Electrochemical Detection System, Measuring Instrument and Electrochemical Detection Method

Abstract

The present invention provides an electrochemical detection system, a measuring instrument and an electrochemical detection method. The electrochemical detection system is used for detecting a sample. The electrochemical detection system includes an electrochemical test strip and a measuring instrument. The electrochemical test strip includes a main body and at least one electrode group. The measuring instrument is electrically connected to at least one electrode group. The measuring instrument is adapted to determine whether the flow field condition of the sample is normal through at least one electrode group. The electrochemical detection system, the measuring instrument and the electrochemical detection method of the present invention can have the effect of improving the detection accuracy.

Description

Technical Field

[0001] The present invention relates to an electrochemical detection system, a measuring instrument and an electrochemical detection method, and in particular to an electrochemical detection system, a measuring instrument and an electrochemical detection method capable of improving detection accuracy. Background Art

[0002] In medical or biochemical testing, the use of electrochemical test strips is already a common technology, for example, to measure the concentration of a sample. When measuring the sample concentration, after the sample reacts with the reaction layer in the electrochemical test strip, the electrodes in the electrochemical test strip can be used to provide a reaction voltage and receive a signal, and then the sample concentration is calculated based on the Cottrelle current.

[0003] However, in the process of using electrochemical test strips to detect samples, the mixing reaction time of the sample and the reaction layer is usually abnormal due to unexpected flow fields such as secondary sampling, abnormal flow channels or extreme samples, which in turn causes the measuring instrument to miss the optimal signal acquisition time and produce a deviated result, and the result of the deviation signal may still fall within the default threshold of the instrument interpretation. In other words, the instrument cannot exclude the results with deviation signals by setting the threshold, so the measurement results of the sample concentration will have significant errors. Therefore, if the reaction signals under these abnormal conditions cannot be effectively distinguished or excluded, the measurement results will be misjudged, thereby reducing the detection accuracy of the electrochemical test strip. Summary of the invention

[0004] In view of this, the present invention is directed to an electrochemical detection system, a measuring instrument and an electrochemical detection method, which can improve the detection accuracy.

[0005] According to an embodiment of the present invention, an electrochemical detection system can be used to detect a sample. The electrochemical detection system includes an electrochemical test strip and a measuring instrument. The electrochemical test strip includes a main body and at least one electrode group. The measuring instrument is electrically connected to the at least one electrode group. The measuring instrument is suitable for judging whether the flow field condition of the sample is normal through the at least one electrode group.

[0006] In the electrochemical detection system according to the embodiment of the present invention, the measuring instrument measures the first characteristic and the second characteristic of at least one of the sample and the electrochemical test strip through at least one electrode group, and calculates the ratio of the first characteristic to the second characteristic to determine whether the flow field condition of the sample is normal. When the ratio is within a predetermined range, the measuring instrument determines that the flow field condition is normal and displays the result of the sample after analysis.

[0007] In the electrochemical detection system according to the embodiment of the present invention, the first characteristic or the second characteristic mentioned above is a fluid characteristic.

[0008] In the electrochemical detection system according to the embodiment of the present invention, the above-mentioned fluid characteristics include flow rate, temperature, viscosity and density of the sample.

[0009] In the electrochemical detection system according to the embodiment of the present invention, the first feature or the second feature mentioned above is a flow channel feature.

[0010] In the electrochemical detection system according to the embodiment of the present invention, the above-mentioned flow channel characteristics include contact angle, charging current, diameter of the reaction zone of the sample, volume flow rate of the sample and cross-sectional area of ​​the reaction zone.

[0011] In the electrochemical detection system according to the embodiment of the present invention, the first feature and the second feature described above have low equivalence.

[0012] In the electrochemical detection system according to the embodiment of the present invention, the above-mentioned flow field conditions include flow channel abnormality and sampling abnormality.

[0013] According to an embodiment of the present invention, a measuring instrument can be used to detect a sample and includes a connector, a microcontroller, a power module and a display. The microcontroller is electrically connected to at least one electrode group through the connector. The power module is electrically connected to the microcontroller. The display is electrically connected to the microcontroller. The microcontroller is suitable for measuring a first feature and a second feature of the sample through at least one electrode group, and analyzing the relationship between the first feature and the second feature and the flow field.

[0014] According to an embodiment of the present invention, an electrochemical detection method can be used to detect a sample and includes the following steps: injecting the sample into an electrochemical test strip. Using a measuring instrument to determine whether the flow field condition of the sample is normal. The step of determining whether the flow field condition of the sample is normal includes: measuring a first feature and a second feature of at least one of the sample and the electrochemical test strip through at least one electrode group of the electrochemical test strip; and calculating a ratio of the first feature to the second feature. When the ratio is within a predetermined range, the measuring instrument determines that the flow field condition is normal and displays the result of the sample after analysis.

[0015] In the electrochemical detection method according to an embodiment of the present invention, the first characteristic mentioned above is related to the ion diffusion and / or migration ability of the sample.

[0016] In the electrochemical detection method according to an embodiment of the present invention, the first characteristic mentioned above includes the flow rate, temperature, viscosity and density of the sample.

[0017] In the electrochemical detection method according to an embodiment of the present invention, the second characteristic is related to the interface characteristic between the sample and the electrode.

[0018] In the electrochemical detection method according to an embodiment of the present invention, the second characteristic mentioned above includes the contact angle, the charging current, the diameter of the reaction zone of the sample, the volume flow rate of the sample and the cross-sectional area of ​​the reaction zone.

[0019] Based on the above, in the electrochemical detection system and the electrochemical detection method of one embodiment of the present invention, since the measuring instrument can be electrically connected to at least one electrode group of the electrochemical test strip, and judge whether the flow field condition of the sample is normal through at least one electrode group, the electrochemical detection system and the electrochemical detection method of this embodiment can avoid misjudgment or have the effect of improving detection accuracy.

