TWI425209B - Biochemical test system, measurement device, biochemical test strip and method of the same - Google Patents

Description

Biochemical sensing system, measuring device, biochemical sensing test piece and manufacturing method thereof

The invention relates to a biochemical sensing system, a measuring device, a biochemical sensing test piece and a manufacturing method thereof, in particular to a biochemical sensing system, a measuring device, a biochemical sensing test piece and an automatic identification function thereof. method.

Many self-testing products, such as various biochemical test strips, can be used to measure the amount of biochemical substances in human body fluids, such as sugar, lactic acid, cholesterol, etc. Each batch of biochemical test strips has unique process variations in the production process. Usually these variability parameters require specific compensation to obtain the correct measurement mechanism. Therefore, most biochemical test strips need to be identified or corrected by a code card.

For example, the biodiagnostic device disclosed in U.S. Patent No. 5,366,609 and PCT Patent No. WO 00/33072 uses an extractable read-only memory (ROM) that calibrates voltage values, test times, and variations of test pieces thereof. All relevant parameters are input into the password card, and the test method and parameters required for a measuring device can be reset by using the password card. However, the burning and preparation of the cryptographic card increases labor and manufacturing costs, and it is often the case that the user forgets to insert or insert the wrong cryptographic card, causing calibration errors and errors in data interpretation, or loss of the PIN card.

In order to improve the inconvenience caused by the use of the PIN card, U.S. Patent No. 6,814,844 discloses a test piece using a bar code as a recognition method for bombarding a gold target that has been coated on a substrate by using high energy pulsed laser light. The surface causes the surface of the gold target to evaporate instantaneously to form a bar code pattern. However, such a barcode identification method needs to be detected with an optical component such as a CCD or an LED, and thus the manufacturing cost is high. Moreover, the reproducibility and accuracy of such identification barcodes are limited by the surface material of the target, which not only causes process limitations, but also increases manufacturing costs.

The new patent No. M304662 of the Republic of China discloses another biometric sensing system for password-free card, which is provided with a plurality of buttons for inputting a predetermined English letter or number in the detecting device, and the predetermined English letter or number is set in the test. The package of the test piece (outer box, plastic box, manual, etc.) corresponds to a set of parameters stored in one of the correction units inside the detecting device. When a predetermined English letter or number is input, the corresponding set of parameters will be transmitted to the microprocessor for a corrective action to achieve an accurate test.

The patent application No. 97208206 of the Republic of China also discloses a test piece for a password-free card, which is provided with a plurality of identification elements on one end of the test piece, and a plurality of patterns are combined by forming an electrical connection of 0 or 1 by punching. However, such a detection system has various limitations, such as high precision of punching, high precision of alignment between the sensing terminal of the measuring device and each identification component. In addition, since the image of the test piece is tooth-shaped, there is a risk of breakage when the measuring device is placed.

All of the above-mentioned conventional techniques have limitations such as high cost, complicated process, and/or inconvenient use. Therefore, it is necessary to provide a biochemical test piece which can eliminate the identification or calibration of the cryptographic card and has the convenience of detection.

In view of the problems of the prior art, the present invention provides a biochemical sensing system, a measuring device, which can eliminate the use of a PIN card, is easy to manufacture, reduces operational errors, and can improve the convenience of detection, and has an automatic identification or calibration function. Biochemical test strip and its manufacturing method.

According to an aspect of the invention, a biochemical sensing test piece having an identification function includes an insulating substrate, an electrode group disposed on the insulating substrate, and an identification unit disposed on the insulating substrate. The insulating substrate has a first side and a second side intersecting, wherein the identification unit comprises a plurality of identification contacts, and the plurality of identification contacts are disposed at different distances from the first side of the insulating substrate. The number of identification contacts varies with the length of the second side of the insulating substrate.

According to another aspect of the present invention, there is provided a biochemical sensing test piece having an identification function, comprising an insulating substrate, an electrode group, and an identification unit. The insulating substrate has a first side and a second side intersecting and has a connecting area and a sensing area defined along the second side. The electrode group is disposed on the insulating substrate, wherein one end of the electrode group is located in the connection region. The identification unit is disposed on the insulating substrate, wherein the identification unit comprises a plurality of identification contacts located at different distances from the first side of the insulating substrate and located in the connection region. The connection zone has a variable length, and the number of identification contacts varies with the length of the biochemical test piece.

According to still another aspect of the present invention, a measuring device is provided for use with the aforementioned biochemical test strip. The measuring device comprises: a connector for electrically contacting the biochemical test strip, and a micro processing unit electrically connected to the connector. The connector includes a plurality of connection terminals corresponding to a plurality of identification contacts on the biochemical test strip.

According to still another aspect of the present invention, a measuring device for use with a biochemical test piece is provided. The biochemical test strip has an insulating substrate, an electrode group disposed on the insulating substrate, and an identification unit disposed on the insulating substrate. The identification unit includes a plurality of identification contacts disposed at different distances from the first side of the insulating substrate. The insulating substrate has a second side that intersects the first side, and the number of identification contacts varies with the length of the second side. The measuring device comprises a connector and a micro processing unit. The connector includes a plurality of connection terminals corresponding to the electrode group and the plurality of identification contacts, wherein the plurality of connection terminals are electrically coupled to the electrode group and the plurality of identification contacts, and receive a signal corresponding to the plurality of identification contacts. A microprocessing unit is coupled to the connector to receive signals from the connector.

According to still another aspect of the present invention, a biochemical sensing system comprising a biochemical test strip and a measuring device is provided. The biochemical test strip has an insulating substrate, an electrode group disposed on the insulating substrate, and an identification unit disposed on the insulating substrate. The identification unit includes a plurality of identification contacts, and the plurality of identification contacts are disposed at different distances from the first side of the insulating substrate. The insulating substrate has a second side that intersects the first side, and the number of identification contacts varies with the length of the second side. The measuring device has a micro processing unit and a connector, wherein the connector comprises a plurality of connecting terminals corresponding to the electrode group and the plurality of identification contacts. The plurality of connection terminals are electrically coupled to the electrode group and the plurality of identification contacts, and receive a signal corresponding to the plurality of identification contacts. A microprocessor unit is coupled to the connector to receive signals from the connector.

According to still another aspect of the present invention, a biochemical sensing system comprising a biochemical test strip and a measuring device is provided. The biochemical test strip has an insulating substrate, an electrode group, and an identification unit. The insulating substrate has a first side and a second side intersecting and has a connecting area and a sensing area defined along the second side. The electrode assembly is disposed on the insulating substrate, and one end of the electrode group is located in the connection region. The identification unit is disposed on the insulating substrate and includes a plurality of identification contacts located at different distances from the first side of the insulating substrate and located in the connection region. The connection zone has a variable length and the number of identification contacts varies with variable length. The measuring device has a micro processing unit and a connector, wherein the connector is electrically coupled to the connection region to receive a signal corresponding to the plurality of identification contacts. A microprocessor unit is coupled to the connector to receive signals from the connector.

According to still another aspect of the present invention, a method for manufacturing a biochemical test piece is provided, comprising the steps of: providing an insulating substrate, wherein the insulating substrate defines a connection region and a sensing region; forming an electrode group and An identification unit is disposed on the insulating substrate, wherein the identification unit is at least partially formed in the connection region; an upper layer of the insulating pad is provided to cover a portion of the electrode group, and the upper layer of the insulating pad exposes the connection region and a portion of the sensing region, wherein The exposed portion of the sensing region forms a reaction zone; a reaction layer is provided in the reaction zone; an upper cover is provided to cover the reaction zone; and a portion of the connection zone and a portion are selectively removed according to the type of the biochemical test piece Identification unit.

