TWI687207B - Detection device and detection method - Google Patents

Abstract

The present disclosure relates to a detection device. The detection device includes a power supply circuit, a convert circuit and a process circuit. The power supply circuit is configured to provide a first detection voltage and a second detection voltage, such that a specimen has current variation according to the first detection voltage and the second detection voltage. When the first detection voltage is switched to the second detection voltage, the convert circuit output a current variation signal according to the current variation of the specimen. The process circuit is coupled to the convert circuit and is configured to calculate a first correlation value of the specimen according to the current variation signal(e.g., HCT index).

Description

Detection device and detection method

The present disclosure relates to a detection device and a detection method, in particular, a detection technology that can be used to detect a blood volume ratio indicator.

At present, the blood tester used in home care is to put the user's whole blood sample directly into the reaction area of the test strip, so that the whole blood sample and the reaction reagent are mixed, and then the electrical change is detected, and then calculated Test results, for example: detection of blood glucose values.

However, during the detection process using "whole blood", the content of blood cells in the whole blood sample (that is, hematocrit, or Hct) will affect the test results. Taking the blood glucose value as an example, when the blood cell volume ratio is high, the blood glucose value detected by the blood detector will be underestimated. On the contrary, when the blood cell volume ratio is low, the blood glucose value detected by the blood detector will be overestimated. There is still room for improvement in detection accuracy.

An aspect of the present invention is a detection device, including a power supply circuit, a conversion circuit and a processing circuit, the power supply circuit is used to provide a continuous first detection voltage and a second detection voltage, so that a sample based The first detection voltage and the second detection voltage have a current change; the conversion circuit is used to output a current change signal according to the current change of the specimen when the first detection voltage is switched to the second detection voltage; the The processing circuit is electrically connected to the conversion circuit, and is used to calculate a first correlation value of the specimen according to the current change signal.

Another aspect of the present invention is a detection method that first detects a sample on a test piece by applying a continuous first detection voltage and a second detection voltage through a conversion circuit. The current changes and output a current change signal; then through a processing circuit, according to the current change signal, calculate a first correlation value of the specimen.

In summary, in various implementations of this case, by detecting the instantaneous current change generated when the specimen is subjected to different detection voltages, the expected first relevant value can be accurately detected to improve the detection efficiency and accuracy .

In the following, a plurality of embodiments of the present invention will be disclosed in the form of diagrams. For the sake of clarity, many practical details will be described together in the following description. However, it should be understood that these practical details should not be used to limit the present invention. That is to say, in some embodiments of the present invention, these practical details are unnecessary. In addition, in order to simplify the drawings, some conventional structures and elements will be shown in a simple schematic manner in the drawings.

In this article, when an element is referred to as "connected" or "coupled", it can be referred to as "electrically connected" or "electrically coupled." "Connected" or "coupled" can also be used to indicate that two or more components interact or interact with each other. In addition, although terms such as "first", "second", etc. are used herein to describe different elements, the terms are only used to distinguish elements or operations described in the same technical terms. Unless the context clearly dictates, the term does not specifically refer to or imply order or order, nor is it intended to limit the present invention.

Please refer to FIG. 1. FIG. 1 is a schematic diagram of a detection device according to some embodiments of the present disclosure. In one embodiment, the detection device 100 includes a blood tester 400. The blood tester 400 includes at least A power supply circuit 110, a conversion circuit 120, and a processing circuit 130 are provided. The power supply circuit 110 is used to provide a continuous first detection voltage and a second detection voltage. When a specimen (such as a blood specimen) is applied with the first detection After the voltage and the second detection voltage, there will be a current change. In one embodiment, the first detection voltage provided by the power supply circuit 110 is a positive voltage, and the magnitude is between 0.2 volts and 1 volt. The second detection voltage may be a positive voltage or a negative voltage, but The absolute value must be smaller than the absolute value of the first detection voltage, that is, there will be a sudden voltage change between the first detection voltage and the second detection voltage. Please refer to FIG. 3A. In one embodiment, the first detection voltage may be 1 volt and the second detection voltage is 0.3 volt. In another embodiment, please refer to FIG. 3B. One detection voltage may be 1 volt, and the second detection voltage is -0.3 volts.

