CN102192929A - Electrochemical biosensing test paper and method for identifying biosensor device - Google Patents

Abstract

The invention discloses an electrochemical biological sensing test paper and a method for identifying a matched biosensor device by using the same. When the electrochemical biological sensing test paper provided by the invention is connected with a matched biosensor device, the parameter identification element can be identified to enable the device to automatically select a group of correction parameter values corresponding to the batch of test paper, so that a parameter correction step executed by a user is omitted, the whole measurement procedure is simplified, and inaccurate detection results caused by omission or operation errors of the user are avoided. The invention also discloses a method for identifying a biosensor device by using the electrochemical biosensing test paper. The invention utilizes the length proportion relation of the variable length area in each test paper conducting layer as the basis for identifying the matched biosensor device.

Description

Electrochemical biosensing test paper and method for identifying biosensor device

technical field

The invention relates to an electrochemical biosensing test paper, in particular to an electrochemical biosensing test paper which is provided with a parameter identification element at one end of the back side of the substrate so as to save the user from performing parameter calibration steps. The present invention also relates to a method for identifying a matched biosensor device, in particular to a method for identifying the matched biosensor device by utilizing the length proportional relationship of each of the variable length regions in the conductive layer of the electrochemical biosensing test paper method.

Background technique

Due to the advancement of science and technology, many tests that used to be carried out in hospitals are now mostly moving towards home testing. At present, there are many biosensor strips on the market that can be discarded after one use and are used for home operation. They are suitable for non-professionals and home care. The sensor device (biosensing device) can measure the correct measurement value.

Taking blood glucose detection technology as an example, due to the advantages of convenient operation and timely inspection, blood glucose meters have become one of the most commonly used point of care test (POCT) medical devices in clinical and home care operations in recent years. According to the statistical report of the Diabetes Association of Taiwan, China, the analysis principle of the current commercially available blood glucose meter is mainly to use the principle of electrochemical (Amperometric electrochemistry) for testing; when the glucose in the blood reacts electrochemically with the enzyme on the electrochemical biosensing test paper Afterwards, through the release of mediator electrons, the current change is converted into a blood glucose concentration value by the blood glucose meter.

The known electrochemical biosensing test paper has a substrate, a conductive layer, a reaction zone and an upper partition, and a conductive layer is formed on the substrate, and the conductive layer includes two separate anode parts and a cathode that are not in contact with each other. Part of the conductive layer is partially covered with an electrical insulating layer to expose a part of the conductive layer. One end of the exposed part of the anode and cathode of the conductive layer forms a working electrode and a reference electrode, and the other end can be connected to the biosensor device. A reaction area is covered on the working electrode and the reference electrode. The reaction area is made according to different principles, and an upper separator is covered on the reaction area. When the sample is inhaled, the sample will react with the substance in the reaction zone and produce electrochemical changes, and the cathode connector and the anode connector at the other end of the conductive layer are conducted from the working electrode and the reference electrode to connect with the biosensor device and receive signals. After calculation, the signal is converted into the concentration of the analyte and displayed on a display.

However, since electrochemical biosensing test papers are currently manufactured in batch production, various factors in the manufacturing process will cause differences between each batch of test papers, such as the volume of the working electrode and the reference electrode, The amount of enzyme in the reaction zone will affect the detection and lead to inaccurate measurement results. Therefore, before the special test strips for blood glucose meters leave the factory, the manufacturer will set a set of specific calibration parameter values according to each batch of products to confirm the consistency of the test and analysis values. The calibration function of the internal parameters of the blood glucose meter is to confirm that the test strips will not have different analysis results due to different manufacturing batch numbers.

At present, the internal parameter calibration methods of commercially available blood glucose meters mainly include the chip setting method, the test strip number checking method, and the like. Taking the chip setting method as an example, each box of blood glucose test strips must first use the included chip to calibrate the parameters in the blood glucose meter before use. However, patients or family members who perform the measurement often forget this calibration action, resulting in incorrect measurements. The blood sugar level is not very accurate without knowing it. US Patent Publication No. 20030204313 provides a biosensor device capable of parameter calibration using parameter calibration test paper, and its parameter calibration method is similar to this. And U.S. Patent No. 7,514,040 is about an intelligent biosensor device with a built-in parameter password or an external parameter password. It has a built-in array calibration parameter value in the biosensor device, and the user must first select Determine the parameter values that match the batch of test papers, and the parameter correction method belongs to the test paper number check method.

As mentioned above, regardless of any current parameter calibration method used by the blood glucose meter, additional user steps are required, resulting in cumbersome testing procedures. Correct test results not only waste time and resources, but also have a negative impact on patients' life and health management. According to the 2006 survey and statistics of Taiwan Diabetes Health Education Association, 32.9% of patients misuse blood glucose meters, including forgetting to calibrate before use, resulting in inaccurate measurement and affecting blood sugar control. It can be seen from this that the inconvenience that aforementioned defect causes to the user. Therefore, how to simplify or even save the user's calibration steps before the measurement, while still maintaining the accuracy of the measurement results, is an urgent need for improvement by the relevant industry.

In addition, in order to ensure that users can use the electrochemical biosensing test paper correctly, different test papers and their matching biosensor devices often have specificity, that is, the test paper can only be correctly inserted into the matching biosensor device. Execute measurement action. However, designers and manufacturers of electrochemical biosensing test strips often have to produce a variety of test strips that match different biosensor devices according to different purposes, different objects to be tested, different customers and different end users, in order to meet the diverse needs of the market. Therefore, At present, the market is full of electrochemical biosensing test papers and biosensor devices with different manufacturers’ logos, designs and purposes. With the rise of medical customization services, we can foresee that electrochemical biosensors will The types of sensory test strips and biosensor devices will become more diverse and complex. Therefore, how to simply and effectively identify the biosensor device matched with different electrochemical biosensing test papers is also a problem to be solved urgently for the designers, manufacturers and users of the test papers.

Contents of the invention

Aiming at the defects existing in the prior art, in order to omit the user’s calibration steps before the measurement, but still maintain the accuracy of the measurement results, the object of the present invention is to provide an electrochemical biosensing test paper, which includes a device The parameter identification element at one end of the back of the substrate enables the automatic selection of a set of calibration parameter values corresponding to the batch of test paper when the test paper is connected to the biosensor device, thus eliminating the parameter calibration steps performed by the user and simplifying the overall measurement procedures to prevent users from inaccurate test results due to omissions or operational errors.

The technical means of the present invention is to provide an electrochemical biosensing test paper, which includes a substrate with a front and a back; a conductive layer arranged on the front of the substrate; a parameter identification element arranged on the back of the substrate One end of which is used to correspond to a set of specific calibration parameter values; an upper spacer covers the conductive layer; and a reaction area is in contact with the conductive layer and used for reaction.

In a preferred embodiment of the present invention, the parameter identification element in the electrochemical biosensing test paper provided by the present invention includes more than four different blocks, and the parameter identification element can be formed by interconnecting or being independent of each block. A variety of different forms, and each form corresponds to a specific set of calibration parameter values, so when a test paper with a specific parameter identification element form is connected to a biosensor device, the device can automatically select the corresponding batch of test paper A set of calibration parameter values for .

In a more preferred embodiment, the parameter identification elements in the electrochemical biosensing test paper provided by the present invention include a first block, a second block, a third block and a fourth block. blocks. Through the interconnection or independence of the four blocks, the parameter identification element in the present invention can form 14 different forms, and each form corresponds to a set of specific correction parameter values.

The parameter identification element in the electrochemical biosensing test paper provided by the present invention can be made up of conductor; Etching or tool etching defines the compartments. In a preferred embodiment, the parameter identifying element is arranged at the sensor end on the back of the substrate.

