TWI223064B - Biological sensor, formation method of thin film electrode, quantity determination device and quantity determination method - Google Patents

Abstract

The invention relates to the biological sensor as indicated in figure 1, and is provided with the substrate 1; and the conductor layer 2 made of the electrical conductive material of carbon or the rare metal of gold or palladium; slits 3a, 3b paralleling the sides of the substrate 1; slits 4a, 4b perpendicular to the sides of the substrate 1; measurement electrode 5; counter electrodes 6, detection electrodes 7; spacers 8 covering the measurement electrode 5, counter electrode 6, and the detection electrode 7 on the substrate 1; rectangular cut off portion 9 which forms the specimen supply route; inlet 9a of the specimen supply route; reagent layer 12 formed by coating the enzyme containing reagent on the measurement electrode 5, the counter electrode 6, and the detection electrode 7 which exposed from the cut off portion 9 of spacer 8; and the cover 13 covering the spacer 8. The biological sensor thus constructed can be formed by simple and compart work method. Besides, this biological sensor can be realized with the excellent measurement precision and the uniform performance by arranging uniformly the reagent layer on the electrodes independent of the ingredient of the reagent solution.

Description

Ϊ223064 A7 B7 i. Description of the invention (1) [Technical technology] The present invention relates to a biosensor for quantifying a matrix contained in a sample liquid, and a preferred method for forming a thin film electrode when the biosensor is manufactured. And a quantitative device and a quantitative method using the biosensor, in particular, a biosensor with less manufacturing error and stable performance, and a thin-film electrode forming method used for electrode manufacturing of such a biosensor, and using the same A quantitative device and method for a biosensor. [Background Art] Biosensors use the molecular recognition capabilities of biological materials such as microorganisms, enzymes, antibodies, DNA, and RNA, and use biological materials as molecular identification elements to quantify the matrix content in the sample solution. That is, the reaction caused by the biological material when identifying the target substrate, such as the consumption of oxygen due to the respiration of microorganisms, the enzyme reaction, and light emission, is used to quantify the substrate contained in the sample solution. In addition, among various biosensors, enzyme sensors have been advanced to practical use. For example, enzyme sensors for blood sugar, lactic acid, cholesterol, and amino acid biosensors are used in medical measurement or the food industry. The enzyme sensor uses, for example, electrons generated by the reaction between a substrate contained in a sample solution as a sample and an enzyme to reduce an electron transmitter, and a quantitative device measures an amount of reduction of the electron transmitter by electrochemical measurement. For quantitative analysis of specimens. Various proposals have been made for such biosensor proposals. The biosensor Z of the conventional biosensor will be described below. Figure 2 1 (a) is an exploded perspective view of the biosensor Z. Figure 2 1 (b) The paper size applies the Chinese National Standard (CNS) A4 specification (210 X 297 mm) (Please read the back Please fill in this page again for attention) Printed by the Consumer Cooperative of the Intellectual Property Bureau of the Ministry of Economic Affairs ·

1223064 A7 B7 Printed by the Consumer Cooperatives of the Intellectual Property Bureau of the Ministry of Economic Affairs 5. Description of the Invention (2) The structure of the electrode part formed at the front end of the biosensor Z. The structure of the biosensor Z is followed by the components having the positional relationship shown by the dashed lines in Fig. 21 (a). In addition, the electrode part of the biosensor Z is formed in three printing processes described below. First, in the first process, a highly conductive silver paste is printed on the insulating substrate I 1 01 by screen printing and dried to form electrode lead portions 1102a and 1102b. Next, in the second process, a carbon paste is printed and dried on the electrode lead portions 1 1 2a, 1 2 0b, and used to form a counter electrode 1 1 03a and a measurement electrode 1 1 03b. The measurement electrode 1103b is disposed inside the ring-shaped counter electrode Π03a, and the counter electrode 1103a and the measurement electrode 1103b are in contact with the electrode lead portions 1102a and 1102b, respectively. Then, in the third process, the etching resistance 1 1 04 of the insulating substance is printed on the counter electrode 1103a and the measurement electrode 1103b and dried to define the areas of the counter electrode 1 1 0 3 a and the measurement electrode 1 1 0 3 b. . On the counter electrode 1 1 03 a and the measurement electrode 1 1 0 3 b formed on the substrate 1 1 1 in this way, a reagent layer 1 1 0 5 is formed, which is formed by coating a reagent containing an enzyme or the like, Then, a spacer 1 1 06 was laminated thereon, and a spacer 1 106 was used to form a specimen supply path, and a cover 1107 was provided with an air hole 1107a. In addition, one end of the cutout portion 1106a of the spacer 1106 leads to an air hole 1 1 07 a provided in the cover 1 1 07. In addition, as shown in FIG. 21 (b), the arrangement of the counter electrode 1103a and the measurement electrode II formed on the substrate 1101 is for the entrance 1106b of the sample supply path, and it will be applicable to electricity China National Standard (CNS) A4 (210 X 297 mm)

! 223〇64 Printed by the Consumers ’Cooperative of the Intellectual Property Bureau of the Ministry of Economic Affairs A7 B7 i, Invention Description (3) Electrode 1 1 Ο 3 a is placed at the nearest position, and the measuring electrode 1 丨 〇3 b and counter electrode 1 1 0 3 a is located deep. The method for quantifying the matrix of the sample liquid of the biosensor Z constructed in this manner will be described below with reference to Fig. 21 (b). First, a quantitative device (hereinafter referred to as a “measurement device”) connected to the biosensor Z is used to apply a certain voltage between the counter electrode 1 1 0 3 a and the measurement electrode 1 1 〇3 b. In this state, A sample liquid (hereinafter referred to as a "sample") is supplied to the inlet 1 1 06b of the sample supply path. The specimen is absorbed into the inside of the specimen supply path via the capillary phenomenon, and reaches the measuring electrode 1 1 0 3 b through the counter electrode 1 1 0 3 a near the entrance l106b, and is used to start the dissolution of the reagent layer 1 105. At this time, the quantitative device detects an electrical change generated between the counter electrode 1 103a and the measurement electrode 1 103b, and starts a quantitative operation. In this way, the matrix content of the sample solution is quantified. However, the output characteristics of each manufacturing lot of the biosensor Z may be different, so in actual use, the difference in the output characteristics of the measuring device needs to be corrected. The following explains the conventional response method. FIG. 22 shows a state where the biosensor Z is inserted into the measuring device. In addition, the symbol 4 1 15 is a measuring device for mounting the biosensor Z. 4 Π 6 is the insertion port of the measuring device 4 1 15 for inserting the biosensor Z. 4 1 1 7 is the display part of the measuring device 4 1 1 5 for displaying the measurement result. The measuring device 4 1 1 5 has calibration data corresponding to the output characteristics of each manufacturing batch. For each manufacturing batch, it is used to make necessary corrections to the output of the biosensor Z to return it to the correct blood glucose. . Therefore, before the measurement, the calibration wafers specified for each manufacturing batch need to be specified (the size of the paper is not shown in the figure. The Chinese National Standard (CNS) A4 specification (210 X 297 mm) is applicable.) #TJ • ϋ an ml ^^ 1 tmmmme ^^ 1 in 1 ^ ϋ * 1 aaiai i ^ i 11 I ϋ -4-U Mouth (Please read the note on the back? Matters before filling out this page) 1223064 Printed by the Intellectual Property Bureau Staff Consumer Cooperatives of the Ministry of Economic Affairs Α7 Β7 5 2. Description of the invention () (shown in the figure) Insert it into the insertion port 4 1 1 6 of the measuring device 4 1 1 5 and specify the necessary calibration data at the measuring device 4 1 1 5. The calibration chip has information on which calibration data to use, and is inserted into the insertion port 4 11 6 to prepare necessary calibration data for the measuring device 4 1 1 5. Then, the calibration wafer is pulled out from the insertion port 4 1 1 6 and the biosensor Z is inserted into the insertion port 41 1 6 of the measuring device 41 1 5 to quantify the basis mass contained in the specimen in the manner described above. The measuring device 4 1 1 5 which has entered the calibration signal in this way returns to the correct blood glucose value from the measured current value and calibration data, and displays the blood glucose value on the display portion 4 1 1 7. The conventional biosensor Z described above has problems to be solved. First, on the biosensor Z, silver paste, carbon paste, etc. are printed and laminated on the substrate by screen printing method, which is used to define the area of the measuring electrode. During the printing, due to the exudation or dripping of various pastes, etc., If the area of the measurement electrode is changed, it is difficult to make the area of the measurement electrode uniform. In addition, since the electrode structure is a three-layer structure of Ag, carbon, and resist, it is very complicated and requires advanced printing technology. In addition, since the electrode section of the biosensor Z is composed of two electrodes, a measuring electrode and a counter electrode, it is connected to the quantitative device of the biosensor Z. When a certain voltage is applied between the two electrodes, electrical properties are generated. When the situation changes, it is detected that the sample has reached the measurement electrode, and the measurement is started. However, when a small amount of sample that cannot be measured is covered on the measurement electrode, the measurement is also started because the sample is insufficient. The problem of measuring the display error of maggot. In addition, in the biosensor Z, in order to improve the sensitivity of the sensor, it is necessary to improve the wettability of the reaction reagent layer and the carbon electrode, so as to improve the adhesion. -6- This paper standard applies Chinese national standards (CNS) A4 Specification (210 X 297 Gong ~ (Please read the note on the back? Matters before filling out this page) Order --------- line—; _ I ^ 1 ^ 1 ϋ ϋ ϋ · · 1 ϋ ϋ ϋ ϋ I ϋ ϋ ϋ ϋ ϋ I ϋ I ϋ · 1223064 A7 B7 Printed by the Consumer Cooperatives of the Intellectual Property Bureau of the Ministry of Economic Affairs. 5. Description of invention (5). Honing or heat treatment is applied to the electrode surface, but this will increase the cost because the man-hours increase, and the accuracy of the honing process will also change the accuracy of the sensor. In addition, the carbon paste used for screen printing is generally a composite material composed of resin binder, graphite, carbon black, organic solvents, etc., so the characteristics of the paste are easy to change according to the batch of raw materials and the manufacturing conditions when the paste is kneaded. Mass production of stable sensors requires tight tubes That is, it is very time-consuming and labor-intensive. In addition, when only the reagent is coated for the formation of the reagent layer on the electrode, the method of expanding the reagent is different due to the state of the electrode surface or the composition of the reagent solution, so The reagent cannot be uniformly coated on the electrode, and the amount of the reagent on the electrode changes. That is, even when the same amount of reagent is dropped and applied, the position of the reagent layer changes because of the expansion of the reagent. Or the area will change. Therefore, the performance of the biosensor z will be deteriorated. In addition, it is very troublesome to insert the calibration wafer every time it is measured. If you forget to insert the calibration wafer, or if you insert it incorrectly, for example, insert lactic acid 値When a calibration wafer for measurement is used, or when a calibration wafer with different output characteristics is inserted even if it is used for blood glucose measurement, there is a problem that the measurement result is incorrect. Therefore, the present invention addresses these problems and aims to provide a biological sense. The detector can be formed in a simple way and has good measurement accuracy. The biosensor can be used at the electrode regardless of the composition of the test solution. The uniform reagent layer is configured on the top to make the performance uniform; the biosensor does not need -7- (Please read the note on the back? Matters and then fill out this page)-. Line · This paper size applies Chinese national standards ( CNS) A4 specification (210 X 297 mm) 1223064 A7 B7 Printed by the Consumers ’Cooperative of the Intellectual Property Bureau of the Ministry of Economy Printed invention description () To insert a calibration chip, just insert a biosensor, and the tester can determine the quality of each manufacturing batch. Calibration information; method for forming thin-film electrodes for these biosensors; and quantitative method and device using these biosensors. [Disclosure of Invention] The first item of the scope of patent application of the present invention is a biosensor The measuring device is used for quantifying the matrix contained in the sample liquid, and is characterized in that the biosensor includes: a first insulating substrate and a second insulating substrate; an electrode part includes at least a measuring electrode and a counter electrode; A sample supply path for introducing the sample solution to the electrode section; and a reagent layer for quantifying a matrix contained in the sample solution; the electrode section, the sample supply path, and The reagent layer exists between the first insulating substrate and the second insulating substrate; the sample supply path is provided on the electrode portion; and the reagent layer is provided on the electrode portion of the sample supply path. ; A first gap is provided on the entire or part of the conductive layer formed on the inner surface of one or both of the first insulating substrate or the second insulating substrate to divide and form the electrode portion. Because the biosensor is constructed in this way, it is possible to easily and highly accurately define the electrode portion, and the response characteristics of each biosensor do not change, and a good response can be obtained. In addition, since the electrode portion is formed in a single layer by using the conductive layer, an electrode portion having a smooth surface can be formed in a simple manner regardless of man-hours. In addition, since the structure of the electrode is a very simple structure, it is possible to easily form a biosensor having the same performance as its effect. This paper size applies to China National Standard (CNS) A4 specification (21 × 297 public love) Printed by the Consumer Cooperatives of the Intellectual Property Bureau of the Ministry of Economic Affairs 1223064 A7 _ B7 V. Description of the invention (7) The scope of patent application for this invention is item 2 In the biosensor, the electrode part is further provided with a detection electrode in the biosensor of the first patent application scope. Since the biosensor is constructed in this way, it can become a biosensor with higher measurement accuracy and its effect. The biosensor of the third patent application scope of the present invention is that the pair of electrodes is provided on the inner surface of the second insulating substrate in whole or in part in the second biosensor of the patent application scope. ; The measurement electrode and the detection electrode are provided in whole or in part on the inner surface of the first insulating substrate; the measurement electrode and the detection electrode provided on the inner surface of the first insulating substrate are used The first gap provided in the conductive layer is divided and formed. Since the biosensor is constructed in this way, the sample supply path can be miniaturized, and the measurement can be performed based on a small amount of samples as the effect. The biosensor of the fourth scope of the present invention is provided in the whole or part of the inner surface of the first insulating substrate among the biosensors of the first or second scope of the patent application. The electrode portion; and the electrode portion provided on the inner surface of the first insulating substrate is formed by dividing the first gap provided in the conductive layer. Since the biosensor is constructed in this way, since all electrodes are provided on the same side, since the electrodes are formed on only one side, manufacturing becomes easy, so the manufacturing cost of the biosensor can be reduced to its effect. . This paper size applies to China National Standard (CNS) A4 (210 X 297 mm) -------- Order _ | ϋ · ϋ III ϋ I n ------------- --------- (Please read the notes on the back before filling this page)-1223064 A7 B7 Printed by the Consumer Cooperatives of the Intellectual Property Bureau of the Ministry of Economic Affairs The biosensor of this item is such that the area of the pair of electrodes is equal to or larger than the area of the measurement electrode in the biosensor of any one of claims 1 to 4 of the scope of patent application. Since the biosensor is constructed in this way, it is possible to prevent the electron transfer reaction between the electrode and the measurement electrode from becoming a regular speed ', and to smoothly promote the response as its effect. In the biosensor of the patent application scope item 6 of the present invention, in the biosensor of any of the patent application scope items 1 to 4, the total area of the pair of electrodes and the area of the detection electrode is equal to or It is larger than the area of the measuring electrode. Since the biosensor is constructed in this way, it is possible to prevent the electron transfer reaction between the counter electrode, the detection electrode, and the measurement electrode from becoming a regular speed, and to smoothly promote the reaction as its effect. The biosensor of item 7 of the scope of patent application of the present invention is to make the area of the detection electrode of the specimen supply path of the biosensor equal to the pair of electrodes in the biosensor of item 6 of the scope of patent application. Of the area. Because the biosensor is constructed in this way, the electron transfer reaction between the counter electrode, the detection electrode, and the measurement electrode can be more reliably prevented from changing to a regular speed, and the reaction can be smoothly promoted for its effect. The biosensor of item 8 of the patent scope is further provided with a spacer in the biosensor of any of claims 1 to 7 of the scope of patent application, and has a notch portion for forming the sample supply path 'and The second insulating substrate is disposed on the electrode portion. -10- Please read the notes on the back first