Other aspects of the invention will be set forth in part in the description which follows. The various aspects of the invention can be understood and attained by the elements and combinations particularly pointed out in the appended claims. It is to be understood that the foregoing general description and the claims

The invention discloses a biochemical sensing system, a measuring device, a biochemical sensing test piece and a method for manufacturing and using the same, which can be identified or calibrated without using a PIN card, which can eliminate the cryptographic card process, convenient operation and prevent forgetting. Errors such as inserting a password card or inserting a wrong password card occur. To make the description of the present invention more detailed and complete, reference is made to the following description in conjunction with the drawings of FIGS. 1 through 13 wherein like reference numerals represent like elements. The apparatus, elements and program steps described in the following examples are merely illustrative of the invention and are not intended to limit the scope of the invention.

1 is an exploded perspective view of a biochemical test strip 100 according to an embodiment of the present invention, wherein a broken line is used to facilitate understanding of the relative positions between the components. The biochemical test strip 100 of the present invention comprises an insulating substrate 110, an electrode group 120, an identification unit 130, an insulating mat high layer 140, and an upper cover 160. The insulating substrate 110 has a first side 116 and a second side 118. The second side 118 defines a connecting area 112 and a sensing area 114. The connecting area 112 is connected to the The measuring device (such as the measuring device 300 of FIG. 3) is configured, and the sensing region 114 is planned to accommodate a sample to be tested. The electrode group 120 includes a plurality of mutually insulated electrical components. In this embodiment, the electrode assembly 120 includes a working electrode 121, a reference electrode 122, and a sensing electrode 123. At least one end of each electrode is located in the connection region 112 for electrically connecting to a measuring device. The identification unit 130 is disposed in the connection region 112 and includes a plurality of identification contacts at different distances from the first side 116 of the insulating substrate 110. In the embodiment shown in FIG. 1 , the identification unit 130 is a linear electrical component including four identification contacts a1 - a4 , and is disposed on the same surface of the insulating substrate 110 together with the electrode group 120 . In general, the number, shape, and number of identification contacts formed on the identification unit 130 correspond to connectors in a measuring device (such as the connector 310 of FIG. 3). However, various adjustments can be made according to the actual application, and the present invention does not limit this. In addition, the identification unit 130 may be disposed on any surface of the insulating substrate 110, and is not limited to be on the same surface as the electrode group 122.

The insulating substrate 110 has electrical insulation, and the material thereof may include, but is not limited to, polyvinyl chloride (PVC), glass fiber (FR-4), polyester, bakelite, polyethylene terephthalate. Ester (PET), polycarbonate (PC), polypropylene (PP), polyethylene (PE), polystyrene (PS), ceramics, and the like.

The material of the electrode group 120 may be any conductive material such as carbon glue, silver glue, copper glue, gold and silver mixed glue, carbon silver mixed glue, or the like and combinations thereof. In one embodiment, the electrode set 120 is composed of a conductive silver paste layer and a conductive carbon powder layer thereon, wherein the conductive carbon powder layer generally has a much larger impedance than the conductive silver paste layer or other metal glue layer. The two ends of the working electrode 121 and the reference electrode 122 are respectively located in the connection region 112 and the sensing region 114 of the insulating substrate 110 to be electrically connected to a measuring device (300 in FIG. 3) and a sample to be tested. In the embodiment shown in FIG. 1 , the sensing electrode 123 is a U-shaped electrode electrically insulated from the working electrode 121 and the reference electrode 122 , and both ends of the sensing electrode 123 are located in the connection region 112 of the insulating substrate 110 . When the biochemical test strip 100 is placed in the measuring device, the sensing electrode 123 will form a loop with the measuring device, thereby starting the measuring device. It should be noted that the present invention does not limit the configuration of the sensing electrode 123 as long as an electrical loop can be formed between the measuring device and the measuring device. In general, as long as the arrangement of the electrodes in the electrode group 120 is as described above, and the electrodes are insulated from each other, the present invention does not limit the arrangement between the electrodes, and does not limit the number of electrodes. Add other electrodes as needed for practical applications.

The identification unit 130 can be a variety of electrically conductive electrical components, such as electrical components having electrical characteristics of the passive components. In an embodiment, the identification unit 130 can be a resistor having the same material as the electrode assembly 120. In another embodiment, the identification unit 130 can include one or more resistors, capacitors, inductors, and/or combinations thereof. The number and arrangement of the identification contacts on the identification unit 130 are not limited. Generally, the identification unit 130 includes at least two identification contacts that are at different distances from the first side 116 of the insulating substrate 110. The connection zone 112 can be removed as needed by the application, and the number of identification contacts located in the connection zone 112 will also vary with the length of the connection zone 112. When the biochemical test strip 100 is placed in a measuring device, the measuring device can detect the number of identifying contacts on the identification unit 130 (or its corresponding electrical characteristics), thereby discriminating the biochemical test piece. The type of 100, and then the corresponding calibration parameters or modes are measured. In other words, the present invention can make the identification unit 130 have a different number of identification contacts by cutting different positions of the connection area 112, so that the measuring device can discriminate the biochemical test piece 100 accordingly.

The insulating pad high layer 140 is placed over the electrode group 120, and the insulating pad high layer 140 includes an opening 141 to expose a portion of the electrode group 120. In general, the opening 141 is sufficient as long as it can expose a portion of the working electrode 121 and a portion of the reference electrode 122, and the present invention does not limit the shape of the opening 141. In addition, the upper layer 140 of the insulating pad exposes the connection region 112 of the insulating substrate 110, so that the identification unit 130 and the electrode group 120 located in the connection region 112 can be connected to a measuring device (such as the measuring device 300 of FIG. 3). Electrically connected. The material of the insulating mat high layer 140 may include, but is not limited to, PVC insulating tape, PET insulating tape, heat drying type insulating varnish or ultraviolet curing type insulating varnish. In addition, in the manufacturing process, the upper surface 140 of the insulating pad that has been cut out of the opening 141 can be placed on the insulating substrate 110 and the electrode group 120, and the position of the connection region 112 of the opening 141 and the insulating substrate 110 can be avoided. The insulating pad high layer 140 is formed over the portion of the insulating substrate 110 and the conductive layer 120 in a printed manner.

The upper cover 160 is placed over the upper layer 140 of the insulating mat and covers the opening 141. The portion between the insulating substrate 110 and the upper cover 160 forms a sampling space (ie, a reaction zone) having a capillary attraction, wherein the sample to be tested can be introduced into the reaction zone by the direction of the arrow in FIG. When the area of the sampling space is fixed, its volume may depend on the thickness of the upper layer 140 of the insulating mat. In general, the thickness of the upper layer 140 of the insulating mat is between about 0.005 mm and about 0.3 mm, although not limited thereto.

The biochemical test strip 100 of the present invention further comprises a reactive layer 150 disposed in the closure 141, which has the ability to uniquely identify biological materials or signals. The material of the reaction layer 150 varies depending on the sample to be tested, and may be, for example, a oxidoreductase or an electron vehicle (such as a ferrous material) for chemical reaction with the sample to be tested. In general, the reaction layer 150 covers at least a portion of the working electrode 121 and the reference electrode 122.

The upper cover 160 of the present invention may be a transparent or translucent material to facilitate observation of whether the opening 141 (ie, the reaction zone) has been filled with the sample, and to prevent the sample from being detected before it is filled, resulting in erroneous measurement results. The lower surface of the upper cover 160 adjacent to the reaction zone may be coated with a hydrophilic material to enhance the capillary action of the inner wall of the reaction zone for more rapid and efficient introduction of the sample into the reaction zone. The upper cover 160 further includes a venting opening 161 corresponding to the opening 141 for discharging the gas in the reaction zone to enhance the capillary action. Generally, the venting opening 161 is adjacent to the inner end of the closing opening 141. The present invention does not limit the shape of the vent 161. For example, the vent 161 may be circular, elliptical, rectangular, diamond-shaped or the like.

