Abstract:
An electrochemical sensor strip is provided. The electrochemical sensor strip includes an insulating substrate having a reaction concavity integrally formed thereon, a cover, an electrochemical reaction layer, and an electrode device. The reaction concavity is peripherally and entirely enclosed by the insulating substrate. The cover partially covers on the reaction concavity by leaving an opening on the reaction concavity. The electrochemical reaction layer is located in the reaction concavity, and the electrode device is located in the reaction concavity for transmitting a signal resulting from an electrochemical reaction performed in the electrochemical reaction layer.

Description:
FIELD OF THE INVENTION  
       [0001]     The present invention relates to an electrochemical sensor strip, and more particular to a disposable electrochemical sensor strip. The contents of U.S. patent Ser. No. 10/462,904 filed on Jun. 17, 2003 are incorporated herewith for reference.  
       BACKGROUND OF THE INVENTION  
       [0002]     The present application is relevant to U.S. patent Ser. No. 10/462,904, and some disposable electrochemical sensor strips with metal electrodes are provided. The electrochemical sensor strips of the present application are suitable for testing the contents of some specific analytes in a sample, especially in a fluid sample. For example, it is possible to test one or more concentrations of glucose, cholesterol, and uric acid in the human blood, or one or more concentrations of the insecticides, pesticides, fungicides, herbicides, heavy metals and so forth in a polluted water by the present invention. In other words, the electrochemical sensor strips according to the present application are suitable to be used in any kind of electrochemical sensors, bio-sensors, fluid biochemical sensors, and some domestic medical sensors (e.g. blood glucose sensor).  
         [0003]     In recent decades, the principle of electrochemical sensor has been developed and applied in the field of detecting kinds of fluid ingredients. An electrochemical sensor may be assembled with different equipments due to their different application fields. Nevertheless, an electrochemical sensor in a general laboratory is generally different from that in a professional checking room. A basic framework of an electrochemical sensor includes the following components:  
         [0004]     1. A container, which is applied to contain a fluid sample and is a region for measuring an electrochemical reaction;  
         [0005]     2. A chemical reagent, which is used for chemically reacting with an analyte contained in the fluid sample and generating an output signal with an electric parameter, wherein the electric parameter is corresponding to an ingredient of the analyte contained in the fluid sample. For example, if the fluid sample is the human blood and the analyte is the glucose, the chemical reagent would be basically a glucose oxidase and a complex thereof;  
         [0006]     3. Plural testing electrodes, which are selected from a group consisting of a counter electrode, a working electrode, a reference electrode, and a detecting electrode; and  
         [0007]     4. A measuring device, such as an electrochemical meter, which provides the essential working voltage (or current) needed by the electrochemical reaction and measures the electric parameter (output voltage or current) produced by the electrochemical reaction to be recorded for processing the numerical analysis and displaying the testing result thereon.  
         [0008]     In general, the plural testing electrodes can include the counter electrode and the working electrode, the reference electrode and the working electrode, or the counter electrode, the working electrode, and the reference electrode. Moreover, a detecting electrode could be included as a fourth electrode, if necessary. The number of the plural testing electrodes is varied according to the requirements of the electrochemical reaction.  
         [0009]     The functions of the plural electrodes are mutually different from each other, and the plural electrodes are made of different materials. In the general laboratory, the counter electrode is made of any conductive material, where one of a lower conductive resistance is the better, such as a copper, a silver, a nickel, a graphite, a carbon, a gold, a platinum or other conductive materials, or can be a conductive membrane electrode formed by printing a carbon paste or a silver paste on a conductive material. The most common reference electrode is a modified electrode produced by means of printing or electroplating an Ag/AgCl film. Because the electrochemical electric potential of the Ag/AgCl film is quite stable, it is extensively used as the reference electrode.  