[0020] In order to make the above features and advantages of the present invention more clearly understood, embodiments are given below with reference to the accompanying drawings for detailed description. BRIEF DESCRIPTION OF THE DRAWINGS

[0021] The accompanying drawings are included to provide a further understanding of the present invention and are incorporated in and constitute a part of this specification. The drawings illustrate embodiments of the present invention and together with the description serve to explain the principles of the present invention.

[0022] Figure 1A A block diagram of an electrochemical detection system according to an embodiment of the present invention;

[0023] Figure 1B for Figure 1A The structural decomposition diagram of the electrochemical test piece;

[0024] Figure 1C for Figure 1B A schematic top view of region A in an electrochemical test strip;

[0025] Figure 2 A flow chart of an electrochemical detection method according to an embodiment of the present invention;

[0026] Figure 3 To measure blood viscosity using the electrochemical detection system according to an embodiment of the present invention;

[0027] Figure 4 To identify abnormal conditions of secondary sampling using an electrochemical detection system according to an embodiment of the present invention;

[0028] Figure 5 This is the relationship between the contact angle and resistance of the sample on the electrochemical test piece;

[0029] Figure 6 This is the relationship between the contact angle of the sample on the electrochemical test piece and the viscosity;

[0030] Fig. 7A It is the measurement deviation value after measuring blood glucose concentration using a general electrochemical detection method;

[0031] Figure 7B It is the measurement deviation value after measuring blood glucose concentration using the electrochemical detection method according to one embodiment of the present invention.

[0032] Description of Figure Numbers

[0033] 10: Electrochemical detection system;

[0034] 100: electrochemical test piece;

[0035] 101: Subject;

[0036] 110: insulating substrate;

[0037] 112: connection area;

[0038] 121: electrode group;

[0039] 121a: Partial;

[0040] 122: electrode group;

[0041] 122a: Partial;

[0042] 1221: electrode;

[0043] 130: first insulating spacer;

[0044] 131: concave structure;

[0045] 140: reaction zone;

[0046] 141: first side;

[0047] 142: Second side;

[0048] 150: reaction layer;

[0049] 160: second insulating spacer;

[0050] 161: vent;

[0051] 200: measuring instrument;

[0052] 210: Connector;

[0053] 220: microcontroller;

[0054] 230: power module;

[0055] 240: temperature sensor;

[0056] 250: Display;

[0057] A: Region;

[0058] D1: first distance;

[0059] D2: second distance;

[0060] S1, S2, S3: steps. DETAILED DESCRIPTION

[0061] Reference will now be made in detail to exemplary embodiments of the present invention, examples of which are illustrated in the accompanying drawings. Whenever possible, the same reference numerals are used in the drawings and the description to refer to the same or like parts.

[0062] The following "liquid essential characteristics", "liquid electrical characteristics" and "intrinsic electrical characteristics" all correspond to the above-mentioned "fluid characteristics".

[0063] The following “sample and electrode interface characteristics”, “channel wall interface characteristics”, “channel interface characteristics” and “channel interface characteristics” all correspond to the above-mentioned “channel characteristics”.

[0064] Figure 1A FIG. 4 is a block diagram of an electrochemical detection system according to an embodiment of the present invention. Figure 1B for Figure 1A Exploded diagram of the structure of the electrochemical test strip. Figure 1C for Figure 1B A schematic top view of region A in an electrochemical test strip. For the sake of clarity and convenience of description, Figure 1A and Figure 1C Several components in the electrochemical test strip are omitted from illustration.

[0065] Please refer to Figures 1A to 1C , the electrochemical detection system 10 of this embodiment can be used to detect samples. The electrochemical detection system 10 includes an electrochemical test strip 100 and a measuring instrument 200. The electrochemical test strip 100 includes a main body 101 and at least one electrode group 121, 122. Among them, the main body 101 includes an insulating substrate 110, a first insulating spacer 130, a reaction area 140, a reaction layer 150 and a second insulating spacer 160. The electrode groups 121, 122 are arranged on the insulating substrate 110. The first insulating spacer 130 and the second insulating spacer 160 are stacked in sequence on the insulating substrate 110. The electrode groups 121, 122 are partially located at the concave structure 131 of the first insulating spacer 130. The reaction layer 150 is arranged on the insulating substrate 110 and is located in the concave structure 131 of the first insulating spacer 130. The reaction area 140 can be defined as the area surrounded by the concave structure 131.

[0066] In this embodiment, the measuring instrument 200 includes a connector 210 for external connection, a microcontroller (MCU) 220, a power module 230, a temperature sensor 240, and a display 250. The connector 210 of the measuring instrument 200 can be electrically connected to the connection area 112 of the electrochemical test strip 100. The microcontroller 220 is electrically connected to at least one electrode group 121, 122 through the connector 210. The power module 230, the temperature sensor 240, and the display 250 are electrically connected to the microcontroller 220, respectively.

[0067] In this embodiment, the measuring instrument 200 is suitable for measuring the first characteristic and the second characteristic of the sample through at least one electrode group 121, 122, and analyzing the relationship between the first characteristic and the second characteristic and the flow field, so as to determine whether the flow field condition of the sample is normal. Then, when the ratio is within a predetermined range, the measuring instrument 200 will determine that the flow field condition is normal and display the result of the sample after analysis. The first characteristic is to measure the liquid essential characteristics such as the diffusion and / or migration ability of the sample ions, thereby analyzing the physical characteristics of the liquid sample, and the physical characteristics include but are not limited to viscosity, diffusion coefficient, etc. The second characteristic is to measure the interface characteristics of the sample and the electrode, thereby analyzing the interface characteristics of the flow channel wall, and the flow channel characteristics include but are not limited to contact angle, charging current, etc. In other words, the first characteristic is related to the ion diffusion and / or migration ability of the sample, and the second characteristic is related to the interface characteristics of the sample and the electrode. It should be noted that the present case does not limit the measurement method of the first characteristic and the second characteristic. In one embodiment, the characteristic is an electrical signal, so the first and second characteristics are the liquid electrical characteristics and the liquid and electrode interface electrical characteristics, respectively. In another embodiment, the first and second characteristics are both liquid electrical characteristics and liquid or electrode interface electrical characteristics. In another embodiment, at least one of the first and second characteristics is measured by an optical method.