The conversion circuit 120 is used to detect the current change on the sample, and when the first detection voltage is switched to the second detection voltage, the conversion circuit 120 can output a current change signal according to the current change in the sample. In one embodiment, the detection device 100 further includes a control circuit 160, which is used to control the conversion circuit 120 to detect the current change. For example, the conversion circuit 120 can detect the current change slope only for the instantaneous current change when the first detection voltage is switched to the second detection voltage, that is, the current change slope is related to the current change of the specimen. In other embodiments, the conversion circuit 120 can also detect the current change in a time period, convert it into a current change graph, and then obtain the current change slope.

The processing circuit 130 is electrically connected to the conversion circuit 120 to calculate the first correlation value of the specimen according to the current change signal. In an embodiment, the first correlation value is a hematocrit volume ratio index (Hct index), which can accurately calculate the hematocrit volume ratio index through the change in the current generated by the specimen during a sudden drop in voltage change, and then Correct the blood sugar level. In one embodiment, the detection device 100 further includes a display device 300, which can display the indicator of the volume ratio of the bleeding cell or the corrected blood glucose value.

The present disclosure is based on the determination of the first relevant value in the sample (ie, the hematocrit volume ratio index) by applying a continuous high-low detection voltage to the sample, through the current change that is generated in the sample under the pressure drop state instantaneously ). Please refer to FIGS. 3A and 3B. FIGS. 3A and 3B are schematic diagrams of voltages applied by the power supply circuit 110 in different embodiments. The power supply circuit 110 applies the first detection voltage in the first time period t1, and immediately applies the second detection voltage in the second time period t2 after the first detection voltage is applied, so that an instant can be generated on the specimen For the recovery current, the duration of the first time period t1 and the second time period t2 are between 0.2 seconds and 5 seconds. Please refer to Figures 4A and 4B. Figure 4A is a graph of the current change produced by the specimen after being subjected to the detection voltage. Since Figure 4A, it is not easy to see the instantaneous change trend of the current, so in Figure 4B A partial enlarged view showing current changes. When subjected to the first detection voltage and the second detection voltage, the specimen has a high and a low detection current P1, P2, respectively, and between the detection currents P1, P2, because of the sudden drop in voltage state, will cause A short recovery current P10 appears on the specimen. The slope of this recovery current will be related to the first relevant value of the specimen. In this embodiment, it is the hematocrit ratio. Therefore, by detecting the first instantaneous time From t10 to the second instantaneous time t20, the instantaneous change of the current from the first instantaneous current i1 to the second instantaneous current i2, and the slope can be calculated to increase the detection accuracy of the hematocrit ratio.

In one embodiment, the detection device further includes a test strip 200. FIG. 2 is a schematic diagram of an embodiment of the test strip 200. The test strip 200 includes a substrate layer 210, at least two working electrodes 220, a An intermediate layer 230 and an upper cap layer 240. A reaction portion 211 is provided on the substrate layer 210 for carrying a specimen; working electrodes 220 are respectively disposed on the substrate layer 210, and one end of each working electrode 220 is at least partially in contact Reaction section 211. The intermediate layer 230 is disposed on the working electrode 220 and the substrate layer 210, and an injection portion 231 is provided on the intermediate layer 230 corresponding to the position of the reaction portion 211, so that the specimen can penetrate the injection portion 231 and be injected into the reaction Department 211. The upper cover layer 240 is disposed on the middle layer 230.

In one embodiment, the detection device 100 further includes a connection circuit 140 and a detection circuit 150. The connection circuit 140 is electrically connected to the working electrode 220 and the conversion circuit 120 of the test strip 200 respectively, so that the conversion circuit 120 passes through the Connect to the circuit 140, and measure the voltage or current changes on the test strip 200. In addition, the first detection voltage and the second detection voltage provided by the power supply circuit 110 can be sequentially applied to the working electrode 220 through the conversion circuit 120 and the connection circuit 150. In other embodiments, the power supply circuit 110 can also directly apply a voltage to the test strip 200 without passing through the conversion circuit 120 and the connection circuit 140. The detection circuit 150 is used to confirm whether the detection test piece 200 has been connected to the connection circuit 140.