         [0010]     The selection of the materials for the working electrodes is more complex and the working electrodes can be categorized as two types according to the used materials. One kind of the working electrode is an electron-transfer mediator modified working electrode, and the other is a metal-catalyzed electrode. The electron-transfer mediator modified working electrode has a chemical reagent immobilized thereon, wherein the chemical reagent includes an enzyme (such as a glucose oxidase) and a redox mediator (such as a potassium ferricyanide, which is extensively used in the glucose testing strip). The enzyme and the analyte will react with each other to produce a new chemical compound (such as H 2 O 2 ), the electrons generated from the redox reaction between the electron mediator and the new chemical compound (such as H 2 O 2 ) is utilized to produce an electric signal, and through the electrode, the electric parameter corresponding to the electric signal can be outputted. The main purpose of this kind of working electrode is only simply a conductor and is not involved in any chemical catalysis. However, the material used to make the electrodes should be selected specifically, so as to avoid the chemical reaction occurring between the electrodes and the fluid sample or between the electrodes and the chemical reagent thereby interfering the testing result.  
         [0011]     The electrode without the chemical interference should be made of an inert conductive material, which is generally a noble metal (such as a gold, a platinum, a palladium, or a rhodium), or a carbon containing material (such as a carbon base screen printing electrode or a graphite bar). Furthermore, because the carbon and the noble metal have no chemical reactivity in a low temperature, the chemical interference would not happen. However, because the noble metal is a little bit expensive, the carbon made electrode is usually applied as the electron-transfer mediator modified working electrode.  
         [0012]     As to the metal-catalyzed electrode, it is made of a material which will directly electrochemically react with the chemical reagent, the analyte, or the derivatives thereof, and have an ability of direct catalysis or a function of a single selectivity for the analyte. Thus, no electron mediator is needed to be added into the chemical reagent. This kind of electrode, not like the electrode only needing to be made of a chemically inactive metal, is generally made of a material that must have an ability to catalyze the reaction. Therefore, the material thereof should not be limited to be a noble metal but matched with the analyte, such as a copper, a titanium, a nickel, a gold, a platinum, a palladium, or a rhodium . . . etc., (in which, a rhodium electrode has an excellent ability to directly catalyze H 2 O 2 ).  
         [0013]     U.S. Pat. No. 5,997,817 had disclosed a metal electrode. In this patent, two conductive metal tracks coated by a palladium are fixed on an insulating substrate for being the metal electrodes (such as a working electrode and a counter electrode). However, the positions that are necessarily formed by palladium are only two tiny sections of the metal electrodes, and the other portions need only be formed by materials having a conductive characteristic rather than being noble metal-palladium. Thus, it would be a waste to coat the palladium onto all the surfaces of the metal electrodes.  
         [0014]     In addition, U.S. Pat. No. 5,985,116 had disclosed a disposable printing electrochemical sensor strip. The electrodes on the sensor strip are formed by printing some conductive pastes onto the insulating substrate. However, the sensitivities of the electrodes are determined by the materials of the conductive pastes. If the conductive pastes are made of a noble metal, the sensitivity of the relevant electrodes will be greater, the unnecessary chemical interference would be reduced, but the corresponding cost will be high. On the contrary, in order to decrease the relevant cost, the conductive pastes might be made of a low-cost conductive material, such as the carbon. However, the sensitivity of the relevant electrodes made of a low-cost material will not be so good due to the impedance thereof.  
         [0015]     As above, although the use of the electrochemical sensor strips has become the main trend of the domestic medical applications (such as the sensor strips for testing the blood glucose, the uric acid, or the cholesterol contents in the human blood), some problems about the testing accuracy and the relevant cost are still awaiting to be overcome.  
         [0016]     Please refer to  FIG. 1 , which is a flow chart showing the manufacturing process of an electrochemical sensor strip in the prior art. As shown in  FIG. 1 , the manufacturing process includes the following steps: 1. An insulating substrate is provided. 2. Some electrodes are located on the insulating substrate. 3. A reaction concavity is assembled on the insulating substrate. 4. An electrochemical reaction layer is formed in the reaction concavity by applying a chemical reagent therein. 5. The reaction concavity is sealed after the chemical reagent is dry. 6. An opening located on the side edge of the insulating substrate is formed by a step of scouring.  