Page II order m This paper size applies the Chinese National Standard (CNS) A4 specification (210 X 297 mm) 1223064 5_ Printed by the Consumers ’Cooperative of the Intellectual Property Bureau of the Ministry of Economic Affairs A7 B7 Description of invention (9) Because this way constitutes a biological sense Therefore, the place where the sample supply path is provided is fixed, and the second insulating substrate is disposed thereon. Therefore, the sample introduced into the sample supply path does not leak out from the sample supply path, which is an effect. In the biosensor of claim 9 of the present invention, the spacer is integrated with the second insulating substrate in the biosensor of claim 8 of the present invention. Since the biosensor is configured in this manner, by integrating the spacer and the second insulating substrate, cost reduction and simple production can be achieved, and the effect can be achieved. The biosensor of the present invention in the scope of application patent No. 10 is an air hole formed in the biosensor of any of the scope of applications in patent application Nos. 1 to 9 to the sample supply path. Because the biosensor is configured in this way, when the specimen is introduced into the specimen supply path, because the excess air is exhausted from the air hole, the capillary phenomenon can be used to reliably introduce the specimen into the specimen supply path. Its effect. The biosensor of the eleventh patent application scope of the present invention is that the formation of the reagent layer in the biosensor of any one of the patent application scopes 1 to 10 is made by dropping the reagent; A second gap is provided around the dropping position of the reagent. Because the biosensor is constructed in this way, when a reagent is dropped on an electrode to form a reagent layer, 'because the reagent is uniformly diffused, a reagent layer of a specified area is formed at a specified position' So form -11- This paper size applies the Chinese National Standard (CNS) A4 specification (210 X 297 mm (please read the precautions on the back before filling this page) · i-line · 1223064 A7 B7 V. Description of the invention (1Q) The uniform test layer has no change in position and area, and as a result, a correct measurement without change can be performed for its effect. The biosensor of item 12 of the patent scope of the present invention is the first In the biosensor of item 1, the second gap is formed into an arc shape. Since the biosensor is configured in this way, a gap equal to the enlarged shape of the test reagent is used to limit the expansion of the test reagent. The effect of limiting the area and position of the reagent layer more accurately is its effect. The biosensor of item 13 of the patent application scope of the present invention is the biosensor of any one of the patent application scopes 1 to 12. Device A third slit is provided to divide the conductive layer to define the area of the electrode portion. Since the biosensor is configured in this way, when the biosensor is actually manufactured, the third is used in advance when the substrate is cut first. The gap is used to limit the area of each electrode, so the area of each electrode will not be changed due to the cutting position of the substrate, so the accuracy will not change, which is its effect. The sensor is a biosensor with the scope of patent application No. 13 that the shapes of the first insulating substrate and the second insulating substrate are substantially rectangular; the third gap is provided with one or more than two , Parallel to any side of the roughly rectangular shape. Because the biosensor is configured in this way, the area of each electrode can be easily specified using the third slit, and the cutting position will not be shifted due to the cutting position of the substrate. And changing the area of each electrode 'can make the accuracy not change, for its effect. -12- This paper size applies the Chinese National Standard (CNS) A4 specification (210 X 297 mm) (Please read the precautions on the back before filling out this page) Order: Printed by the employee's cooperative of the Intellectual Property Bureau of the Ministry of Economic Affairs Printed by the employee's cooperative of the Intellectual Property Bureau of the Ministry of Economy 1223064 A7 B7 The biosensor in the scope of patent application No. 15 is the information of the calibration data in the biosensor in any of the scope of patent applications No. 1 to 14, which is generated in each manufacture of the biosensor. The 'batch' corresponds to the characteristics related to the output of the electrical change when the sample solution and the reagent layer react, and can be discriminated by the measuring device using the biosensor. Because the biosensor is constituted in this way , So only need to insert the biosensor into the measuring device, the measuring device can determine what kind of calibration data is needed. In addition, the user does not need to use calibration chips and other information to enter the calibration data, which is not troublesome and can prevent Operation error 'can get the correct result for its effect. The biosensor of item 16 of the scope of patent application of the present invention is to have one or more of the fourth gap for dividing the electrode portion in the biosensor of item 15 of the scope of patent application; At the position of the fourth slot, the measuring device can discriminate the information of the calibration data. Since the biosensor is configured in this way, the measuring device can discriminate the information of the calibration data according to the position of the fourth gap, and can instruct the calibration data corresponding to a plurality of manufacturing lots by inserting the biosensor into the measuring device. The tester can easily determine what kind of calibration data is needed, and it will not be troublesome to search, so it can prevent operation errors and obtain correct results for its effect. The biosensor of item 17 of the scope of patent application of the present invention is a biosensor of any of the scope of claims 1 to 16 of the patent scope of the application. The conductive layer is processed by laser to form a conductive layer. The 1st slit and the 2nd slit-13- This paper size applies to China National Standard (CNS) A4 (210 X 297 public love) -------- Order ---------- • Line J (please read the precautions on the back before filling out this page) €! 223〇64 Printed by the Consumer Cooperatives of the Intellectual Property Bureau of the Ministry of Economic Affairs A7 B7 i, Invention Note (12), the third slot, and the first slot Any or all of the 4 gaps. Because the biosensor is constructed in this way, high-precision processing can be performed, and the area of each electrode can be specified with high accuracy. In addition, because the interval between each electrode can be narrowed, the biosensor can be miniaturized For its effect. The biosensor of item 18 of the scope of patent application of the present invention is to make the first slot, the second slot, the third slot, and the fourth slot in the biosensor of claim 17 of the scope of patent application. The gap width of each of the slits is 0.005 mm to 0.3 mm. Because the biosensor is configured in this way, the interval between the electrodes can be narrowed, so the biosensor can be miniaturized as its effect. The biosensor of item 19 of the scope of patent application of the present invention is to make the first slot 'the second slot, the third slot, and The depth of each of the fourth slits is greater than the thickness of the conductive layer. Since the biosensor is constructed in this way, it can be a biosensor in which the electrodes are surely separated, and its effect is achieved. The biosensor of claim 20 of the present invention applies the enzyme to the reagent layer in the biosensor of any of claims 1 to 19. Because the biosensor is constructed in this way, it can be an enzyme biosensor suitable for enzyme inspection. Its effect ° The biosensor of item 21 of the patent application scope of the present invention is Make the test music in the biosensor of any one of items 1 to 19. 14- This paper size is applicable to China National Standard (CNS) A4 (210 X 297 mm) -------- Order --------- • Line J (Please read the precautions on the back before filling this page) 1223064 A7 B7 V. Description of the invention (13) The layer contains electronic transmitters. (Please read the precautions on the back before filling in this page.) Because the biosensor is constructed in this way, it can be used as a biosensor suitable for inspection using an electronic transmitter's effect. The biosensor of the 22nd patent application scope of the present invention is a biosensor of any one of the patent application scopes 1 to 19, wherein the test layer comprises a water-soluble polymer. Since the biosensor is constructed in this way, the formation of §style music can be made easy, and a high-precision biosensor 'can be achieved. In the biosensor according to claim 23 of the present invention, the insulating substrate is formed of a resin in the biosensor according to any of claims 1 to 22 of the claims. Since the biosensor is constructed in this way, it is possible to make a cheaper biosensor as an effect. The Consumer Property Cooperative of the Intellectual Property Bureau of the Ministry of Economic Affairs printed the scope of application for the invention. Item 24 is a method for forming a thin-film electrode, which is used to form a thin-film electrode on the surface of an insulating substrate. In a vacuum environment, the excited gas is impinged on the surface of the insulating substrate to make the surface of the insulating substrate rough; and the conductive layer forming process is performed on the surface of the insulating substrate to become rough. Forming the conductive layer of a thin film electrode made of a conductive substance. Because the thin-film electrode is formed in this way, no pre-treatment such as surface honing is required, and a thin-film electrode can be formed in a simpler way, and a thin-film electrode with high adhesion between the substrate and the electrode layer is -15. -This paper size is in accordance with Chinese National Standard (CNS) A4 (210 X 297 mm) Ϊ223064 A7 ~ --- -B7 V. Description of the invention (14) The effect. (Please read the precautions on the back before filling out this page) The method for forming a thin film electrode in the scope of the patent application No. 25 of the present invention is to form the rough surface in the method of forming the thin film electrode in the scope of patent application No. 24 The project includes: a substrate installation project 'for setting the insulating substrate into a vacuum tank; a vacuum exhaust project' for exhausting the inside of the vacuum tank to a vacuum; a gas filling project 'for filling a gas to The inside of the vacuum tank; and a collision project for exciting the gas to ionize it so as to collide with the insulating substrate. Since the thin-film electrode is formed in this way, it is more effective and reliable to form the thin-film electrode, and an appropriate substrate surface can be formed. Therefore, a thin-film electrode can be more effectively formed as its effect. The method for forming a thin-film electrode according to the scope of patent application No. 26 of the present invention is to make the vacuum degree of the vacuum exhaust engineering in the method for forming the thin-film electrode under the scope of patent application No. 25 to lx 10 ″ ~ 3x 10-3 bar Within the range of Ska. Since the thin-film electrode is formed in this manner, a thin-film electrode can be formed more reliably, and an appropriate substrate surface can be formed. Therefore, a thin-film electrode can be formed more effectively as its effect. Printed by the Employees' Cooperative of the Intellectual Property Bureau of the Ministry of Economic Affairs The method for forming a thin-film electrode in the scope of patent application No. 27 of the present invention is to make the gas an inert gas in the method for forming the thin-film electrode in scope of the patent application No. 26. Since the thin-film electrode is formed in this manner, the substrate surface is not deteriorated, and the substrate surface can be adapted to a state where the thin-film electrode is formed 'as an effect. -16- The size of the mound paper is applicable to the Chinese National Standard (CNS) A4 (210 X 297 mm) Printed by the Consumer Cooperatives of the Intellectual Property Bureau of the Ministry of Economic Affairs 1223064 A7 B7_ V. Description of the invention (15) The scope of patent application for the invention The method for forming the thin film electrode of item 8 is to make the inert gas into a rare gas of argon, neon, ammonia, krypton, xenon, or nitrogen in the method for forming the thin film electrode of item 27 of the patent application. Since the thin-film electrode is formed in this manner, it is possible to form the thin-film electrode as a result without causing deterioration of the substrate surface more reliably. The method for forming a thin-film electrode according to the scope of patent application No. 29 of the present invention is to form the conductive layer project in the method for forming a thin-film electrode according to any one of scopes 24-28 of the patent application to include: the second substrate setting project , Used to install the roughened insulating substrate after the rough surface forming process is completed, and set it into the second vacuum tank; the second vacuum exhaust project is used to exhaust the inside of the second vacuum tank into a vacuum; 2 gas filling projects to charge a second gas into the second vacuum tank; and a film formation project to stimulate the second gas to ionize and cause it to collide with a conductive substance to make the The atoms of the conductive substance are emitted, and a film is formed on the roughened insulating substrate. Since the thin-film electrode is formed in this manner, no prior processing such as surface honing treatment is required, and a thin-film electrode with high adhesion to the substrate can be obtained as an effect. The method for forming a thin film electrode in the scope of patent application No. 30 of the present invention is to make the conductive layer forming process in the method for forming the thin film electrode in any of the scope of patent applications No. 24 to 28 including: the second substrate The setting project is used to set the insulating substrate after forming the rough surface after the rough surface forming project is completed, and set it into the second vacuum tank; for the second vacuum exhaust project, use -17- This paper size applies to Chinese national standards ( CNS) A4 size (210 X 297 mm) (Please read the phonetic on the back? Matters before filling out this page)

-------- Order -------- • Line 1 ^ 23064 A7 B7 ____ 1. Description of the invention (16) to evacuate the inside of the second vacuum tank to a vacuum; and film-forming project ' It is used to heat and evaporate a conductive material, thereby forming a black gas film on the roughened insulating substrate. Since the thin-film electrode is formed in this manner, no prior processing such as surface honing treatment is required, and a thin-film electrode with high adhesion to the substrate can be obtained as an effect. The method for forming a thin film electrode according to item 31 of the scope of patent application of the present invention is to make the vacuum degree of the second vacuum exhausting project at lx 1 in the method for forming a thin film electrode according to item 29 or 30 of the scope of patent application. 〇 ”~ 3x 10 · 3 Baska range. Since the thin-film electrode is formed in this way, a thin-film electrode with high adhesion to the substrate can be formed more reliably, which is an effect. The method for forming a thin-film electrode according to the present invention in the scope of patent application No. 32 is to make the second gas an inert gas in the method for forming the thin-film electrode in any of the scopes of patent applications No. 29 to 31. Since the thin-film electrode is formed in this way, the surface of the substrate or the thin-film electrode itself does not deteriorate, and a thin-film electrode with close adhesion to the substrate can be formed as an effect. The method for forming the thin film electrode of the present invention in the scope of patent application No. 33 is printed by the employee's consumer cooperative of the Intellectual Property Bureau of the Ministry of Economic Affairs. , Rare gas of helium, krypton, xenon, nitrogen. Because the thin-film electrode is formed in this way, the surface of the substrate or the thin-film electrode itself will not be deteriorated, and it can be more reliably formed. The adhesion to the substrate is very high. -18-This paper size applies to China National Standard (CNS) A4 (210 X 297) (Mm) Printed by the Consumer Cooperatives of the Intellectual Property Bureau of the Ministry of Economic Affairs 1223064 A7 ___ B7 V. Description of the invention (7) The high film electrode is its effect. The method for forming a thin-film electrode according to item 34 of the present invention is to form the vacuum chamber and the second vacuum tank in the method for forming a thin-film electrode according to any one of items 29 to 33. A slot. Since the thin-film electrode is formed in this way, the device for forming the thin-film electrode can be simplified, and therefore, the manufacturing cost of the thin-film electrode can be reduced as a result. The method for forming a thin-film electrode in accordance with the scope of patent application No. 35 of the present invention is to make the conductive material expensive in the method for forming a thin-film electrode in any of scopes of patent applications ranging from 29 to 34. Because the thin-film electrode is formed in this way, by making the thin-film electrode not a composite material but a single material, it is not used to be controlled by the manufacturing conditions, and the difference between the manufacturing batches can be made small, and stable electrodes can be manufactured in large quantities. For its effect. The method for forming a thin film electrode according to item 36 of the application for the present invention is to form a thin film electrode having a thickness of 3 nm in the method for forming a thin film electrode according to any one of items 24 to 35. lOOnm. Since the thin-film electrode is formed in this way, the thickness of the electrode is not limited and can be thinned. Therefore, by increasing the production volume and reducing the material cost, the manufacturing cost can be reduced to its effect. The biosensor of the 37th patent scope of the present invention is to use the conductive layer in the biosensor of any one of the patent scopes 1 to 23, please use any of the patent scope 24 to 36. One item of thin film electrode-19- This paper size is applicable to China National Standard (CNS) A4 specification (210 X 297 mm) • ------------ · I ------ Order · -------- (Please read the notes on the back before filling out this page) 1223064 A7 ___ B7 V. The method for forming the description of the invention (18). Because the biosensor is formed in this way, the electrode of the thin film reflects the unevenness of the surface of the substrate being processed into a rough surface, and is used to improve the wettability and adhesion of the electrode and the reagent. As a result, it can form a high The performance of the biosensor is its effect. Item 38 of the scope of patent application of the present invention is a quantitative method using a biosensor of any of the scope of claims 1 to 23 or 37 of the scope of patent application for the sample liquid supplied to the biosensor. The matrix contained therein is quantified and has the following features: a first application step for applying a voltage between the detection electrode and the pair of electrodes or the measurement electrode; and a reagent supply step for supplying the sample liquid. To the reagent layer; the first change detection step, by providing the sample liquid to the reagent layer, is used to detect an electrical change between the detection electrode and the pair of electrodes or the measurement electrode; the second application A step of applying a voltage between the measuring electrode, the pair of electrodes and the detecting electrode after detecting the electrical change in the first changing step; and a current measuring step using the voltage of the second applying step Application is used to measure the current generated between the measurement electrode 'to which the voltage is applied and the pair of electrodes and the measurement electrode. Printed by the Consumers 'Cooperative of the Intellectual Property Bureau of the Ministry of Economic Affairs. Because the quantitative measurement is performed in this way, when an electrical change occurs between the detection electrode of the biosensor and the measurement electrode or the counter electrode,' the fixed stomach action is started, so it can prevent The measurement error caused by the insufficient supply of the sample layer of the drug layer can be measured with higher safety. In addition, 'when the measurable sample is supplied to the test layer', because the test 1 is also used as the counter electrode, It is used for measurement, so the area of the electrode part can be -20- This paper size applies the Chinese National Standard (CNS) A4 specification (210 X 297 mm) 1223064 A7 ______ B7 V. Description of the invention (19) Quantitative analysis using micro-samples is performed correctly for its effect. (Please read the precautions on the back before filling out this page) Item 39 of the scope of patent application of the present invention is a quantitative method, using biosensing of any of the scope of patent applications 1 to 23 or 37 The device is used for quantifying the matrix contained in the sample liquid supplied to the biosensor, and is characterized by having a third application step for the detection electrode and the pair of electrodes or the measurement electrode. A voltage is applied between the measurement electrode and the pair of electrodes; a reagent supply step is used to supply the sample liquid to the reagent layer; a first change detection step is to provide the sample liquid to the reagent layer, It is used to detect the electrical change generated between the detection electrode and the pair of electrodes or the measurement electrode. The second change detection step is to provide the sample liquid through the test reagent layer to detect the difference between the measurement electrode and the measurement electrode. Electrical changes between the counter electrodes; a second applying step, after detecting the electrical changes of the first change detection step and the second change detection step, is used to measure the electrodes, and the pair of electrodes and the Detection electrode Applying a voltage between; and a current measuring step for measuring the voltage measuring electrodes, and the current is applied with the second step of applying between the electrode and the detection electrode arising. Printed by the Consumer Cooperative of the Intellectual Property Bureau of the Ministry of Economic Affairs. Because the quantitative measurement is performed in this way, when an electrical change occurs between the detection electrode and the measurement electrode or the counter electrode of the biosensor, the quantitative operation is started. The measurement error caused by insufficient supply of specimens in the strata can be measured with higher safety. In addition, when a measurable specimen is supplied to the reagent layer, since the detection electrode doubles as a counter electrode for measurement, the area of the electrode part can be -21- Chinese standard (CNS) A4 Specifications (210 X 297 mm) Printed by the Consumer Cooperatives of the Intellectual Property Bureau of the Ministry of Economic Affairs 1223064 A7 B7 20 V. Description of the invention () To reduce the size, it is possible to accurately perform quantitative analysis using micro-samples for its effect. The quantitative method of the scope of patent application No. 40 of the present invention is the quantitative method of scope No. 38 or 39 of the scope of patent application. After the second change detection step, there is a change notification step. When it is detected within a specified period When there is no electrode change between the detection electrode and the pair of electrodes or the detection electrode, the user is notified of the change. Since the quantification is performed in this way, the user can be notified of the insufficient supply of the sample to the reagent layer of the biosensor, and it can be a quantitative method with improved convenience and safety as its effect. Item 41 of the scope of patent application of the present invention is a quantitative device, which is detachably connected to a biosensor of any of the scope of patent applications 1 to 23 or 37, and is used to supply the biosensor to the biosensor. The matrix contained in the sample liquid of the measuring device is quantified, and is characterized by having: a first current / voltage conversion circuit for converting a current from the measuring electrode provided in the biosensor into a voltage; An A / D conversion circuit for converting a voltage from the current / voltage conversion circuit into a digital voltage; a first switch is provided between a counter electrode and a ground line provided in the biosensor; and a control section, For controlling the first A / D conversion circuit and the first switch; the control section: applying a voltage between the detection electrode and the measurement electrode in a state where the first switch is insulated from the pair of electrodes; The sample solution is supplied to the reagent layer on the sample supply path, and an electrical change between the detection electrode and the measurement electrode due to the supply is detected; and the first switch is connected to a counter electrode. State of Measure-22- This paper size applies to China National Standard (CNS) A4 (210 X 297 mm) • I ^ 1 I 1 · — I ϋ i ϋ n 1 ϋ n · nn —ϋ ϋ I ϋ IB. ϋ · I · ϋ · ϋ ϋ III 1 (Please read the precautions on the back before filling this page) 1223064 A7 B7 Printed by the Consumer Cooperatives of the Intellectual Property Bureau of the Ministry of Economic Affairs 5. Description of the invention (21) Fixed electrode, and the counter electrode And applying a voltage between the detection electrodes; and measuring a response current generated by the application of the voltage. Since the quantitative device is configured in this way, measurement errors caused by insufficient sample supply to the reagent layer of the sample supply path can be prevented, and a more secure measurement can be performed. In addition, since the detection electrode of the biosensor is also used as a counter electrode during measurement, the sample supply path can be miniaturized, and the quantitative analysis of a small amount of sample can be accurately performed as its effect. Item 42 of the scope of patent application of the present invention is a quantitative device, which is detachably connected to a biosensor of any one of the scope of patent applications 1 to 23 or 37, and is used to supply to the organism The matrix contained in the sample liquid of the sensor for quantification is characterized by having a first current / voltage conversion circuit for converting a current from the measurement electrode provided in the biosensor into a digital voltage; A second current / voltage conversion circuit is used to convert the current from the measurement electrode provided in the biosensor into a digital voltage; a first A / D conversion circuit is used to convert the current from the first current / voltage conversion circuit The voltage is converted into a digital voltage; a second A / D conversion circuit is used to convert the voltage from the second current / voltage conversion circuit into a digital voltage; a first conversion switch is used to detect the biosensor. Connection of the electrodes to the first current / voltage conversion circuit or the ground; and a control unit for controlling the first A / D conversion circuit, the second A / D conversion circuit, and the first conversion switch;该 控 芾 [J In the state where the first conversion switch is connected to the first current / voltage conversion circuit, between the detection electrode and the pair of electrodes, -23- (Please read the precautions on the back before