2A, 2B, 2C and 3, FIGS. 2A to 2C are biochemical test strips 200a, 200b, and 200c according to different embodiments of the present invention, and FIG. 3 is a biochemical sense corresponding to FIG. 2A-2C. One of the test pieces 200a, 200b, and 200c measures the device 300. The biochemical test strips 200b and 200c illustrated in FIGS. 2B and 2C are respectively the appearance of the biochemical test strip 200a of FIG. 2A after changing the length of the test strip, wherein the broken line indicates the cut portion, and the solid line indicates that the test strip actually exists. Part of it. For convenience of description, FIGS. 2A, 2B, and 2C do not show the upper layer of the insulating mat and the upper cover. Referring to FIG. 2A, the biochemical test strip 200a includes an insulating substrate 210, and a working electrode 221, a reference electrode 222, a sensing electrode 223, and a strip-shaped identification unit 230. In the present embodiment, the identification unit 230 is disposed in the connection region 212 of the insulating substrate 210 and includes four identification contacts a1, a2, a3, and a4 for electrically connecting to the measuring device 300 of FIG. . In addition, one end of each electrode in the connection area 212 has a detection contact a5-a8 for electrically connecting with the measuring device 300, as shown in FIG. 2A. The biosensitivity test pieces 200b and 200c in Figs. 2B and 2C are formed by removing the broken line portions in Figs. 2B and 2C. For example, the dashed portions in FIGS. 2B and 2C can be removed by cutting or other techniques using a stamping process or a machining process.

Referring next to FIG. 3, the measurement device 300 is used in conjunction with the biochemical test strips 200a-200c of FIGS. 2A-2C, and includes a connector 310 and a micro processing unit 320 coupled to the connector 310. The micro-processing unit 320 has a built-in digital data 325, which may be, for example, a correction parameter, a detection mode, or other information. The biochemical test strips 200a-200c are electrically connected to the measuring device 300 through coupling with the connector 310. In this embodiment, the connector 310 includes at least eight connection terminals d1-d8 corresponding to the identification contacts a1-a4 and the detection contacts a5-a8 in the biochemical test strip 200a.

Taking the biochemical test strip 200a of FIG. 2A as an example, when the biochemical test strip 200a is placed in the measuring device 300 in the direction indicated by the arrow in FIG. 3, the working electrode 221, the reference electrode 222, the sensing electrode 223, and the identification unit 230 Each of the contacts a1-a8 will be respectively connected to each of the connection terminals d1-d8 in the connector 310, wherein the connection terminal d1 can provide a grounding function. The connection terminals d7 and d8 of the connector 310 are connected to the detection contacts a7 and a8 of the sensing electrode 223 to form a loop, which can be used to activate the measuring device 300. Compared with the biochemical test piece 200a, the length of the connection region 212 in the biochemical test piece 200b of FIG. 2B is reduced by x1, so when the biochemical test piece 200b is placed in the measuring device 300 of FIG. 3, each electrode is used. The position of the detecting contact a5-a8 connected to the connecting terminal d5-d8 of the connector 310 will be shifted downward by x1 according to the decrease of the length of the connecting area 212, and the connecting terminals d1-d3 in the connector 310 will be respectively tested with the biochemical sense. The identification contacts a2-a4 of the sheet 200b are connected, and the connection terminal d4 is in contact with the non-conductive area under the identification unit 230 of the test strip 200b to form an electrical path. Similarly, since the length of the connection region 212 in the biochemical test piece 200c is reduced by x2, when the biochemical test piece 200c of FIG. 2C is placed in the measuring device 300 of FIG. 3, the detecting contact on each electrode thereof The position of a5-a8 will be shifted downward by x2 in response to the decrease in the length of the connection area 212, and the connection terminals d1-d2 in the connector 310 will be respectively connected to the identification contacts a3-a4 of the biochemical test strip 200c, and the connection terminal d3 And d4 will contact the non-conductive area under the identification unit 230 of the test piece 200c to form an electrical path. Therefore, different biochemical test pieces will form different electrical connections with the connector 310 to generate different identification signals to the micro processing unit 320. The micro-processing unit 320 can identify the identification signal according to the identification signal, and select a calibration parameter or mode corresponding to the signal from the data 325 for measurement. In other words, the embodiment can change the overall electrical characteristics of the identification unit by changing the length of the test piece, thereby changing the electrical connection relationship between the test piece and the measuring device 300, so that the measuring device can distinguish according to this. The type of biochemical test piece. In addition, since the length of the test piece affects the depth in which the test piece is placed in the measuring device 300, it is ensured that the electrodes of the shorter length in the biochemical test piece can be electrically connected to the connection terminals of the measuring device 300. Connected, the portion of each electrode located in the connection area will be reserved for a sufficient length. On the other hand, a space will also be reserved below the identification unit 230 to prevent the connector 310 in the measuring device 300 from erroneously contacting other components on the test strip when the length of the test strip is shortened. In the embodiment shown in FIGS. 2A-2C, when the connection region 212 is cut to change the number of identification contacts, the lengths of the electrodes of the biochemical test strips 200a-200c do not change. However, in other embodiments, the length of each electrode on the biochemical test strip may vary with the length of the joint zone. It should be noted that the present invention does not limit the length, shape, and orientation of the electrodes as long as they can be electrically connected to the measuring device.

Referring again to FIG. 3, the measurement device 300 further includes a display 330 for displaying various measurements, and a power supply 340 for providing the required power. In another embodiment, display 330 and power supply 340 can be external devices and are not included in measurement device 300.

4A and 4B illustrate biochemical sensing test strips 400a and 400b according to other embodiments of the present invention, wherein the detection contacts on the electrodes are not illustrated for convenience of description, but only the identification unit is depicted. Identify the contacts. Referring to FIG. 4A, the biochemical sensing test piece 400a includes an insulating substrate 410a, and a working electrode 421a, a reference electrode 422a, a sensing electrode 423a, and an identification unit 430a. The identification unit 430a includes two insulating layers. Straight strip passive elements 432a and 434a are respectively disposed on two sides of the connection region 412a of the insulating substrate 410a. The passive component 432a includes three identification contacts e1, e2, and e3, and the other passive component 434a includes four identification contacts e4, e5, e6, and e7. In conjunction with the positions of the connection terminals of the connector in the measuring device, the identification contacts on the test piece may be located at the same horizontal position, or may be disposed at different horizontal positions in a staggered manner. By cutting at different positions of the test strip 400a, the positions of the respective identification contacts are correspondingly moved downward, so that the number of identification contacts electrically connected to the measuring device in the identification unit 430a is correspondingly reduced. . In general, the identification unit can include a minimum number of identification contacts: an identification contact for providing a ground function, and an identification contact for forming a path. In addition, the working electrode 421a, the reference electrode 422a, and the sensing electrode 423a are reserved in the connecting region 412a with a sufficient length to ensure that each electrode and measurement can be maintained when the biochemical test strip 400a has a minimum length. Electrical connection between devices. On the other hand, space is also required below the passive components 432a and 434a for insulating contact with the connector of the measuring device when the length of the test strip is shortened.

The biochemical sensing test piece 400b in FIG. 4B includes an insulating substrate 410b, and a working electrode 421b, a reference electrode 422b, a sensing electrode 423b, and an identification unit 430b, wherein the identification unit 430b is insulated and parallel to each other. Three straight strip passive elements 432b, 434b, 436b. The passive component 432b includes four identification contacts fl, f2, f3, and f4, the passive component 434b includes three identification contacts f5, f6, and f7, and the passive component 436b includes four identification contacts f8, f9, f10, and f11. In this embodiment, the identification contacts f4, f7, and f11 are disposed at the same horizontal position, the identification contacts f1 and f8 are disposed at the same horizontal position, the identification contacts f2 and f9 are disposed at the same horizontal position, and the identification contacts are recognized. F3 and f10 are set at the same horizontal position, so that the identification unit 430b can generate at least five different electrical characteristics by cutting at different positions of the test piece, and the measuring device can identify the biochemical test piece type. . In addition, a space having a sufficient length is reserved under the passive components 432b, 434b, and 436b, and the working electrode 421b, the reference electrode 422b, and the sensing electrode 423b are also required to have a sufficient length to ensure that when the length of the test strip is shortened, The test piece and the measuring device can still operate normally.

