicability. 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.

552411 Brief description of the diagram. The first diagram is a general view of a plate-like insulating substrate and various electrodes arranged thereon, which is a specific example of a test specimen that can be sampled in a fixed direction in any direction. The second diagram is an arbitrary orientation of the invention. A sample of the test specimen with Zhao's intermediate insulation layer; Figure 3 of the specific example is a plate-shaped covering substrate for the test specimen that can be sampled in any direction according to the present invention; Figure 4 A cross-sectional view of the present invention may be taken along the line AA for the completion of the invention; FIG. 5 is a cross-sectional view of the present invention may be taken on the BB line for the completion of the invention; The figure is a block diagram of a system to which an arbitrary-side sensing device of the present invention is applied. Symbol _ sign brief description 1 Plate-shaped insulating substrate 11 Ring configuration 2 Working electrode 21 Working electrode detection area 22 Working electrode connection area 3 Opposite electrode 31 Opposite electrode detection area 32 Opposite electrode connection area 4 Insulating layer 5 Support 6 Plate-shaped covering substrate 552411 Brief description of the drawings 7 Metal layer 8 Bioactive film mHii Page 19

Claims (1)

552411 VI. Patent application test specimens that can be sampled in any direction, including a plate-shaped insulating substrate; working electrodes and opposing electrodes formed of conductive materials on the insulating substrate, which are separated from each other; A detection region and a connection region are respectively formed at both ends; an intermediate insulating layer covering a part of the surface of the insulating substrate and a part of the surfaces of the electrodes, and the intermediate insulating layer does not cover the detection regions and connection regions of the electrodes; A plate-shaped covering substrate; and 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 capillary can be sucked in by any position around the end The sample immerses the electrode detection part to complete the sampling step. A test specimen that can be sampled in any direction, including: a plate-shaped insulating substrate; a working electrode, an opposing electrode, and a reference electrode separated from each other formed of a conductive material on the insulating substrate; two of these electrodes The detection area and the connection area are respectively formed at the ends; an intermediate insulation layer covering part of the surface of the insulating substrate and part of the surfaces of the electrodes, the intermediate insulation layer does not cover the detection and connection areas of the electrodes; ^ covering one of the above structures A plate-shaped covering substrate; and a space where a capillary phenomenon can occur between the insulating substrate and the covering beauty material at the ends of the detection areas of the electrodes, so that it can be around the end ^ Page 20 6. At any position in the scope of patent application, the sampling step is completed by the i 3 · bit. Phenomenon inhalation test substance immersed the electrode detection unit (such as the scope of patent application) or 2 pieces, among which, the test was taken in the direction of insulation and sampling. 4 · A metal layer was formed to form the substrate. The upper electrode of the conductive colloid, the counter electrode and the reference electrode 5 and the counter electrode, or the test electrode that can be sampled in any direction of the working electricity == item and the carbon glue are formed to form the worker. A first electrode, a counter electrode and a reference electrode 5. As in the first or second box of the patent application of the patent application, which is a sample taken in the direction of the silver sample, the test is made of thunder; fes / /, directly on the soil plate The metal layer is deposited to form the working electrode and the counter electrode, or the working electrode, the counter electrode and the reference electrode. 6. Second application: The test test of the arbitrary range of sampling in the second item of the patent scope. After the copper pig is pasted on the insulating substrate, I think that the predetermined pattern is engraved on the copper foil of the predetermined pattern to form the working electrode and the counter electrode, or the working electrode, the counter electrode and the reference. Electrode person. The application test of the patent application scope item 1 or 2 can be sampled in any direction. Among them, the working electricity is formed by attaching a metal foil on an insulating substrate -W ° • If the patent application scope item 1 or 2 can be used in any direction Sampling test f and counter electrode, or working electrode, counter electrode and reference electrode. Page 21 552411 VI. Patent application film, in which the ^ A of the detection area enables the inspection product acceptance space of the inspection field to further contain materials capable of performing specific reactions during the inspection. 