The paper size of this paper applies the Chinese National Standard (CNS) A4 specification (210 X 297 mm). Printed by the Consumer Cooperatives of the Intellectual Property Bureau of the Ministry of Economic Affairs. Voltage is applied; the sample liquid is supplied to the reagent layer provided on the sample supply path, and the electrical changes between the detection electrode and the measurement electrode due to the supply are detected, and the measurement An electrical change between the electrode and the pair of electrodes; grounding the first changeover switch; applying a voltage between the measurement electrode, the counter electrode and the detection electrode; and measuring a response current generated by the application of the voltage. Since the quantitative device is configured in this way, measurement errors caused by insufficient sample supply to the reagent layer of the sample supply path can be prevented, and a more secure measurement can be performed. In addition, since the detection electrode of the biosensor is also used as a counter electrode during measurement, the sample supply path can be miniaturized, and the quantitative analysis of a small amount of sample can be accurately performed as its effect. The quantitative device of the 43rd patent application range of the present invention is that the quantitative device of the 42nd patent application scope is provided with a second conversion switch for changing the connection of the measurement electrode of the biosensor. To the second current / voltage conversion circuit or the ground; the control unit performs: connecting the first conversion switch to the first current / voltage conversion circuit, and connecting the second conversion switch to the second current / voltage conversion In the state of the circuit, a voltage is applied between the detection electrode and the pair of electrodes, and between the measurement electrode and the pair of electrodes; the sample liquid is supplied to the reagent layer provided on the sample supply path. When it is detected that an electrical change occurs between the measurement electrode and the pair of electrodes due to the supply, the second changeover switch is grounded; then, it is detected that there is a -24- Paper size applies to China National Standard (CNS) A4 (210 X 297 mm) • I--I -------- III I-- 丨 ^^ · 丨 丨 丨 丨 丨 丨 r. (Please (Read the notes on the back before filling out this page) 1223064 Economy Printed by the Consumer Property Cooperative of Intellectual Property Bureau A7 B7 V. Description of Invention (23) In the case of electrical changes, connect the second conversion switch to the second current / voltage conversion circuit, and ground the first conversion switch; A voltage is applied between the measurement electrode and the pair of electrodes and the detection electrode; and a response current generated by the application of the voltage is measured. Since the quantitative device is configured in this way, measurement errors caused by insufficient sample supply amount to the reagent layer of the sample supply path can be prevented, and measurement with higher safety can be performed. In addition, since the detection electrode of the biosensor is also used as a counter electrode during measurement, the sample supply path can be miniaturized, and the quantitative analysis of a small amount of samples can be accurately performed to its effect. The quantitative device of the scope of patent application No. 44 of the present invention is provided with a notification device in the quantitative device of scope 42 or 43 of the patent scope of the application. When the control unit detects that there is an electrical change between the measurement electrode and the pair of electrodes, and when there is no electrical change between the detection electrode and the measurement electrode or the pair of electrodes, Notify users of changes. Since the quantitative device is configured in this way, the user can be notified of the insufficient sample supply amount to the reagent layer of the sample supply path of the biosensor, which can be a quantitative device with improved convenience and safety. For its effect. [Brief description of the drawings] Fig. 1 is an exploded perspective view of the biosensor of the first and fifth embodiments. Fig. 2 shows an example of a method of setting the electrode portion. Fig. 3 is an exploded perspective view of the biosensor of the second embodiment. -25- This paper size applies to China National Standard (CNS) A4 (210 X 297 mm) * U ----------- Shang -------- Order ----- --1 (Please read the notes on the back before filling this page) 1223064 A7 __ B7_ _ V. Description of the Invention (24) Figure 4 shows the detection supply path of the biosensor of the second embodiment. (Please read the precautions on the back before filling out this page.) Figure 5 is a plan view showing the state where a gap is formed in the conductive layer of the biosensor of the third embodiment. Fig. 6 shows each sheet of the biosensor of the third embodiment. Fig. 7 is an exploded perspective view of the biosensor of the third embodiment. Fig. 8 shows the state of the electrodes of the biosensor of the third embodiment. Fig. 9 is an exploded perspective view of the biosensor of the fourth embodiment. Fig. 10 is a plan view showing an example of the formation of the second slit of the biosensor of the fourth embodiment. Fig. 11 is a schematic view showing a concept of forming a biosensor in the fifth embodiment. Fig. 12 is a schematic view showing the concept of a device for forming a thin film electrode according to the fifth embodiment. Fig. 13 shows the structure of a biosensor and a metering device according to the sixth embodiment. Printed by the Consumer Cooperative of Intellectual Property Bureau of the Ministry of Economic Affairs. Fig. 14 shows another structure of the biosensor and the quantitative device of the sixth embodiment. Fig. 15 is an enlarged view of a sample supply path of the biosensor of the first embodiment. Fig. 16 shows the structure of a biosensor and a metering device according to the seventh embodiment. -26- [Paper size applies Chinese National Standard (CNS) A4 specifications (21G X 297 issued) 'Printed by the Consumer Cooperatives of the Intellectual Property Bureau of the Ministry of Economic Affairs 1223064 A7 B7? 5 5. Description of the invention Structure of the biosensor and metering device of the eighth embodiment. Fig. 18 shows changes in the wettability index (surface tension) of the substrate surface and the adhesion between the electrode layer and the substrate. Figure 19 shows the relationship between the thickness of the palladium film and the wet index (surface tension) of the electrode surface. Figure 20 shows a comparison of the sensitivity of sensors with blood glucose concentrations of 40 to 600 mg / dl. Fig. 21 is an exploded perspective view of a conventional biosensor. Fig. 22 shows a state where the biosensor is inserted into the measuring device. Fig. 23 is a plan view showing a state where a conductive layer is formed on the sensing sheet of the third embodiment after forming a gap. Fig. 24 is a plan view showing the state of the electrodes of the biosensor in the manufacturing method of the third embodiment. Fig. 25 shows the concept of the cross-sectional structure of a conventional biosensor. [Best Embodiment for Carrying Out the Invention] An embodiment of the present invention will be described below with reference to the drawings. In addition, the embodiment shown here is only an example, and the present invention is not limited to this embodiment. (Embodiment 1) First, a biosensor for describing the patent application scope of items 1 to 10 of the present invention as a first embodiment with reference to the drawings. Figures 1 (a) to 1 (C) are exploded perspective views of the biosensor A according to the first embodiment of the present invention. First, the components constituting the biosensor A will be described. -27- This paper size applies to China National Standard (CNS) A4 (210 X 297 mm) --------------------- Order ------ --- Wire (please read the precautions on the back before filling this page) 1223064 A7 —_ B7 V. Description of the invention (2) Symbol 1 is the first insulating substrate (hereinafter referred to as "substrate"). It consists of ethylene glycol benzoate and the like. 2 is a conductor layer, which is formed on the entire surface of the substrate 1, and is made of, for example, a precious metal such as gold or palladium or a conductive material such as carbon. 3 a, 3 b are gaps parallel to the side of the substrate 1 and are provided on the conductor layer 2 on the substrate 1. 4 a '4 b are gaps perpendicular to the side of the substrate 1 and are provided on the conductor layer on the substrate 1 2. 5, 6, and 7 are the measurement electrode, the counter electrode, and the detection electrode, which are formed by dividing the conductor layer 2 by the slits 3a, 3b, and 4a, 4b. The counter electrode 6 and the detection electrode 7.9 are rectangular notch portions, which are provided in the center of the front edge portion of the spacer to form a detection supply path. 9a is the entrance of the specimen supply path, 10 is the longitudinal width of the notch 9 of the spacer 8, and 11 is the interval between the two slits 4a, 4b provided in the conductor layer 2. 12 is a reagent layer, which is formed by applying a reagent containing an enzyme or the like to the measurement electrode 5, the counter electrode 6, and the detection electrode 7 exposed from the notch 9 of the spacer 8. The 13 (the second) An insulating substrate) is covered with the spacer 8 and 13a is an air hole provided in the center portion of the cover 13. A method for manufacturing the biosensor A constructed in this manner will be described below with reference to the drawings. First, as shown in FIG. 1 (a), a conductive printing material such as a metal or palladium or a conductive material such as carbon is entirely coated on the surface of the substrate 1 by a screen printing method or a sputtering method to form a conductive layer. 2. Next, as shown in FIG. 1 (b), a laser is used to form two gaps 3a'3b parallel to the side of the substrate 1 and two gaps perpendicular to the conductor layer 2 formed on the substrate 1 using a laser. 4a, 4b, so as to divide the counter electrode 6'-28- This paper size applies the Chinese National Standard (CNS) A4 specification (210 X 297 mm) ------------- € (please first Read the notes on the back and fill in this page) Printed by the Consumer Cooperatives of the Intellectual Property Bureau of the Ministry of Economic Affairs · tn i_i H ϋ ϋ I ϋ ϋ 1 [ϋ I ϋ H ϋ ϋ ϋ ϋ ϋ ^ 1 ϋ ^ 1 ϋ ι > — I 1 ^ 1 ϋ-Printed by the Consumer Cooperative of the Intellectual Property Bureau of the Ministry of Economic Affairs 1223064 A7 B7 V. Description of the invention (27) Measurement electrode 5 and detection electrode 7. At this time, the slits 4a '4b are set so that the interval between the front end of the substrate 1 and the slit 4a is equal to or larger than the gap 11 between the two slits 4a, 4b. In addition, another method of providing three electrodes on the substrate 1 is to use a printing plate or a mask plate or the like used when a conductive material is formed on the substrate 1 by a screen printing method, a sputtering method, or the like. Not shown) The pattern required to form the conductor layer 2 (with two parallel gaps 3 a, 3 b) is pre-configured, and then a laser is used to set the gap 4 a on the conductor layer 2 formed on the substrate 1. 4b, by dividing the measurement electrode 5, the counter electrode 6, and the detection electrode 7, an electrode portion can be formed in this manner. Another applicable method is to use a printing plate or a mask plate that is configured in advance to form the conductor layer 2 (having two slits 3 a, 3 b parallel to the side of the substrate 1 and two slits 4 a, 4 b vertical) The required pattern is formed by using a screen printing method or a sputtering method to form a conductive substance on the substrate 1 to form a detection electrode 5, a counter electrode 6, and a detection electrode 7. A preferred method of forming a thin film electrode for forming the conductive layer of the biosensor A will be described in detail in other embodiments. In addition, the electrode portion includes the measurement electrode 5, the counter electrode 6, and the detection electrode 7. However, the electrode portion may include at least the measurement electrode 5 and the counter electrode 6. However, it is preferable to have a detection electrode 7 for performing a reliable measurement, that is, a biosensor for obtaining a reliable measurement. Next, as shown in FIG. 1 (c), the test electrode 5, the counter electrode 6, and the detection electrode 7 formed on the substrate 1 as electrode portions are coated with a reagent to form a reagent layer 12 and then, A spacer 8 is provided on it to form -29- This paper size is applicable to Chinese National Standard (CNS) A4 (210 X 297 mm) (Please read the precautions on the back before filling this page)