As mentioned in the background art, in order to easily and effectively identify the biosensor devices matched with different electrochemical biosensing test papers, in the electrochemical biosensing test paper provided by the present invention, the conductive layer includes at least three Electrodes, wherein at least one electrode has a variable length region. The variable length region is used to identify a biosensor device matched with the electrochemical biosensing test paper. By changing the length of the electrode, the resistance value of the electrode can be adjusted. When the electrochemical biosensing test paper is connected with a biosensor device, the resistance value measurement can be used to identify the matched biosensor device. In a preferred embodiment, the variable length region has four different lengths, so four different biosensor devices can be identified. Furthermore, in a more preferred embodiment, the electrode with the variable length region serves as a reference electrode.

In another preferred embodiment, the conductive layer includes at least three electrodes, wherein at least two electrodes each have a variable length region, and the length ratio relationship of each variable length region can be used to identify a variety of different electrochemical A biosensor device matched with a biosensing test paper.

In another preferred embodiment mentioned above, the lengths of each of the variable length regions have a proportional relationship, and the proportional relationship is used to identify a biosensor device matched with the electrochemical biosensing test paper. In this embodiment, the ratio can be any ratio between 1:10 and 10:1. In another more preferred embodiment of the present invention, each of the variable length regions has four forms of different lengths, and the length ratio relationship of each of the variable length regions can be any one between 1:4 and 4:1. Proportion.

By changing the length of the electrode, the resistance value of the electrode can be adjusted. When the electrochemical biosensing test paper is connected with a biosensor device, the resistance value measurement can be used to identify the matched biosensor device. The formula for calculating the resistance (R) is: R=ρ(L/A), where ρ is the resistivity, L is the length of the conductor, and A is the cross-sectional area of the conductor. Therefore, when the resistivity of the conductor and the cross-sectional area of the conductor are fixed, the resistance value of the conductor is proportional to the length of the conductor. And the resistivity has nothing to do with the length, cross-sectional area and other factors of the conductor. It is the electrical property of the conductor material itself and is determined by the conductor material. In the electrochemical biosensing test paper provided by the present invention, the material of each electrode of the conductive layer is fixed, so the resistivity is the same, and each electrode of the conductive layer is laid on the substrate by screen printing, so the same electrochemical The cross-sectional area of each electrode of the conductive layer of the biosensing test paper can also be regarded as the same. Therefore, in the electrochemical biosensing test paper provided by the present invention, the resistance value of each electrode is proportional to the length of the electrode.

In the electrochemical biosensing test paper provided by the present invention, the conductive layer includes a conductive silver glue layer and a conductive carbon powder layer, the conductive carbon powder layer is arranged on the conductive silver glue layer, and each conductive layer The electrodes include a corresponding conductive silver adhesive layer electrode and a conductive carbon powder layer electrode. For example, the first electrode of the conductive layer includes the first electrode of the conductive silver adhesive layer and the first electrode of the conductive carbon powder layer, and the second electrode of the conductive layer includes conductive silver. The second electrode of the glue layer and the second electrode of the conductive carbon powder layer, and so on.

In yet another preferred embodiment of the present invention, the conductive layer includes five electrodes, two of which each have a variable length region, and the variable length region is disposed on the conductive silver glue layer. There is a proportional relationship between the lengths of the two variable length regions, and the proportional relationship is used to identify a biosensor device matched with the electrochemical biosensing test paper. In this embodiment, the ratio can be any ratio between 1:10 and 10:1. In yet another preferred embodiment of the present invention, each of the two variable-length regions has four different length forms, and the length ratio relationship between the two variable-length regions can be between 1:4 and 4:1. any ratio.

Because the conductive silver adhesive layer and the conductive carbon powder layer in the conductive layer form each electrode of the conductive layer jointly in the form of parallel connection (hereinafter referred to as the carbon-silver parallel circuit), the resistance value formula of the parallel circuit is: R=(R1xR2)/ (R1+R2), when R1 is much smaller than R2, it can be known from the formula that the resistance value R of the parallel circuit will approach R1. In the electrode structure provided by the present invention, because the resistivity of silver is extremely small (about 1.6x10 ^-8 ρ/Ω·m), the resistance value of the conductive silver glue layer electrode is much smaller than the resistance value of the conductive carbon powder layer electrode, Therefore, the overall resistance value of the conductive layer electrode will approach the resistance value of the conductive silver glue layer electrode.

In the electrochemical biosensing test paper provided by the present invention, the variable length region is set on the conductive silver adhesive layer. By making a default conductive silver glue layer of a specific length in the variable length region of the electrode (such as a default full length of 1/4, 1/2 or 3/4 of the length of the conductive silver glue layer), the Only the conductive carbon powder layer remains in the default part, so that the effect of changing the resistance value of the electrode can be achieved. As mentioned above, the resistance value of the carbon-silver parallel circuit will be close to the resistance value of the conductive silver adhesive layer, so in the case of the default conductive silver adhesive layer, the resistance value of the carbon-silver parallel connection part is extremely small, so that The total resistance value of the electrode will approach the resistance value of only the remaining conductive carbon powder layer in the electrode, that is, the resistance value of the electrode will be the same as the length of the remaining conductive carbon powder layer (that is, the conductive silver glue layer is missing). The length of the province part) is approximately proportional to the relationship.

For example, in the electrochemical biosensing test paper provided by the present invention, if the default length of the conductive silver adhesive layer in the first electrode of the conductive layer is twice the default length of the conductive silver adhesive layer in the second electrode of the conductive layer , then the resistance value of the first electrode of the conductive layer will be approximately twice the resistance value of the second electrode of the conductive layer, and so on. Through the aforementioned method, the present invention can design default parts of different lengths on the electrodes to achieve the effect of effectively controlling the resistance value of each electrode, and use the calculation of the proportional relationship between the resistance values between the two electrodes in the same electrochemical biosensing test paper to obtain Excluding the influence of the resistivity and the cross-sectional area of the electrode, the proportional relationship of the resistance value is further simplified to the proportional relationship between the lengths of the variable length regions of the two electrodes, which is used to identify biosensor devices that are compatible with different electrochemical biosensing test papers without considering Errors that may be caused by different batches of test paper due to various differences in manufacturing (such as the printing width, thickness, and uniformity of the carbon powder layer, etc.).

In the electrochemical biosensing test paper provided by the present invention, the five electrodes of the conductive layer are the first electrode of the conductive layer, the second electrode of the conductive layer, the third electrode of the conductive layer, and the conductive layer from one side to the other. layer fourth electrode and conductive layer fifth electrode.

In yet another preferred embodiment, the first electrode of the conductive silver glue layer and the third electrode of the conductive silver glue layer each have a variable length region, and the length of the variable length region of the first electrode of the conductive silver glue layer There is a proportional relationship with the length of the variable length region of the third electrode of the conductive silver glue layer, and the proportional relationship is used to identify a biosensor device matched with the electrochemical biosensing test paper. In this embodiment, the ratio can be any ratio between 1:10 and 10:1. In yet another preferred embodiment of the present invention, the variable length region of the first electrode of the conductive silver glue layer and the variable length region of the third electrode of the conductive silver glue layer each have four forms of different lengths, and the two The length ratio of the variable length region can be any ratio between 1:4 and 4:1. In addition, the first electrode of the conductive layer, the second electrode of the conductive layer are connected with the third electrode of the conductive layer to form a short circuit structure.