5A, 5B, 5C, and 5D, FIG. 5A is a biochemical test strip 500a according to another embodiment of the present invention, and FIG. 5B and FIG. 5C are diagrams showing the biochemical test strip 500a of FIG. 5A reduced. The biochemical sensing test pieces 500b and 500c formed after different lengths, and FIG. 5D is a schematic view of one of the measuring devices 570 corresponding to one of the biochemical sensing test pieces 500a-500c of FIGS. 5A-5C. Referring to FIG. 5A, the biochemical sensing test piece 500a includes an insulating substrate 510, and one insulating working electrode 521, a reference electrode 522, a sensing electrode 523, and one of two straight strip passive elements 532 and 534. Unit 530. The biochemical test strip 500a further includes a recess 518 between the two passive components 532 and 534. As shown in FIG. 5A, the passive component 532 includes identification contacts g1, g2, and g3, and the passive component 534 includes identification contacts g4, g5, g6, and g7, and one end of each electrode includes detection contacts g8 and g9, respectively. , g10, and g11, the contacts are used to electrically connect with a measuring device. In this embodiment, the biochemical test strip 500a can be selectively cut along the position z1, z2, z3, or z4, which can cause the identification unit 530 to generate five different electrical characteristics, wherein along the position z1 The cut biochemical test piece 500a will form the biochemical test piece 500b in Fig. 5B, and the biochemical test piece 500a cut along the position z2 will form the biochemical test piece 500c in Fig. 5C.

Referring to FIG. 5D, the connector 570 is used in conjunction with the biochemical sensing test strips 500a-500c of FIGS. 5A-5C, and includes connection terminals h1-h11 corresponding to the contacts g1-g11 in the biochemical test strip 500a and corresponding portions. One of the grooves 518 is a baffle 575. When the biochemical test piece 500a, 500b, or 500c is engaged with the connector 570 in the direction indicated by the arrow of FIG. 5D, the groove 518 can be engaged with the baffle 575 to fix the biochemical test piece 500a, 500b, or 500c. The position of the measuring device. In other words, the depth in which the biochemical test strips 500a, 500b, or 500c are placed in the measuring device is determined by the groove structure 518 and the baffle structure 575 in the corresponding measuring device, regardless of the length of the test piece itself. influences. Therefore, unlike the embodiment shown in FIGS. 2A-2D, the positions of the detecting contacts g8-g11 of the electrodes on the biosensitivity test pieces 500a, 500b, and 500c do not change as the length of the test piece changes. When the biochemical sensing test piece 500a of FIG. 5A is connected to the connector 570, the identification contacts g1-g7 are respectively connected to the connection terminals h1-h7 of the connector 570. When the biochemical test strip 500b of FIG. 5B is connected to the connector 570, the identification contacts g1-g3 and g5-g7 are respectively connected to the connection terminals h1-h3 and h5-h7 of the connector 570, and the connector 570 is The connection terminal h4 forms an open circuit structure. When the biochemical sensing test piece 500c of FIG. 5C is connected to the connector 570, the identification contacts g2-g3 and g5-g7 are respectively connected to the connection terminals h2-h3 and h5-h7 of the connector 570, and the connection of the connector 570 is connected. Terminals h1 and h4 form an open circuit structure. It should be noted that the present invention does not limit the shape and position of the recess 518 and the baffle 575. For example, the recess 518 may be a serrated or stepped joint structure, and the baffle 575 may be of various structures. It suffices that the joint structure can correspond to the structure of the test piece.

6A, 6B, 6C, and 6D, FIG. 6A is a biochemical test strip 600a according to another embodiment of the present invention, and FIG. 6B and FIG. 6C are diagrams showing the biochemical test strip 600a of FIG. 6A reduced. Biochemical sensing test pieces 600b and 600c formed after different lengths, and FIG. 6D is a schematic view of one of the measuring devices 670 corresponding to one of the biochemical sensing test pieces 600a-600c of FIGS. 6A-6C. Referring to FIG. 6A, the biochemical test strip 600a includes an insulating substrate 610, and a working electrode 621, a reference electrode 622, a sensing electrode 623, a strip-shaped identification unit 630, and a stepped structure 618. In this embodiment, the identification unit 630 includes identification contacts i1, i2, i3, and i4 whose positions respectively correspond to different step positions of the stepped structure 618. The biochemical test strip 600b in FIG. 6B is formed by cutting one step of the stepped structure 618 in the biochemical test strip 600a, and the biochemical test strip 600c in FIG. 6C is cut by the biochemical test strip 600a. The second stepped structure 618 is formed by two steps.

Referring to FIG. 6D, the connector 670 is used in conjunction with the biochemical test strips 600a-600c of FIGS. 6A-6C, and includes connection terminals j1-j8 corresponding to the contacts i1-i8 in the biochemical test strip 600a, and Corresponding to a stepped baffle 675 of the stepped structure 618. When the biochemical test strip 600a, 600b, or 600c is engaged with the connector 670 in the direction indicated by the arrow of FIG. 6D, the stepped structure 618 will contact or engage with the baffle 675, thereby fixing the test strip placement measurement. The depth in the device. Therefore, the positions of the detection contacts i5-i8 of the biochemical test strips 600a, 600b, and 600c do not change as the length of the test strip changes. Similarly, similar to the embodiment shown in FIGS. 5A-5D, when the biochemical test strip 600b of FIG. 6B is connected to the connector 670, the connection terminal j1 of the connector 670 forms an open circuit structure, and the biochemical sense of FIG. 6C When the test piece 600c is connected to the connector 670, the connection terminals j1 and j2 of the connector 670 form an open circuit structure.

7A, 7B, 7C, and 7D, FIG. 7A is a biochemical test strip 700a according to another embodiment of the present invention, and FIGS. 7B and 7C are diagrams showing the biochemical test strip 700a of FIG. 7A. The biochemical sensing test pieces 700b and 700c formed after different lengths are reduced, and FIG. 7D is a schematic view of one of the measuring devices 710 corresponding to one of the biochemical sensing test pieces 700a-700c of FIGS. 7A-7C. The biochemical sensing test strips 700a-700c of Figures 7A-7C are similar in structure to the biochemical sensing test strips 600a-600c of Figures 6A-6C, respectively, except that the identification unit 730 is a sawtooth passive element and abuts the stepped structure 718. And set. In this embodiment, the identification contacts 11, 12, 13, and 14 included in the identification unit 730 are respectively disposed corresponding to each of the steps of the stepped structure 718. Referring to FIG. 7D, the connector 770 is used in conjunction with the biochemical test strips 700a-700c of FIGS. 7A-7C, and has a structure similar to that of the connector 670 of FIG. 6D except that the connection terminals m1-m4 are adjacent to a step file. A plate 775 is provided to correspond to the identification contacts 11-14 in the biochemical test strip 700a. The functions of the other elements of Figures 7A-7D are similar to the corresponding elements of Figures 6A-6D and will not be described again. As can be seen from the above embodiments, the identification unit of the present invention can include passive elements of various shapes, such as straight strips, steps, waves, arcs, or ridges, and the like.