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V. Description of the invention (28) The notch 9 of the specimen supply path. Then set the lid 1 3 thereon. Among them, one of the notch portion 9 of the 'spacer 8 is finely passed to the air hole 1 3 a provided in the lid 13. That is, the measurement electrode 5, the counter electrode 6, and the detection electrode 7 formed on the substrate 1 are arranged so that the counter electrode 6 is closest to the entrance 9a of the sample supply path, and the measurement electrode 5 and Detecting electrode 7. The area of each of the measurement electrode 5, the counter electrode 6, and the detection electrode 7 of the sample supply path is determined according to the area of the notch portion 9 of the spacer 8 and the interval 11 between the slits 4a and 4b. In the first embodiment, since the distance from the front end of the sensor to the gap 4a is equal to or larger than the gap 11 between the gaps 4a and 4b, the area of the counter electrode 6 in the specimen supply path becomes equal to or greater than The area of the electrode 5 was measured. In this case, the conductor layer 2 is formed on the entire surface of the substrate 1. However, since the electrode portion is not formed on the entire surface of the substrate 1, the conductor layer 2 may be formed only on a required portion. This point will be described below. Figure 2 (a) is a schematic diagram showing the method for setting the electrodes of the biosensor A described above. Here, since the electrode portion is formed only on the inner surface of the substrate 1, only the necessary conductive layer 2 is provided. The conductive layer 2 is not provided on the inner surface of the cover 1 3. The electrode portion provided on the inner surface of the substrate 1 is provided by The slits 3a, 3b, 4a, and 4b are used to divide the counter electrode 6, the measurement electrode 5, and the detection electrode 7. On the other hand, there is also a method in which the conductor layer 2 is provided not only on the inner surface of the substrate 1 but also on the inner surface of the cover 13. An example of this case will be briefly described with reference to Figs. 2 (b) and 2 (c). The situation shown in Figure 2 (b) is that the conductor layer 2 provided on the inner surface of the cover 13 is directly used as a pair. -30- This paper size applies the Chinese National Standard (CNS) A4 specification (210 X 297 mm) (Please read the precautions on the back before filling this page) -ϋ ai > — n ϋ an ϋ 1 0, II 1 · ϋ I · ϋ ϋ I, printed by the Intellectual Property Bureau Staff Consumer Cooperatives of the Ministry of Economic Affairs 1223064 A7 B7 V. Description of the invention (29) The electrode 6 uses the slits 3a, 3b, 4a, and 4b, and the conductor layer 2 provided on the inner surface of the substrate 1 is used as the measurement electrode 5 and the detection electrode 7. In addition, the conductor layer 2 is provided on the entire inner surface of the substrate 1, but unnecessary portions need not be used as electrodes. That is, the entire conductor layer 2 is provided on the inner surface of the substrate 1 because the conductor layer 2 is provided on the entire surface, rather than forming the conductor layer 2 on the entire surface of the inner surface 1 of the substrate 1. As an electrode. In addition, Fig. 2 (c) is the same as Fig. 2 (b), and is used to briefly show that the counter electrode 6 is provided on the inner surface of the cover 1 3, and the measurement electrode 5 and the detection electrode 7 are provided on the inner surface of the substrate 1. In this case, the method of setting the gap in the substrate 1 is different from that in FIG. 2 (b). That is, when compared with FIG. 2 (b), the gap 4a in FIG. 2 (c) is omitted, but in this case, the area of the counter electrode 6 of the specimen supply path must be equal to or larger than the measurement The area of the electrode 5. By reducing the number of slits provided on the substrate 1 in this way, manufacturing can be facilitated. In addition, in Fig. 2 (c), since the measurement electrode 5 is positioned to face the counter electrode 6, the length of the sample supply path is shortened, the size can be reduced, and measurement can be performed based on a small amount of samples. Printed by the Consumer Cooperative of the Intellectual Property Bureau of the Ministry of Economic Affairs (please read the precautions on the back before filling out this page). In addition, in this Example 1, the measurement electrode 5, the counter electrode 6, and the detection electrode 7 are divided using lasers. However, it is also possible to use a jig or the like having a sharp tip to cut out a part of the conductor layer 2 described above to form an electrode portion. The method of forming the electrode portion is not limited to the screen printing method and the sputtering method. In the biosensor of the first embodiment of the present invention according to the above-mentioned method, a gap 3a, 3b, 4a, 4b is provided on the conductor layer 2 on the substrate 1, and a gap with a notch 9 is provided thereon. Object 8, because it can be easily and highly accurate -31- This paper size applies the Chinese National Standard (CNS) A4 (21Q x 297 public love) " — 1223〇64 A7 ____B7_ __ Printed by the Consumers ’Cooperative of the Intellectual Property Bureau of the Ministry of Economic Affairs The invention describes (%) the electrode area of each of the measuring electrode 5, the counter electrode 6 ′ and the detecting electrode 7 which define the sample supply path, so the response characteristics of each biosensor will not change, and accurate Good biosensor. In addition, in the present invention, since a noble metal such as gold or palladium or a conductive material such as carbon is used as a material to form the electrode portion in a single layer, it is not necessary to sequentially print and laminate silver paste, carbon on the substrate 1 in a conventional manner. Steps such as paste can be used to form an electrode portion with a smooth surface in a simple manner. In addition, for the conductor layer 2 provided on the substrate 1, since the slits 4a, 4b are formed by laser, the area of each electrode can be specified with high accuracy. In addition, the distance between the electrodes is very short, so that the sample supply path can be miniaturized, and even a small amount of sample that cannot be measured by conventional techniques can be measured. In addition, since the electrode structure is a very simple structure, a biosensor having the same performance can be easily formed. (Embodiment 2) A biosensor B according to claims 11 and 12 of the patent application scope of the present invention will be described below as a second embodiment. FIG. 3 is a perspective view of the biosensor B, which is used to show the manufacturing process sequence, and FIG. 4 is a sample supply path of the biosensor B. First, the structure of the biosensor B will be described. Reference numeral 21 is an insulating substrate, and is made of polyethylene terephthalate or the like. 22 is a conductive layer formed on the entire surface of the substrate 21, and is formed of a conductive material such as a precious metal such as gold or palladium or carbon. 23a, 23b, 23c, and 23d are the first slits and are provided on the conductive layer 22. 25, 26, and 27 are electrodes through which the conductive layer is divided by the first slits 23a, 23b, 23c, and 23d. -32- This paper size applies to China National Standard (CNS) A4 specification (210 χ 297 mm) 1223064 A7 B7 V. Description of the invention (31) It is formed as a measuring electrode, a counter electrode, and to confirm whether the sample is attracted to the sample supply. Detection electrode inside the path. 24a '24b is a second gap for defining the position and area of the reagent to be coated on the electrode. Reference numeral 28 is a gap covering the measurement electrode 25, the counter electrode 25, and the detection electrode 27. 29 is a rectangular notch portion provided in the center of the edge portion in front of the spacer 28 to form a sample supply path. 30 is the entrance to the sample supply path. Reference numeral 14 is a reagent layer, which is formed by dripping a reagent containing an enzyme and coating the measurement electrode 25, the counter electrode 26, and the detection electrode 27. Reference numeral 15 is a cover covering the spacer 28. 16 is an air hole provided at the center of the cover 15. A method of manufacturing the biosensor B constructed in this manner will be described below. As shown in FIG. 3 (a), a conductive layer 22 of gold or an absolutely precious metal thin film is formed by a sputtering method that is a method of forming a thin film on the entire surface of the substrate 21. In addition, the conductive layer 22 may not be formed on the entire surface of the substrate 21, but may also be formed on a portion where an electrode needs to be formed. Next, as shown in FIG. 3 (b), a first gap 23a, 23b, 23c, 23d is formed in the conductive layer 22 using a laser to divide the conductive layer 22 into a measurement electrode 25, a counter electrode 26 and Detecting electrode 27. Then, a laser is used to form a circular arc-shaped second gap 24a, 24b around the place where the reagent drops, so as to surround the place. Then, as in the first embodiment, a printing plate, a mask plate, or the like may also be used (configured in advance to form a conductive layer having first slits 23a, 23b, 23c, 23d, and second slits 24a, 24b. 22 necessary patterns), using the screen printing method or the sputtering method, etc., to form the electrode and the first slit on the substrate 21 -33- This paper size applies to China National Standard (CNS) A4 (210 X 297 mm) ) (Please read the precautions on the back before filling out this page) -------- Order --------- Printed by the Consumer Property Cooperative of the Intellectual Property Bureau of the Ministry of Economic Affairs Yin Zuinong 1223064 A7 B7 32 V. Description of the invention () The gaps 23a, 23b, 23c, 23d and the second gaps 24a, 24b. In addition, one of the conductive layers 2 2 can be cut by using a sharp-pointed jig, etc. Part. Next, as shown in FIG. 3 (c), for example, in the case of a blood glucose sensor, the measurement electrode 25, the counter electrode 26, and the detection electrode 27 are dropped and coated with a blood glucose oxidase that becomes an enzyme and an electron. Tester consisting of potassium ferricyanide, etc. The portion coated with the reagent is located between the second slits 24a and 24b, so the second slits 24a and 24b can be used as a mark for the place where the reagent is applied. In addition, the applied reagent becomes a liquid dripping, and the circle is enlarged to the outside with the center of the applied position. The second gaps 24a and 24b serve as breakwaters to limit the position and area of the reagent layer 14. So that it does not expand beyond the second gaps 24a, 24b. Therefore, the reagent layer 14 is formed at a designated area with a designated area. Next, a spacer 28 is provided on the measurement electrode 25, the counter electrode 26 and the detection electrode 27, and has a notch portion 29 for forming a sample supply path. The specimen supply path is in the state shown in FIG. 4. Next, a cover 15 is provided on the spacer 28. Among them, one end of the notch portion 29 of the spacer 28 leads to an air hole 16 provided in the cover 15. Alternatively, after the spacer 28 is formed on the measurement electrode 25, the counter electrode 26, and the detection electrode 27, the reagent may be dropped on the measurement electrode 25, the counter electrode 26, and the detection electrode 27 to be exposed from the notch portion 29. Portions are used to form the reagent layer 1 4. According to this structure, blood, which is the sample liquid of the sample, is supplied to the entrance 30 of the sample supply path, and the air hole 16 is used for capillary phenomenon -34- ^ The paper size is in accordance with China National Standard (CNS) A4 (210 X 297 mm) '• «ϋ ϋ II ί ϋ · ϋ I · ϋ ϋ · ϋ · n ϋ mm— ϋ H ϋ ϋ One 0, I 1 · ϋ ϋ (Please read the notes on the back before filling (This page)》 line 丨 dance ----------------------- 1223064 A7 B7 i. Description of the invention (33) Make a certain amount of specimens attracted to the inspection The inside of the body supply path is thereby reached on the counter electrode 26, the measurement electrode 25, and the detection electrode 27. The reagent layer 14 formed on the electrode dissolves in the blood as a specimen, and a redox reaction occurs between the reagent and a specific component in the specimen. Among them, if the inside of the specimen supply path is filled with a correct specimen, an electrical change occurs between the counter electrode 26 and the detection electrode 27. In this way, it is confirmed that the specimen is attracted to the detection electrode 27. In addition, since electrical changes also occur between the measurement electrode 25 and the detection electrode 27, it is also possible to confirm that the sample is attracted to the detection electrode 27. After the specimen is attracted to the detection electrode 27, the reaction between the specimen and the reagent is promoted for a certain period of time, and then a certain voltage is applied between the measurement electrode 25 and the counter electrode 26 or both the counter electrode 26 and the detection electrode 27. Since a blood glucose sensor is formed, a current proportional to the blood glucose concentration is generated, and the blood glucose can be measured by using this current. In addition, in the second embodiment, the blood glucose sensor is taken as an example. However, by changing the composition and sample of the reagent layer 14, the biosensor other than the blood glucose sensor can also be used. . In addition, in the second embodiment, the biosensor B has three electrodes, but the number of electrodes may not be three. In addition, in the second embodiment, the second slits 24a and 24b are formed into an arc shape, but the position and area of the reagent layer can also be limited. For example, if the accuracy of the electrode does not decrease, the shape may not be limited. For example, It can also be formed into a straight hook shape. In this way, the biosensor B of this embodiment 2 is a biosensor for quantifying the matrix contained in the sample liquid, and includes: an insulator substrate; and a plurality of electrodes, which are formed during the formation For this insulator substrate -35- This paper size is applicable to China National Standard (CNS) A4 (210 X 297 mm) (Please read the notes on the back before filling in this I) -n ϋ ϋ · ϋ n I n 一 ( · 1 —a— a— an ϋ in I-printed by the Consumer Cooperatives of the Intellectual Property Bureau of the Ministry of Economic AffairsΪ223064 A7 B7____ V. The conductive layer on the whole or part of the invention description (34), the first gap is set; arc The second gap of the shape is provided in the conductive layer to limit the application position and area of the reagent. The spacer is disposed on the electrode and has a notch to form a test for supplying the sample liquid to the measurement electrode. A reagent supply path; a reagent layer containing an enzyme is provided on the electrode of the sample supply path; and a cover is disposed on the spacer and has an air hole to the sample supply path; because the first 2 gaps to control the coated reagent It is expanded, so that when a reagent is applied to the electrode to form a reagent layer, the reagent can be uniformly diffused, and a reagent layer having no change in position and area can be formed. It has the effect that accurate measurement can be performed without change. (Embodiment 3) The specific manufacturing method of the biosensors A and B described above will be further explained. Among them, the biosensors A and B Integrated into the biosensor X. Fig. 22 is a plan view showing a state where a gap is formed in the conductive layer provided on the surface of the sensor sheet P as the basis of the biosensor X. Symbol 3102 is a conductive layer It is formed on the entire surface of the substrate 3101 and is composed of lime or a metal substance. 3103a, 3103b, 3103c, and 3103d are gaps formed in the conductive layer 3 1 0 2 ◦ 3 1 0 5, 3 1 0 6, 3 1 0 7 The electrode is a measuring electrode, a counter electrode, and a detection electrode, which are formed by dividing the conductive layer 3102 by gaps 3103a, 3103b, 3103c, and 3103d. 3110 is a cutting line indicating the cutting position of the substrate. In addition, the sensor sheet P Is in the base To form the conductive layer 3102, use the gaps 3103a, 3103b, 3103c, and -36- scales to apply Chinese National Standard (CNS) A4 specifications (210 χ 297 mm) " " " (Please read the precautions on the back first (Fill in this page)

-------- Order -------- r Line I Printed by the Consumer Cooperatives of the Intellectual Property Bureau of the Ministry of Economic Affairs A7