         [0017]     Please refer to FIGS.  2 (A)- 2 (B), which are the schematic diagrams showing the different statuses of the electrochemical sensor strip during the step of scouring in the prior method. In addition, please refer to  FIG. 2 (C), which is the schematic diagram showing the status of the fluid sample during the testing step in the prior method. As shown in FIGS.  2 (A)- 2 (C), the electrochemical sensor strip  3  includes the insulating substrate  31 , the electrodes  32 , the electrochemical layer  33 , the reaction cavity  34 , the cover  35  and the air hole  37 . As shown in  FIG. 2 (A), the reaction concavity  34  is peripherally and entirely enclosed before a step of scouring. As shown in  FIG. 2 (B), the opening  36  is formed on the side edge of the electrochemical sensor strip  3  after the electrochemical sensor strip is scoured. In addition, there are some cracks  331  that will be formed due to the mechanical force resulting from the step of scouring. As shown in FIGS.  2 (B)- 2 (C), however, since there are some cracks  331  on the electrochemical layer  33 , it is possible that the testing sample A would be contacted with the electrodes  32  before being reacted with the electrochemical layer  33  so that the electrochemical reaction between the testing sample A and the electrochemical layer  33  might be affected by the cracks  331 . As the above discussions, it would be found that the step of scouring is the main reason of the undesired testing accuracy of the electrochemical sensor strip  3 .  
         [0018]     According to the technical defects described above, for reducing the manufacturing cost of the metal electrode in the sensor strip and overcoming the problems of the structural damage, the applicant has devoted himself to develop another electrochemical sensor strip through a series of experiments, tests and researches. In addition to effectively solving the wasting problem of the noble metal and avoiding the relevant damaging manufacturing procedure in the prior arts, the present application further provides more complete structures of the electrochemical reaction layer for increasing the testing accuracy accordingly. Furthermore, the sensor strip according to the present invention can be applied to kinds of electrochemical testing devices, such as biosensor strips, fluid biochemical sensor strips (e.g., the testing strips for a sewage, a pesticide content, a heavy metal ingredient etc.), and kinds of domestically medical application testing strips (e.g., the testing strips for a blood glucose, a uric acid, and a cholesterol).  
       SUMMARY OF THE INVENTION  
       [0019]     In accordance with an aspect of the present invention, an electrochemical sensor strip is provided. The electrochemical sensor strip includes an insulating substrate having a reaction concavity located thereon and peripherally and entirely enclosed by the insulating substrate, a cover partially covering on the reaction concavity for retaining an opening on the reaction concavity, an electrochemical reaction layer located in the reaction concavity, and an electrode device located in the reaction concavity for transmitting a signal resulting from an electrochemical reaction performed in the electrochemical reaction layer.  
         [0020]     Preferably, a distance between a side of the reaction concavity and an edge of the insulating substrate is in a range from 0.1 mm to 3.0 mm.  
         [0021]     Preferably, the electrode device has a first end connected to the electrochemical reaction layer and a second end connected to a measuring device for transmitting the signal into the measuring device.  
         [0022]     Preferably, the reaction concavity includes at least a hole.  
         [0023]     Preferably, the electrode device passes through the hole.  
         [0024]     Preferably, the electrode device includes plural electrodes selected from a group consisting of a counter electrode, a working electrode, a reference electrode and a detecting electrode.  
         [0025]     Preferably, each of the plural electrodes includes a metal and a thin film.  
         [0026]     Preferably, the metal is one selected from a group consisting of a copper, a titanium, a nickel, a gold, a platinum, a rhodium, a palladium, a ruthenium, a silver, a chromium, an iron, an aluminum, an iridium and an alloy thereof.  
         [0027]     Preferably, the metal is one selected from a group consisting of a brass, an oxygen-free copper, a bronze, a phosphorized copper, a nickel silver copper and a beryllium copper.  
         [0028]     Preferably, the thin film is made of one selected from a group consisting of a copper, a titanium, a nickel, a gold, a platinum, a rhodium, a palladium, a ruthenium, a silver, a chromium, an iron, an aluminum, an iridium and an alloy thereof.  
         [0029]     Preferably, each of the plural electrodes includes a carbon body and a thin film.  
         [0030]     Preferably, the electrochemical reaction layer further includes a chemical agent for reacting with an analyte of a sample to generate the signal.  
         [0031]     Preferably, the sample is added into the reaction concavity via the opening.  
         [0032]     Preferably, the insulating substrate is made of one selected from a group consisting of a polyvinyl chloride (PVC), a polypropylene (PP), a polycarbonate (PC), a polybutylene terephthalate (PBT), a polyethylene terephthalate (PET), a modified polyphenylene oxide (PPO) and an acrylonitrile butadiene styrene (ABS).  