[0068] Figure 2 This is a flow chart of an electrochemical detection method according to an embodiment of the present invention. The electrochemical detection method according to this embodiment can be used to detect the first characteristic and the second characteristic of a sample. The electrochemical detection method includes the following steps: step S1, injecting the sample into the reaction zone 140 of the electrochemical test strip 100; step S2, measuring the first characteristic of the sample and the second characteristic of the sample; step S3, calculating the ratio of the first characteristic to the second characteristic to determine whether the flow field condition of the sample filling the reaction zone 140 is normal. When the ratio is within a predetermined range, the flow field condition is determined to be normal, and the result of the sample analysis is displayed.

[0069] For more details, please also refer to Figures 1A to 1C as well as Figure 2 In this embodiment, the electrochemical test strip 100 is inserted into the measuring instrument 200, and the microcontroller 220 provides a potential to the reaction zone 140. When the sample is injected into the reaction zone 140 of the electrochemical test strip 100 and covers the electrode loop of the electrode group 121, causing the impedance of the electrode group 121 to change, the microcontroller 220 can confirm that the sample has begun to flow into the reaction zone 140. In this embodiment, the microcontroller 220 can determine whether the sample fills the reaction zone 140 by the change of the signal threshold value of the electrode group 122 (such as resistance, capacitance, voltage, current or a combination thereof); in this embodiment, the injection and filling status of the sample can be determined by the meaning of the positions of the electrode group 121 and the electrode group 122, such as Figure 1CAs shown, since electrode set 121 is closer to the sampling port (ie, first side 141 ) and electrode set 122 is closer to the end of reaction zone 140 (ie, second side 142 ), electrode set 121 can be used to determine the sample injection starting point, and electrode set 122 can be used to determine whether the sample is full.

[0070] In this embodiment, the microcontroller 220 detects the first characteristic and the second characteristic of the sample and starts analyzing the flow field condition only after the sample is filled. In another embodiment, the microcontroller 220 detects the first characteristic and the second characteristic of the sample during the sample filling process, including but not limited to the electrical signal for determining the filling; in another embodiment, the microcontroller 220 detects the first characteristic or the second characteristic of the sample during and after the sample is filled.

[0071] Under normal circumstances, when the sample flows into the reaction zone 140 due to capillary force, it is a one-dimensional natural flow. However, the sample may have an abnormal flow field condition due to abnormal flow state or abnormal flow channel structure. In other words, when the sample gradually flows under the action of capillary force, an unpredictable flow time difference will be generated between the sample and the pipe channel boundary of the reaction zone 140 due to non-preset effects. The difference may be caused by factors such as friction, disturbance or turbulence generated by the flowing fluid, and the abnormal flow field condition will cause errors or inaccuracies in the measurement results of the sample concentration. Therefore, one of the purposes of this embodiment is to eliminate the problem of error in the measurement results of the sample concentration caused by abnormal flow field by judging the flow field condition of the sample, thereby improving the detection accuracy and reliability. Further, this embodiment analyzes the flow time difference caused by the sample and the flow channel convection field by measuring the electrical characteristics of the sample interface and the electrical characteristics of the sample and electrode interface, so as to eliminate or correct the measurement deviation caused by the abnormal flow field.

[0072] In detail, in the present embodiment, the first feature and the second feature may include two of the flow rate, temperature, viscosity, density or contact angle of the sample, but are not limited thereto. In the present embodiment, by performing a two-dimensional cross analysis on at least two detected features (e.g., the first feature and the second feature), the flow field condition of the sample in the reaction zone 140 can be known. It should be noted that the two features are not limited, as long as the two features are not of the same physical meaning (i.e., there is a low equivalence between the first feature and the second feature), and the two features are highly correlated to the flow field. The best first feature is the intrinsic feature of the liquid, and the second feature is the flow channel interface feature.

[0073] In this embodiment, the flow field condition of the sample can be obtained by using the Reynolds number formula in the tube wall, and the formula is as follows:

[0074]

[0075] Where V is the average flow velocity (m / s); D is the diameter of the reaction zone tube (m); μ is the dynamic viscosity of the fluid (Pa·s or N·s / m 2 ); γ-system kinematic viscosity (μ / ρ)(m 2 / s); ρ is the fluid density (kg / m 3 ); Q is the volume flow rate (m 3 / s); A cross-sectional area (m 2 ). Among them, V, μ, γ, ρ belong to the intrinsic characteristics of the liquid, and D, Q and A belong to the flow channel interface characteristics, so it is possible to judge whether the flow field condition is abnormal by comparing two of the physical characteristics with the Reynolds number or other relative physical characteristics. In this embodiment, the above-mentioned reaction zone tube diameter can be regarded as the diameter of the reaction zone 140 of the sample, but it is not limited to this. It should be noted that this case does not limit the relationship between the physical characteristics represented by the two physical characteristics. It only requires that the two have different physical meanings and that the two characteristics are highly correlated to the flow field. The best at least one characteristic is the intrinsic characteristic of the liquid; it is better to have at least one intrinsic characteristic of the liquid and a flow channel interface characteristic.

[0076] The following describes how to use two features (ie, the first feature and the second feature) to determine the flow field condition using a first method, a second method, and a third method.