In one embodiment, the power supply circuit 110 is further used to apply a third detection voltage to the specimen. The third detection voltage is also a positive voltage and is between 0.2 volts and 1 volt, as shown in FIGS. 3A-4B It can be seen that the third time period t3 of the third detection voltage can be between 0.2 seconds and 5 seconds, and the sample will have the detection current P3 when it receives the third detection voltage. The conversion circuit 120 is used to detect the voltage change of the specimen when the third detection voltage is applied to output a voltage change signal. According to the voltage change signal, the processing circuit 130 can calculate a second correlation value (Eg: an initial blood glucose value).

After calculating the first correlation value and the second correlation value, the processing circuit 130 can correct the second correlation value according to the first correlation value. For example, the processing circuit 130 may correct the initial blood glucose value according to the hematocrit ratio index. Since the initial blood glucose value will be affected by the hematocrit ratio index and deviate from the actual situation, therefore, one of the corrected Only the actual blood glucose value can truly reflect the user's true blood glucose status.

」，其中，Hct index即為血球容積比指標，亦可代換為電流變化斜率或一血球容積比例。G0為初始血糖值，f則為一權重常數，介於0.5～2.0之間，G1即為校正後的實際血糖值。In an embodiment, the processing circuit 130 may correct the initial blood glucose value according to the following formula: "

"In which, Hct index is the index of hematocrit volume ratio, and it can also be replaced by the slope of current change or a hematocrit volume ratio. G0 is the initial blood glucose value, and f is a weight constant between 0.5 and 2.0, and G1 is the corrected actual blood glucose value.

In one embodiment, the processing circuit 130 further includes an analog-to-digital conversion unit 131 and a memory unit 132. The analog-to-digital unit 131 is used to make an analogy between the current change signal and the voltage change signal from the conversion circuit 120 To digital conversion; the memory unit 132 stores the first relevant numerical judgment data and the second relevant numerical judgment data. In one embodiment, the first relevant numerical judgment data may be the correspondence between the hematocrit ratio and the current change slope; the second relevant numerical judgment data may be the correspondence between the initial blood glucose value and the voltage change signal to enable the processing The unit can calculate the hemorrhage volume ratio index and initial blood glucose value according to the received current change signal and voltage change signal.

In one embodiment, the processing circuit 130 corrects the second correlation value based on a linear regression data and the first correlation value. When the first relevant value is an index of the blood cell volume ratio, the processing circuit 130 can determine a corresponding blood cell volume proportional value according to the linear regression data stored in the memory unit 132, and then correct the initial blood glucose value according to the blood cell volume proportional value (Ie, the second relevant value). Please refer to Figure 5 for a schematic diagram of the linear regression data. The linear regression data is based on a standard blood sample. The blood sample is tested for the actual blood cell volume ratio under different blood cell volume ratio indicators, and then a first line is established. Sexual relationship, for example: when the blood volume ratio index is 15.2, the blood volume ratio is 22%; when the blood volume ratio index is 13, the blood volume ratio is 43%. According to this, when the processing circuit 130 calculates the index of the hematocrit volume ratio as 14, it can calculate the proportion of the hematocrit volume as 38% based on the linear regression data.

Please refer to FIG. 6, which is a flowchart of a detection method according to some embodiments of the present disclosure. For convenience and clarity, the following detection methods are described in conjunction with the embodiments shown in Figure 1 to Figure 5, but not limited to this. Anyone who is familiar with this skill will not deviate from the spirit and scope of this case , When you can make various changes and retouching. As shown in FIG. 6, the control method includes steps S610 to S609.

First, in step S601, the power supply circuit 110 provides continuous first detection voltage and second detection voltage, the first detection voltage and the second detection voltage will be applied to the operation of the detection test piece 200 through the conversion circuit 120 and the connection circuit 140 The electrode 220 causes the current and voltage of the specimen to change.