FIG. 8 is an exploded perspective view of a biochemical sensing test strip 800 according to another embodiment of the present invention, including an insulating substrate 810, an electrode group 820, an identification unit 830, an insulating mat high layer 840, and a reactive layer 850. And an upper cover 860 having a venting opening 861. The insulating substrate 810 has a first side 816 and a second side 818 that intersect, wherein a connecting region 812 and a sensing region 814 having different functions can be defined along the second side 818. Comparing the two embodiments shown in FIG. 1 and FIG. 8, the length of the first side 816 of the biochemical test strip 800 of FIG. 8 is greater than the length of the second side 818, and the first side 116 of the biochemical test strip 100 of FIG. The length is less than the length of the second side 118.

In this embodiment, the electrode assembly 820 includes a plurality of mutually insulated working electrodes 821 and reference electrodes 822, wherein the two ends of the working electrode 821 and the reference electrode 822 are respectively located in the connection region 812 and the sensing region 814 to respectively The measuring device (1100 of FIG. 11) and a sample to be tested are electrically connected. The identification unit 830 is disposed in the connection region 812 of the insulating substrate 810 and includes straight strip passive elements 831 and 832 disposed on two sides of the electrode group 820. In general, the passive components 831 and 832 can each include a plurality of identification contacts at different distances from the first side 816 of the insulating substrate 810 for electrically connecting to a measuring device. In this embodiment, the passive component 831 includes three identification contacts n1, n2, and n3, and the passive component 832 also includes three identification contacts n4, n5, and n6. In addition, one end of each electrode located in the connection region 812 also has detection contacts n7 and n8 for electrically connecting to a measuring device. The functions of the other elements of FIG. 8 are similar to the corresponding elements of FIG. 1, and therefore will not be described again.

Referring to FIG. 8, a part of the connection area 812 can be selectively removed according to the type or batch of the test piece, so as to change the number of identification contacts included in the identification unit 830, so that the identification unit 830 can generate various types. Electrical characteristics. In general, different positions of the connection region 812 can be cut along the direction parallel to the first side 816 to adjust the length of the connection region 812 to adjust the number of identification contacts. In this embodiment, the locations of the sensing contacts n7 and n8 on the electrode set 820 will vary with the length of the connection region 812. In addition, referring to FIG. 8, since no other element is formed on the right half of the insulating substrate 810, the right half of the test piece can be used as a hand-held portion for the user to hold, which increases the convenience of operation.

FIG. 9 is an exploded perspective view of a biochemical sensing test strip 900 according to another embodiment of the present invention, including an insulating substrate 910, an electrode group 920, an identification unit 930, an insulating mat high layer 940, and a reactive layer 950. And an upper cover 960 having a venting opening 961. The insulating substrate 910 has a first side 916 and a second side 918 intersecting, wherein a connecting area 912 and a sensing area 914 having different functions can be defined along the second side 918. The identification unit 930 includes two straight strip passive elements 931 and 932, and unlike the embodiment shown in FIG. 8, the passive elements 931 and 932 can be located in the connection area 912 and the sensing area 914 at the same time. In this embodiment, the passive component 931 includes the identification contacts p1-p3, the passive component 932 includes the identification contacts p4-p6, and the working electrode 921 and the reference electrode 922 respectively include detection contacts p7 and p8, respectively. Electrically connected to a measuring device. Generally, each of the identification contacts and the detection contacts are located in the connection area 912, and the number of identification contacts varies with the length of the connection area 912. It is worth mentioning that the upper layer 940 of the insulating pad only needs to be able to define a reaction zone in the sensing area 914 that can accommodate the sample to be tested, and the invention does not limit its shape and size.

10A, 10B, 10C and FIG. 11, FIGS. 10A to 10C are biochemical test pieces 1000a, 1000b, and 1000c according to different embodiments of the present invention, and FIG. 11 is a biochemical sense corresponding to FIGS. 10A-10C. The measuring device 1100 is one of the test pieces 1000a, 1000b, and 1000c. Referring to FIG. 10A, the biochemical test strip 1000a includes an insulating substrate 1010, an electrode group 1020, an identification unit 1030, and an insulating mat high layer 1040. The electrode group 1020 includes a working electrode 1021 and a reference electrode 1022 that are insulated from each other, and the identification unit 1030 includes passive elements 1031 and 1032. The insulating pad high layer 1040 covers a portion of the insulating substrate 1010, wherein the insulating substrate 1010 is not formed by a portion of the insulating pad upper layer 1040 to form a connecting region 1012 and a reaction region 1041. The identification contacts q1-q7 on the passive components 1031 and 1032 and the detection contacts q8-q9 on the electrodes are all located in the connection region 1012 for electrically connecting with the measuring device 1100 of FIG. In this embodiment, except that the identification contacts q1 and q4 are disposed at the same horizontal position, the other identification contacts q2-q3 and q5-q7 are disposed at different horizontal positions in a staggered manner. The biochemical sensing test pieces 1000b and 1000c shown in Figs. 10B and 10C are the same as the biochemical sensing test piece 1000a of Fig. 10A, respectively, after changing the length of the test piece, wherein the broken line indicates the cut portion, and the solid line indicates that the test piece actually exists. Part of it. The dotted line portions in FIGS. 10B and 10C can be removed by cutting or the like using a stamping process or a machining process.

Referring to FIG. 11, the measuring device 1100 is used in conjunction with the biochemical sensing test strips 1000a-1000c of FIGS. 10A-10C, and includes a connector 1110 coupled to a micro processing unit 1120 of the connector 1110 for display. A display 1130 for various measurements, and a power supply 1140 for providing the required power, wherein the microprocessor unit 1120 has a digital data 1125 built in. In this embodiment, the connector 1110 includes at least nine connection terminals r1-r9 corresponding to the identification contacts q1-q7 and the detection contacts q8-q9 in the biochemical test strip 1000a, wherein the connection terminal r4 is provided. A grounding function.

When the biochemical test strips 1000a-1000c of FIGS. 10A-10C are joined to the connector 1110 in the direction indicated by the arrow in FIG. 11, the length of the test strip will affect the depth of the test strip placed in the measuring device 1100, thereby affecting The form of connection between the connectors 1110. For example, when the biochemical test piece 1000a is placed in the measuring device 1100, the identification contacts q1-q7 are respectively connected to the connection terminals r1-r7 in the connector 1110, and the detection contacts q8 on the respective electrodes -q9 will be connected to the connection terminals r8-r9 in the connector 1110, respectively. On the other hand, when the biochemical sensing test piece 1000b of FIG. 10B is placed in the measuring device 1100 of FIG. 11, the identification contact q1 on the test piece 1000b for connecting with the connector 1110 is required in response to the decrease in the length of the connecting portion 1012. The position of -q7 and the detection contact q8-q9 will also move down. In this embodiment, the position of the identification contact q7 will be moved down to the upper layer 1040 of the insulating mat to form a path with the connection terminal r7 of the connector 1110. Similarly, when the biochemical test piece 1000c of FIG. 10C is placed in the measuring device 1100 of FIG. 11, the positions of the identification contacts q1-q7 and the detecting contacts q8-q9 are further moved downward, so that the contact q3 is recognized. The position of q7 and the position of q7 are moved down to the upper layer 1040 of the insulating pad to form a via. In other words, the connection terminals r3 and r7 in the connector 1110 corresponding to the identification contacts q3 and q7 will form an open circuit configuration. Therefore, in this embodiment, the length of the test strip can be changed, thereby changing the electrical connection relationship between the test strip and the measuring device 1100 to generate different paths and open signals for the micro processing unit 1120 to identify the test strip type.