9. Π = test strip that can be sampled in any direction in item 8 of the range, ^ The material that can make the sample react in a specific way is a biologically active material 10. ΓΠ: range 8_ detection test that can be sampled in any direction The materials that can be inspected in 2 are specific reactions that cover the insulating substrate and the whole or part of the surface of the whole or part of the electrode. The second test strip of any patent in the scope of the patent, which can be sampled in any direction. The sentence | item | The material that conducts the specific reaction of the test product is the enzyme, antigen, antibody, receptor, small S, Microbial cells, animal and plant cells, animal and plant tissues, etc. 12 · = A test that can be sampled in any direction according to item 丨 or 2 of the scope of patent application = 2 One or more small supports are set between the insulating substrate and the covering substrate at the end of the detection area of the test strip . 13 · = A test for sampling in any direction according to item i or 2 of the patent scope of the application, in which the configuration of the end of the test area of the test strip is circular. 14. If the test strip can be sampled in any direction according to item 丨 or 2 of the patent application, the configuration of the detection area end of the test strip is an equiangular polygonal configuration with an angle of 〇 08 or more. 1 5 · The test strip that can be sampled in any direction as described in item i or 2 of the patent scope, where the shape of the detection area end of the test strip is square. 552411 Page 23 552411. The scope of the patent application is thin and the capillary and the substrate can be sucked between the substrate and the covering substrate of the detection area of the test strip. 2 0 · If the system of patent application No. 18 or 19 The working electrode and the counter electrode, or the working electrode? The process of forming the test electrode is completed by plating a metal layer on the insulating substrate = the electrode and the reference colloid. 1 ^ Conductive glue is used to guide 21. If the method of application for the scope of patent application No. 18 or 19: the working electrode and the opposite electrode, or the working electrode, the relative electricity ": The process of testing the electrode is based on the insulation base ^ This Finish the way by electrode.坌 布 Made of carbon glue 22. If the manufacturing method of the scope of application for the patent No. 18 or 19, and the opposite electrode, or working electrode: phase = and reference Ui: 23 to directly deposit a metal layer on the insulating substrate. :: = : The method of enclosing item 18 or 19, wherein step ⑷ is formed as 2 :: electrode and counter electrode, or working electrode, counter electrode and parameter ::: electrode: process, which uses PC board technology to paste copper on the insulating substrate ^ Steel Dangfan engraved into a predetermined pattern, and completed by forging metal on a copper pig with a predetermined pattern. 24. The manufacturing method of scope 18 or 19, wherein the process of forming the t φ electrode and the counter electrode, or the working electrode, the counter electrode and the parameter in step ⑷ is a manufacturing method in which a metal foil is pasted on an insulating substrate. In step (a), a material method for performing a specific reaction on the test specimen in the detection area of the test strip, wherein the test specimen can be loaded with immobilized or unimmobilized substances, small organs, and micro-weaves with biological properties. The manufacturing method of identification ability further includes a step between the insulating substrate and the covering substrate. A manufacturing method in which the test is made round. The manufacturing method in which the detection angle is 108. Or an equal angle method, in which the test is made square. System, in which the test is made by a triangle. In the manufacturing method, the interval between the test specimen and the covering substrate is greater than 552411. 25. If the scope of patent application is No. 18 or 19 or (b) or (c), the test product acceptance space shall be further included to enable steps to be performed. 26. If the material for the specific reaction in item 25 of the scope of patent application is the one using enzyme antigens, antibodies, receptor protein cells, animal and plant cells, and animal and plant components. 2 7. The step of setting up one or more small supports such as the test area of the 18th or 19th test strip of the patent application 28. The structure of the test area end of the 18th or 19th tablet of the patent application Formed as 29. If the structure of the detection area end of the piece of patent application No. 18 or 19 is formed into a polygonal configuration. 30. If the structure of the detection area end of the 18th or 19th piece of the patent application scope is 31 · If the structure of the detection area end of the 18th or 19th piece of the patent application park is 32 The insulating substrate at the end of the detection area of item 19 page 552411