In step S602, the conversion circuit 120 detects the current change on the test strip 200. For example, the conversion circuit 120 may have a galvanometer to detect the current on the working electrode 220, and in step S603, The conversion circuit 120 outputs a current change signal to the processing circuit 130

In step S604, the processing circuit 130 determines an instantaneous current change slope according to the current change signal, and performs analog-to-digital conversion through the analog-to-digital conversion unit 131, and then stores the first A relevant value judges the data, and calculates the first relevant value, that is, the hematocrit ratio.

In step S605, the power supply circuit 110 applies a third detection voltage to the specimen to cause a voltage change in the specimen. In step S606, the conversion circuit 120 detects the voltage change on the test strip 200 and outputs in step S607 A voltage change signal, for example, the conversion circuit 120 can detect the working voltage 220 or the voltage value on the connection unit 140 through a voltmeter.

In step S608, the analog-to-digital conversion unit 131 performs analog-to-digital processing on the voltage change signal, and then calculates the second related value, that is, the initial blood glucose value, based on the second related value judgment data stored in the memory unit 132.

In step S609, after the processing circuit 130 calculates the hematocrit index and the initial blood glucose value, the initial blood glucose value can be corrected according to the hematocrit index to calculate the actual blood glucose value.

In the foregoing embodiment, the detection device 100 first applies the continuous first detection voltage and the second detection voltage, calculates the index of the hemorrhage volume ratio, and then applies the third detection voltage to calculate the initial blood glucose value, but this disclosure Without being limited to this, the third detection voltage may be applied first, after calculating the initial blood glucose value, then the continuous first detection voltage and the second detection voltage may be applied to calculate the index of the hemorrhage volume ratio. In addition, the detection device 100 can continuously apply the first detection voltage, the second detection voltage, and the third detection voltage with no pause time in between; the detection device 100 can also continuously apply the first detection voltage and the second detection voltage first, After calculating the index of the hemorrhage volume ratio, the third detection voltage is applied to calculate the initial blood glucose value. That is, as shown in FIGS. 3A and 3B, there may be an interval time or no interval time between the time periods t1 to t2 and the third time period t3.

Although the content of the present invention has been disclosed as above by way of implementation, it is not intended to limit the content of the present invention. Anyone who is familiar with this art can make various changes and modifications without departing from the spirit and scope of the content of the present invention. Therefore, the present invention The protection scope of the content shall be deemed as defined by the scope of the attached patent application.

100‧‧‧ detection device 110‧‧‧ power supply circuit 120‧‧‧ conversion circuit 130‧‧‧ processing circuit 131‧‧‧ analog digital conversion unit 132‧‧‧ memory unit 140‧‧‧ connection circuit 150‧‧‧ detection Circuit 160‧‧‧Control circuit 200‧‧‧Test test piece 210‧‧‧Substrate layer 211‧‧‧Reaction part 220‧‧‧Working electrode 230‧‧‧Intermediate layer 231‧‧‧Injection part 240‧‧‧ Upper cap layer 300‧‧‧Display 400‧‧‧Blood Tester t1‧‧‧ First time period t10‧‧‧First instant time t2‧‧‧Second time period t20‧‧‧Second instant time t3‧‧‧Third Time period P1～P3‧‧‧ Detection current P10‧‧‧ Recovery current i1‧‧‧ First instant current i2‧‧‧ Second instant current S601～S609‧‧‧ Steps

FIG. 1 is a schematic diagram of a detection device according to some embodiments of the present disclosure. FIG. 2 is a schematic diagram of a test strip according to some embodiments of the present disclosure. 3A and 3B are waveform diagrams of detection voltages according to some embodiments of the present disclosure. 4A and 4B are waveform diagrams of detection currents according to some embodiments of the present disclosure. FIG. 5 is a schematic diagram of linear regression data according to some embodiments of the present disclosure. FIG. 6 is a flowchart of a detection method according to some embodiments of the present disclosure.