In the electrochemical biosensing test paper provided by the present invention, the length ratio relationship of each variable length region can be adjusted to correspond to different biosensor devices. For example, a 1:1 length ratio can be set to correspond to the A biosensor device, a 1:2 length ratio can be set to correspond to the B biosensor device, and so on. In addition, the variable length region can also be disposed on the conductive silver adhesive layer of any other two electrodes as required. For example, the first electrode of the conductive silver glue layer and the second electrode of the conductive silver glue layer each have a variable length region; or the second electrode of the conductive silver glue layer and the third electrode of the conductive silver glue layer each have a variable length Areas, respectively corresponding to different biosensor devices. Combining the above two methods, the electrochemical biosensing test paper provided by the present invention can be derived into a variety of different electrode structures to cooperate with a variety of different biosensor devices.

In the electrochemical biosensing test paper provided by the present invention, the electrodes of the conductive layer are retracted, so that the end of the conductive layer at the sensor end is 0.1 to 1 mm away from the end of the substrate at the sensor end, so as to avoid the electrochemical biosensing test paper. The device is activated prior to proper insertion of the biosensor device.

In the electrochemical biosensing test paper provided by the present invention, the conductive layer includes at least three electrodes, at least one of which is a reference electrode, and at least one of which is a working electrode. In a preferred embodiment, the conductive layer includes five electrodes, two of which are connected to form a short-circuit structure, and together serve as a reference electrode, and the other two electrodes are working electrodes, which are used to detect the blood glucose level in the sample and the blood volume ratio; and the other electrode is a detection electrode, which is used to detect whether the sample has completely entered the reaction area. In a more preferred embodiment, the conductive layer includes five electrodes, wherein the second electrode of the conductive layer is connected to the third electrode of the conductive layer to form a short circuit structure, and together serve as a reference electrode, and the fourth electrode of the conductive layer are detection electrodes, and the first electrode of the conductive layer and the fifth electrode of the conductive layer are working electrodes.

In another more preferred embodiment, the conductive layer includes five electrodes, wherein the first electrode of the conductive layer is connected to the second electrode of the conductive layer to form a short circuit structure, and together serve as a reference electrode, and the third electrode of the conductive layer The electrodes are detection electrodes, and the fourth electrode and the fifth electrode of the conductive layer are working electrodes.

In the electrochemical biosensing test paper provided by the present invention, it further includes a middle partition covering the conductive layer and part of the substrate, and the middle partition is provided with a groove at the reaction end, which is longitudinal and opens to the reaction end. The middle partition is further provided with an opening, which is adjacent to the groove and not connected with the groove, and corresponds to the reaction zone.

In the electrochemical biosensing test paper provided by the present invention, the upper partition is provided with an opening for ventilation corresponding to the opening of the middle partition. And the upper partition is provided with a notch at the reaction end, and in a preferred embodiment, the notch is in the shape of a semicircle or a semiellipse.

In addition, in the electrochemical biosensing test paper provided by the present invention, the conductive carbon powder layer is provided with a rough section outside the reaction end. The rough section is a multi-segment straight line, which is used to increase the roughness of the substrate, prevent the substances in the reaction area from falling off, and increase the accuracy of detection.

In the electrochemical biosensing test paper provided by the present invention, an adhesive layer between the middle separator and the upper separator is further included for joining the upper separator and the middle separator, and the adhesive A second groove is provided on the layer corresponding to the groove and the opening of the middle partition. In the electrochemical biosensing test paper provided by the present invention, an insulating layer between the conductive layer and the middle partition can be further included, wherein the insulating layer is provided corresponding to the groove and the opening of the middle partition. There is a third groove.

Another object of the present invention is to provide a method for identifying a biosensor device using an electrochemical biosensing test paper with at least two electrodes each having a variable length region, which includes contacting the conductive layer with a biosensor device ; Detecting the resistance values of the electrodes with the variable length region respectively, and obtaining a plurality of resistance values; performing operations on the plurality of resistance values according to an arithmetic formula, and obtaining a final value; and confirming that the final value is consistent with the biosensor Whether a preset value of the device matches. Wherein the final value is used to identify a biosensor device matched with the electrochemical biosensing test paper.

In the method for identifying a biosensor device provided by the present invention, it further includes an activation step, that is, when the final value matches the preset value, then activate the biosensor device, and when the final value matches the preset value When the values do not match, the biosensor device is not activated. The aforesaid coincidence means that the final value is equal to the preset value or the final value falls above the preset value and within the next acceptable error range. The aforementioned inconsistency means that the final value falls above the preset value and outside the next acceptable error range.

The present invention further provides a method for identifying a biosensor device using an electrochemical biosensing test paper in which two electrodes in the aforementioned conductive layer each have a variable length region, which includes contacting the conductive layer with a biosensor device ; Detect the resistance values of the two electrodes with the variable length region respectively, and obtain a first resistance value and a second resistance value; calculate a ratio between the first resistance value and the second resistance value; and confirm the Whether the ratio matches a preset value of the biosensor device.

According to the description about the variable length region in the conductive layer in the previous content, it can be known that the aforementioned first resistance value and the second resistance value are respectively proportional to the length of the default part of the conductive silver glue layer in the two variable length regions, so the two The ratio of the resistance values is approximately equal to the length ratio of the default portion of the conductive silver adhesive layer in the two variable length regions. In a preferred embodiment of the present invention, the ratio can be any value between 0.1 and 10. In the method provided by the present invention, the ratio is used to identify a biosensor device matched with the electrochemical biosensing test paper.

In the aforementioned method, an activation step may be further included, that is, when the ratio matches the preset value, the biosensor device is activated, and when the ratio does not match the preset value, the biosensor device is not activated . The aforesaid coincidence means that the ratio is equal to the preset value or the ratio falls above the preset value and within the next acceptable error range. The aforementioned inconsistency means that the ratio falls above the preset value and outside the next acceptable error range.

In summary, compared with the background technology and existing products, the electrochemical biosensing test paper provided by the present invention has the following beneficial effects:

1. When the electrochemical biosensing test paper provided by the present invention is connected to the biosensor device, the device can automatically select a set of calibration parameter values corresponding to the batch of test paper, thereby eliminating the parameter calibration steps performed by the user , Simplify the overall measurement procedure and avoid inaccurate test results due to user omissions or operational errors.

2. Eliminate the extra manufacturing cost required to use the chip card for calibration.

3. Arranging the parameter identification element on the back of the substrate, avoiding co-location with the conductive layer on the front of the substrate, reducing the complexity and manufacturing cost of the mechanism design of the test strip and the matching biosensor device.

4. Utilizing the length of the variable length region in the conductive layer or its proportional relationship to identify the biosensor device matched with the test paper, increasing the convenience of use.

Description of drawings

FIG. 1 is an exploded perspective view of a preferred embodiment of the present invention.

Fig. 2 is a front perspective view of a preferred embodiment of the present invention.

Fig. 3 is a rear perspective view of a preferred embodiment of the present invention.

FIG. 4 is a schematic diagram of the distribution of electrodes of the conductive layer in a preferred embodiment of the present invention.

5A-5N are various forms of parameter identification elements in the present invention.

6A-6E show the first electrode distribution situation and various forms of the variable length region of the second electrode of the conductive silver adhesive layer in the present invention.

7A-7E show the second electrode distribution situation of the present invention and various forms of the variable length region of the second electrode of the conductive silver glue layer.

Fig. 8 is a schematic diagram of the third electrode distribution situation of the present invention.

Fig. 9 is an exploded view of the third electrode distribution situation of the present invention.

10A-10P are partial electrode structure forms of the third electrode distribution situation of the present invention (the variable length region is set in the first electrode of the conductive layer and the third electrode of the conductive layer).

Fig. 11 is an exploded perspective view of a better embodiment of the present invention.

Fig. 12 is an exploded perspective view of yet another preferred embodiment of the present invention.