12A, 12B, and 12C show biochemical test strips 1200a, 1200b, and 1200c having different identification unit structures according to other embodiments of the present invention. In the embodiment shown in FIG. 12A, the biochemical test strip 1200a includes a working electrode 1221, a reference electrode 1222, and an identification unit 1230a, wherein the identification unit 1230a includes four mutually insulated straight strip passive elements 1231a, 1232a, 1233a, And 1234a, which are respectively disposed in the connection region 1212 of the insulating substrate 410a. In the embodiment shown in FIG. 12B, the identification unit 1230b of the biochemical test strip 1200b includes two mutually insulated straight strip passive elements 1231b and 1232b, wherein the passive elements 1231b and 1232b are simultaneously located in the connection area 1212 and the sensing area. 1214. In the embodiment shown in FIG. 12C, the identification unit 1230c of the biochemical test strip 1200c includes four mutually insulated straight strip passive elements 1231c, 1232c, 1233c, and 1234c, which are simultaneously located in the connection region 1212 and the sensing region. 1214. As can be seen from FIGS. 12A-12C, the identification unit of the present invention can include various numbers of passive components, and the distribution manner of each passive component and the number and location of the identification contacts included therein can be performed according to actual application requirements. Various adjustments.

Figure 13 is a flow chart showing a method of manufacturing a biochemical test strip according to an embodiment of the present invention. First, in step S1300, an insulating substrate is provided, which defines a connection region and a sensing region. Next, an identification unit and an electrode group including at least two mutually insulated electrodes are formed on the insulating substrate in step S1310. The identification unit can be completely distributed in the connection area, or can be located in the connection area and the sensing area at the same time. The identification unit may include one or more passive components, and each passive component may include more than one identification contact. Generally, the identification contacts included in the identification unit are distributed in the connection area. The identification unit and the electrode group can be, for example, screen printing, imprinting, thermal transfer printing, spin coating, or ink-jet printing. The technology is formed on an insulating substrate. In an embodiment of the invention, the electrode assembly includes a reference electrode and a working electrode that are insulated from each other. In another embodiment of the invention, the electrode assembly includes a reference electrode, a working electrode, and a sensing electrode that are insulated from each other. Next, in step S1320, an upper portion of the insulating pad is provided to cover a portion of the electrode group, wherein the upper portion of the insulating pad has an opening in a portion corresponding to the sensing region of the insulating substrate, the opening exposing a portion of the electrode group to form a reaction region . In addition, the upper layer of the insulating pad does not cover the connection area of the insulating substrate, so the identification unit and part of the electrode group located in the connection area will not be covered by the upper layer of the insulating pad, but can be electrically connected to a measuring instrument. The manufacturing method of the upper layer of the insulating pad may be that the upper layer of the insulating pad which has been cut out is placed on the insulating substrate and the electrode group, and the position of the connection region of the opening and the insulating substrate may be avoided by printing, and directly on the insulating substrate. The upper surface of the insulating mat is formed. Next, in step S1330, a reaction layer is provided in the reaction zone for chemical reaction with the sample, wherein the material of the reaction layer may vary depending on the sample to be tested. In step S1340, an upper cover is provided on the upper layer of the insulating pad, which covers at least the reaction zone, so that the reaction zone between the insulating substrate and the upper cover forms a sampling space with capillary attraction. In addition, the surface of the upper cover may also be coated with a hydrophilic material, and the surface coated with the hydrophilic material may face downward to contact the upper layer of the insulating mat. Next, in step S1350, a single biochemical test piece profile is formed using techniques such as a stamping process or a mechanical processing process, and the portion can be selectively removed depending on the batch, model, or function of the test piece. The connection area and the portion of the identification unit located thereon change the length of the test piece and also change the number of identification contacts included in the identification unit. It can be seen from the foregoing embodiments that the length of the test piece may refer to the length of the longer side of the test piece, and may also refer to the length of the shorter side of the test piece, depending on the position and relative relationship of the components on the test piece. In another embodiment, a groove, a stepped structure, or other specific shaped structure may be cut in the connection region of the substrate in conjunction with the shape and position of the identification unit.

The identification unit of the present invention can change the electrical characteristics by changing the length of the test piece, so that the measuring device can detect the electrical characteristics and recognize the type of the test piece, and can be used to specify the built in the measuring device. The data is used to perform a corrective action, wherein the measuring device has built-in correction parameters, detection modes, or other information corresponding to different electrical characteristics of the identification unit on the test strip. The biochemical test strip disclosed by the invention not only achieves the purpose of not requiring a password card, but also reduces the manufacturing cost of the password card, improves the convenience of detection, and avoids the loss of human operation.

The above is only the preferred embodiment of the present invention, and is not intended to limit the scope of the present invention; all other equivalent changes or modifications which are not departing from the spirit of the present invention should be included in the following. Within the scope of the patent application.

100. . . Biochemical test strip

110. . . Insulating substrate

112. . . Connection area

114. . . Sensing area

116. . . First side

118. . . Second side

120. . . Electrode group

121. . . Working electrode

122. . . Reference electrode

123. . . Sense electrode

130. . . Identification unit

140. . . Insulation pad

141. . . Opening

150. . . Reaction layer

160. . . Upper cover

161. . . Vent

200a, 200b, 200c. . . Biochemical test strip

210. . . Insulating substrate

212. . . Connection area

221. . . Working electrode

222. . . Reference electrode

223. . . Sense electrode

230. . . Identification unit

300. . . Measuring device

310. . . Connector

320. . . Micro processing unit

325. . . Digital data

330. . . monitor

340. . . power supply

400a, 400b. . . Biochemical test strip

410a, 410b. . . Insulating substrate

412a, 412b. . . Connection area

421a, 421b. . . Working electrode

422a, 422b. . . Reference electrode

423a, 423b. . . Sense electrode

430a, 430b. . . Identification unit

432a, 432b, 434a, 434b, 436b. . . Passive component

500a, 500b, 500c. . . Biochemical test strip

510. . . Insulating substrate

518. . . Groove

521. . . Working electrode

522. . . Reference electrode

523. . . Sense electrode

530. . . Identification unit

532, 534. . . Passive component

570. . . Connector

575. . . Baffle

600a, 600b, 600c. . . Biochemical test strip

618. . . Stepped structure

630. . . Identification unit

670. . . Connector

675. . . Stepped baffle

700a, 700b, 700c. . . Biochemical test strip

718. . . Stepped structure

730. . . Identification unit

770. . . Connector

775. . . Stepped baffle

800. . . Biochemical test strip

810. . . Insulating substrate

812. . . Connection area

814. . . Sensing area

816. . . First side

818. . . Second side

820. . . Electrode group

821. . . Working electrode

822. . . Reference electrode

830. . . Identification unit

831, 832. . . Passive component

840. . . Insulation pad

850. . . Reaction layer

860. . . Upper cover

861. . . Vent

900. . . Biochemical test strip

910. . . Insulating substrate

912. . . Connection area

914. . . Sensing area

916. . . First side

918. . . Second side

920. . . Electrode group

921. . . Working electrode

922. . . Reference electrode

930. . . Identification unit

931, 932. . . Passive component

940. . . Insulation pad

950. . . Reaction layer

960. . . Upper cover

961. . . Vent

1000a, 1000b, 1000c. . . Biochemical test strip

1010. . . Insulating substrate

1012. . . Connection area

1020. . . Electrode group

1021. . . Working electrode

1022. . . Reference electrode

1030. . . Identification unit

1031, 1032. . . Passive component

1040. . . Insulation pad

1041. . . Reaction zone

1100. . . Measuring device

1110. . . Connector

1120. . . Micro processing unit

1125. . . Digital data

1130. . . monitor

1140. . . power supply

1200a, 1200b, 1200c. . . Biochemical test strip

1212. . . Connection area

1214. . . Sensing area

1221. . . Working electrode

1222. . . Reference electrode

1230a, 1230b, 1230c. . . Identification unit

1231a, 1232a, 1233a, 1234a. . . Passive component

1231b, 1232b. . . Passive component

1231c, 1232c, 1233c, 1234c. . . Passive component

A1-a4. . . Identification contact

A5-a8. . . Detection contact

D1-d8. . . Connection terminal

E1-e7. . . Identification contact

F1-f11. . . Identification contact

G1-g7. . . Identification contact

G8-g11. . . Detection contact

H1-h11. . . Connection terminal

I1-i4. . . Identification contact

I5-i8. . . Detection contact

J1-j8. . . Connection terminal

L1l14. . . Identification contact

K1-k3. . . position

M1-m4. . . Connection terminal

N1-n6. . . Identification contact

N7-n8. . . Detection contact

P1-p6. . . Identification contact

P7-p8. . . Detection contact

Q1-q7. . . Identification contact

Q8-q9. . . Detection contact

R1-r9. . . Connection terminal

X1, x2. . . length

Y1, y2. . . length

Z1, z2, z3, z4. . . position

The invention will be more fully understood and appreciated from the following detailed description of the embodiments of the invention.