1223064 V. Description of the invention (35) 3103d The conductive layer 3102 is divided to form a plurality of biosensors χ, χ, .. of the electrode 3 1 0 5, the counter electrode 3 1 0 6, and the detection electrode 3 1 0 7 state of the substrate. The production of the biosensor X using the sensor sheet P configured in this manner will be described below with reference to the drawings. First, a conductive layer 3102 is formed on the entire surface of a strip-shaped substrate 3101 by a sputtering method for forming a thin film. Next, as shown in FIG. 23, in the areas where the thin sheets Q are formed on each of the conductive 3 102s formed on the substrate 3101, lasers are used to form the gaps 3103a, 3103b, 3103c, and 3103d, and the conductive layer 3102 is divided into measurements. The electrode 3105, the counter electrode 3106, and the detection electrode 3107 are formed side by side to form a sensor sheet P. Then, the electrodes of a plurality of biosensors X made by this process are cut by a cutting line 3 1 10, and the electrodes of the biosensor X obtained after cutting are laminated with a reagent layer and a spacer. , Cover (not shown here), used to make each biosensor X. However, in the biosensor X manufactured in this manner, when the plurality of biosensors are cut into individual biosensors, there are cases where the biosensor X is not cut off at the cutting line 3 1 0, resulting in The problem of deviation of cutting line 3 1 1 0. This is explained further below. Fig. 24 (a) shows the state of the electrode when it is cut correctly, and Fig. 24 (b) shows the state of the electrode when the cut position deviates to the left of the cut line 3 1 10. Fig. 24 (c) shows the state of the electrode when the cutting position is shifted to the right of the cutting line 3110. The area of the measuring electrode 3 1 0 5 and the counter electrode 3 1 0 6 is determined according to the cutting position of each sheet Q. Therefore, as shown in the example shown in the figure, when the cutting position deviates from the cutting line 3 1 10 Measuring electrode -37- This paper size is applicable to China National Standard (CNS) A4 specification (210 x 297 mm) -------- Order --------- Line (Please read the note on the back first Please fill in this page for further information) Printed by the Employees 'Cooperative of the Intellectual Property Bureau of the Ministry of Economic Affairs Printed by the Employees' Cooperative of the Intellectual Property Bureau of the Ministry of Economic Affairs 1223064 A7 B7 36 V. Description of the invention () 3 1 05 and the area of the counter electrode 3 1 06 have changed Therefore, the resistance of each electrode changes. Therefore, the change in the resistance 値 of the electrode flow contains a problem that the accuracy of the biosensor X is changed. The biosensor C of the claims 13 and 14 of the scope of patent application of the present invention for the purpose of solving such a problem will be described below as a third embodiment. Fig. 5 is a plan view 'used to indicate a biosensor profile: the basis of C. A state where a gap is formed in the conductive layer provided on the surface of the sensor sheet R. FIG. 6 shows each sheet S of the biosensor C. Figure 7 is a perspective view showing the manufacturing process of the biosensor C. FIG. 8 is a plan view showing the state of the electrodes of the biosensor C. FIG. First, components of the biosensor C will be described. Reference numeral 41 is an insulating substrate, and is made of polyethylene terephthalate or the like. 42 is a conductive layer, which is formed on the entire surface of the substrate 41, and is made of, for example, a precious metal such as gold or palladium or a conductive material such as carbon. 43a, 43b, 43c, and 4 3 d are the first slits and are provided in the conductive layer 4 2. 4 5, 4 6, 4 7 are the electrodes through the first slits 4 3 a, 4 3 b, 4 3 c, 4 3 d is formed by dividing the conductive layer 4 2 into a measurement electrode, a counter electrode, and a detection electrode for confirming whether or not the sample is attracted to the inside of the sample supply path. 50 is a cutting line used to indicate the cutting position of the substrate. 44a and 44b are third slits, which are used to define the area of the electrodes. Reference numeral 48 is a lid covering the measurement electrode 45, the counter electrode 46, and the detection electrode 47. The 49 is a rectangular cutout portion and is provided in the center of the front edge portion of the spacer 48 to form a sample supply path. 51 1 is the reagent layer, which is formed on the measurement electrode 45, the counter electrode 46, and the detection electrode -38- This paper size applies the Chinese National Standard (CNS) A4 specification (210 X 297 mm) (Please read the back Note 咅? Please fill in this page again) -------- Order --------- line 1223064 Printed by the Consumers' Cooperative of Intellectual Property Bureau of the Ministry of Economic Affairs A7 B7_____ V. Description of Invention (37) 47 Test drug containing enzymes. 52 is a lid covering the spacer 48. 53 is an air hole provided in the center of the cover 52. In addition, the sensor sheet R forms a conductive layer 4 2 on the substrate 41, and uses the first slits 4 3 a, 4 3 b, 43 c, 43 d and the third slits 44 a, 44 b to form a plurality of biological layers, respectively. The substrate of the state of the electrode of the sensor, the measurement electrode 45, the counter electrode 46, and the detection electrode 47. In addition, each sheet S is the state of each of the biosensors of the sensor sheet R. The manufacturing method of the biosensor C will be described below in an engineering sequence. First, a conductive layer 42 is formed on the entire surface of the band substrate 41 by a sputtering method using a precious metal film such as gold or palladium. Next, as shown in FIG. 5, lasers are used to form the first gaps 4 3 a, 4 3 b, 4 3 c in each of the regions S of the conductive layer 42 formed on the substrate 41. 4 3 d, the conductive layer 42 is divided into measurement electrodes 45. Counter electrode 4 6 and detection electrode 4 7. Then, a third slit 44a is formed on the right side of the first slit 4 3 a, and a third slit 44b is formed on the left side of the first slit 43b, parallel to the long sides of the biosensors after cutting. The area of the counter electrode 46 is a predetermined area, and is formed using a laser to form a plurality of sheets S. Fig. 6 (a) shows a plan view of each sheet S, and Fig. 6 (b) shows a front view of each sheet S. In addition, in order to form the conductive layer 42 having the first slits 43a, 43b, 43c, 43d and the third slits 44a, 44b, a printing plate or a mask plate in which necessary patterns are arranged in advance may be used. The lithography method or the sputtering method is used to form a first gap 43 a, 43b, 43c, 43d and a third gap 44a, 44b on the substrate 41 by forming a conductive layer 42 on the substrate 41. It can also be used with a sharp -39- ^ paper size. China National Standard (CNS) A4 Specification (210 X 297 mm) One --------------------- Order --------- Line 1 ^ (Please read the precautions on the back before filling out this page) Printed by the Consumers' Cooperative of the Intellectual Property Bureau of the Ministry of Economic Affairs I223〇64 A7 -____ B7_______ Worker 3 8 IX. Description of the invention Part of it. Next, as shown in FIG. 7, in the case of each thin sheet S, for example, in the case of a blood glucose sensor, a reagent consisting of a blood glucose oxidase that becomes an enzyme and potassium ferricyanide as an electron carrier is applied. It is arranged on the measuring electrode 45, the counter electrode 46, and the detection electrode 47 as the electrodes to form a reagent layer 51. Second, the measurement electrode 45, the counter electrode 46, and the detection electrode 47 are electrodes. A spacer 48 is provided thereon, and a notch portion 49 is provided to form a specimen supply path. Next, a cover 52 is provided on the spacer 48. One end of the notch portion 49 of the spacer 48 opens to an air hole 53 provided in the cover 52. Alternatively, the spacers 48 may be formed on the electrodes of the measurement electrode 45, the counter electrode 46, and the detection electrode 47. The test electrode 45, the counter electrode 46, and the detection electrode 47 are exposed from the cutout portions 49 by applying a reagent to form a reagent layer 51. Next, the tape cutting line 50 cuts a plurality of biosensors made by the above-mentioned process, and is used to make each biosensor. Fig. 8 (a) shows the state of the electrode when the cutting position deviates to the left of the cutting line 50, and Fig. 8 (b) shows the state when the cutting position deviates to the right of the cutting line 50 Of the electrode. Regardless of the deviation to the right or left, the first slot and the third slot are all used to specify the area of the measuring electrode 45 and the counter electrode 46. Therefore, if the third slot 44a and 44b of the adjacent biosensor is When it is cut off, the area of the electrode 45 and the counter electrode 46 is measured as shown in FIG. 8, and it is cut at the cutting line 50 as shown in FIG. 6 (a). (CNS) A4 specification (210 X 297 mm) -------------------- Order --------- line (Please read the note on the back first Please fill in this page again for details) l223〇64 The area of the electrode is the same when the A7 B7 is printed by the Consumer Cooperative of the Intellectual Property Bureau of the Ministry of Economic Affairs. In addition, since the correlation between the area of the measurement electrode 45 and the response during measurement of the specimen is large, the area of the measurement electrode 45 can be specified only by the third slot 44a without the third slot 44b '. When measuring a specimen, blood as a specimen liquid is supplied to a specimen supply path formed by the notch portion 49 of the spacer 48, and a certain amount of specimen is attracted to the specimen by a capillary phenomenon using the air hole 53. Inside the body supply path, it reaches the counter electrode 46, the measurement electrode 45, and the detection electrode 47. The reagent layer formed on the electrode dissolves in the blood of the specimen, and a redox reaction occurs between the reagent and a specific component in the specimen. Among them, if the inside of the specimen supply path is filled with the correct specimen, an electrical change occurs between the counter electrode 46 and the detection electrode 47. In this way, it is confirmed that the specimen is attracted to the detection electrode 47. In addition, since electrical changes also occur between the measurement electrode 45 and the detection electrode 47, it is also possible to confirm that the specimen is attracted to the detection electrode 47 by this method. After the specimen is attracted to the detection electrode 47, after a certain period of time, the reaction between the specimen and the reagent is promoted, and a certain voltage is applied to the measurement electrode 45 and the counter electrode 46 or both the counter electrode 46 and the detection electrode 47. . For example, in a blood glucose sensor, a current that is proportional to the blood glucose concentration can be used to determine the blood glucose. In addition, in the third embodiment, the above is an example of the case of a blood glucose sensor, but by changing the components and samples of the reagent layer 51, it is also possible to use a biological sensor other than a blood glucose sensor. Device. In addition, the one described in this embodiment 3 is a biosensor with three electrodes, but even at -41- this paper size applies the Chinese National Standard (CNS) A4 specification (210 X 297 mm) --- -------- ^ -------- Order --------- (Please read the notes on the back before filling this page) 1223064 A7 V. Description of the invention (Number of electrodes For cases other than three, the third gap can also be used to specify the area of the electrode. In addition, the area of the measuring electrode that at least greatly affects the measurement accuracy can also be defined by the third gap. In addition, the third The position of the slit is not limited to the position as long as the area of the electrode can be specified. In addition, the shape of the biosensor may be a shape other than the shape of the biosensor of the third embodiment, or a third slit may be used. Specify the area of the electrodes. In the biosensor of this embodiment 3 in this way, since the area of each electrode is specified by two third gaps parallel to the long side of the biosensor, the area of each electrode is determined in advance by The third gap stipulates that each electrode will not It has the effect that the accuracy does not change. In addition, it has: the reagent layer is formed of a reagent that reacts with the sample liquid; the spacer has a notch to form the sample liquid to be supplied to The sample supply path of the electrode; and the cover are arranged on the spacer and have an air hole communicating with the sample supply path; therefore, there is an effect that the sample liquid can be easily attracted to the sample supply path. The conductive layer is formed on the entire surface of the insulating substrate and is divided into a plurality of electrodes by the first slit, so it can be made into a highly accurate electrode, which has the effect of improving the accuracy of the measurement. In addition, because the first slit is formed by a laser And the third gap, so that high-precision processing can be performed, and the area of each electrode can be specified with high accuracy. In addition, because the interval between each electrode is narrowed, it has the effect of miniaturizing the biosensor. Example 4) -42- Private paper size applies to China National Standard (CNS) A4 (210 X 297 public love) (Please read the precautions on the back before filling in this Page) Order -------- Line j Printed by the Employees 'Cooperatives of the Intellectual Property Bureau of the Ministry of Economic Affairs Printed by the Employees' Cooperatives of the Intellectual Property Bureau of the Ministry of Economic Affairs 1223064 A7 B7 V. Description of the Invention (41) The application of the present invention will be explained below The biosensor D of the patent scope Nos. 15 and 6 is used as the fourth embodiment. Fig. 9 shows the manufacturing process of the oblique view of the biosensor D. Fig. 10 is a plan view for showing Example of the formation of the fourth slit of the biosensor D. Figure 22 shows the state where the biosensor D is inserted into the measuring device. First, the constituent members of the biosensor D will be described. Reference numeral 61 is an insulating substrate, and It is composed of ethylene terephthalate, etc. 62 is a conductive layer formed on the entire surface of the substrate 61, and is formed of a conductive material such as a precious metal such as gold or IG or carbon. 63a, 63b, 63c, and 63d are the first slits and are provided in the conductive layer 62. 65, 66, and 67 are electrodes formed by dividing the conductive layer 62 by the first slits 63a, 63b, 63c, and 63d, and become measurement electrodes ^ A counter electrode, and a detection electrode for confirming whether the sample is surely attracted to the inside of the sample supply path. 64a, 64b, and 64c are the fourth slits for dividing the counter electrode 66, the sample electrode 67, and the measurement electrode 65. 68 is a spacer covering the measurement electrode 65, the counter electrode 66, and the detection electrode 67. 69 is a rectangular shape. The notch portion is provided in the center of the front edge portion of the spacer 68 to form a specimen supply path. Reference numeral 54 is a reagent layer, which is formed by dripping a reagent containing an enzyme, and coating it on the measurement electrode 25, the counter electrode 26, and the detection electrode 27. A reference numeral 5 5 is a cover covering the spacer 6 8. A reference numeral 56 is an air hole and is provided at a center portion of the cover 55. 5 8, 5 9 and 57 are correction sections. The measurement electrode 65, the counter electrode 66, and the detection electrode 67 are the terminations of the respective electrodes. 71, 72, and 73 are measurement portions, which are located on the periphery of the cover 55 of the measurement electrode 65, the counter electrode 66, and the detection electrode 66, respectively, and the portions of the cover 55 exposed from the cover 55. D is a biosensor. 41 1 5 is loaded -43- This paper size applies Chinese National Standard (CNS) A4 (210 X 297 mm) -------------------- Order --------- Line-1 ^ (Please read the notes on the back before filling out this page) Printed by the Consumer Cooperatives of the Intellectual Property Bureau of the Ministry of Economic Affairs 1223064 A7 B7 42 V. Description of Invention () Biosensor Tester for device D. 4 11 6 is the insertion port of the measuring device 4 1 1 5 for the biosensor D to be inserted. 4 1 1 7 is the display part of the measuring device 4 1 15 for displaying the measurement result. As shown in FIG. 9 (a), a conductive layer 62 of a precious metal thin film such as gold or palladium is formed by a sputtering method of forming a thin film on the entire surface of the substrate 61. In addition, the conductive layer 62 may not be formed on the entire surface of the substrate 61, but may be formed only on a necessary portion for forming an electrode. Next, as shown in FIG. 9 (b), a laser is used to form a first gap 63a, 63b, 6 3c, 63d in the conductive layer 62, which is used to divide the conductive layer 62 into a measurement electrode 65, a counter electrode 66 and a detection Electrode 67. Then, a fourth slit 64a, 64b, and 64c is formed on the measurement electrode 65 by the laser, and the electrodes of the counter electrode 66 and the detection electrode 67 are formed. Here, the fourth slits 64a, 64b, and 64c are used to divide all the measuring electrodes 65, the counter electrode 66, and the detection electrode 67, but the method of setting the fourth slits 64a, 64b, and 64c can also be used as shown in Figure 10 8 combinations shown. Figure 10 (a) shows the case where the fourth slot is not provided. Fig. 10 (b) shows a case where the fourth slit 64a is provided only on the counter electrode 66. Fig. 10 (c) shows a case where the fourth slit 64b is provided only in the detection electrode 67. Fig. 10 (d) shows a case where the fourth slit 64c is provided only in the measurement electrode 65. Fig. 10 (e) shows a case where the fourth slits 64a and 64b are provided in the electrode 66 and the detection electrode 67. Fig. 10 (f) shows a case where the fourth slits 64c and 64a are provided in the measurement electrode 65 and the counter electrode 66. Fig. 10 (g) shows the case where the fourth slits 6 4 c and 6 4 b are provided in the measurement electrode 65 and the detection electrode 67. Fig. 10 (h) shows the measurement electrode 65, the counter electrode 6 6 and the detection. All electrodes 6 and 7 are provided with a fourth gap -44- ^ The paper size applies the Chinese National Standard (CNS) A4 (210 X 297 mm) (Please read the precautions on the back before filling this page)