Fig. 13 is a flowchart of a preferred embodiment of the method provided by the present invention.

Fig. 14 is a flowchart of another preferred embodiment of the method provided by the present invention.

Fig. 15 is a flowchart of a better embodiment of the method provided by the present invention.

Fig. 16 is a flowchart of another preferred embodiment of the method provided by the present invention.

Wherein, the reference signs are explained as follows:

10: Substrate

102: Substrate front

104: Substrate back side

12: Chamfer

20, 20A, 20B: conductive layer

202, 202A, 202B: the first electrode of the conductive layer

204, 204A, 204B: the second electrode of the conductive layer

206, 206A, 206B: the third electrode of the conductive layer

208, 208A, 208B: the fourth electrode of the conductive layer

209, 209A, 209B: the fifth electrode of the conductive layer

22, 22A, 22B: conductive silver adhesive layer

222, 222A, 222B: the first electrode of the conductive silver adhesive layer

2220, 2220A, 2220B, 2220C, 2220D: Conductive silver adhesive layer first electrode variable length area

224, 224A, 224B: the second electrode of the conductive silver adhesive layer

2240, 2240A, 2240B, 2240C, 2240D, 2240E, 2240F, 2240G, 2240H: conductive silver adhesive layer second electrode variable length area

226, 226B: the third electrode of conductive silver glue layer

2260, 2260A, 2260B, 2260C, 2260D: conductive silver adhesive layer third electrode variable length area

228, 228B: the fourth electrode of the conductive silver glue layer

229, 229B: the fifth electrode of the conductive silver adhesive layer

24, 24A, 24B: conductive carbon powder layer

240: rough segment

242, 242B: the first electrode of the conductive carbon powder layer

244, 244B: conductive carbon powder layer second electrode

246, 246B: the third electrode of conductive carbon powder layer

248, 248B: the fourth electrode of the conductive carbon powder layer

249, 249B: the fifth electrode of the conductive carbon powder layer

30: Parameter identification component

30A: parameter identification element corresponding to the first set of calibration parameter values

30B: parameter identification element corresponding to the second set of calibration parameter values

30C: parameter identification element corresponding to the third set of calibration parameter values

30D: parameter identification element corresponding to the fourth set of calibration parameter values

30E: The parameter identification element corresponding to the fifth set of calibration parameter values

30F: parameter identification element corresponding to the sixth group of calibration parameter values

30G: parameter identification element corresponding to the seventh set of calibration parameter values

30H: The parameter identification element corresponding to the eighth group of calibration parameter values

30I: parameter identification element corresponding to the ninth group of calibration parameter values

30J: parameter identification element corresponding to the tenth group of calibration parameter values

30K: parameter identification element corresponding to the eleventh set of calibration parameter values

30L: parameter identification element corresponding to the twelfth group of calibration parameter values

30M: parameter identification element corresponding to the thirteenth group of calibration parameter values

30N: parameter identification element corresponding to the fourteenth group of calibration parameter values

31: The first block 32: The second block

33: The third block 34: The fourth block

40: upper partition 42: opening

44: Gap 50: Intermediate partition

52: Groove 54: Opening

60: Adhesive layer 62: Second groove

70: Insulation layer 72: The third groove

80: Reaction area 91: Sensor end

92: Reaction end

S1, S1A: contacting the conductive layer with a biosensor device

S2: Detect the resistance values of the electrodes with the variable length region respectively, and obtain multiple resistance values

S2A: respectively detecting the resistance values of the two electrodes with the variable length region, and obtaining a first resistance value and a second resistance value

S3: Calculate the multiple resistance values according to an arithmetic formula, and obtain a final value

S3A: Calculating a ratio between the first resistance value and the second resistance value

S4: Confirm whether the final value is consistent with a preset value of the biosensor device

S4A: Confirm whether the ratio is consistent with a preset value of the biosensor device

S5, S5A: start the biosensor device

S6, S6A: do not start the biosensor device

Detailed ways

Please refer to the accompanying drawings for the technical solution and several specific embodiments of the present invention, which are described in detail as follows. Indeed, the invention may be embodied in different forms and should not be construed as limited to the embodiments set forth herein.

noun definition

biosensor device

It refers to a device that cooperates with the electrochemical biosensing test paper provided by the present invention to detect the concentration of a specific substance in a sample, such as a blood glucose meter, a cholesterol meter, a uric acid meter, and the like.

sensor end

It refers to the end of the electrochemical biosensing test paper provided by the present invention that is in contact with the biosensor device during use.

Response end

It refers to the end of the electrochemical biosensing test paper provided by the present invention that reacts with the sample during use, usually the end where the reaction zone is located, and is opposite to the sensor end.

FIG. 1 , FIG. 2 and FIG. 3 are respectively an exploded perspective view, a front perspective view and a rear perspective view of a preferred embodiment of the present invention. As shown in Figures 1 to 3, the electrochemical biosensing test paper provided by the present invention comprises a substrate 10, provided with a front 102 and a back 104; a conductive layer 20, located on the front 102 of the substrate 10; The parameter identification element 30 is arranged at one end of the back surface 104 of the substrate 10 and is used to correspond to a set of specific calibration parameter values; an upper spacer 40 covers the conductive layer 20; and a reaction area 80 is connected with the conductive layer 20. Layer 20 is contacted and used to react. In addition, the electrochemical biosensing test paper provided by the present invention can be further divided into a sensor end 91 and a reaction end 92 .

In the electrochemical biosensing test paper provided by the present invention, the substrate 10 can be a rectangular sheet, preferably the substrate 10 has electrical insulation properties. In a preferred embodiment, the four corners of the base plate 10 are chamfered 12 to prevent the user from accidentally being stabbed or cut by the sharp point during operation. The conductive layer 20 is coated on the front surface 102 of the substrate 10 , and the conductive layer includes a conductive silver glue layer 22 and a conductive carbon powder layer 24 , and the conductive carbon powder layer 24 covers the conductive silver glue layer 22 . The conductive layer 20 includes at least three electrodes, and the three electrodes at least include a working electrode and a reference electrode. In a preferred embodiment, the conductive layer 20 extends longitudinally at the sensor end 91 and the long side of the substrate 10 and is parallel to each other, and is used for contacting with the biosensor device to detect electrochemical changes.

In a preferred embodiment, the electrodes of the conductive layer 20 are retracted so that the end of the conductive layer 20 at the sensor end 91 is 0.1 to 1 mm away from the end of the substrate 10 at the sensor end 91, so as to avoid electrochemical bioinduction. The test strip activates the biosensor device before it is properly inserted into the device. In a more preferred embodiment, the end of the conductive layer 20 at the sensor end 91 is 0.3 to 0.8 mm away from the end of the substrate 10 at the sensor end 91; The distance between the end and the end of the substrate 10 at the sensor end 91 is 0.5 to 0.6 mm.

As shown in Figure 1, in the electrochemical biosensing test paper provided by the present invention, the upper separator 40 is covered on the conductive layer 20, and the upper separator 40 is provided with an opening 42 for ventilation, and The upper partition is provided with a gap 44 at the reaction end 92 . In a preferred embodiment, the notch 44 is semicircular or semielliptical, and the area of the sample suction reaction zone 80 is increased by the design of the notch 44 . Since the notch 44 increases the sample suction area, the sample can not only be sucked into the reaction zone 80 from the side parallel to the direction of the test paper, but also can be sucked into the reaction zone 80 from different angles above, so it not only increases the convenience of use, but also increases the number of samples. The speed of inhalation increases the accuracy of the test strip.

In the electrochemical biosensing test paper provided by the present invention, the reaction zone 80 is covered on the substrate 10 and part of the conductive layer 20, which contains biologically active substances (such as enzymes), enzyme cofactors, stabilizers (such as macromolecular polymers) substances) and buffer solutions, etc., to react with the sample.