         [0033]     Preferably, the cover further includes an air hole.  
         [0034]     Preferably, the reaction concavity and the insulating substrate are formed integrally.  
         [0035]     Preferably, a size of the opening is in a range from 0.1 mm to 3.0 mm.  
         [0036]     In accordance with another aspect of the present invention, a method for manufacturing an electrochemical sensor strip is provided. The manufacturing method includes steps of a) providing an insulating piece having a reaction concavity formed thereon and peripherally and entirely enclosed by the insulating piece, b) locating at least an electrode device in the reaction concavity, c) forming a reaction layer connected to the electrode device in the reaction concavity, and d) partially covering the reaction concavity to remain an opening on the reaction concavity.  
         [0037]     Preferably, the reaction concavity and the insulating substrate are formed integrally.  
         [0038]     Preferably, the reaction layer is formed by applying a chemical reagent in the reaction concavity.  
         [0039]     Preferably, the reaction layer is formed by coating the chemical reagent in the reaction concavity.  
         [0040]     Preferably, the reaction layer is formed by dropping the chemical reagent in the reaction concavity.  
         [0041]     Preferably, the reaction layer is formed by spreading the chemical reagent in the reaction concavity.  
         [0042]     In accordance with another aspect of the present invention, an electrochemical sensor strip is provided. The electrochemical sensor strip includes an insulating substrate having a reaction concavity integrally formed thereon, a cover covering on the reaction concavity for forming an opening, an electrochemical reaction layer located in the reaction concavity, and an electrode device located in the reaction concavity for transmitting a signal resulting from an electrochemical reaction performed in the electrochemical reaction layer. The reaction concavity includes a first area and a second area. The second area is adjacent to the opening and has a second coarseness lower than the coarseness of the first area.  
         [0043]     Preferably, the second area includes a width ranged from 0.1 to 2.0 mm.  
         [0044]     Preferably, the electrode device has a first end connected to the electrochemical reaction layer and a second end connected to a measuring device for transmitting the signal into the measuring device.  
         [0045]     Preferably, the reaction concavity includes at least a hole.  
         [0046]     Preferably, the electrode device passes through the hole.  
         [0047]     Preferably, the electrode device includes plural electrodes selected from a group consisting of a counter electrode, a working electrode, a reference electrode and a detecting electrode, and each of the electrodes includes a metal and a thin film.  
         [0048]     Preferably, the cover further includes an air hole.  
         [0049]     Preferably, an edge portion of the insulating substrate is uneven.  
         [0050]     The above contents and advantages of the present invention will become more readily apparent to those ordinarily skilled in the art after reviewing the following detailed descriptions and accompanying drawings, in which: 
     
    
     DESCRIPTION OF THE DRAWINGS  
       [0051]      FIG. 1  is a flow chart showing the manufacturing process of an electrochemical sensor strip in the prior art;  
         [0052]     FIGS.  2 (A)- 2 (B) are the schematic diagrams showing the different statuses of the electrochemical sensor strip during the step of scouring in the prior method;  
         [0053]      FIG. 2 (C) is the schematic diagram showing the status of the fluid simple during the testing step in the prior method;  
         [0054]      FIG. 3  is a flow chart showing the manufacturing steps of the electrochemical sensor strip according to the present invention;  
         [0055]      FIG. 4 (A) is an exploded view of the disposable electrochemical sensor strip according to the first embodiment of the present invention;  
         [0056]      FIG. 4 (B) is a schematic view of the disposable electrochemical sensor strip according to the first embodiment of the present invention;  
         [0057]      FIG. 4 (C) is the back view of the disposable electrochemical sensor strip according to the first embodiment of the present invention;  
         [0058]     FIGS.  5 (A)- 5 (B) are the schematic views showing the steps of testing a sample with the electrochemical sensor strip according to the first embodiment of the present invention;  
         [0059]     FIGS.  6 (A)- 6 (B), which are the perspective views showing the combination of the sensor and the electrochemical sensor strip according to the first embodiment of the present invention;  
         [0060]      FIG. 7 (A) is an exploded view of the disposable electrochemical sensor strip according to the second embodiment of the present invention;  
         [0061]      FIG. 7 (B) is a perspective view of the disposable electrochemical sensor strip according to the second embodiment of the present invention;  
         [0062]      FIG. 7 (C) is the back view of the disposable electrochemical sensor strip according to the second embodiment of the present invention;  
         [0063]     FIGS.  8 (A)- 8 (B) are perspective views showing the combination of the sensor and the electrochemical sensor strip according to the second embodiment of the present invention;  
         [0064]      FIG. 9 (A) is an exploded view of the disposable electrochemical sensor strip according to the third embodiment of the present invention;  
         [0065]      FIG. 9 (B) is a perspective view of the disposable electrochemical sensor strip according to the third embodiment of the present invention; and  
         [0066]      FIG. 9 (C) is the back view of the disposable electrochemical sensor strip according to the third embodiment of the present invention.  