[0077] [First method] Taking the flow rate of the sample as the first characteristic and the viscosity of the sample as the second characteristic as an example, this paper explains how to use flow rate and viscosity to judge the flow field condition:

[0078] First, the sample is injected into the reaction zone 140 of the electrochemical test strip 100, so that after the sample is injected, the sample can flow into the reaction zone 140 by capillary force and continue to flow toward the vent 161. Then, during the flow of the sample, the flow rate and viscosity of the sample are measured. In the present embodiment, the flow rate is measured and calculated by measuring and calculating the time required for the sample to pass through the electrode group 121 and the electrode group 122, but is not limited thereto. Specifically, in the present embodiment, the step of measuring the flow rate of the sample from the electrode group 121 in the reaction zone 140 to the electrode group 122 may include: first, the sample flows through and covers the electrode group 121 in the reaction zone 140, so that the electrode group 121 can generate a first signal at a first time, and the first time is recorded; then, the sample continues to flow through and covers the electrode group 122 in the reaction zone 140, so that the electrode group 122 can generate a second signal at a second time, and the second time is recorded; then, the difference between the first time and the second time is calculated to obtain the flow rate. When the first signal is generated, it indicates that the sample has entered the reaction area 140 and reached the electrode set 121; when the second signal is generated, it indicates that the sample has reached the electrode set 122. The first signal or the second signal may be, for example, impedance change, capacitance change, voltage change, current change, or a combination thereof on the electrode, but is not limited thereto.

[0079] More specifically, since the insulating substrate 110, the first insulating spacer 130, the reaction zone 140 and the second insulating spacer 160 can define a single-flow capillary after being combined, when the sample is injected into the reaction zone 140, the sample will flow toward the vent 161 due to the capillary force, and will flow through and cover the electrode group 121 and the electrode group 122 in sequence. Therefore, the difference between the first time of the first signal and the second time of the second signal is the time when the sample flows from the electrode group 121 in the reaction zone 140 to the electrode group 122. In addition, since the first distance D1 between the electrode group 121 and the electrode group 122 in the reaction zone 140 is a constant, the difference between the first time and the second time can be regarded as the flow rate. Among them, the larger the difference, the slower the flow rate of the sample; conversely, the smaller the difference, the faster the flow rate of the sample.

[0080] In this embodiment, the viscosity of the sample can be measured in the following manner. For example, in one embodiment, since the composition and concentration of the sample itself will vary with different samples, different samples will have different intrinsic electrical characteristics, so the ion diffusion and / or migration state of the sample can be known by detecting the intrinsic electrical characteristics of the sample. For example, when the sample is blood, since blood contains blood cells and plasma, and the human hematocrit is between 20% and 65%, when the hematocrit increases, the ion diffusion and / or migration ability of the blood will also change. Therefore, the intrinsic electrical characteristics of the blood, such as the viscosity of the blood, can be represented by detecting the hematocrit in the blood, but it is not limited to this. In some embodiments, the intrinsic electrical characteristics of the blood can be obtained by methods such as capacitance, reactance, diffusion current, etc. In addition, in addition to the hematocrit, components such as plasma proteins, minerals or vitamins in the plasma may also affect the ion diffusion and / or migration ability of the blood. In another embodiment, when the sample covers the electrode set 121 and / or the electrode set 122 and changes the electrical properties of the electrodes, the measuring instrument 200 can detect the physical characteristics of the sample and calculate the viscosity through the electrode set 121 and / or the electrode set 122, that is, the flow rate and viscosity are measured in the same step.

[0081] Then, after measuring the flow rate and viscosity as described above, the ratio of the flow rate to the viscosity is calculated to determine whether the flow field condition of the sample filling the reaction zone is normal, and to determine whether to display the results of the sample after analysis. When the ratio is within the predetermined range, it can be determined that the flow field condition of the sample is normal, and therefore, the results of the sample after analysis can be displayed. When the ratio is within the correctable range, the concentration measurement result can be corrected by the ratio, and therefore, the analyzed and corrected concentration measurement result can also be displayed after correction. Conversely, when the ratio exceeds the predetermined range or the correctable range, it can be determined that the flow field condition of the sample is abnormal, and therefore, "error" can be displayed and the concentration measurement result of the sample after analysis will not be displayed. So far, it has been clearly explained how to use the flow rate of the sample and the liquid electrical characteristics of the sample to determine the flow field condition.

[0082] It should be noted that, although the intrinsic electrical characteristic of the sample used in this embodiment is viscosity, and the flow field condition of the sample can be known by analyzing the viscosity and flow rate, the present invention does not limit the intrinsic electrical characteristic of the sample to viscosity. That is, in another embodiment, the intrinsic electrical characteristic of the sample should include at least one of all physical characteristics that change the flow field, and the physical characteristics can be detected by the electrochemical detection system disclosed in the present invention. More preferably, the intrinsic electrical characteristic of the sample can be, for example, a signal generated by the physical characteristics of multiple samples.

[0083] [Second method] Take the flow rate of the sample as the first feature and the liquid electrical characteristics that the sample should have in experience as the second feature as an example to illustrate how to use the flow rate and liquid electrical characteristics to determine the flow field condition:

[0084] In this embodiment, since the method of measuring the flow rate of the sample is similar to the first method described above, it will not be repeated here. As for the liquid electrical characteristics that the sample should have in experience, it can be obtained according to the corresponding table of the viscosity and liquid electrical characteristics of the sample after measuring the viscosity of the sample. For example, when the sample is blood, since the viscosity or blood cell ratio of the blood will affect the flow rate of the sample, a corresponding table of the viscosity (or blood cell ratio) and liquid electrical characteristics of the blood can be established by measuring a variety of different blood viscosities (or blood cell ratios) and their corresponding liquid electrical characteristics. Among them, the corresponding table can represent the liquid electrical characteristics that the blood should have in experience when the blood is at a specific viscosity (or blood cell ratio). Then, by calculating the ratio of the flow rate to the liquid electrical characteristics, it is determined whether the flow field condition of the sample filling the reaction area is normal, and whether the results of the sample after analysis are displayed. So far, it has been clearly explained how to use the flow rate of the sample and the liquid electrical characteristics that the sample should have in experience to determine the flow field condition.

[0085] [Third Method] Taking the viscosity of the sample as the first characteristic and the contact angle of the sample on the electrochemical test strip as the second characteristic, this example illustrates how to use viscosity and contact angle to determine the flow field condition:

[0086] In this embodiment, since the method for measuring the viscosity of the sample is similar to the first method described above, it will not be described in detail here. In addition, since the contact angle is positively correlated with the resistance, the contact angle can be calculated by measuring the signal of the blood sample in the flow channel. Then, by calculating the ratio of viscosity to contact angle, it is determined whether the flow field condition of the sample filling the reaction area is normal, and whether the result after the sample analysis is displayed. So far, it has been clearly explained how to use the viscosity and contact angle of the sample to determine the flow field condition.