Printed by the Consumer Cooperatives of the Intellectual Property Bureau of the Ministry of Economic Affairs 1223064 A7 B7 _ 43 V. Description of the invention () 6 4 c, 6 4 a and 6 4 b. Using the combination of the fourth slits 6 4 a, 6 4 b, and 6 4 c, the information of the correction data can be discriminated at the tester 4115 to correct the difference in the output characteristics of each manufacturing batch. For example, in the case where the fourth slot is not provided in FIG. 10 (a), it becomes a biosensor with output characteristics of the manufacturing lot number "1". In addition, only the When the fourth slit is provided to the electrode 66, it becomes a biosensor having the output characteristics of the manufacturing lot number "2". In addition, it is also possible to use a printing plate or a mask plate (configured in advance to form a pattern necessary for conducting 62 with the first slits 63a, 63b, 63c, 63d and the fourth slits 64a, 64b, 64c), etc. The electrodes or the first slits 63a, 63b, 63c, 63d and the fourth slits 64a, 64b, 64c are formed on the substrate 61 by the lithography method or the sputtering method, and the conductive layer can be removed by using a sharp-pointed fixture or the like. Part of 62. In addition, the fourth slits 64a, 64b, and 64c can also be used to check the formation of the output characteristics after the biosensor 164 is completed. In this way, the selection of each manufacturing batch can be reliably performed. Next, as shown in FIG. 9 (c), for example, in the case of a blood glucose sensor, a reagent consisting of a blood glucose oxidase that becomes an enzyme and potassium ferricyanide as an electron transmitter is dropped to The measurement electrode 65, the counter electrode 66, and the detection electrode 67 are used for coating. Next, a spacer 68 is provided above the electrodes of the measurement electrode 65, the counter electrode 66, and the detection electrode 67, and a notch 69 is provided to form a sample supply path. -45- This paper size is in accordance with China National Standard (CNS) A4 (210 X 297 mm) (Please read the notes on the back before filling this page) T > _i ^ i etm emmt i ^ ii ^ i I 1 ^ am ammKm in 1_1 tMMm mmmmma I Mouth 1223064 A7 B7 V. Description of the invention () Secondly, a cover 55 is provided on the spacer 68 ◦ One end of the notch 69 of the spacer 68 leads to the air hole 56 provided on the cover 55 ◦ (Please read the precautions on the back before filling in this page.) Alternatively, spacers 68 can be formed on the electrodes of measurement electrode 65, counter electrode 66, and detection electrode 67, and the reagent can be dropped onto measurement electrode 65 and counter electrode. 6 6 and a portion of the detection electrode 67 exposed from the notched portion 6 9 are used to form a reagent layer 54. Printed by the Consumer Cooperative of the Intellectual Property Bureau of the Ministry of Economic Affairs. In the case of a biosensor specimen, first, the biosensor D is inserted into the insertion port 411 6 of the measuring device 4115 as shown in FIG. 22. When blood, which is the sample liquid of the specimen, is supplied to the entrance of the specimen supply path, a certain amount of specimen is sucked into the inside of the specimen supply path by a capillary phenomenon using the air holes 56, so that it reaches the counter electrode 66, The measurement electrode 65 and the detection electrode 67 are provided. The reagent layer 54 formed on the electrode is dissolved in the blood of the specimen, and a redox reaction occurs between the reagent and a specific component in the specimen. If the specimen is correctly inside the specimen supply path, an electrical change occurs between the counter electrode 66 and the detection electrode. In this way, it is confirmed that the specimen is attracted to the detection electrode 67. In addition, since electrical changes also occur between the measurement electrode 65 and the detection electrode 67, it can also be used to confirm that the sample is attracted to the detection electrode. After the specimen is attracted to the detection electrode 67, after a certain period of time, the reaction between the specimen and the reagent is promoted, and then applied to both the measurement electrode 65 and the counter electrode 6 6 or the counter electrode 6 6 and the detection electrode 67. A certain voltage. If it is a blood glucose sensor, a current that is proportional to the blood glucose concentration is generated, and the measurement is performed by the measuring device 4 1 15. The measurement sections 71, 72, and 73 are used to sense the electrical changes of the measurement electrodes 65, counter electrodes 66, and detection electrodes 67 above the sensor. _46_ ^ The paper size applies the Chinese National Standard (CNS) A4 specification (210 X 297 mm) " ~ 丄 223064 A7 '----- B7______ 5. Description of the invention (45) In addition, the tester 4 1 1 5 inspects biological Whether the measurement electrode 6 5 ′ counter electrode 66 and the detection electrode 67 of each electrode of the sensor D are divided by the fourth slits 64c, 64a, and 64b. For example, if the conduction between the measurement section 7 and the correction section 57 is checked, it can be known whether the fourth slit 64C is formed. Similarly, if the electrical continuity between the measurement and determination unit 72 and the correction unit 58 is detected, it can be known whether the fourth gap 64a is formed, and if the electrical continuity between the measurement and measurement unit 73 and the correction unit 59 can be known Whether the fourth slit 6 4 b is formed. For example, if the fourth gap is not formed on any of the electrodes, the biosensor will be manufactured with the batch number "1". Since it is in the state shown in Fig. 10 (a), the measuring device 4115 uses and stores it in advance. The calibration data corresponding to the output characteristics of the manufacturing lot number "1" and the measured current 値 are used to obtain the blood glucose 値, and the blood glucose 値 is displayed on the display portion 4 1 1 7. Similarly, if only the fourth gap 64a is formed on the counter electrode 66, the correction data corresponding to the output characteristics of the manufacturing lot "2" and the measured current 値 are used to obtain the blood glucose 値, and the blood glucose is obtained.値 is displayed on the display unit 4117. In addition, in the fourth embodiment, the blood glucose sensor is taken as an example, but by changing the composition and sample of the reagent layer 54, it can also be used as a biosensor other than the blood glucose sensor. For example, It can be used in a lactic acid sensor or a cholesterol sensor. In this case, the tester can use the position of the fourth gap to judge the information of the correction data corresponding to the output characteristics of the lactic acid sensor or the cholesterol sensor. The tester 4 1 1 5 uses the memorized and lactic acid sensor in advance. The calibration data and current corresponding to the output characteristics of the sensor or cholesterol sensor are obtained, and the measurement is obtained and displayed on the display section 4 1 1 7. -47- This paper size is applicable to Chinese National Standard (CNS) A4 (210 X 297 mm) (Please read the precautions on the back before filling this page) -------- Order ------ --- Printed by the Consumer Cooperative of the Intellectual Property Bureau of the Ministry of Economic Affairs 1223064 A7 _ B7 Printed by the Consumer Cooperative of the Intellectual Property Bureau of the Ministry of Economic Affairs 46 Number of biosensors, but the number of electrodes can be other than that. In addition, the fourth slot may be provided with multiple electrodes. In this way, in the biosensor D of the fourth embodiment, it can be discriminated that the fourth gap dividing each electrode is formed on which electrode and which biosensor is manufactured in batches. The sensor is inserted into the measuring device, and the measuring device can determine which calibration data is needed, so the user does not need to use a calibration chip or the like to input calibration data, which has the effect of not being complicated and preventing operation errors. In addition, the reagent layer includes: a reagent layer formed of a reagent that reacts with the sample liquid; a spacer having a cutout portion for forming a sample supply path to supply the sample liquid to the electrode; and a cover disposed on the electrode. The spacer has an air hole leading to the sample supply path; therefore, it has the effect that the sample liquid can be easily attracted to the sample supply path. In addition, since the conductivity is formed on the entire surface of the insulator substrate and is divided into a plurality of electrodes by the first gap, it can be used to produce a highly accurate electrode, which has the effect of improving the measurement accuracy. In addition, because the first slit and the fourth slit are formed by a laser, high-precision processing can be performed, and the area of each electrode can be specified with high accuracy. In addition, because the interval between each electrode can be narrowed, a biosensor is provided. Can be miniaturized. In addition, among the biosensors A, B, C, and D of the first to fourth embodiments described so far, as shown in items 16 to 18 of the scope of patent application of the present invention, it is best to use The laser processes the gaps provided in the conductive layer. In addition, the width of each gap is 0.005mm ~ 0.3mm, and each -48- This paper size applies the Chinese National Standard (CNS) A4 (210 X 297 mm) ) (Please read the precautions on the back before filling out this page) ¾ Order: "Line · Printed by the Consumer Cooperatives of the Intellectual Property Bureau of the Ministry of Economic Affairs 1223064 A7 __B7 47 V. Description of the invention () The coating of the gap is greater than the thickness of the conductive layer In addition, 'As shown in items 19 to 21 of the scope of patent application of the present invention, the reagent layer of the biosensor A' B 'C, D preferably contains an enzyme, an electronic transmitter, or water-soluble In addition, as shown in item 22 of the scope of patent application of the present invention, the insulating substrate used in the biosensor A'B'C'D is preferably made of a resin material. (Embodiment 5) Next, References are made to illustrate the scope of patent application of the present invention from 23 to The method for forming a thin film electrode of item 35 is the fifth embodiment. In addition, if the method for forming the thin film electrode described in this embodiment 5 is applied to the above-mentioned biosensor A of the first to fourth embodiments, When the electrode parts of B, C, and D are formed, the biosensor of item 36 of the patent application scope of the present invention can be obtained. Figure Π is a schematic diagram of the biosensor, which is used to show the implementation of this embodiment. The thin-film electrode formed by the method of forming the thin-film electrode, and the state where the reaction reagent layer is unfolded. The biggest difference between the structure of the biosensor and the conventional biosensor shown in FIG. 25 is the convergence. The surface of the insulating resin substrate 81 such as ethylene terephthalate or polycarbonate is roughened to improve the substrate 81 and the electrode layer 82, and the electrode layer 82 and the reaction reagent layer 83. In addition, the material constituting the electrode layer 82 is a single material composed of noble metal or carbon, and the thickness of the electrode layer 82 is controlled to be 3 to 100 nm, which is different. The surface of the substrate 81 will be described below. Specific methods of roughening -49- This paper size applies to China National Standard (CNS) A4 (210 X 297 mm) ·） n βϋ n 1 ϋ «ϋ n · ϋ · 1_1 ϋ ϋ mmm§ Mmm9 am— J, I ml amtm II 1 I ϋ I —Bi ϋ ϋ 1 · ϋ ί · 1 n ϋ 1 11 I ϋ -ϋ_1 ι i: 口 ^ (Please read the note on the back? Matters before filling out this page) Staff Consumption of Intellectual Property Bureau of the Ministry of Economic Affairs Printed by the cooperative 1223064 A7 _______B7___ 5. Description of the invention (48) In addition, the material of the substrate 8 1 is best to use polyethylene terephthalate, polycarbonate, polybutylene terephthalate, polyamine , Polyvinyl chloride, polyvinyl chloride fork, polyimide, nylon, etc. First set the substrate 8 1 in a vacuum tank, and evacuate to a certain vacuum degree (can be in the range of lx 10'1 ~ 3x 1 (the range of T3 Baska). Then fill the vacuum tank with an inert gas (charge The degree of vacuum after that is in the range of 0.1 to 10 Baska). When a high-frequency voltage of about 0.01 to 54 kV is applied, the inert gas is excited to ionize and collide on the surface of the substrate 81. The ion With high motion energy, a sufficient surface roughening effect can be obtained by applying high-frequency voltage for a short time (about 0.1 to 10 seconds). In addition, in addition to high-frequency voltage, DC voltage can also be applied to obtain the same effect. Surface roughening effect. In addition to this inert gas, nitrogen can be used in addition to argon, neon, helium, krypton, and gas. In addition, when an active (reactive) gas represented by oxygen is used, the substrate can also be used. The surface of 81 is roughened, but in this case, an oxide film is formed on the surface of the substrate 81, and as a result, the electrode characteristics and the sensing response are adversely affected, so it is not good. Too thick The method of forming a thin-film electrode layer made of a conductive material on the surface of the substrate 81, which is chemically treated. In the same manner as the surface roughening treatment of the substrate 81, vacuum exhaust to a certain degree of vacuum (can be at lx 10 · 1 ~ 3x 10_3 Baska range). Then the vacuum tank is filled with an inert gas (the vacuum degree after filling is in the range of 0.1 ~ 10 Baska level) ◦ by applying 0. 0 1 ~ A high-frequency voltage of about 5 kV is used to excite the inert gas to ionize it. The ionic -50- ^ paper size applies to China National Standard (CNS) A4 (210 X 297 mm) " " ---- ---------------- Order --------- line (please read the precautions on the back before filling this page) 1223064 Printed by the Consumer Cooperatives of the Intellectual Property Bureau of the Ministry of Economic Affairs Manufacturing A7 B7 49 V. Description of the invention () The converted gas collides with a target plate made of conductive material, which is used to release the atoms of the conductive substance, and the atoms are formed into a film on the substrate 1 to form a thin-film electrode layer. After the vacuum evacuation, the conductive substance can be heated to evaporate to form a film on the substrate. 8 1 is used to form a thin-film electrode layer. The representative method of the former is sputtering and evaporation, and the representative of the latter is vacuum evaporation. Among them, palladium and platinum 'gold can be used as the conductive material for forming the target plate. Precious metals such as ruthenium or carbon, and the use of such monomer materials as electrode raw materials are not easily affected by manufacturing conditions, and a large number of stable electrodes with small differences between batches can be manufactured. In addition, the rough surface of the substrate surface The chemical treatment process and the formation process of the thin-film electrode can be discontinuously performed in separate spaces, but as shown in FIG. 12, the process of roughening the surface of the substrate 81 and the process for continuously roughing the same surface can also be performed in the same space. The process of forming a thin-film electrode can be used to reduce manufacturing man-hours and increase production capacity to increase production efficiency, thereby achieving cost reduction of the biosensor. In addition, FIG. 12 is a schematic structural diagram for illustrating the manufacturing process of the thin-film electrode of Embodiment 5. Reference numeral 84 in the figure is a vacuum tank, 85 is a substrate sending roller, 86 is a substrate winding roller, and 87 is Electrodes for roughening, 88 is a cooling roller, 89 is a cathode / target, and 90 is a gas inlet. According to this method, when two projects are continuously performed in the same space, vacuum evaporation may be difficult, but high-frequency sputtering evaporation, offset sputtering evaporation, asymmetric AC sputtering evaporation, and Ion plating and the like are effective. -51- This paper size is applicable to China National Standard (CNS) A4 (210 X 297 mm) ------------ || ^ 尚 -------- Order --- ------_ (Please read the note on the back? Matters before filling this page) 1223064 A7 B7 ____ V. Description of the invention (M) (Please read the notes on the back before filling this page) In addition, the electrode layer There is no limitation on the thickness. When it is thinned, the manufacturing cost can be reduced. It can directly reflect the rough surface of the substrate as the rough surface of the electrode layer. It can greatly improve the electrode layer 8 2 and the reaction reagent layer 8 3 (by enzyme or The effect of the adhesion of electronic communication bodies. In order to reflect the rough surface of the surface of the substrate 81 as the rough surface of the electrode layer, the thickness of the electrode layer needs to be less than 100 nm. In addition, when a high-performance thin-film electrode and a biosensor are to be provided, the electrode layer The thickness is preferably 3 to 50 nm. The method for forming the thin film electrode of the fifth embodiment described above will be described below with reference to specific experimental examples. A high-frequency voltage having a frequency of Π. 56 MHz and an output of 100 W was applied to an insulating substrate 81 made of polyethylene terephthalate. After a certain period of time, the surface was roughened, and On the roughened substrate, palladium having a thickness of about 10 mm was formed under the same conditions to form a noble metal thin film electrode. Printed by the Consumer Cooperative of the Intellectual Property Bureau of the Ministry of Economic Affairs. Figure 18 shows that the application time of the high-frequency voltage is 0 to 60 seconds (0 seconds indicates that the roughening process is not applied). The change in the wet index (surface tension) and the adhesion between the electrode layer and the substrate. The figure shows that roughening the substrate surface by applying it for more than 5 seconds can improve the surface wettability and improve the adhesion between the electrode layer and the substrate. Sex. In addition, this embodiment is a result of a high-frequency voltage of 10 W. By increasing the high-frequency voltage, the processing time can be further shortened. The evaluation of adhesion is based on JIS 5600-5-10 (general test method for coatings: mechanical properties of coating film: abrasion resistance). The number of adhesion in the figure indicates the palladium film. Destroyed until the surface of the substrate is exposed -52- The size of this paper applies to Chinese National Standard (CNS) A4 (210 X 297 mm) 1223064 A7 B7 V. Description of the invention (51) The number of strokes in the state of reciprocation, the larger the number The higher the adhesion. In addition, "% 19" shows the relationship between the thickness of iG and 0% and the wet index (surface tension) of the electrode substrate. In addition, the roughening treatment conditions of the substrate surface are a high-frequency voltage of 100W and an application time of 5 seconds. In addition, the thickness of the palladium layer used can be arbitrarily adjusted in the range of 5 to 1 000 nm. When the thickness of the palladium layer is in the range of 3 to 50 nm, the wettability index of the substrate surface after the roughening treatment is maintained at 5 4 dyn / cm, and when it exceeds 100 nm, the wettability index is reduced to 48dy n / cm, then its number 値 becomes stable. That is, when the thickness is less than 100 nm, the rough surface of the substrate surface reflects the rough surface of the electrode. When it exceeds 100 nm, the wettability of the electrode material itself (palladium in the case of the embodiment) is reflected. Next, on the thin film electrode with a thickness of 1 Onm in the palladium layer formed under the above conditions, a reaction reagent layer (containing carboxymethyl cellulose containing a water-soluble polymer, a blood glucose oxidase (GOD) that acts as an enzyme, and The electronic transmitter is potassium ferricyanide), and it is used to make a biosensor for measuring blood glucose level as shown in Fig. 1 with the spacer and the lid expanded. Figure 20 is a comparison of the sensitivity of a sensor with a blood glucose concentration of 40 to 600 mg / dl. The so-called sensor sensitivity here means that after the blood is drawn into the capillary, the reaction between the test reagent and the blood glucose in the blood is promoted for about 25 seconds, and a certain voltage is applied between the working electrode and the opposite electrode. The current obtained after 5 seconds 値. In addition, in the conventional sensor and the sensor of this embodiment, because the electrode materials are different, the applied voltage is 0.5V in the conventional carbon paste electrode and 0.2V in the palladium film electrode in this embodiment. In addition, the fixed number is η = 10 in each concentration region. Figure 20 -53- This paper size is applicable to China National Standard (CNS) A4 (210 X 297 public love) (Please read the precautions on the back before filling this page)

Order ------- I--Line | Printed by the Employees 'Cooperatives of the Intellectual Property Bureau of the Ministry of Economic Affairs Printed by the Employees' Cooperatives of the Intellectual Property Bureau of the Ministry of Economic Affairs 1223064 A7 B7 V. Description of the invention (52) It can be understood that the The sensitivity of the sensor of the present embodiment to which honing treatment or heat treatment is applied is equal to or more than that of a sensor 'that is conventionally required to apply honing treatment or heat treatment to improve the sensitivity of the sensor. The accuracy (cv 使) of 10 repeated measurements in (Table 1) is compared. According to the results shown in the table, it can be confirmed that the conventional sensor significantly deteriorates CV 値 due to changes in honing processing, etc., and In contrast, the sensor of this embodiment has excellent accuracy in which the variation of each sensor is reduced. (Table 1) Example of a blood glucose concentration sensor Sensor 40mg / d 1 15. 25% 3. 89% 8 2mg / d 1 6.15% 2. .87% 165mg / dl 3. 89% 2.43% 248mg / d 1 3.24% 1.80% 48 5mg / d 1 3.79% 2.16% 600mg / d 1 3.28% 1.65% (Example 6) The film of Example 5 using the above description will be described below The electrode forming method is used to form the biosensors A, B, C, and D. The quantification method according to item 38 of the present patent application scope of the present invention for quantifying a substrate using the biosensor, and the patent scope of the present invention The quantitative device of item 41. In addition, the biosensor used in the following description is the one using the biosensor A of the first embodiment, but it is not limited to using the biosensor. Fig. 13 shows the structure of the biosensor and quantitative device using the quantitative method with biosensor. In this figure, it is the same as the first figure. -54- This paper size applies to China National Standard (CNS) A4 (210 X 297 mm) (Please read the precautions on the back before filling this page)