     
    
     DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT  
       [0067]     The present invention will now be described more specifically with reference to the following embodiments. It is to be noted that the following descriptions of preferred embodiments of this invention are presented herein for purpose of illustration and description only; it is not intended to be exhaustive or to be limited to the precise form disclosed.  
         [0068]     Please refer to  FIG. 3 , which is a flow chart showing the manufacturing processes of the electrochemical sensor strip according to the present invention. The manufacturing process includes steps of a) providing an insulating piece having a reaction concavity formed thereon, b) locating at least an electrode device in the reaction concavity, c) forming an electrochemical reaction layer connected to the electrode device in the reaction concavity, and d) partially covering the reaction concavity to leave an opening on the reaction concavity. The reaction layer is formed by coating, spreading, or dropping a chemical reagent in the reaction cavity. The electrode device is formed by plural electrodes and the metal thin films on the plural electrodes. The plural electrodes are made of a metal, an alloy, a carbon or other conductive material. In general, the electrode is made of one selected from a group consisting of a copper, a titanium, a nickel, a gold, a platinum, a rhodium, a palladium, a ruthenium, an iridium, a silver, a chromium, an iron, an aluminum and an alloy thereof. In general, the metal thin films are made of one selected from a group consisting of a copper, a titanium, a nickel, a gold, a platinum, a rhodium, a palladium, a ruthenium, a silver, a chromium, an iron, an aluminum, an iridium and an alloy thereof. In general, the insulating substrate is made of one selected from a group consisting of a polyvinyl chloride (PVC), a polypropylene (PP), a polycarbonate (PC), a polybutylene terephthalate (PBT), a polyethylene terephthalate (PET), a modified polyphenylene oxide (PPO) and an acrylonitrile butadiene styrene (ABS). Since the electrochemical sensor strip of the present invention is formed by combining the components having particular structures, the step of scouring in the prior manufacturing method is successfully dispended with. Therefore, the reaction layer in the electrochemical sensor strip of the present invention will not be damaged by the unnecessary stress resulting from the step of scouring.  
         [0069]     Please refer to FIGS.  4 (A)- 4 (C).  FIG. 4 (A) is an exploded view of the disposable electrochemical sensor strip according to the first embodiment of the present invention.  FIG. 4 (B) is the schematic view of the disposable electrochemical sensor strip according to the first embodiment of the present invention.  FIG. 4 (C) is the back view of the disposable electrochemical sensor strip according to the first embodiment of the present invention. As shown in FIGS.  4 (A)- 4 (C), the electrochemical sensor strip S 1  includes the insulating substrate  1 , the reaction concavity  11  located on the insulating substrate  1 , the electrochemical reaction layer  12 , the cover  13 , the opening  14 , and the side  15 . In which, the cover  13  further includes a ventilator  131  and a window  132 , and partially covers the reaction concavity  11 . In addition, there are two holes  111  located at the bottom of the reaction concavity  11 , and the counter electrode  112  and the working electrode  113  respectively pass through the holes  111 . There are metal films  1121  and  1122  on the end surfaces of the counter electrode  112 , and there are metals films  1131  and  1132  on the end surfaces of the working electrode  113 , wherein the metal films  1121  and  1131  are connected to the electrochemical reaction layer  12  for testing the electrochemical reaction happening in the electrochemical reaction  12 . Since the electrochemical sensor strip S 1  of the present invention has the side  15  and the opening  14 , the prior step of scouring for providing an opening is omitted. Therefore, it is possible to assure the structural completeness of the electrochemical reaction layer  12 , and the testing accuracy thereof is increased accordingly. It should be noted that the positions and the shapes of the reaction concavity  11  and the cover  13  should not be limited to the disclosures of this embodiment.  