[0087] It should be noted that, although the intrinsic electrical characteristic of the sample used in this embodiment is viscosity, and the flow field condition of the sample can be known by analyzing the viscosity and the contact angle, the present invention does not limit the intrinsic electrical characteristic of the sample to viscosity. That is, in other embodiments, the intrinsic electrical characteristic of the sample should be flow rate, and in another embodiment, the intrinsic electrical characteristic of the sample should include at least one of all physical characteristics that change the flow field, and the physical characteristics can be detected by the electrochemical detection system disclosed in the present invention. More preferably, the intrinsic electrical characteristic of the sample can be, for example, a signal generated by the physical characteristics of multiple samples.

[0088] It should be noted that although the first method, the second method and the third method use two features as an example to determine the flow field conditions, the present invention is not limited to only two features to determine the flow field conditions. That is to say, in another embodiment, three or more features can also be used to determine the flow field conditions. For example, the temperature can be measured using a temperature sensor on a measuring instrument, and then the temperature characteristics, viscosity and contact angle are used for three-dimensional analysis to obtain an accurate flow field condition of the reaction zone. In addition, the present invention is not limited to the three-dimensional analysis method. That is to say, in another embodiment, the viscosity can be corrected by temperature first, and then the flow field can be analyzed with the corrected viscosity and flow rate. In another embodiment, the flow velocity, viscosity and contact angle can be calculated simultaneously to analyze the flow field, and then the flow field resolution can be improved through three-dimensional information.

[0089] The following will describe in detail the detailed features of the electrochemical test strip 100, wherein the detailed features are applicable to all the above embodiments. Figure 1B and Figure 1C In this embodiment, the reaction area 140 has a first side 141 and a second side 142 opposite to the first side 141. The measuring instrument 200 may be electrically connected to the electrode set 121 and the electrode set 122.

[0090] Specifically, the reaction zone 140 includes a portion 121a of the electrode group 121 and a portion 122a of the electrode group 122. The portion 121a of the electrode group 121 is adjacent to the first side 141 of the reaction zone 140, and the portion 122a of the electrode group 122 is adjacent to the second side 142 of the reaction zone 140. In this embodiment, there is a first distance D1 between the portion 121a of the electrode group 121 and the portion 122a of the electrode group 122, and there is a second distance D2 (i.e., the length of the reaction zone 140 or the concave structure 131) between the first side 141 and the second side 142 of the reaction zone 140. The first distance D1 is, for example, the distance between the side of the electrode group 121 adjacent to the first side 141 in the reaction zone 140 and the electrode 1221 of the electrode group 122 adjacent to the first side 141. In this embodiment, the first distance D1 may be, for example, greater than or equal to 0.3 times the second distance D2 (i.e., D1≧30%×D2); preferably, the first distance D1 may also be, for example, greater than or equal to 0.5 times the second distance D2 (i.e., D1≧50%×D2); more preferably, the first distance D1 may also be, for example, greater than or equal to 0.8 times the second distance D2 (i.e., D1≧80%×D2), thereby ensuring the accuracy of the flow rate measured above.

[0091] In this embodiment, the second insulating spacer 160 covers at least a portion of the reaction area 140 and exposes the connection area 112 of the insulating substrate 110 and the electrode groups 121 and 122 located on the connection area 112 .

[0092] The following will be accompanied by drawings and experimental examples to illustrate the technical means adopted by the present invention to achieve the purpose. The following sample is blood, but it is not limited to this. Therefore, those skilled in the art can easily replace it with other liquid samples according to the content disclosed in this embodiment.

[0093] Experimental example

[0094] Experimental Example 1: Effect of blood cell ratio on viscosity

[0095] As mentioned above, viscosity can be used as a characteristic of the essential characteristics of a liquid. Therefore, the following explains how to use Figure 1A The electrochemical detection system shown in the figure is used to measure the viscosity of blood. In Experimental Example 1, the blood cell ratio and viscosity can be detected by the first signal generated by the electrode group 121 at the first time or / and the second signal generated by the electrode group 122 at the second time. Please refer to Figure 3 , the X-axis is the hematocrit (HCT) of different blood samples, and the Y-axis is the viscosity after measurement. Figure 3The results show that in blood with a hematocrit of 0%-30%, the viscosity of the blood does not change much. However, in blood with a hematocrit of 30%-70%, as the hematocrit increases, the viscosity of the blood also gradually increases. Among them, in blood with a hematocrit of 50%, the viscosity of the blood has obviously fluctuated or changed (i.e., 200±20); and in blood with a hematocrit of 70%, the fluctuation or change of the viscosity of the blood is more obvious (i.e., 500±80ms). However, although the viscosity of blood with a hematocrit of 50%-70% has a certain floating range, the viscosity ranges of blood with various hematocrits can still be clearly distinguished. Among them, the fluctuation and the change may be caused by the superposition effect of protein concentration, red blood cell deformability and aggregation.

[0096] Experimental Example 2: Comparison of the flow field conditions of blood under normal conditions and after secondary sampling

[0097] In Experimental Example 2, by using Figure 1A The electrochemical detection system and electrochemical detection method shown are used to compare the flow field conditions of blood under normal conditions and during secondary sampling, so as to identify the occurrence of secondary sampling based on the abnormal flow field conditions. For details, please refer to Figure 4 , the flow rate (Y-axis) and viscosity (X-axis) of 45 blood samples under normal conditions (represented by circular symbols in the figure) and 5 blood samples under abnormal sampling conditions (represented by square symbols in the figure) are measured. The abnormal sampling condition may be, for example, secondary sampling, but is not limited to this. The secondary sampling refers to the situation where, after the normal injection of blood, the user suddenly finds that there is insufficient blood in the reaction area and injects more blood again. However, the secondary sampling situation will destroy the dissolution and diffusion of the reaction layer, thereby disrupting the original standing time process and affecting the measurement results. In addition, the secondary sampling situation will also change the original capillary force in the capillary, thereby affecting the original flow rate.