1 is an exploded perspective view of a biochemical test strip according to an embodiment of the invention;

2A to 2C are biochemical test strips according to various embodiments of the present invention;

Figure 3 is a measuring device corresponding to the biochemical sensing test piece of Figures 2A-2C;

4A and 4B are biochemical test strips according to other embodiments of the present invention;

FIG. 5A is a biochemical test piece according to another embodiment of the present invention; FIG.

5B and FIG. 5C are schematic diagrams showing the biochemical test piece after reducing the biochemical test piece of FIG. 5A by different lengths;

5D is a schematic view of a connector corresponding to the biochemical sensing test piece of FIGS. 5A-5C;

6A is a biochemical test piece according to another embodiment of the present invention;

6B and FIG. 6C are schematic diagrams showing the biochemical test piece after reducing the biochemical test piece of FIG. 6A by different lengths;

6D is a schematic view of a connector corresponding to the biochemical sensing test piece of FIGS. 6A-6C;

7A is a biochemical test strip according to still another embodiment of the present invention;

7B and FIG. 7C are schematic diagrams showing the biochemical test piece after reducing the biochemical test piece of FIG. 7A by different lengths;

7D is a schematic view of a connector corresponding to the biochemical sensing test piece of FIGS. 7A-7C;

FIG. 8 is an exploded perspective view of a biochemical test strip 800 according to another embodiment of the present invention; FIG.

FIG. 9 is an exploded perspective view of a biochemical test strip 900 according to another embodiment of the present invention; FIG.

10A to 10C are biochemical test strips according to various embodiments of the present invention;

Figure 11 is a measuring device corresponding to the biochemical sensing test piece of Figures 10A-10C;

12A, 12B, and 12C are biochemical test strips having different identification unit structures according to other embodiments of the present invention;

Figure 13 is a flow chart showing a method of manufacturing a biochemical test strip according to an embodiment of the present invention.

100. . . Biochemical test strip

110. . . Insulating substrate

112. . . Connection area

114. . . Sensing area

116. . . First side

118. . . Second side

120. . . Electrode group

121. . . Working electrode

122. . . Reference electrode

123. . . Sense electrode

130. . . Identification unit

140. . . Insulation pad

141. . . Opening

150. . . Reaction layer

160. . . Upper cover

161. . . Vent

A1-a4. . . Identification contact

Claims (48)