         [0070]     Please refer to FIGS.  5 (A)- 5 (B), which are schematic views showing the processes of testing a sample with the electrochemical sensor strip according to the first embodiment of the present invention. As shown in FIGS.  5 (A)- 5 (B), when a sample A gets into the reaction concavity  11  through the opening  14 , an electrochemical reaction will happen between the sample A and the chemical compositions contained in the electrochemical reaction layer  12 . During the electrochemical reaction, the ventilator  131  is applied to exhaust the redundant air in the reaction concavity  11  so as to maintain the pressure balance between the inner air of the reaction concavity  11  and the outer air thereof. There is a transparent membrane mounted in the window  132  for observing the movement of the sample A and the electrochemical reaction in the reaction concavity  11 . The width b of the side  15  is in a range from 0.1 mm to 3.0 mm, wherein the preferable range is from 0.2 mm to 0.6 mm. The width a of the opening  14  is in a range from 0.1 mm to 3.0 mm, wherein the preferable range is from 0.2 mm to 1.2 mm. Since the side  15  is so narrow that it is easy for a fluid sample A to flow the side  15  and get contact with the opening  14 . In addition, since some air will be exhausted via the ventilator  131 , the fluid sample A will get into the reaction concavity  11  due to the capillarity. Furthermore, the counter electrode  112  is able to be replaced by a reference electrode, and some detecting electrodes are able to be located on the electrochemical sensor strip S 1 , if necessary. Nowadays, in general, the electrodes and the metal films are made of one material selected from a group consisting of a copper, a titanium, a nickel, a gold, a platinum, a rhodium, a palladium, a ruthenium, a silver, a chromium, an iron, an aluminum, an iridium and an alloy thereof. In which, a brass, an oxygen-free copper, a bronze, a phosphorized copper, a nickel silver copper and a beryllium copper are the most commonly used materials. Because the end surfaces of the electrodes should have the high sensitivity and stability, and the requirements of the sensitivity and the stability of the other portions of the electrodes are not so strict, only the end surfaces of the electrodes are necessarily formed by the noble metal and the other portions could be formed by general metals or the carbon for reducing the relevant cost. In addition, since the insulating substrate  1  and the reaction concavity  11  are formed integrally via the plastic injection molding, the relevant costs spent on stacking the elements are reduced.  
         [0071]     Please refer to FIGS.  6 (A)- 6 (B), which are schematic views showing the combination of the sensor and the electrochemical sensor strip according to the first embodiment of the present invention. As shown in FIGS.  4 (A)- 6 (B), when the electrochemical sensor strip S 1  is combined to the sensor  2 , the signal resulting from the electrochemical reaction happening in the electrochemical reaction layer  12  would be transmitted to the sensor  2  via the metal films  1122  and  1132 . And then the sensor  2  will measure the transmitted signal for being figured out the corresponding value. The sensor  2  includes a display  21  for showing the figured out value, a control key for controlling the sensor  2 , and a connecting device  23 .  