[0098] like Figure 4As shown, the solid line in the figure is the ratio under ideal conditions, that is, it means that the flow rate is proportional to the viscosity, and the ratio of the flow rate to the viscosity (i.e., = / ) is equal to 1. The dotted line in the figure indicates that the ratio is still within ±2% of the allowable error range. The dashed line in the figure indicates that the ratio is still within ±5% of the correctable error range, so that the measurement results of blood in this range can still be corrected by expressions or other correction methods. In this embodiment, the predetermined range or the correctable range of the ratio is, for example, in the range of 0.5 to 1.5 and does not include 0.5 and 1.5 (i.e., 0.5<predetermined range or correctable range<1.5), but is not limited thereto. Preferably, the predetermined range or the correctable range is, for example, in the range of 0.8 to 1.2 and does not include 0.8 and 1.2 (i.e., 0.8<predetermined range or correctable range<1.2). More preferably, the predetermined range or the modifiable range is, for example, in the range of 0.95 to 1.05 and does not include 0.95 and 1.05 (i.e., 0.95<predetermined range or modifiable range<1.05). In addition, it should be noted that those skilled in the art can also define the predetermined range or the modifiable range of the ratio according to the allowable error of their system.

[0099] Depend on Figure 4 From the results, we can see that under normal conditions, the ratio of flow rate to viscosity of the 45 blood samples is within the allowable error range of ±2%. Therefore, the system will judge that the flow field conditions of these 45 blood samples are normal, and display the results of the analysis of these 45 blood samples. However, since the flow rates of the 5 blood samples with sampling abnormalities (i.e., secondary sampling) are much greater than the viscosity, the ratio of their flow rate to viscosity exceeds the correctable error range of ±5%. Therefore, the system will judge that the flow field conditions of these 5 secondary blood samples are abnormal, and display "error" and will not display the results of the analysis of these 5 secondary blood samples. It can be seen that Figure 1A The electrochemical detection system and electrochemical detection method shown can indeed be used to identify the occurrence of secondary sampling.

[0100] Experimental Example 3: Comparison of blood flow conditions under normal conditions and during secondary use

[0101] In Experimental Example 3, by using Figure 1A The electrochemical detection system and electrochemical detection method shown are used to compare the flow field conditions of blood under normal conditions and during secondary use, so as to identify the secondary use situation based on the abnormal flow field conditions. For details, please refer to Figure 4, the flow rate (Y-axis) and viscosity (X-axis) of 45 blood samples under normal conditions (represented by circular symbols in the figure) and 5 blood samples under abnormal sampling conditions (represented by square symbols in the figure) were measured. Among them, the abnormal sampling condition can be, for example, secondary use, but is not limited to this. The secondary use means that when the test strip is reused, under the premise that the exhaust hole is not blocked, the blood can still enter the reaction area through capillary force and start the electrochemical measurement procedure. However, since the reaction layer has been dissolved and mixed with the previous blood and then crystallized again, the reaction layer in the reaction area at this time presents an unpredictable and irregular state. In addition, the crystallization of the reaction layer and the previous blood will also change the flow channel condition of the reaction area, thereby affecting the flow rate. However, in another embodiment, the crystallization condition of the reaction layer can also be judged by the characteristics of the sample and electrode interface.

[0102] As Experimental Example 2 has shown Figure 4 The solid lines, dotted lines and dashed lines in FIG. 1 have already explained the range of the predetermined range or the range that can be modified, so they will not be repeated here. Figure 4 From the results, we can see that under normal conditions, the ratio of flow rate to viscosity of the 45 blood samples is within the allowable error range of ±2%. Therefore, the system will judge that the flow field conditions of these 45 blood samples are normal and display the results of the analysis of these 45 blood samples. However, since the flow rates of the 5 blood samples with sampling abnormalities (i.e., secondary use) are much greater than the viscosity, the ratio of their flow rate to viscosity exceeds the correctable error range of ±5%. Therefore, the system will judge that the flow field conditions of these 5 secondary used blood samples are abnormal, and display "error" and will not display the results of the analysis of these 5 secondary used blood samples. It can be seen that Figure 1A The electrochemical detection system and electrochemical detection method shown can indeed be used to identify the occurrence of secondary use.

[0103] Experimental Example 4: Comparison of blood flow conditions under normal conditions and when the flow channel is abnormal

[0104] In Experimental Example 4, by using Figure 1A The electrochemical detection system and electrochemical detection method shown are used to compare the flow field conditions of blood under normal conditions and when the flow channel is abnormal, so as to identify the flow channel abnormality according to the abnormal flow field conditions. For details, please refer to Figure 4, the flow rate (Y-axis) and viscosity (X-axis) of 45 blood samples under normal conditions (indicated by circular symbols in the figure) and 5 blood samples under abnormal flow channel conditions (indicated by diamond symbols in the figure) were measured. The abnormal flow channel condition may refer to, for example, deformation of the electrochemical test piece due to the process, poor bonding, burrs or foreign matter falling into the reaction area when the concave structure is cut, but is not limited to this. In addition, the abnormal flow channel condition will also change the flow channel condition of the reaction area, thereby affecting the flow rate.

[0105] As Experimental Example 2 has shown Figure 4 The solid lines, dotted lines and dashed lines in FIG. 1 have already explained the range of the predetermined range or the range that can be modified, so they will not be repeated here. Figure 4 From the results, we can see that the ratio of flow rate to viscosity of the 45 blood samples under normal conditions is within the allowable error range of ±2%. Therefore, the system will judge that the flow field conditions of these 45 blood samples are normal and display the results of the analysis of these 45 blood samples. However, because the flow rates of the 5 blood samples with abnormal flow paths are much smaller than the viscosity, the ratio of their flow rate to viscosity exceeds the correctable error range of ±5%. Therefore, the system will judge that the flow field conditions of these 5 blood samples with abnormal flow paths are abnormal, and display "error" and will not display the results of the analysis of these 5 blood samples with abnormal flow paths. It can be seen that Figure 1A The electrochemical detection system and electrochemical detection method shown can indeed be used to identify the occurrence of flow channel abnormalities.