FIG. 4 shows the distribution of electrodes of the conductive layer in a preferred embodiment of the present invention. In this embodiment, the conductive layer 20 of the electrochemical biosensing test paper provided by the present invention includes five electrodes, which are respectively the first electrode 202 of the conductive layer, the second electrode 204 of the conductive layer, the third electrode 206 of the conductive layer, The fourth electrode 208 of the conductive layer and the fifth electrode 209 of the conductive layer, one end of the five electrodes all extend longitudinally and are parallel to each other, and each conductive layer electrode includes a corresponding conductive carbon powder layer electrode and a conductive silver glue layer electrode, Respectively, the first electrode 222 of the conductive silver glue layer, the second electrode 224 of the conductive silver glue layer, the third electrode 226 of the conductive silver glue layer, the fourth electrode 228 of the conductive silver glue layer and the fifth electrode 229 of the conductive silver glue layer; and the conductive carbon The powder layer first electrode 242 , the conductive carbon powder layer second electrode 244 , the conductive carbon powder layer third electrode 246 , the conductive carbon powder layer fourth electrode 248 and the conductive carbon powder layer fifth electrode 249 . In addition, the conductive silver paste second electrode 224 has a variable length region 2240 .

In a preferred embodiment of the present invention, two of the five electrodes of the conductive layer 20 are connected to form a short circuit structure. Referring to FIG. 4 , in a more preferred embodiment, the second electrode 204 of the conductive layer is connected to the third electrode 206 of the conductive layer to form a short circuit structure, and together serve as a reference electrode.

In a preferred embodiment of the present invention, one of the five electrodes of the conductive layer 20 is a detection electrode for detecting whether a sample has completely entered the reaction area. Referring to FIG. 4 , in a more preferred embodiment, the fourth electrode 208 of the conductive layer is a detection electrode for detecting whether a sample has completely entered the reaction area.

In a preferred embodiment of the present invention, one of the five electrodes on the conductive layer 20 is a working electrode for detecting the blood glucose level of the sample. Referring to FIG. 4 , in a more preferred embodiment, the fifth electrode 209 of the conductive layer is a working electrode for detecting the blood glucose level of the sample.

In a preferred embodiment of the present invention, one of the five electrodes of the conductive layer 20 is a working electrode for detecting the hematocrit of the sample. Referring to FIG. 4 , in a more preferred embodiment, the conductive layer first electrode 202 is a working electrode for detecting the hematocrit of the sample.

In the electrochemical biosensing test paper provided by the present invention, the parameter identification element 30 is disposed at one end of the back surface 104 of the substrate 10 . Referring to Fig. 1 and Fig. 3, in a preferred embodiment, the parameter identification element 30 is arranged on the sensor end 91 of the back side 104 of the substrate 10, and forms an up-down relative positional relationship with the conductive layer 20 on the front side 102 of the substrate 10, for Parameter identification is performed in contact with a biosensor device.

5A-5N show various forms of the parameter identification element 30 in the present invention. In the electrochemical biosensing test paper provided by the present invention, the parameter identifying element 30 includes more than four different blocks. In a preferred embodiment, the parameter identification element 30 includes four different blocks, namely a first block 31 , a second block 32 , a third block 33 and a fourth block 34 . Through interconnection or independence of each block, the parameter identification element 30 in the present invention can form 14 different forms, and each form corresponds to a set of specific correction parameter values. In the present invention, the connection and independence between the blocks of the parameter identification element 30 are defined by laser etching or tool etching. The double dashed lines in FIG. 5A-FIG. 5N represent that the blocks are connected to each other, and the double solid lines represent that the blocks are independently not connected to each other after being etched.

Figure 5A shows the form of the parameter identification element 30A corresponding to the first set of calibration parameter values, wherein the first block 31, the second block 32, the third block 33 and the fourth area of the parameter identification element 30A Blocks 34 are all interconnected.

FIG. 5B and FIG. 5C show that any two of the four blocks of the parameter identification element 30 are connected to each other and independent from the other two blocks, while the remaining two blocks are connected to each other.

Figure 5B shows the form of the parameter identification element 30B corresponding to the second set of correction parameter values, wherein the first block 31 and the second block 32 of the parameter identification element 30B are connected to each other and the third block 33 and the second block 33 are connected to each other. The four blocks 34 are connected to each other, while the first block 31 , the second block 32 , the third block 33 , and the fourth block 34 are not connected to each other independently.

5C shows the form of the parameter identification element 30C corresponding to the third set of correction parameter values, wherein the first block 31 and the third block 33 of the parameter identification element 30C are connected to each other and the second block 32 and the second block 32 are connected to each other. The four blocks 34 are connected to each other, while the first block 31 , the third block 33 , the second block 32 , and the fourth block 34 are not connected to each other independently.

Figure 5D shows the form of the parameter identification element 30D corresponding to the fourth set of calibration parameter values, wherein the first block 31, the second block 32, the third block 33 and the fourth area of the parameter identification element 30D Blocks 34 are independent and not connected to each other.

FIG. 5E-FIG. 5H show that any one of the four blocks of the parameter identification element 30 is independently not connected to other blocks, and the remaining three blocks are connected to each other.

Figure 5E shows the form of the parameter identification element 30E corresponding to the fifth set of correction parameter values, wherein the first block 31 of the parameter identification element 30E is not connected to other blocks independently and the second block 32, the second block 32 The third block 33 and the fourth block 34 communicate with each other.

Figure 5F shows the form of the parameter identification element 30F corresponding to the sixth group of calibration parameter values, wherein the third block 33 of the parameter identification element 30F is not connected to other blocks independently and the first block 31, the second block The second block 32 and the fourth block 34 communicate with each other.

Figure 5G shows the form of the parameter identification element 30G corresponding to the seventh set of calibration parameter values, wherein the fourth block 34 of the parameter identification element 30G is not connected to other blocks independently and the first block 31, the second block The second block 32 and the third block 33 communicate with each other.

Figure 5H shows the form of the parameter identification element 30H corresponding to the eighth group of correction parameter values, wherein the second block 32 of the parameter identification element 30H is not connected to other blocks independently and the first block 31, the second block The third block 33 and the fourth block 34 communicate with each other.

5I-5N show that any two of the four blocks of the parameter identification element 30 are connected to each other, and the other two blocks are independent and not connected to other blocks.

Figure 5I shows the form of the parameter identification element 30I corresponding to the ninth set of correction parameter values, wherein the first block 31 and the second block 32 of the parameter identification element 30I are connected to each other and the third block 33 and the second block 32 are connected to each other. The four blocks 34 are independent and not connected to each other.

Figure 5J shows the form of the parameter identification element 30J corresponding to the tenth set of correction parameter values, wherein the third block 33 and the fourth block 34 of the parameter identification element 30J are connected to each other and the first block 31 and the second block 31 are connected to each other. The two blocks 32 are independent and not connected to each other.

Figure 5K shows the form of the parameter identification element 30K corresponding to the eleventh group of correction parameter values, wherein the first block 31 and the third block 33 of the parameter identification element 30K are connected to each other and the second block 32 and The fourth blocks 34 are independent and not connected to each other.

Figure 5L shows the form of the parameter identification element 30L corresponding to the twelfth group of correction parameter values, wherein the second block 32 and the fourth block 34 of the parameter identification element 30L are connected to each other and the first block 31 and the fourth block 34 are connected to each other. The third blocks 33 are independent and not connected to each other.