         [0072]     Please refer to FIGS.  7 (A)- 7 (C).  FIG. 7 (A) is an exploded view of the disposable electrochemical sensor strip according to the second embodiment of the present invention.  FIG. 7 (B) is a schematic view of the disposable electrochemical sensor strip according to the second embodiment of the present invention.  FIG. 7 (C) is the back view of the disposable electrochemical sensor strip according to the second embodiment of the present invention. As shown in FIGS.  7 (A)- 7 (C), the electrochemical sensor strip S 2  includes the insulating substrate  1 , the reaction concavity  11  located on the insulating substrate  1 , the electrochemical reaction layer  12 , the cover  13 , the opening  14 , and the side  15 . In which, the cover  13  further includes a ventilator  131  and a window  132 , and partially covers the reaction concavity  11 . In addition, there are three holes  111  located at the bottom of the reaction concavity  11 , and the counter electrode  112 , the working electrode  113 , and the reference electrode  114  that respectively pass through the holes  111 . There are metal films  1121  and  1122  on the end surfaces of the counter electrode  112 , there are metals films  1131  and  1132  on the end surfaces of the working electrode  113 , and there are metal films  1141  and  1142  on the end surfaces of the reference electrode  114 , wherein the metal films  1121 ,  1131  and  1141  are connected to the electrochemical reaction layer  12  for testing the electrochemical reaction happening in the electrochemical reaction  12 . Since the electrochemical sensor strip S 2  of the present invention has the side  15  and the opening  14 , the prior step of scouring for providing an opening is omitted. Therefore, it is possible to assure the structural completeness of the electrochemical reaction layer  12 , and the testing accuracy thereof is increased accordingly. Furthermore, the width of the side  15  is in a range from 0.1 mm to 3.0 mm, wherein the preferable range is from 0.2 mm to 0.6 mm. The width of the opening  14  is in a range from 0.1 mm to 3.0 mm, wherein the preferable range is from 0.2 mm to 1.2 mm. Since the side  15  is so narrow that it is easy for a fluid sample (not shown) to flow through the side  15  and get contact with the opening  14 . In addition, since some air will be exhausted via the ventilator  131 , the fluid sample will get into the reaction concavity  11  due to the capillarity. It should be noted that the positions and the shapes of the reaction concavity  11  and the cover  13  should not be limited to the disclosures of this embodiment.  
         [0073]     As shown in FIGS.  7 (A)- 7 (B), when a sample (not shown) gets into the reaction concavity  11  through the opening  14 , an electrochemical reaction will happen between the sample and the chemical compositions contained in the electrochemical reaction layer  12 . During the electrochemical reaction, the ventilator  131  is applied to exhaust the redundant air in the reaction concavity  11  so as to maintain the pressure balance between the inner air of the reaction concavity  11  and the outer air thereof and the sample is able to be filled in the reaction concavity  11 . There is a transparent membrane mounted in the window  132  for observing the movement of the sample and the electrochemical reaction in the reaction concavity  11 . Furthermore, some detecting electrodes are able to be located on the electrochemical sensor strip S 2 , if necessary. Nowadays, in general, the electrodes and the metal films are made of one material selected from a group consisting of a copper, a titanium, a nickel, a gold, a platinum, a rhodium, a palladium, a ruthenium, a silver, a chromium, an iron, an aluminum, an iridium and an alloy thereof. In which, a brass, an oxygen-free copper, a bronze, a phosphorized copper, a nickel silver copper and a beryllium copper are the most commonly used materials. Because the end surfaces of the electrodes should have the high sensitivity and stability, and the requirements of the sensitivity and the stability of the other portions of the electrodes are not so strict, only the end surfaces of the electrodes are necessarily formed by the noble metal and the other portions could be formed by general metals or the carbon for reducing the relevant cost. In addition, since the insulating substrate  1  and the reaction concavity  11  are formed integrally via the plastic injection molding, the relevant costs spent on the stacking the elements are reduced.  
         [0074]     Please refer to FIGS.  8 (A)- 8 (B), which are schematic views showing the combination of the sensor and the electrochemical sensor strip according to the second embodiment of the present invention. As shown in FIGS.  7 (A)- 8 (B), when the electrochemical sensor strip S 2  is combined to the sensor  2 , the signal resulting from the electrochemical reaction happening in the electrochemical reaction layer  12  would be transmitted to the sensor  2  via the metal films  1122 ,  1132  and  1142 . And then the sensor  2  will measure the transmitted signal for being figure out the corresponding value. The sensor  2  includes a display  21  for showing the figured out value, a control key for controlling the sensor  2 , and a connecting device  23 .  