[0106] It should be noted that although Experimental Example 4 shows that the flow velocity and viscosity of the sample can be used to determine and identify the flow field condition when the flow path is abnormal, the present invention does not limit the method of determining and identifying the flow path abnormality. In other experimental examples, the contact angle can also be used to determine and identify the flow path abnormality, as shown in Experimental Example 6.

[0107] Experimental Example 5: Comparison of blood flow conditions under normal conditions and under correctable conditions

[0108] In Experimental Example 5, by using Figure 1A The electrochemical detection system and electrochemical detection method shown compare the flow field conditions of blood under normal conditions and under correctable conditions, so as to identify the situation where the blood has extreme viscosity or there is a slight defect in the flow path of the reaction zone according to the flow field conditions. For details, please refer to Figure 4, the flow rate (Y axis) and viscosity (X axis) of 45 blood samples under normal conditions (indicated by circular symbols in the figure) and 5 blood samples under correctable conditions (indicated by triangle symbols in the figure) are measured. The correctable condition may be, for example, that the blood sample has extreme viscosity or there is a slight defect in the flow path of the reaction zone, and the cause and range of the error can be known through the technology disclosed in this case, so the measuring instrument can be corrected through expressions or other correction methods, but it is not limited to this.

[0109] As Experimental Example 2 has shown Figure 4 The solid lines, dotted lines and dashed lines in FIG. 1 have already explained the range of the predetermined range or the range that can be modified, so they will not be repeated here. Figure 4 From the results, it can be seen that the ratio of flow rate to viscosity of the 45 blood samples under normal conditions is within the allowable error range of ±2%. Therefore, the system will determine that the flow field conditions of these 45 blood samples are normal and display the results of the analysis of these 45 blood samples. However, the flow rate of the 5 blood samples with correctable conditions (i.e., the blood samples have extreme viscosity) is slightly greater or less than the viscosity, so that the ratio of their flow rate to viscosity falls within the correctable error range of ±5%. Therefore, the system can correct its results through expressions or other correction methods and display the corrected measurement results.

[0110] Experimental Example 6: Comparison of blood flow conditions under normal conditions and when the flow channel is abnormal

[0111] In Experimental Example 6, by using Figure 1A The electrochemical detection system and electrochemical detection method shown are used to compare the flow field conditions of blood under normal conditions and when the flow channel is abnormal, so as to identify the flow channel abnormality according to the abnormal flow field conditions. For details, please refer to Figure 5 , in electrochemical test strips made of three different materials, the contact angle (Y-axis) and resistance (X-axis) of 5 different blood samples under normal conditions are tested respectively. The diamond symbols in the figure represent the test results of 5 different blood samples in the electrochemical test strip made of the first material, the triangle symbols in the figure represent the test results of 5 different blood samples in the electrochemical test strip made of the second material, and the square symbols in the figure represent the test results of 5 different blood samples in the electrochemical test strip made of the third material. Next, the contact angle and resistance of 2 different blood samples under abnormal flow channel conditions (indicated by * symbols in the figure) are tested respectively. Among them, since the contact angle is positively correlated with the resistance, the contact angle can be calculated by measuring the signal of the blood sample in the flow channel.

[0112] Depend on Figure 5The results show that although the contact angles and resistances of the five different blood samples in the electrochemical test strips made of the first material, the second material, and the third material are different, the differences in contact angles and resistances between the three materials are more significant. In other words, the differences in contact angles caused by different materials are more significant than the differences in contact angles caused by different blood samples. Therefore, the contact angle can be used as a feature of the interface between the sample and the electrode.

[0113] Next, when the contact angle and resistance of 5 different blood samples under normal conditions are used to define the possible contact angle range and resistance range of the blood samples, it can be found that the contact angle and resistance of 2 different blood samples under abnormal flow conditions are both outside the range. Therefore, the system can judge that the flow field conditions of the 2 blood samples with abnormal flow channels are abnormal through the relationship between contact angle and resistance, and display "error" and will not display the results of the analysis of the 2 blood samples with abnormal flow channels. It can be seen from this that Figure 1A The electrochemical detection system and electrochemical detection method shown can indeed be used to identify the occurrence of flow channel abnormalities.

[0114] Experimental Example 7: Measuring the Equivalence Relationship between Contact Angle and Viscosity

[0115] In Experimental Example 7, by using Figure 1A The electrochemical detection system and electrochemical detection method shown are used to measure the equivalent relationship between contact angle and viscosity to ensure that contact angle and viscosity can be used as the first and second characteristics to determine the flow field conditions. For details, please refer to Figure 6 The electrochemical test strip made of the second material in Experimental Example 6 was used to measure the contact angle and viscosity of 20 blood samples with different hematocrit ratios.

[0116] Depend on Figure 6 From the results, it can be seen that the viscosity of 20 blood samples with different hematocrit ratios can be roughly distributed between about 40 and 550, and the contact angle can be roughly distributed between about 60 and 70 degrees. In other words, even though the viscosity difference between the 20 blood samples with different hematocrit ratios is quite large, the difference in contact angle between these 20 blood samples with different hematocrit ratios is not significant. Therefore, it can be said that the relationship between viscosity and contact angle is a low equivalence relationship. In addition, since viscosity can be used as the liquid essential characteristic of the blood sample, and the contact angle can be used as the interface characteristic of the blood sample and the electrode, in other experimental examples, the relationship between viscosity and contact angle can be used to determine the flow field condition of the blood sample.