5M shows the form of the parameter identification element 30M corresponding to the thirteenth group of correction parameter values, wherein the second block 32 and the third block 33 of the parameter identification element 30M are connected to each other and the first block 31 and the third block 33 are connected to each other. The fourth blocks 34 are independent and not connected to each other.

Figure 5N shows the form of the parameter identification element 30N corresponding to the fourteenth set of correction parameter values, wherein the first block 31 and the fourth block 34 of the parameter identification element 30N are connected to each other and the second block 32 and the second block 30N are connected to each other. The three blocks 33 are independent and not connected to each other.

In the electrochemical biosensing test paper provided by the present invention, the parameter identifying element 30 is composed of a conductor. In a preferred embodiment, the parameter identification element 30 is composed of carbon. When the parameter identification element 30 with a specific form in the test paper is connected to a biosensor device, the device can automatically find out the parameters related to the parameter identification element 30 by identifying the connection or independence of each block in the parameter identification element 30. A set of correction parameter values corresponding to the 30 form.

Fig. 6A shows the first electrode distribution situation of the present invention, and Fig. 6B-Fig. 6E are various forms of the second electrode variable length region 2240 of the conductive silver glue layer in the first electrode distribution situation of the present invention, wherein the The conductive silver paste layer 22 is shown by a dotted line, and the conductive carbon powder layer 24 is shown by a solid line. In a preferred embodiment of the present invention, the second electrode 204 of the conductive layer is connected to the third electrode 206 of the conductive layer to form a short circuit structure and can be used as a reference electrode together, and wherein the second electrode 224 of the conductive silver glue layer It has a variable length region 2240, and the biosensor device matched with the electrochemical biosensing test paper can be identified through the difference of resistance value. In a more preferred embodiment, the second electrode variable length region 2240 of the conductive silver glue layer has four different lengths. FIG. 6B shows that the variable length region 2240A of the second electrode of the conductive silver glue layer has a full length and is connected to the sensor end 91 of the second electrode 224 of the conductive silver glue layer. 6C shows that the second electrode variable length region 2240B of the conductive silver glue layer has a length of two-thirds of the full length, and is not connected to the sensor terminal 91 of the second electrode 224 of the conductive silver glue layer. As shown in FIG. 6D , the variable length region 2240C of the second electrode of the conductive silver glue layer has a length of one-third of the full length, and is not connected to the sensor end 91 of the second electrode 224 of the conductive silver glue layer. 6E shows that the variable length region 2240D of the second electrode of the conductive silver glue layer is completely absent, and is not connected to the sensor terminal 91 of the second electrode 224 of the conductive silver glue layer.

It can be known from the previous description of this specification that the resistance value of the second electrode 204 of the conductive layer will be approximately proportional to the length of the default portion of the second electrode variable length region 2240 of the conductive silver glue layer. When the electrochemical biosensing test paper is connected with a biosensor device, since the device can identify the difference in resistance value caused by the length difference of the second electrode variable length region 2240 of the conductive silver adhesive layer, and then confirm the electrochemical biosensor Whether the sensory test paper is the test paper matched with the biosensor device.

Figure 7A shows the second electrode distribution situation of the present invention, wherein the conductive layer first electrode 202A of the conductive layer 20A is connected to the conductive layer second electrode 204A to form a short circuit structure, and together serve as a reference electrode; The third electrode 206A of the conductive layer is a detection electrode; the fourth electrode 208A of the conductive layer is a working electrode for detecting the blood glucose level of the sample; the fifth electrode 209A of the conductive layer is a working electrode for detecting the hematocrit of the sample.

Also refer to FIG. 7B , FIG. 7C , FIG. 7D and FIG. 7E which show various forms of the second electrode variable length region 2240 of the conductive silver glue layer in the second electrode distribution situation of the present invention. The second electrode 224A of the conductive silver glue layer has a variable length region 2240 . In a preferred embodiment, the second electrode variable length region 2240 of the conductive silver glue layer has four different lengths. FIG. 7B shows that the variable length region 2240E of the second electrode of the conductive silver glue layer has a full length and is connected to the sensor terminal 91 of the second electrode 224A of the conductive silver glue layer. As shown in FIG. 7C , the variable length region 2240F of the second electrode of the conductive silver glue layer has a length of two-thirds of the full length, and is not connected to the sensor end 91 of the second electrode 224A of the conductive silver glue layer. FIG. 7D shows that the variable length region 2240G of the second electrode of the conductive silver glue layer has a length of one third of the full length, and is not connected to the sensor terminal 91 of the second electrode 224A of the conductive silver glue layer. FIG. 7E shows that the variable length region 2240H of the second electrode of the conductive silver glue layer is completely absent, and is not connected to the sensor terminal 91 of the second electrode 224A of the conductive silver glue layer.

Fig. 8 is a schematic diagram of the third electrode distribution situation of the present invention. Referring to FIG. 8 , in another preferred embodiment of the present invention, the conductive layer 20B includes at least three electrodes, at least two of which each have a variable length region 2220 , 2260 . Wherein the conductive layer 20B includes a conductive silver glue layer 22B and a conductive carbon powder layer 24B, the dotted line in the conductive layer 20B represents the conductive silver glue layer 22B, and the solid line represents the conductive carbon powder layer 24B, and the conductive carbon powder layer 24B is located on the conductive carbon powder layer 24B. On the silver glue layer 22B, the electrodes of the conductive layer 20B are jointly formed in parallel.

As shown in FIG. 8, in yet another preferred embodiment of the present invention, the conductive layer 20B includes five electrodes, and the five electrodes are the first electrode 202B of the conductive layer, the conductive The second electrode 204B of the conductive layer, the third electrode 206B of the conductive layer, the fourth electrode 208B of the conductive layer and the fifth electrode 209B of the conductive layer, and the first electrode 202B of the conductive layer, the second electrode 204B of the conductive layer and the third electrode of the conductive layer 206B are connected to form a short circuit structure. Two of the five electrodes each have a variable length region 2220, 2260, and the variable length region 2220, 2260 is disposed on the conductive silver glue layer 22B.

Fig. 9 is an exploded view of the third electrode distribution situation of the present invention. As shown in Figure 9, in yet another preferred embodiment of the present invention, each conductive layer electrode includes a corresponding conductive silver glue layer electrode and a conductive carbon powder layer electrode, which are respectively the first electrode of the conductive silver glue layer 222B, conductive silver adhesive layer second electrode 224B, conductive silver adhesive layer third electrode 226B, conductive silver adhesive layer fourth electrode 228B and conductive silver adhesive layer fifth electrode 229B; and conductive carbon powder layer first electrode 242B, conductive carbon The powder layer second electrode 244B, the conductive carbon powder layer third electrode 246B, the conductive carbon powder layer fourth electrode 248B and the conductive carbon powder layer fifth electrode 249B. Referring to Fig. 8 and Fig. 9, wherein the conductive layer first electrode 202B comprises the conductive silver glue layer first electrode 222B and the conductive carbon powder layer first electrode 242B, and the conductive layer second electrode 204B comprises the conductive silver glue layer first electrode 222B. The second electrode 224B is connected to the second electrode 244B of the conductive carbon powder layer, and so on.

In still another preferred embodiment of the present invention, the conductive silver paste layer first electrode 222B has a variable length region 2220 , and the conductive silver paste layer third electrode 226B has a variable length region 2260 . In still another more preferred embodiment, the variable length region 2220 of the first electrode of the conductive silver glue layer and the variable length region 2260 of the third electrode of the conductive silver glue layer each have four different lengths.