A biochemical sensing test piece having an identification function, comprising: an insulating substrate having a first side and a second side intersecting; an electrode group disposed on the insulating substrate; and an identification unit disposed on the insulating layer On the substrate, the identification unit includes a plurality of identification contacts, and the plurality of identification contacts are disposed at different distances from the first side of the insulating substrate; wherein the identification unit comprises one or more resistors and capacitors And an inductance, or any combination thereof; and the number of the identification contacts is different according to a length of one of the second sides; wherein a part of the identification unit is located in the connection area, and part of the identification unit is located In the sensing area, when a part of the connection area and a portion of the identification unit located thereon are selectively removed, the length of the test piece is changed, and the identification contact of the identification unit is also changed. Quantity. The biochemical test strip of claim 1, wherein the identification unit is in the form of a strip, a step, a wave, an arc, or a dome. The biochemical test strip of claim 1, wherein the length of the second side is adjusted by cutting the biochemical test piece by a stamping process or a machining process. The biochemical sensing test piece according to claim 1, wherein the electrode group and the identification unit are disposed on a surface of one of the insulating substrates. The biochemical sensing test piece according to claim 1, wherein the electrode assembly is disposed on a first surface of the insulating substrate, and the identification unit is disposed on a second surface of the insulating substrate different from the first surface on. The biochemical test strip of claim 1, further comprising: a high-rise insulating layer covering a portion of the insulating substrate, wherein the insulating substrate is not covered by the high-rise portion of the insulating mat to form a connecting region and a reaction region. And the plurality of identification contacts are located in the connection region; a reaction layer is disposed in the reaction zone, wherein the reaction layer comprises an oxidoreductase; and an upper cover is disposed on the upper layer of the insulating pad and covers the In the reaction zone, the upper cap has a vent corresponding to one of the reaction zones. The biochemical test strip of claim 6, wherein the electrode group comprises a working electrode and a reference electrode insulated from each other, and the reactive layer covers at least a portion of the working electrode and the reference electrode. The biochemical sensing test piece of claim 7, wherein the electrode group further comprises a sensing electrode, the sensing electrode, the working electrode, and the reference electrode are insulated from each other, and both ends of the sensing electrode are located In the connection area. The biochemical test strip of claim 1, wherein the first side of the insulating substrate has a zigzag shape, a step shape, or a groove shape. The biochemical sensing test piece according to claim 1, wherein the electrode group and the material of the identification unit are selected from the group consisting of carbon glue, silver glue, copper glue, gold and silver mixed glue, carbon silver mixed glue and Its mixture. The biochemical test strip of claim 1, wherein the length of the second side is greater than a length of the first side. The biochemical test strip of claim 1, wherein the length of the second side Less than one of the lengths of the first side. The biochemical test strip of claim 1, wherein one of the electrode groups is fixed in length. The biochemical test strip of claim 1, wherein one of the lengths of the electrode group differs depending on the length of the second side. A biochemical sensing test piece having an identification function, comprising: an insulating substrate having a first side and a second side intersecting, and having a connecting region and a sensing region defined along the second side; an electrode And an identification unit disposed on the insulating substrate, wherein the identification unit comprises a distance from the first side of the insulating substrate a plurality of identification contacts located at different distances and located in the connection region; wherein the identification unit comprises one or more resistors, capacitors, inductors, or any combination thereof; and wherein the connection region has a variable length, and the identification The number of contacts varies according to the variable length; a part of the identification unit is located in the connection area, and part of the identification unit is located in the sensing area, when the part is selectively removed When the connection area and the portion of the identification unit located thereon are changed, the length of the test piece is changed, and the number of identification contacts included in the identification unit is also changed. The biochemical test strip of claim 15, wherein the identification unit is in the form of a strip, a step, a wave, an arc, or a dome. The biochemical test strip of claim 15, wherein the variable length is one of the lengths The inch is adjusted by cutting the biochemical test piece by a stamping process or a machining process. The biochemical sensing test piece according to claim 15, wherein the electrode group and the identification unit are disposed on a surface of one of the insulating substrates. The biochemical sensing test piece of claim 15, wherein the electrode assembly is disposed on a first surface of the insulating substrate, and the identification unit is disposed on a second surface of the insulating substrate different from the first surface on. The biochemical test strip of claim 15 further comprising: a high-rise insulating layer disposed on the insulating substrate, the high-level insulating layer exposing the connecting region and a portion of the sensing region, wherein the exposed portion is exposed The sensing region of the portion forms a reaction zone; a reaction layer is disposed in the reaction zone, wherein the reaction layer comprises an oxidoreductase; and an upper cover is disposed on the upper layer of the insulating mat and covers the reaction zone The upper cover has a vent corresponding to one of the reaction zones. The biochemical test strip of claim 20, wherein the electrode set comprises a working electrode and a reference electrode insulated from each other, and the reactive layer covers at least a portion of the working electrode and the reference electrode. The biochemical sensing test piece of claim 21, wherein the electrode group further comprises a sensing electrode, the sensing electrode, the working electrode, and the reference electrode are insulated from each other, and both ends of the sensing electrode are located In the connection area. The biochemical test strip of claim 15, wherein the first side of the insulating substrate has a zigzag shape, a step shape, or a groove shape. The biochemical sensing test piece according to claim 15, wherein the electrode group and the material of the identification unit are selected from the group consisting of carbon glue, silver glue, copper glue, gold and silver mixed glue, carbon silver mixed glue and Its mixture. The biochemical test strip of claim 15, wherein one of the second sides has a length greater than a length of the first side. The biochemical test strip of claim 15, wherein one of the second sides has a length that is less than a length of the first side. The biochemical test strip of claim 15, wherein one of the electrode sets is fixed in length. The biochemical test strip of claim 15, wherein one of the lengths of the electrode group differs depending on the variable length of the connection region. A measuring device for use with a biochemical sensing test piece, wherein the biochemical sensing test piece has an insulating substrate including a first side and a second side intersecting, an electrode group disposed on the insulating substrate, And an identification unit disposed on the insulating substrate, wherein the identification unit includes one or more resistors, capacitors, inductors, or any combination thereof, and the identification unit includes a plurality of identification contacts, and the plurality of identification contacts The method is disposed at different distances from the first side of the insulating substrate, wherein the number of the identification contacts is different according to a length of one of the second sides, and a part of the identification unit is located in the connection area And a part of the identification unit is located in the sensing area, and when the part of the connection area and the part of the identification unit located thereon are selectively removed, the length of the test piece is changed, and also changes The identification unit includes the number of identification contacts, and the measuring device comprises: a connector comprising a plurality of connection terminals corresponding to the electrode group and the plurality of identification contacts, wherein the plurality of connection terminals are electrically coupled to the electrode group and the plurality of identification contacts, and receive a plurality of corresponding contacts Identifying one of the contacts; and a micro processing unit coupled to the connector to receive the signal from the connector. The measuring device of claim 29, wherein the micro processing unit has a plurality of correction parameters or a plurality of detection modes, and the processing unit selects one of the correction parameters or one of the detection modes according to the received signal. The measuring device of claim 29, wherein the position of the electrode group electrically coupled to the connecting terminal is different depending on the length of the second side of the insulating substrate. The measuring device of claim 29, wherein the connector further comprises a baffle for fixing a position where the electrode group is electrically coupled to the connecting terminal. A measuring device for use with the biochemical test strip according to claim 1 or 15, the measuring device comprising: a connector for electrically contacting the biochemical test strip; and a micro processing And a unit electrically connected to the connector; wherein the connector includes a plurality of connection terminals corresponding to the plurality of identification contacts on the biochemical test strip. A biochemical sensing system comprising: a biochemical sensing test piece having an insulating substrate including a first side and a second side intersecting, an electrode group disposed on the insulating substrate, and being disposed on the insulating substrate An identification unit, wherein the identification unit comprises a Or a plurality of resistors, capacitors, inductors, or any combination thereof, and the identification unit includes a plurality of identification contacts, and the plurality of identification contacts are disposed at different distances from the first side of the insulating substrate, wherein The number of the identification contacts is different according to the length of one of the second sides, and a part of the identification unit is located in the connection area, and part of the identification unit is located in the sensing area, when the selectivity When the portion of the connection area and the portion of the identification unit located thereon are removed, the length of the test piece is changed, and the number of identification contacts included in the identification unit is also changed; and a measuring device having a micro processing unit and a connector, wherein the connector includes a plurality of connection terminals corresponding to the electrode group and the plurality of identification contacts, wherein the plurality of connection terminals are electrically coupled to the electrode group and the plurality of identifications And receiving a signal corresponding to the plurality of identification contacts, the microprocessor unit being coupled to the connector to receive the signal from the connector. The biochemical sensing system of claim 34, wherein the length of the second side is adjusted by cutting the biochemical test piece by a stamping process or a machining process. The biochemical sensing system of claim 34, wherein the electrode group comprises a working electrode and a reference electrode insulated from each other, and the working electrode and the position of the reference electrode electrically coupled to the connecting terminal are associated with the insulating substrate The length of the second side is different and different. The biochemical sensing system of claim 34, wherein the electrode group comprises a working electrode insulated from each other, a reference electrode, and a sensing electrode, the working electrode, the reference electrode, and the sensing electrode are connected thereto The position of the electrical coupling between the terminals is different according to the length of the second side of the insulating substrate, and wherein two of the plurality of connecting terminals of the connector form an electrical property with the sensing electrode Loop. The biochemical sensing system of claim 34, wherein the first side of the insulating substrate comprises a bonding structure, and the connector comprises a baffle corresponding to the bonding structure, wherein the plurality of connecting terminals are electrically coupled To the electrode group and the plurality of identification contacts, the bonding structure is in contact with the baffle to fix a position where the electrode group is electrically coupled to the connection terminal. The biochemical sensing system of claim 38, wherein the engaging structure has a zigzag shape, a stepped shape, or a groove shape. The biochemical sensing system of claim 34, wherein the micro processing unit has a plurality of calibration parameters or a plurality of detection modes, and the processing unit selects one of the calibration parameters or one of the detection modes according to the received signal. . A biochemical sensing system includes: a biochemical sensing test piece having an insulating substrate, an electrode group, and an identification unit having a first side and a second side intersecting and having a second side along the second side And defining one of the connection region and the sensing region, the electrode group is disposed on the insulating substrate and one end of the electrode group is located in the connection region, wherein the identification unit comprises one or more resistors, capacitors, inductors, or In any combination, the identification unit is disposed on the insulating substrate and includes a plurality of identification contacts located at different distances from the first side of the insulating substrate and located in the connection region, wherein the connection region has a variable length And the number of the identification contacts is different according to the variable length, and a part of the identification unit is located in the connection area, and part of the identification unit is located in the sensing area, when selectively When the portion of the connection area and the portion of the identification unit located thereon are removed, the length of the test piece is changed, and the number of identification contacts included in the identification unit is also changed; a measuring device having a micro processing unit and a connector, wherein the connector is electrically coupled to the connection region to receive a signal corresponding to the plurality of identification contacts, and the micro processing unit is coupled to the connection To receive the signal from the connector. A method for manufacturing a biochemical test piece, comprising the steps of: providing an insulating substrate, the insulating substrate comprising a connecting region and a sensing region; forming an electrode group and an identifying unit on the insulating substrate, wherein the identifying unit The identification unit including one or more resistors, capacitors, inductors, or any combination thereof, and at least a portion thereof, is formed in the connection region, and a portion of the identification unit is located in the sensing region; an insulating pad is provided The upper layer covers a portion of the electrode set, the upper layer of the insulating pad exposing the connecting region and a portion of the sensing region, wherein the exposed sensing portion of the portion forms a reaction region; providing a reaction layer in the reaction Providing an upper cover to cover the reaction zone; and selectively removing a portion of the connection zone and a portion of the identification unit according to the type of the biochemical test piece, thereby changing the length of the test piece and also changing The identification unit contains the number of identification contacts. The method of claim 42, wherein the step of selectively cutting a portion of the connection region and the portion of the identification unit further comprises cutting the electrode assembly. The method of claim 42, wherein the electrode group and the identification unit are formed on the insulating substrate using screen printing, stamping, thermal transfer, spin coating, or inkjet printing. The method of claim 42, wherein the step of forming the electrode group comprises forming a reference electrode and a working electrode that are insulated from each other. The method of claim 42, wherein the step of forming the electrode group comprises forming a reference electrode, a working electrode, and a sensing electrode that are insulated from each other. The method of claim 42, wherein the acutting step is performed using a stamping process or a machining process. The method of claim 42, further comprising: coating a hydrophilic material on a surface of the upper cover.