[0117] Experimental Example 8: Comparison Figure 1A The measurement deviation between the detection method of the electrochemical detection system shown and the detection method of the general electrochemical detection system

[0118] In Experimental Example 7, by using Figure 1A The electrochemical detection system and electrochemical detection method shown are used to determine the flow field condition of the sample, so as to correct or eliminate the problem that the measurement result of the sample concentration may have errors due to the abnormal flow field condition, thereby improving the detection accuracy. For details, please refer to Fig. 7A and Figure 7B , Fig. 7A It uses the general electrochemical test strip detection method to measure the blood glucose concentration of different blood samples (100, 200, 300, 400, 500, 600, 700 mg / dL). Figure 7B The detection method of the electrochemical test strip of this embodiment is used to measure the blood glucose concentration of different blood samples (100, 200, 300, 400, 500, 600, 700 mg / dL); then, the results obtained by the two electrochemical test strips are compared with the results obtained by the large-scale measuring instrument YSI to obtain the deviation value. Among them, the X-axis is the blood glucose concentration, and the Y-axis is the deviation value after the comparison between the results obtained by the electrochemical test strip and the results obtained by the large-scale measuring instrument YSI. In addition, the dotted line in the figure represents the allowable error range.

[0119] Depend on Fig. 7A The results show that, in the measurement results of the general electrochemical test strip detection method, most of the deviation values ​​compared with the large-scale measuring instrument YSI are within the dotted line (that is, within the allowable error range), but there are still about 10% of the deviation values ​​outside the dotted line (that is, outside the allowable error range), indicating that the general electrochemical test strip detection method will have about 10% of the measurement results with significant errors. Figure 7B It can be seen from the results that in the measurement results of the detection method using the electrochemical test strip of this embodiment, since the electrochemical test strip of this embodiment can judge, correct or eliminate abnormal conditions by the ratio of flow rate to viscosity during measurement, the deviation values ​​of all the results after comparison with the results of the large-scale measuring instrument YSI are within the dotted line (i.e., within the allowable error range). In other words, compared with the detection method using the general electrochemical test strip, the detection method of the electrochemical test strip of this embodiment can significantly improve the accuracy of detection.

[0120] In summary, in the electrochemical detection system and the electrochemical detection method of one embodiment of the present invention, by measuring the first feature and the second feature and calculating the ratio of the first feature to the second feature, it can be used to determine whether the flow field condition of the sample is normal. Among them, only when the ratio is within a predetermined range, the flow field condition is judged to be normal and the results of the sample after analysis are displayed. In addition, in this embodiment, the results can be corrected or the results of abnormal conditions can be excluded based on the ratio. Thereby, the electrochemical detection system and the electrochemical detection method of this embodiment can avoid misjudgment or have the effect of improving detection accuracy.

[0121] Finally, it should be noted that the above embodiments are only used to illustrate the technical solutions of the present invention, rather than to limit it. Although the present invention has been described in detail with reference to the aforementioned embodiments, those skilled in the art should understand that they can still modify the technical solutions described in the aforementioned embodiments, or replace some or all of the technical features therein with equivalents. However, these modifications or replacements do not cause the essence of the corresponding technical solutions to deviate from the scope of the technical solutions of the embodiments of the present invention.

Claims

1. An electrochemical detection system for detecting a sample, It is characterized in that include: An electrochemical test strip comprises a main body and at least one electrode group; as well as A measuring instrument is electrically connected to the at least one electrode group and is suitable for judging whether the flow field condition of the sample is normal through the at least one electrode group. The measuring instrument measures the first characteristic and the second characteristic of at least one of the sample and the electrochemical test strip through the at least one electrode group, and calculates the ratio of the first characteristic to the second characteristic to determine whether the flow field condition of the sample is normal. When the ratio is within a predetermined range, the measuring instrument determines that the flow field condition is normal and displays the result of the analysis of the sample. The first feature and the second feature have low equivalence, The first feature or the second feature is a fluid feature or a flow channel feature.

2. The electrochemical detection system according to claim 1, It is characterized in that The fluid characteristics include flow rate, temperature, viscosity and density of the sample.

3. The electrochemical detection system according to claim 1, It is characterized in that The flow channel characteristics include contact angle, charging current, diameter of the reaction zone of the sample, volume flow rate of the sample, and cross-sectional area of ​​the reaction zone.

4. The electrochemical detection system according to claim 1, It is characterized in that The flow field conditions include flow channel anomalies and sampling anomalies.

5. A measuring instrument for detecting a sample, It is characterized in that include: Connectors; a microcontroller, electrically connected to at least one electrode group through the connector; A power module, electrically connected to the microcontroller; as well as a display, electrically connected to the microcontroller, wherein the microcontroller is adapted to measure a first characteristic and a second characteristic of the sample through the at least one electrode group, and analyze the relationship between the first characteristic, the second characteristic and the flow field, The first feature and the second feature have low equivalence, The first characteristic is related to the ion diffusion and / or migration ability of the sample, and the second characteristic is related to the interface characteristic between the sample and the electrode.

6. An electrochemical detection method for detecting a sample, It is characterized in that include: injecting the sample into an electrochemical test strip; as well as The flow field condition of the sample is judged by a measuring instrument whether it is normal. The step of judging whether the flow field condition of the sample is normal comprises: Measuring a first characteristic and a second characteristic of at least one of the sample and the electrochemical test strip through at least one electrode group of the electrochemical test strip; as well as Calculating a ratio of the first feature to the second feature, wherein when the ratio is within a predetermined range, the measuring instrument determines that the flow field condition is normal and displays the result of the analysis of the sample, The first feature and the second feature have low equivalence, The first characteristic is related to the ion diffusion and / or migration ability of the sample, and the second characteristic is related to the interface characteristic between the sample and the electrode.

7. The electrochemical detection method according to claim 6, It is characterized in that The first characteristics include flow rate, temperature, viscosity and density of the sample.

8. The electrochemical detection method according to claim 6, It is characterized in that The second characteristic includes a contact angle, a charging current, a diameter of a reaction zone of the sample, a volume flow rate of the sample, and a cross-sectional area of ​​the reaction zone.

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