10A-10P are partial electrode structure forms of the third electrode distribution situation of the present invention. As shown in FIGS. 10A-10P , in the case where the variable length regions are set on the first electrode 222B of the conductive silver glue layer and the third electrode 226B of the conductive silver glue layer, since the variable length regions 2220 and 2260 are respectively There are four forms of different lengths, respectively having full length (variable length region 2220A, variable length region 2260A), two-thirds full length (variable length region 2220B, variable length region 2260B), three One-half of the full length (variable length region 2220C, variable length region 2260C) and the variable length region is completely default (variable length region 2220D, variable length region 2260D) and other four length forms, so the permutation and combination 10A-10P have sixteen kinds of electrode structures, which can respectively correspond to different biosensor devices.

Taking the electrode structure in FIG. 10B as an example, the first electrode variable length region 2220A of the conductive silver glue layer has a full length and the third electrode variable length region 2260B of the conductive silver glue layer has two-thirds of the full length; The electrode structure of FIG. 10C is that the first electrode variable length region 2220A of the conductive silver glue layer has a full length and the third electrode variable length region 2260C of the conductive silver glue layer has a third full length. analogy.

It can be known from the previous description of this specification that in the aforementioned embodiments, the length of the first electrode variable length region 2220 of the conductive silver adhesive layer has a proportional relationship with the length of the third electrode variable length region 2260 of the conductive silver adhesive layer. Taking the electrode structure in FIG. 10B as an example, the ratio is 3:2; taking the electrode structure in FIG. 10C as an example, the ratio is 3:1, and so on. In the foregoing embodiments, the ratio can be any ratio between 1:10 and 10:1; in yet another better embodiment, the ratio can be any ratio between 1:4 and 4:1 Proportion. In the electrode structure provided by the present invention, the proportional relationship is used to identify a biosensor device matched with the electrochemical biosensing test paper.

Fig. 11 is an exploded perspective view of a better embodiment of the present invention. As shown in the figure, the electrochemical biosensing test paper provided by the present invention may further include a separator 50 covering the conductive layer 20 and part of the substrate 10 . Wherein, the intermediate partition 50 is provided with a groove 52 at the reaction end 92 , which is longitudinal and opens to the reaction end 92 . In addition, the middle partition 50 is provided with an opening 54 adjacent to the groove 52 and not communicating with the groove 52 , and corresponding to the reaction zone 80 .

As shown in FIG. 11 , in a more preferred embodiment of the present invention, the conductive carbon powder layer 24 is provided with a rough section 240 outside the reaction end 92 . Preferably, the rough section 240 can be in the form of a straight line or multiple straight lines. The rough section 240 can be a conductive material, and the rough section 240 is preferably formed of carbon powder. In addition, the rough section 240 can also be made of non-conductive material. The rough section 240 is used to increase the roughness of the substrate 10 , increase the adhesion strength of the substance in the reaction zone 80 , and prevent the substance in the reaction zone 80 from falling off. In a preferred embodiment of the present invention, the rough section 240 is located near the outside of the reaction zone 80 .

The electrochemical biosensing test paper provided by the present invention may further include an adhesive layer 60 between the middle separator 50 and the upper separator 40 for connecting the upper separator 40 and the middle separator 50 . Wherein the adhesive layer 60 is provided with a second groove 62 corresponding to the groove 52 and the opening 54 of the middle partition 50 . In a preferred embodiment of the present invention, the adhesive layer 60 is composed of polyethylene terephthalate (PET for short), and adhesive materials such as water glue are coated on the upper and lower sides for bonding the adhesive layer 60. The upper partition 40 and the middle partition 50 .

Fig. 12 is an exploded perspective view of yet another preferred embodiment of the present invention. As shown in the figure, the electrochemical biosensing test paper provided by the present invention can further include an insulating layer 70 between the conductive layer 20 and the middle separator 50, and the insulating layer 70 corresponds to the middle separator 50 A third groove 72 is disposed at the groove 52 and the opening 54 .

In addition, the present invention further provides a method for identifying a biosensor device by using the electrochemical biosensing test paper with at least two electrodes in the conductive layer 20B each having a variable length region. Fig. 13 is a flowchart of a preferred embodiment of the method provided by the present invention. Referring to FIG. 13 , the method includes step one S1: contacting the conductive layer 20B with a biosensor device; step two S2: detecting the resistance values of the electrodes with the variable length region respectively, and obtaining a plurality of resistance values; step Step 3 S3: Calculate the plurality of resistance values according to an operation formula to obtain a final value; and Step 4 S4: Confirm whether the final value is consistent with a preset value of the biosensor device.

In the method provided by the present invention, the contacting in step 1 S1 includes but is not limited to connecting the conductive layer 20B with the biosensor device, or forming a conduction in the sense of circuit. The calculation formula in Step 3 S3 refers to mathematical calculation formulas often used by those skilled in the art, including but not limited to addition, subtraction, multiplication, division or the above-mentioned comprehensive operations. The preset value in step 4 S4 is preset in the memory of the biosensor device, and the preset value can be matched with different application purposes of electrochemical biosensing test paper, different analytes, different customers and It can be set by different end users. In the method provided by the present invention, the final value is used to identify a biosensor device matched with the electrochemical biosensing test paper.

Fig. 14 is a flowchart of another preferred embodiment of the method provided by the present invention. Referring to FIG. 14, in the method for identifying a biosensor device provided by the present invention, when the final value matches the preset value, it further includes an activation step S5 of activating the biosensor device, and when the final value If it does not match the preset value, the biosensor device is not activated (step S6). The aforesaid coincidence means that the final value is equal to the preset value or the final value falls above the preset value and within the next acceptable error range. The aforementioned inconsistency means that the final value falls above the preset value and outside the next acceptable error range.

Fig. 15 is a flowchart of a better embodiment of the method provided by the present invention. Referring to FIG. 15 , the present invention further provides a method for identifying a biosensor device using electrochemical biosensing test paper with two electrodes in the conductive layer 20B each having a variable length region, which includes step 1 S1A: The conductive layer 20B is in contact with a biosensor device; step two S2A: respectively detect the resistance values of the two electrodes with the variable length region, and obtain a first resistance value and a second resistance value; step three S3A: calculate the A ratio between the first resistance value and the second resistance value; and step 4 S4A: confirm whether the ratio is consistent with a preset value of the biosensor device.

In the method provided by the present invention, the contact in Step 1 S1A includes but is not limited to connecting the conductive layer 20B with the biosensor device, or forming a conduction in the sense of circuit. The first resistance value and the second resistance value in the step 2 S2A are not fixedly corresponding to a specific electrode having the variable length region. Taking the embodiment of FIG. 8 as an example, if the first resistance value is the resistance value of the first electrode 202B of the conductive layer, then the second resistance value is the resistance value of the third electrode 206B of the conductive layer. And if the first resistance value is the resistance value of the third electrode 206B of the conductive layer, then the second resistance value is the resistance value of the first electrode 202B of the conductive layer. The ratio in step 3 S3A may be a value obtained by dividing the first resistance value by the second resistance value, or a value obtained by dividing the second resistance value by the first resistance value. The preset value in step 4 S4A is pre-set in the memory of the biosensor device, and the preset value can be matched with different application purposes of electrochemical biosensing test paper, different analytes, different customers and It can be set by different end users.

From the description about the variable length region before this specification, it can be seen that the aforementioned first resistance value and the second resistance value are respectively proportional to the length of the default part of the conductive silver glue layer in the two variable length regions, so the two resistance values The ratio of is approximately equal to the length ratio of the default portion of the conductive silver glue layer 22B in the two variable length regions. Taking the electrode structure in FIG. 10F as an example, the ratio is 1; taking the electrode structure in FIG. 10G as an example, the ratio is 0.5 or 2, and so on. In a preferred embodiment of the present invention, the ratio can be any value between 0.1 and 10. In the method provided by the present invention, the ratio is used to identify a biosensor device matched with the electrochemical biosensing test paper.