         [0075]     Please refer to FIGS.  9 (A)- 9 (C).  FIG. 9 (A) is an exploded view of the disposable electrochemical sensor strip according to the third embodiment of the present invention.  FIG. 9 (B) is a schematic view of the disposable electrochemical sensor strip according to the third embodiment of the present invention.  FIG. 9 (C) is the back view of the disposable electrochemical sensor strip according to the third embodiment of the present invention. As shown in  FIG. 9 (A), the electrochemical sensor strip S 3  includes the insulating substrate  1 , the reaction concavity  11  integrally formed on the insulating substrate  1 , the electrochemical reaction layer  12 , the cover  13  and the uneven side  15 . In which, the cover  13  further includes a ventilator  131  and a window  132 , and the opening  14  would be formed by the cover  13  and the substrate  1  (please refer to  FIG. 9 (B)). In addition, there are two holes  111  located at the bottom of the reaction concavity  11 , and the counter electrode  112  and the working electrode  113  respectively pass through the holes  111 . The reaction concavity  11  further includes the first area  114  and the second area  115 . In general, the width of the second area is ranged from 0.1 to 2.0 mm. In practice, it is general that there will be a height difference between the first area  114  and the second area  115 . The coarseness of the first area  114  (a so-called coarse area) is higher than that of the second area  115  (a so-called polish aera) so that when a liquid (not shown) enters the reaction concavity  11 , it would not easily be leaked out from the first area  114  due to the different surface tensions respectively caused by the first area  114  with the liquid and by the second area  115  with the liquid. Please refer to FIGS.  9 (A) and  9 (C), there are metal films  1121  and  1122  on the end surfaces of the counter electrode  112 , and there are metals films  1131  and  1132  on the end surfaces of the working electrode  113 , wherein the metal films  1121  and  1131  are connected to the electrochemical reaction layer  12  for testing the electrochemical reaction happening in the electrochemical reaction  12 . Since the electrochemical sensor strip S 3  of the present invention has the opening  14  formed by the cover  13  and the substrate  1 , the prior step of scouring for providing an opening is omitted. Therefore, it is possible to assure the structural completeness of the electrochemical reaction layer  12 , and the testing accuracy thereof is increased accordingly. Furthermore, since the substrate  1  has the uneven side  15 , the probability of the whole opening  14  being blocked simultaneously could be effectively reduced and the sample (not shown) could enter the electrochemical reaction layer  12  more easily. It should be noted that the positions and the shapes of the reaction concavity  11  and the cover  13  should not be limited to the disclosures of this embodiment.  
         [0076]     As shown in FIGS.  9 (A)- 9 (B), when a sample (not shown) gets into the reaction concavity  11  through the opening  14 , an electrochemical reaction will happen among the sample and the chemical compositions contained in the electrochemical reaction layer  12 . During the electrochemical reaction, the ventilator  131  is applied to exhaust the redundant air in the reaction concavity  11  so as to maintain the pressure balance between the inner air of the reaction concavity  11  and the outer air thereof and the sample is able to be filled in the reaction concavity  11 . There could be a transparent membrane mounted in the window  132  for observing the movement of the sample and the electrochemical reaction in the reaction concavity  11 . Furthermore, some detecting electrodes are able to be located on the electrochemical sensor strip S 3 , if necessary. Nowadays, in general, the electrodes and the metal films are made of one material selected from a group consisting of a copper, a titanium, a nickel, a gold, a platinum, a rhodium, a palladium, a ruthenium, a silver, a chromium, an iron, an aluminum, an iridium and an alloy thereof. In which, a brass, an oxygen-free copper, a bronze, a phosphorized copper, a nickel silver copper and a beryllium copper are the most commonly used materials. Because the end surfaces of the electrodes should have the high sensitivity and stability, and the requirements of the sensitivity and the stability of the other portions of the electrodes are not so strict, only the end surfaces of the electrodes are necessarily formed by the noble metal and the other portions could be formed by general metals or the carbon for reducing the relevant cost. In addition, since the insulating substrate  1  and the reaction concavity  11  are formed integrally via the plastic injection molding, the relevant costs spent on the stacking the elements are reduced.  
         [0077]     In view of the aforesaid, the present invention provides a novel manufacturing method of the disposable electrochemical sensor strip, wherein the step of scouring is omitted and the relevant cost is saved. In addition, since the electrochemical sensor strip of the present invention is formed by the components with specific geometric structures and no step of scouring is necessary, the structural completeness and the relevant testing accuracy of the electrochemical sensor strip are certainly improved. Therefore, the present invention is extremely suitable for being used in the industrial production.  
         [0078]     While the invention has been described in terms of what is presently considered to be the most practical and preferred embodiment, it is to be understood that the invention needs not be limited to the disclosed embodiments. On the contrary, it is intended to cover various modifications and similar arrangements included within the spirit and scope of the appended claims which are to be accorded with the broadest interpretation so as to encompass all such modifications and similar structures.