Printed by the Consumer Cooperatives of the Intellectual Property Bureau of the Ministry of Economic Affairs 1223064 A7 _____ B7. 53 V. The description of the invention () The symbol is used to indicate the same or equivalent part. The biosensor A is used in a state of being connected to the quantitative device M 丨, and the content of the matrix of the sample supplied to the biosensor a is measured by the quantitative device M1. In the quantitative device M1, the symbols 115a, 115b, and 115c are connectors, which are respectively connected to the measurement electrode 5, the detection electrode 7, and the counter electrode 6 ′ 11 6a of the biosensor A, and are provided on the connector. 5 c and ground (the meaning of constant potential may not necessarily be "φ", the same in the following description), Π 8a is a current / voltage conversion circuit, which is used to connect the measuring electrode 6 and other electrodes The current flowing between them is converted into voltage and output. 11 9 a is an A / D conversion circuit. It is connected to the current / voltage conversion circuit 1 1 8 a and is used to convert the voltage from the current / voltage conversion circuit 1 1 8 a. Converted into a pulse wave, 120 is the CPU, which is used to control the ON / OFF of the switch 1 1 6a. Based on the pulse wave from the A / D conversion circuit 1 1 9 a, it is used to calculate the content of the matrix of the specimen. 121 is An LCD (Liquid Crystal Display) is used to display the measurement value calculated by the CPU 20. The operation of the biosensor A and the quantification device M1 when the content of the matrix of the specimen is measured by the quantitative method using the biosensor in Example 6 of the present invention will be described below. First, when the biosensor A is connected to the connectors 1 1 5 a to 1 1 5 c of the quantitative device M1, the switch 1 1 6 a is turned OFF by the control of the CPU 1 20, and the counter electrode 6 and the ground wire are switched off. There is no connection between them, and a certain voltage is applied between the measurement electrode 5 and the detection electrode 7. The current generated between the measurement electrode 5 and the detection electrode 7 is converted into a voltage by a current / voltage conversion circuit 1 1 8 a, and then the voltage is converted into -55 by an A / D conversion circuit USa. This paper is applicable to China Standard (CNS) A4 specification (210 X 297 mm) -------------------- ^ --------- Cord (Please read the Note: Please fill in this page again) 1223064 A7 ___B7___ 54 5. Description of the invention () is a pulse wave, which is output to the CPU 1 20. (Please read the precautions on the back before filling this page.) Second, when the specimen is supplied to the entrance 9a of the specimen supply path of the biosensor A, the specimen is attracted to the inside of the specimen supply path and passed through the counter electrode. 6. On the measuring electrode 5, reach the detecting electrode 7. At this time, the reagent layer 12 is dissolved to generate redox, and an electrical change occurs between the measurement electrode 5 and the detection electrode 7. The CPU 1 20 generates an electrical change between the measurement electrode 5 and the detection electrode 7 in accordance with a change in the pulse wave input from the A / D conversion circuit 1 1 9 a, that is, when a specimen of the biosensor A is detected. When a measurable specimen is supplied to the supply path, a quantitative operation is started. Next, the CPU 120 turns on the switch 116a to ground the counter electrode 6, and controls the current / voltage conversion circuit 1 1 8 a at a certain time thereafter to form a reagent layer on the electrode portion without supplying a voltage. 1 1 2 react with the specimen. About 5 seconds after a certain time has elapsed, a certain voltage is applied between the measurement electrode 5 and the counter electrode 6 and the detection electrode 7 by the current / voltage conversion circuit 1 1 8a. Printed by the Consumer Cooperative of the Intellectual Property Bureau of the Ministry of Economic Affairs. At this time, between the measurement electrode 5 and the counter electrode 6 and the detection electrode 7, a current proportional to the matrix concentration in the sample is generated. This current is converted into a voltage by the current / voltage conversion circuit 18a, and this voltage 变换 is converted into a pulse wave by the A / D conversion circuit 119a, and is output to the CPU 120. The CPU 120 counts its pulse wave number to calculate the response 値, and displays the result on the LCD 121. In addition, here, the detection electrode 6 is always grounded, but a quantitative device M2 as shown in FIG. 14 can also be configured. A switch 116b is provided between the detection electrode 7 and the ground wire to control the detection electrode 7 and the ground. ON / OFF between lines. When the connector 115a ~ 115c of the quantitative device M constructed in this way is connected to -56-, this paper size applies the Chinese National Standard (CNS) A4 specification (210 X 297 mm): 1223064 A7 B7 V. Description of the invention (55) When the biosensor A is connected, the switch 1 1 6a is turned off by the control of the CPU 1 20, the connection between the counter electrode 6 and the ground wire is turned off, the switch 1 1 6b is turned on, and the measurement electrode 5 and the detection electrode 7 are turned on. Apply a certain voltage between them. Then, after the start of aspiration of the specimen with the biosensor A, and before the quantitative device M2 completes the quantitative operation, the switch Π 6b is ON, and the quantitative operation is the same as that of the aforementioned quantitative device M1. The area of each electrode of a preferred biosensor for measuring the content of the matrix of the sample liquid will be described below. Fig. 15 is an enlarged view of a sample supply path of the biosensor A according to the first embodiment of the present invention. The area of the counter electrode 6 in the sample supply path of the biosensor A, the measurement electrode 5 and the detection electrode 7 are in order to prevent the rate of electron transfer reaction between the electrodes, so it is preferable to make the area of the counter electrode 6 equal to or It is larger than the area of the measuring electrode 5. In addition, in Example 6 of the present invention, since the detection electrode of the biosensor A is also used as the counter electrode during measurement, if the total area of the counter electrode 6 and the detection electrode 7 is larger than the area of the measurement electrode 5, It can prevent the electron transfer reaction between the electrodes from becoming a speed. For example, by making the area of the counter electrode 6 and the measurement electrode 5 equal and the area of the detection electrode 7 equal to the area of the counter electrode 6, it is possible to ensure that the area of the counter electrode 6 and the detection electrode 7 is larger than the area of the measurement electrode 5. In addition, in order to make the electron transfer reaction between the measurement electrode 5 and the counter electrode 6 and the detection electrode 7 more uniform, it is preferable to display the counter electrode 6 and the detection electrode adjacent to the measurement electrode 5 as shown in FIG. 15. The area of each of the electrodes 7 becomes equal. The biosensor used in Example 6 of the present invention in accordance with the above method-57- This paper size is applicable to the Chinese National Standard (CNS) A4 specification (210 X 297 mm) ------------ (Please read the precautions on the back before filling out this page) Order --------- Line Printed by the Employees 'Cooperatives of the Intellectual Property Bureau of the Ministry of Economic Affairs Printed by the Employees' Cooperatives of the Intellectual Property Bureau of the Ministry of Economic Affairs 1223064 A7 ___ B7 56 V. Description of the invention () In the quantitative method of A, when the sample is attracted to the sample supply path of the biosensor A, and there is an electrical change between the detection electrode 7 and the measurement electrode 5, the quantitative device M 1. Both the quantitative device 2 detects its electrical changes' to start the quantitative operation, so regardless of the insufficient amount of the sample supplied to the biosensor in the conventional manner, the quantitative devices M1 and M2 can be operated and started As a result of the quantitative operation, it is possible to prevent an incorrect operation such as an incorrect measurement display. In addition, when only a quantifiable amount of the sample is supplied to the biosensor A in the present invention, since the detection electrode 7 is used as a counter electrode after the start of the quantification, if the counter electrode 6 and the detection are used, When the total area of the electrode 7 is at least equal to the area of the measurement electrode 5, the electron transfer reaction between the electrodes can be prevented from becoming a regular speed, and the reaction can be performed smoothly. At the same time, the capacity of the sample supply path can be miniaturized, and accurate quantitative analysis can be performed based on a conventionally impossible sample. Furthermore, when the areas of the detection electrode 7 and the counter electrode 6 are equal, the electron transfer reaction between the electrodes can be performed uniformly, and a better response can be obtained. (Embodiment 7) The quantitative method for forming biosensors A to D using the thin-film electrode formation method described in Embodiment 5 will be described below. The difference from Embodiment 6 described above is the application of the present invention. A quantitative method for quantifying a substrate in item 40 of the patent scope, and a quantitative device for quantifying a substrate in item 42 of the patent application scope of the present invention. In addition, the biosensor used in the following description is still the biosensor A of the first embodiment. -58- This paper size is applicable to Chinese National Standard (CNS) A4 (210 X 297 mm) (Please read the note on the back? Matters before filling out this page) Order --------- line i 1223064 A7 B7 57 V. Description of the Invention (16) Figure 16 shows the structure of the biosensor A and the quantitative device used in the quantitative method using the biosensor according to the seventh embodiment of the present invention. In this figure, the same symbols as in Figure 13 are used to indicate the same or equivalent parts. In the quantitative device M3, symbols 115a, 115b, and 115c are connectors, which are respectively connected to the measurement electrode 5, the detection electrode 7, and the counter electrode of the biosensor A, and the 1 1 6 c is a changeover switch, and one end thereof is connected to the connector 1 1 5 b, the other end of which can be converted to the current / voltage conversion circuit 1 1 8b or ground, 118a is a current / voltage conversion circuit, connected to connector 1 1 5 a, used to connect the measuring electrode 6 The current flowing between the other electrodes is converted into voltage and output. 118b is a current / voltage conversion circuit. It is connected to the connector 11 5b via a changeover switch 1 1 6c. It is used to flow between the detection electrode 7 and other electrodes. The current is converted into voltage and output. 119a, 119b are A / C conversion circuits, which are connected to the current / voltage conversion circuits 1 1 8a, 1 1 8b, respectively, and are used to convert the voltage from the current / voltage conversion circuits 118a, 118b. The pulse wave is converted into 120. The CPU is used to control the switch 1 1 6 c, and the pulse wave from the A / C conversion circuit 1 1 a, 1 1 9 b is used to calculate the content of the matrix of the specimen. 1 2 1 is LCD, used to display CPU 1 20 Calculated measurement 値. Next, the operation of the biosensor A and the quantification device M 3 when measuring the content of the substrate in the specimen using the biosensor A measurement method according to the seventh embodiment of the present invention will be described. First, when the biosensor A is connected to the connector 1 1 5 a to 1 1 5 c of the quantitative device M3, the control of the CPU 1 20 is used to connect the changeover switch 1 1 6 c to the current / voltage conversion circuit. 1 1 8b, measuring electrode 5 at counter electrode 6 -59- This paper size applies Chinese National Standard (CNS) A4 (210 X 297 mm) (Please read the precautions on the back before filling this page) ---- ---- Order --------- Printed by the Consumer Cooperatives of the Intellectual Property Bureau of the Ministry of Economic Affairs 1223064 A7 B7 V. Description of the invention () and between the counter electrode 6 and the detection electrode 7 Voltage. The current generated between the counter electrode 6 and the measurement electrode 5 and between the counter electrode 6 and the detection electrode 7 is converted into a voltage by a current / voltage conversion circuit 1 1 8 a, 118 b, and then converted by an A / D conversion circuit. 119a, 119b become pulse waves. Next, when the specimen is supplied to the inlet 9a of the specimen supply path of the biosensor A, the specimen is attracted to the inside of the specimen supply path, passes through the counter electrode 6 and the measurement electrode 5, and reaches the detection electrode 7. . At this time, the reagent layer 12 is dissolved by the specimen to generate a redox reaction, and electrical changes occur between the counter electrode 6 and the measurement electrode 5, and between the counter electrode 6 and the detection electrode 7. The CPU 120 uses the pulse waves input from the A / D conversion circuits 119a, 119b to detect electrical changes between the counter electrode 6 and the measurement electrode 6 and the detection electrode 5 and between the counter electrode 6 and the detection electrode 7, It is used to confirm that a quantifiable amount of specimen is supplied to the specimen supply path of the biosensor A. Secondly, the CPU 1 20 grounds the changeover switch 1 1 6c and controls the current / voltage conversion circuit 118a to not supply voltage for a certain period of time, and is used to perform the reagent layer 1 12 and the specimen formed on each electrode. reaction. About 5 seconds after a certain time has passed, a certain voltage is applied between the measurement electrode 5 and the counter electrode 6 and the detection electrode 7 using the current / voltage conversion circuit 1 1 8a. Based on the response current, the CPU 120 calculates the response 値, The result is displayed on the LCD 121. However, the specimen is supplied through the specimen supply path to be used for counter electrodes 6 -60- This paper size applies the Chinese National Standard (CNS) A4 specification (210 X 297 mm) 蠊 (Please read the precautions on the back before (Fill in this page) Printed by the Consumer Cooperatives of the Intellectual Property Bureau of the Ministry of Economy——Order ---------, Line 1 ^ · ------------------- ---- 1223064 A7 B7 59 V. Description of the invention () A current is generated between the measuring electrode and the measuring electrode 5, but when a current is not generated between the counter electrode 6 and the detecting electrode 7 at a certain time thereafter, the CPU 1 20 It is judged that the specimen is insufficient, and it is displayed on the LCD 1 2 1. In addition, once the specimen is displayed as insufficient on the LCD 21, the CPU 1 20 does not start the quantitative operation even if the specimen is replenished to the specimen supply path. In the quantitative method using the biosensor according to the seventh embodiment of the present invention, when the specimen is attracted to the specimen supply path of the biosensor A, a gap is generated between the counter electrode 6 and the measurement electrode 5. There is no electrical change between the counter electrode 6 and the detection electrode 7, because the quantitative device M3 displays the lack of the sample on the LCD 121 to inform the user, so the measurement time can be improved. Convenience and safety. (Embodiment 8) The quantitative method of biosensors A to D for forming a conductive layer using the method of forming a thin-film electrode described in Embodiment 5 will be described below. Different from the above-mentioned sixth and seventh embodiments, the following will be described. Describe the quantitative method for quantifying substrates in the 39th or 40th patent application scope of the present invention, and the quantitative device for quantifying the substrates in the 42th to 44th patent application scope of the present invention. In addition, the biosensor used in the following description is still the biosensor A of the first embodiment. Fig. 17 shows the structure of the biosensor A and the quantitative device used in the biosensor quantitative method of the eighth embodiment of the present invention. In this figure, the same symbols as those in Figure 16 are used to indicate the same or equivalent parts. The structure of the dosing device M4 of this embodiment 8 is basically the same as that of the embodiment 7. 'However, the connector 115a and the current / voltage conversion circuit of the dosing device M4 -61- This paper is in accordance with China National Standard (CNS) A4 specification (210 X 297 mm) (Please read the precautions on the back before filling out this page) Order ------- Buxian | Printed by the Intellectual Property Bureau of the Ministry of Economic Affairs Consumer Cooperatives 1223064 A7 B7 60 V. Description of Invention () Road A changeover switch 1 丨 6d is added between 1 1 8 a, so that the connection of the measurement electrode 5 can be converted to a current / voltage conversion circuit 1 8 a or a ground wire. The operation of the biosensor and the quantification device when quantifying the matrix content of a specimen using the biosensor-based quantification method according to the eighth embodiment of the present invention will be described with reference to FIG. 17. First, when the biosensor A is connected to the connectors 1 1 5 a to 1 1 5 c of the quantitative device M4, the changeover switches 1 1 6d and 116c are connected to the current / voltage conversion circuits respectively under the control of the CPU 120. π 8a, n 8b, a certain voltage is applied between the counter electrode 6 and the measurement electrode 5, and between the measurement electrode 5 and the detection electrode 7. The current generated between the counter electrode 6 and the measurement electrode 5 and between the measurement electrode 5 and the detection electrode 7 is converted into a voltage by a current / voltage conversion circuit 1 1 8 a, 1 1 8 b, and then A / D. The conversion circuits 119a, 119b convert into pulse waves. Secondly, when the specimen is supplied to the inlet 9a of the specimen supply path of the biosensor A, it is attracted to the inside of the specimen supply path. When it is covered on the measurement electrode 5, the corresponding electrode 6 and the measurement electrode 5 Electrical changes occur between the CPUs 1 to 20, and the pulse wave input from the A / D conversion circuit 1 1 9 a is used to detect the electrical changes, thereby grounding the conversion switch 1 16d. Secondly, when the sample reaches the detection voltage 7, an electrical change occurs between the measurement electrode 5 and the detection electrode 7. The CPU 1 20 uses the pulse wave input from the A / D conversion circuit 1 1 9b to detect the electrical It is determined that the specimen is sufficiently supplied to the specimen supply path. Secondly, the CPU 120 connects the changeover switch 116d to the current / voltage conversion circuit 1 1 8 a, grounds the changeover switch 1 1 6 c, and controls it to a certain time. -62- This paper standard applies Chinese National Standard (CNS) A4 Specifications (210 X 297 mm) ------------- Lose (Please read the precautions on the back before filling out this page) Order --------- Line · Ministry of Economy Wisdom Printed by the Consumer Cooperative of the Property Bureau τ 1223064 Printed by the Consumer Cooperative of the Intellectual Property Bureau of the Ministry of Economic Affairs A7 B7 61 V. Description of the invention () The current / voltage conversion circuit 1 1 8 a does not supply voltage, so that it is formed on each electrode The upper reagent layer 12 reacts with the specimen. About 5 seconds after a certain period of time, a certain voltage is applied between the measurement electrode 5 and the counter electrode 6 and the detection electrode 7 using the current / voltage conversion circuit 1 1 8 a, and the CPU 120 calculates the sample voltage based on the response current. The content of the matrix was measured and displayed on the LCD 121. However, since the sample is supplied to the sample supply path, even if a current is generated between the counter electrode 6 and the measurement electrode 5, no current is generated between the measurement electrode 5 and the detection electrode 7 at a later time. In this case, the CPU 120 determines that the sample amount is insufficient, and displays the matter on the LCD 121. Then, once the sample amount is displayed on the LCD 1 2 1, even if the sample is replenished to the sample supply path, the CPU 1 20 does not start the quantitative operation. According to the quantitative method using the biosensor according to the above-mentioned embodiment 8 of the present invention, the specimen is attracted to the specimen supply path of the biosensor A, and when it is generated between the counter electrode 6 and the measurement electrode 5 If the electrical change does not occur between the measurement electrode 5 and the detection electrode 7, the metering device M4 displays the insufficient sample amount on the LCD 121 to notify the user, so the measurement can be improved. Convenience and safety. In the sixth to eighth embodiments described above, the person described is a biosensor that is an enzyme sensor, but the type of the test drug may be antibodies, microorganisms, DNA, RAN, etc. in addition to enzymes. The biosensors that make use of these can be the same. [Industrial application possibility] The biosensor of the present invention in the above manner can be shaped in a simple way -63- This paper size applies to China National Standard (CNS) A4 (210 X 297 mm) rr --- ----------------- Order --------- Line · (Please read the precautions on the back before filling this page) 1223064 A7 B7 62 V. Description of the invention () (Please read the precautions on the back before filling in this page). You can obtain a biosensor with good measurement accuracy, which has nothing to do with the composition of the test solution, and can evenly arrange the test layer on the electrode. The biosensor is a biosensor that does not affect the performance of the electrode area when the substrate is cut, and does not need to insert a calibration chip. Only the biosensor can be inserted to determine the calibration of each manufacturing batch. The biosensor of the data, in addition, when the thin film electrode forming method of the present invention is used, it is suitable for forming the conductive layer of the biosensor described above, and when using the quantitative method and the quantitative device of the present invention, Physical examination is extremely useful. Explanation of symbols 1 ... Insulating substrate 2 ... Conductive layers 3 a, 3 b .... Gap 4 a, 4 b .... Gap 5 ... Measurement Electrode 6 ...... Counter electrode 7 ...... Detection electrode 8 ...... Printed by the Consumer Cooperative of the Intellectual Property Bureau of the Ministry of Economy 9 ...... Notch 12. ... Reagent layer 1 3 ..... Lid-64- This paper size applies to China National Standard (CNS) A4 (210 X 297 mm)