Fig. 16 is a flowchart of another preferred embodiment of the method provided by the present invention. Referring to FIG. 16, in the aforementioned method, when the ratio matches the preset value, it further includes an activation step S5A of activating the biosensor device, and when the ratio does not match the preset value, it does not activate The biosensor device (step S6A). The aforesaid coincidence means that the ratio is equal to the preset value or the ratio falls above the preset value and within the next acceptable error range. The aforementioned inconsistency means that the ratio falls above the preset value and outside the next acceptable error range.

Although the foregoing embodiments illustrate the specific facts of the present invention, it should be understood that any possible modifications and changes will not deviate from the spirit and scope of protection claimed in the claims.

Claims (40)

1. An electrochemical biosensing test paper, comprising: a substrate with a front side and a back side; a conductive layer disposed on the front surface of the substrate; A parameter identification element is arranged at one end of the back of the substrate and is used to correspond to a set of specific calibration parameter values; an upper partition covering the conductive layer; and A reaction area is in contact with the conductive layer and used for reaction. 2 . The electrochemical biosensing test paper according to claim 1 , wherein the parameter identification element has multiple different forms formed by laser etching or knife etching. 3 . 3 . The electrochemical biosensing test paper according to claim 2 , wherein the parameter identifying element comprises more than four different blocks. 4 . 4. The electrochemical biosensing test paper according to claim 3, characterized in that, the parameter identification element comprises four different blocks, which are respectively the first block, the second block, the third block and the second block. Four blocks. 5. The electrochemical biosensing test paper according to claim 4, wherein the four blocks are all connected to each other. 6. The electrochemical biosensing test paper according to claim 4, characterized in that, any two blocks in the four blocks are connected to each other and are independent from the remaining two blocks, while the remaining two blocks are connected to each other. are connected to each other. 7 . The electrochemical biosensing test paper according to claim 4 , wherein the four blocks are independent of each other and do not communicate with other blocks. 8 . 8. The electrochemical biosensing test paper according to claim 4, characterized in that, any block in the four blocks is independently not connected to other blocks and the remaining three blocks are connected to each other. 9 . The electrochemical biosensing test paper according to claim 4 , wherein any two of the four blocks are connected to each other and the remaining two blocks are independent and not connected to other blocks. 10. The electrochemical biosensing test paper according to any one of claims 1 to 9, characterized in that the parameter identification element is composed of a conductor. 11. The electrochemical biosensing test paper according to claim 10, wherein the conductor is carbon. 12. The electrochemical biosensing test paper according to claim 11, wherein the conductive layer comprises at least three electrodes, at least one of which has a variable length region. 13. The electrochemical biosensing test paper according to claim 12, wherein the variable length region is used to identify a biosensor device matched with the electrochemical biosensing test paper. 14. The electrochemical biosensing test paper according to claim 13, characterized in that the variable length region has four different lengths. 15. The electrochemical biosensing test paper according to claim 14, wherein the electrode having the variable length region is a reference electrode. 16. The electrochemical biosensing test paper according to claim 12, wherein at least two electrodes in the conductive layer each have a variable length region. 17 . The electrochemical biosensing test paper according to claim 16 , wherein the lengths of the variable length regions have a proportional relationship. 18. The electrochemical biosensing test paper according to claim 17, wherein the proportional relationship is used to identify a biosensor device matched with the electrochemical biosensing test paper. 19. The electrochemical biosensing test paper according to claim 18, wherein the ratio is any ratio between 1:10 and 10:1. 20 . The electrochemical biosensing test paper according to claim 19 , wherein each of the variable length regions has four different lengths. 21 . 21. The electrochemical biosensing test paper according to claim 20, characterized in that the ratio can be any ratio between 1:4 and 4:1. 22. The electrochemical biosensing test paper according to claim 16, wherein the conductive layer comprises a conductive silver glue layer and a conductive carbon powder layer, and the conductive carbon powder layer is covered on the conductive silver glue layer , and each conductive layer electrode includes a corresponding conductive silver glue layer electrode and a conductive carbon powder layer electrode. 23. The electrochemical biosensing test paper according to claim 22, wherein the conductive layer comprises five electrodes, and two of the electrodes each have a variable length region. 24 . The electrochemical biosensing test paper according to claim 23 , wherein the variable length region is set on the conductive silver adhesive layer. 25. The electrochemical biosensing test paper according to claim 24, wherein there is a proportional relationship between the lengths of the two variable length regions. 26. The electrochemical biosensing test paper according to claim 25, wherein the proportional relationship is used to identify a biosensor device matched with the electrochemical biosensing test paper. 27. The electrochemical biosensing test paper according to claim 26, wherein the ratio is any ratio between 1:10 and 10:1. 28. The electrochemical biosensing test paper according to claim 27, wherein each of the variable length regions has four different lengths. 29. The electrochemical biosensing test paper according to claim 28, characterized in that the ratio can be any ratio between 1:4 and 4:1. 30. The electrochemical biosensing test paper according to claim 29, characterized in that, the five electrodes of the conductive layer are the first electrode of the conductive layer, the second electrode of the conductive layer, and the conductive layer from one side to the other. The third electrode of the conductive layer, the fourth electrode of the conductive layer and the fifth electrode of the conductive layer, and the first electrode of the conductive silver glue layer and the third electrode of the conductive silver glue layer each have a variable length region. 31 . The electrochemical biosensing test paper according to claim 30 , wherein at least two electrodes in the conductive layer are connected to form a short circuit structure and serve as a reference electrode together. 32. The electrochemical biosensing test paper according to claim 31, characterized in that, the first electrode of the conductive layer, the second electrode of the conductive layer and the third electrode of the conductive layer are connected to form a short circuit structure, and together serve as a Reference electrode. 33. The electrochemical biosensing test paper according to claim 32, characterized in that, the electrochemical biosensing test paper is further divided into a sensor end and a reaction end, and wherein the end of the conductive layer at the sensor end is connected to the sensor end The end of the substrate at the sensor end is 0.1 to 1 mm apart. 34. A method of using an electrochemical biosensing test paper to identify a biosensor device, the electrochemical biosensing test paper comprising a conductive layer comprising at least three electrodes, wherein at least two electrodes each have A variable length region; the method comprises the steps of: (1) contacting the conductive layer with a biosensor device; (2) Detecting the resistance values of the electrodes with the variable length regions respectively, and obtaining a plurality of resistance values; (3) calculating the plurality of resistance values according to an arithmetic formula, and obtaining a final value; and (4) Confirm whether the final value is consistent with a preset value of the biosensor device. 35. The method according to claim 34, wherein the final value is used to identify a biosensor device matched with the electrochemical biosensing test paper. 36. The method according to claim 35, further comprising an activation step of activating the biosensor device when the final value matches the preset value, and when the final value matches the preset value If not, the biosensor device will not be activated. 37. A method of identifying a biosensor device using an electrochemical biosensing test paper comprising a conductive layer comprising five electrodes, two of which each have a variable-length region; the method comprises the steps of: (1) contacting the conductive layer with a biosensor device; (2) respectively detecting the resistance values of the two electrodes having the variable length region, and obtaining a first resistance value and a second resistance value; (3) calculating a ratio between the first resistance value and the second resistance value; and (4) Confirm whether the ratio is consistent with a preset value of the biosensor device. 38. The method according to claim 37, wherein the ratio is used to identify a biosensor device matched with the electrochemical biosensing test paper. 39. The method according to claim 38, further comprising an activation step of activating the biosensor device when the ratio matches the preset value, and when the ratio does not match the preset value , the biosensor device is not activated. 40. The method according to claim 39, wherein the ratio is any value between 0.1 and 10.

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