100‧‧‧Detection device

110‧‧‧Power supply circuit

120‧‧‧Conversion circuit

130‧‧‧ processing circuit

131‧‧‧ Analog Digital Conversion Unit

132‧‧‧Memory unit

140‧‧‧ connection circuit

150‧‧‧ detection circuit

160‧‧‧Control circuit

200‧‧‧Test test piece

300‧‧‧Monitor

400‧‧‧blood tester

Claims (21)

A detection device includes: a power supply circuit for providing a continuous first detection voltage and a second detection voltage, so that a specimen has a current change according to the first detection voltage and the second detection voltage; a conversion A circuit for outputting a current change signal according to the instantaneous current change generated by the specimen after the second detection voltage is applied after the first detection voltage is switched to the second detection voltage; and a processing circuit, It is electrically connected to the conversion circuit and used to calculate a first relevant value of the sample according to the current change signal. The detection device according to claim 1, wherein the detection device further comprises a detection test piece, the detection test piece is used to carry the specimen, and the power supply circuit provides the first detection voltage and the second detection voltage to The test piece. The detection device according to claim 2, wherein the detection test piece comprises: a substrate layer on which a reaction portion is provided for carrying the specimen; two working electrodes are provided on the substrate layer, and Each of the working electrodes is partially in contact with the reaction part; an intermediate layer is provided on the working electrodes, an injection part is provided on the intermediate layer corresponding to the position of the reaction part; and an upper cover layer is provided on the intermediate layer on. The detection device according to claim 1, wherein the first detection voltage provided by the power supply circuit is a positive voltage, the second detection voltage is a positive voltage or a negative voltage, and the absolute value of the second detection voltage is less than The absolute value of the first detection voltage. The detection device according to claim 1, wherein the conversion circuit is used to detect a current change slope generated by the sample when the second detection voltage is applied to output the current change signal, wherein the current The change slope is related to the current change of the specimen. The detection device according to claim 1, wherein the power supply circuit is further used to apply a third detection voltage to the specimen; the conversion circuit is still used to detect the voltage when the third detection voltage is applied to the specimen Change, and output a voltage change signal; the processing circuit calculates a second relevant value of the sample according to the voltage change signal. The detection device according to claim 6, wherein the processing circuit corrects the second correlation value based on the first correlation value. The detection device according to claim 7, wherein the processing circuit corrects the second correlation value based on a linear regression data and the first correlation value. The detection device according to claim 1, wherein the first detection voltage is between 0.2 volts and 1 volt. The detection device according to claim 1, wherein the durations of the first detection voltage and the second detection voltage are respectively between 0.2 second and 5 seconds. A detection method includes: detecting, through a conversion circuit, that a sample on a test piece is applied with a continuous first detection voltage and a second detection voltage, after the sample is applied with the second detection voltage The generated instantaneous current changes and outputs a current change signal; and a processing circuit calculates a first relevant value of the specimen according to the current change signal. The detection method according to claim 11, wherein the first detection voltage is a positive voltage and the second detection voltage is a positive voltage or a negative voltage, but the absolute value of the second detection voltage is less than the absolute value of the first detection voltage value. The detection method according to claim 11, further comprising: sequentially supplying the first detection voltage and the second detection voltage to the detection test piece through a power supply circuit. The detection method described in claim 13 further includes: A third detection voltage is applied to the specimen through the power supply circuit; a voltage change when the third detection voltage is applied to the specimen is detected through the conversion circuit, and a voltage change signal is converted; and through the processing The circuit calculates a second correlation value of the specimen based on the voltage change signal. The detection method according to claim 14, further comprising: correcting the second correlation value according to the first correlation value through the processing circuit. The detection method according to claim 14, wherein the third detection voltage is between 0.2 volts and 1 volt. The detection method according to claim 14, wherein the duration of the third detection voltage is between 0.2 seconds and 5 seconds. The detection method according to claim 14, wherein the power supply circuit provides the first detection voltage and the second detection voltage in sequence, and then provides the third detection voltage. The detection method according to claim 11, wherein the conversion circuit is used to detect a current change slope generated by the specimen when the second detection voltage is applied Rate to output the current change signal, where the slope of the current change is related to the current change of the specimen. The detection method according to claim 11, wherein the first detection voltage is between 0.2 volts and 1 volt. The detection method according to claim 11, wherein the durations of the first detection voltage and the second detection voltage are respectively between 0.2 seconds and 5 seconds.

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