Claims (1)

1223064 Amendment and patent application scope No. 8 9 1 2 4 0 5 0 "Biosensor, thin-film electrode formation method, quantitative device, and quantitative method" patent case (Amended on July 15, 1993) Six patent application scope : 1 · A biosensor for quantifying the matrix contained in a sample liquid, characterized in that the biosensor includes: a first insulating substrate and a second insulating substrate; and the electrode portion is provided with at least a measurement An electrode and a counter electrode; a sample supply path for introducing the sample solution to the electrode section; and a reagent layer for quantifying a matrix contained in the sample solution; the electrode section, the sample supply path And the reagent layer exists between the first insulating substrate and the second insulating substrate; the sample supply path is provided on the electrode portion, and a test is provided on the electrode portion of the sample supply path. A drug layer; a full or a part of the conductive layer formed on the inner surface of one or both of the first insulating substrate or the second insulating substrate, a first gap is provided for dividing and forming the Electrode section. 2 · The biosensor according to item 1 of the patent application scope, wherein the electrode section is further provided with a detection electrode. 3 · If the scope of patent application is the second biosensor, the pair of electrodes are provided on the inner surface of the second insulating substrate in whole or in part; 1223064 VI. The scope of patent application is in the first insulation The measurement electrode and the detection electrode are provided in whole or in part on the inner surface of the substrate; the measurement electrode and the detection electrode provided on the inner surface of the first insulating substrate use the The first gap is formed by dividing. 4. If the biosensor of item 1 or 2 of the patent application scope, wherein the electrode part is provided only on the entire or part of the inner surface of the first insulating substrate; provided on the first insulating substrate The electrode portion on the inner surface is formed by dividing the first gap provided in the conductive layer. 5. The biosensor according to item 1 or 3 of the patent application scope, wherein the area of the pair of electrodes is equal to or larger than the area of the measuring electrode. 6. The biosensor of claim 2 or 3, wherein the total area of the pair of electrodes and the area of the detection electrode is equal to or greater than the area of the measurement electrode. 7. The biosensor according to item 6 of the patent application scope, wherein the area of the detection electrode of the sample supply path of the biosensor is equal to the area of the pair of electrodes. 8. The biosensor according to any one of claims 1 to 3, which further includes a spacer, a notch portion for forming the sample supply path, and an electrode portion disposed on the electrode portion; The second insulating substrate is arranged on the spacer. 1223064 VI. Scope of patent application 9 • The biosensor of item 8 of the scope of patent application, wherein the spacer and the second insulating substrate are integrated. 1 0. The biosensor according to any one of claims 1 to 3, wherein an air hole is formed to pass to the sample supply path. 1 1 · The biosensor as described in any one of claims 1 to 3, wherein the reagent layer is formed by dropping the reagent; a second gap is provided around the dropping position of the reagent. 12. The biosensor according to item 11 of the scope of patent application, wherein the second slit has a circular arc shape. 1 3. The biosensor according to any one of claims 1 to 3, wherein a third gap is provided for dividing the conductive layer to define the area of the electrode portion. 14. If the biosensor of item 13 of the scope of patent application, wherein the shape of the first insulating substrate and the second insulating substrate are substantially rectangular; the third gap is provided with one or more than two, Parallel to either side of the generally rectangular shape. 1 5. The biosensor as described in any one of items 1 to 3 of the scope of patent application, wherein the information with calibration data is generated in each of the biosensors. 1223064 VI. Scope of Patent Application Each manufacturing lot corresponds to the characteristics related to the output of electrical changes when the sample solution and the reagent layer react, and can be judged by the measuring device using the biosensor. 1 6 · If the biosensor of item 15 of the scope of patent application, wherein the fourth slot for dividing the electrode part has one or more, according to the position of the fourth slot, the measuring device can judge the correction Information about the data. 1 7 · The biosensor according to any one of claims 1 to 3, wherein the conductive layer is processed by laser to form the first slit, the second slit, and the third slit. And any or all of the fourth gap, in order to form the reagent layer, the second gap is provided around the dropping position of the dropping reagent, and the third gap divides the conductive layer and defines the electrode The electrode area is divided by the fourth slit. 1 8 · The biosensor according to item 17 of the scope of patent application, wherein the width of each of the first slit, the second slit, the third slit, and the fourth slit is 0.005 mm (mn0 ~ 0.3 millimeter (mm) 〇1 9 · As in the biosensor of item 17 of the patent application scope, wherein each of the first slit, the second slit, the third slit, and the fourth slit The depth is greater than the thickness of the conductive layer. 20 · For example, the biosensor of item 1 of the scope of patent application, of which 1223064 6. The scope of the patent application, the reagent layer contains enzymes. 2 1. The organism of scope 1 of the patent application "Sensor" wherein the reagent layer contains an electronic transmitter. *. · 22. The biosensor according to item 1 of the patent application 'wherein the reagent layer contains a water-soluble polymer. 2 3. If applied The biosensor according to any one of the scope of patents 1 to 3, wherein the insulating substrate is formed of resin. 24. A method for forming a thin film electrode, which is used to form a thin film electrode on the surface of an insulating substrate. In order to have: the rough surface forming process The excited gas hits the surface of the insulating substrate to make the surface of the insulating substrate rough; and forms a conductive layer to form a conductive material on the surface of the insulating substrate that becomes rough. The conductive layer of a thin film electrode. 25. The method for forming a thin film electrode according to item 24 of the application, wherein the rough surface forming process includes: a substrate setting process for setting the insulating substrate in a vacuum tank; a vacuum Exhaust project, used to exhaust the inside of the vacuum tank to become a vacuum; gas filling project, used to fill the inside of the vacuum tank; and 1223064 VI. Patent application collision project, used to stimulate the gas to make it Ionization, so that it collides with the insulating substrate. 2 6. The method for forming a thin film electrode according to item 25 of the patent application scope, wherein the vacuum degree of the vacuum exhaust project is 1X10-1 to 3X10-3 Baska 2 7. The method for forming a thin-film electrode according to item 26 of the patent application, wherein the gas becomes an inert gas. 2 8 · As described in item 27 of the patent application A method for forming a membrane electrode, wherein the inert gas is any of the rare gases of argon, neon, helium, krypton, and xenon, and nitrogen. 2 9 · The thin film electrode according to any one of the claims 24 to 28 The forming method, wherein the conductive layer project includes: the second substrate setting project, which is used to set the rough insulating substrate after the rough surface forming process is completed into the second vacuum tank; the second vacuum exhaust Gas project to exhaust the inside of the second vacuum tank into a vacuum; the second gas filling project to charge a second gas into the second vacuum tank; and a film formation project to stimulate the second vacuum tank 2 The gas ionizes it, causing it to strike 1223064. 6. The scope of the patent application hits the conductive substance to release the atoms of the conductive substance, thereby forming a film on the rough insulating substrate. 30. The method for forming a thin-film electrode according to any one of claims 24 to 28, wherein the conductive layer forming process includes: the second substrate setting project, which is used to complete the rough surface forming project. After the rough surface is formed, the insulating substrate is placed in the second vacuum tank; the second vacuum exhaust process is used to exhaust the inside of the second vacuum tank to a vacuum; and the film formation process is used to conduct conductive materials The vapor is deposited on the roughened insulating substrate by heating and evaporating the vapor. 31. The method for forming a thin-film electrode according to item 29 of the scope of patent application, wherein the vacuum degree of the second vacuum evacuation project is in the range of lx 10.1 ~ 3x10 Baska. 32. The method for forming a thin-film electrode according to item 29 of the application, wherein the second gas is an inert gas. 33. The method for forming a thin film electrode according to item 32 of the application, wherein the inert gas is any of rare gases of argon, neon, helium, krypton, and xenon, and nitrogen. 34. If the method for forming a thin-film electrode according to item 29 of the scope of patent application is 1223064 6. In the scope of patent application, the vacuum chamber and the second vacuum chamber become the same tank. 35. The method for forming a thin-film electrode according to item 29 of the application, wherein the conductive substance becomes a precious metal or carbon. 36. The method for forming a thin film electrode according to any one of claims 24 to 28, wherein a thickness of the formed thin film electrode is in a range of 3 nm (nm) to 100 nm (n.m). 37. If the biosensor of any one of claims 1 to 3 is applied for, the conductive layer is formed by using the thin film electrode forming method of any one of claims 24 to 36. 3 8 · — A quantitative method using a biosensor in any of claims 1 to 23 or 37 in the scope of patent application for the matrix contained in the sample solution supplied to the biosensor Quantification is characterized by having the following steps: a first application step for applying a voltage between the detection electrode and the pair of electrodes or the measurement electrode; a reagent supply step for supplying the sample liquid to the reagent Layer; a first change detection step, by providing the sample liquid to a reagent layer, for detecting an electrical change generated between the detection electrode and the pair of electrodes or the measurement electrode; 1223064 6. The second application step of the scope of patent application, after detecting the electrical change in the first change step, is used to apply a voltage • between the measurement electrode 5 and the pair of electrons and the detection electrode, and a current measurement step, Application of voltage using the second application step > Used to measure the voltage applied to the measurement electrode, and the current generated between the pair of electrodes and the measurement electrode 0 39.--A quantitative method using the scope of patent application Items 1 to: The biosensor of any one of items 23 or 37 is used to quantify the matrix contained in the sample liquid supplied to the biosensor, and is characterized by having the following steps: The third application step is for Apply a voltage y between the detection electrode 1 and the pair of electrodes or the measurement electrode and between the measurement electrode and the pair of electrodes. A drug supply step is used to supply the sample liquid to the reagent layer 9 The first change detection step is to provide the sample liquid to the reagent layer to detect between the detection electrode and the pair of electrodes or the measurement electrode Generated electrical change > Second change detection step > The second application step of detecting the electrical change generated between the measurement electrode and the pair of electrodes is provided by supplying the sample solution to the reagent layer in the detection The electrical changes of the first change detection step and the second change detection step are used to apply a voltage between the measurement electrode 1 and the pair of electrodes and 9- 1223064 6. Scope of patent application The current measurement step is used to measure the current generated between the measurement electrode and the pair of electrodes and the detection electrode to which the voltage is applied by the second application step. 40. The quantitative method according to item 38 or 39 of the scope of patent application, wherein a notification step is provided after the second change detection step, when the detection electrode is detected within a specified period, and between the pair of electrodes or the detection electrode When there is no change in the electrode, the user is notified of the change. 41. A quantitative device that is detachably connected to a biosensor in any of claims 1 to 23 or 37 for applying for a patent, and is used to measure the content of the biosensor contained in a sample liquid supplied to the biosensor. The substrate is quantified and is characterized by having the following devices: a first current / voltage conversion circuit for converting a current from the measurement electrode provided in the biosensor into a voltage; a first A / D conversion circuit for To convert the voltage from the current / voltage conversion circuit into a digital voltage; a first switch is provided between a counter electrode and a ground wire provided in the biosensor; and a control unit for controlling the first A / D conversion circuit and the first switch; the control unit performs: applying a voltage between the detection electrode and the measurement electrode in a state where the first switch is insulated from the pair of electrodes; -10- 1223064 VI. Application The scope of the patent is to supply the sample solution to the reagent layer on the specimen supply path, and to detect an electrical change between the detection electrode and the measurement electrode due to the supply; after the first switch is connected to To electricity The state ', and the pair of electrodes is applied between the measuring electrode and the voltage sensing electrode; measuring the current and voltage is applied via the response arising. 42. A quantitative device that can be detachably connected to the biosensor in any of claims 1 to 23 or 37 of the scope of patent application, and is used to contain the content of the sample liquid supplied to the biosensor. The substrate is quantified and is characterized by having the following devices: a first current / voltage conversion circuit for converting a current from the measurement electrode provided in the biosensor into a digital voltage; a second current / voltage conversion circuit, The first A / D conversion circuit is used to convert the voltage from the first current / voltage conversion circuit into a digital voltage. 2. A / D conversion circuit for converting the voltage from the second current / voltage conversion circuit into a digital voltage; a first conversion switch for converting the connection of the detection electrode of the biosensor to the A first current / voltage conversion circuit or a ground; and a control section for controlling the first A / D conversion circuit, the second A / D conversion circuit, and the first conversion switch; the control section performs: -11 -1223064 vi The scope of patent application is in a state where the first conversion switch is connected to the first current / voltage conversion circuit, and a voltage is applied between the detection electrode and the pair of electrodes, and between the measurement electrode and the pair of electrodes; The sample solution is supplied to the reagent layer provided on the sample supply path, and the electrical changes between the detection electrode and the measurement electrode due to the supply are detected, and the measurement electrode and the pair of electrodes are respectively detected. Electrical changes between time; grounding the first conversion switch; applying a voltage between the measurement electrode, the counter electrode and the detection electrode; and measuring a response current generated by the application of the voltage. 43. The quantification device according to item 42 of the scope of patent application, wherein the quantification device is provided with a second conversion switch for converting the connection of the measurement electrode of the biosensor to the second current / voltage conversion circuit or a ground wire The control unit performs: in a state where the first conversion switch is connected to the first current / voltage conversion circuit and the second conversion switch is connected to the second current / voltage conversion circuit, the detection electrode and the A voltage is applied between the counter electrode and between the measurement electrode and the pair of electrodes. The sample solution is supplied to the reagent layer provided on the specimen supply path. When there is an electrical change between the pair of electrodes, the second change-over switch is grounded; -12-1223064 VI. Patent application scope Then, when an electrical change is detected between the detection electrode and the measurement electrode Connecting the second conversion switch to the second current / voltage conversion circuit and grounding the first conversion switch; applying a voltage between the measurement electrode, the pair of electrodes, and the detection electrode; and The response current generated by the application of voltage. 44. If the quantitative device of the scope of patent application No. 42 or 43 is provided, which includes a notification device 'supply the sample liquid to the reagent layer of the sample supply path', when the control section detects that the measurement electrode and the When there is an electrical change between the counter electrodes, and when there is no electrical change between the detection electrode and the measurement electrode or the pair of electrodes, it is used to notify the user that there is no change. -13-