CN109991281B - Detection device and detection method - Google Patents

Detection device and detection method Download PDF

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CN109991281B
CN109991281B CN201810001531.0A CN201810001531A CN109991281B CN 109991281 B CN109991281 B CN 109991281B CN 201810001531 A CN201810001531 A CN 201810001531A CN 109991281 B CN109991281 B CN 109991281B
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voltage
detecting
detection
sample
detection voltage
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CN109991281A (en
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蔡宗轩
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Delbio Inc
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Delbio Inc
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    • GPHYSICS
    • G01MEASURING; TESTING
    • G01NINVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N27/00Investigating or analysing materials by the use of electric, electrochemical, or magnetic means

Abstract

The disclosure relates to a detection device, comprising a power supply circuit, a conversion circuit and a processing circuit, wherein the power supply circuit is used for providing a first detection voltage and a second detection voltage continuously, so that a detected body has current change according to the first detection voltage and the second detection voltage; the conversion circuit is used for outputting a current change signal according to the current change of the sample when the first detection voltage is switched to the second detection voltage; the processing circuit is electrically connected to the converting circuit for calculating a first related value (e.g., hematocrit index) of the sample according to the current variation signal. The detection device disclosed by the invention can accurately detect the expected first relevant numerical value by detecting the instantaneous current change generated when the detection body bears different detection voltages, thereby improving the detection efficiency and the detection accuracy.

Description

Detection device and detection method
Technical Field
The present disclosure relates to a detection device and a detection method, and particularly to a detection technique that can be used for detecting an index of hematocrit.
Background
At present, the blood detector used for home care directly puts the whole blood sample of a user into the reaction area of the test strip, so that the whole blood sample is mixed with the reaction reagent, and then the electrical property change is detected, and then the test result is calculated, for example: the blood glucose level is detected.
However, in the process of using "whole blood", the content of blood cells (i.e. hematocrit, Hct) in the whole blood sample will affect the test result. Taking blood sugar as an example, when the hematocrit is high, the blood sugar detected by the blood detector will be underestimated, whereas when the hematocrit is low, the blood sugar detected by the blood detector will be overestimated, and therefore, there is still room for improvement in the detection accuracy of the blood detector.
Disclosure of Invention
One embodiment of the present invention is a detection device, including a power supply circuit, a conversion circuit and a processing circuit, wherein the power supply circuit is configured to provide a first detection voltage and a second detection voltage continuously, so that a sample has a current variation according to the first detection voltage and the second detection voltage; the conversion circuit is used for outputting a current change signal according to the current change of the sample when the first detection voltage is switched to the second detection voltage; the processing circuit is electrically connected with the conversion circuit and used for calculating a first correlation value of the sample according to the current change signal.
Another embodiment of the present invention is a detection method, which comprises detecting a current change in a sample on a test strip by a converting circuit when a first detection voltage and a second detection voltage are applied to the sample continuously, and outputting a current change signal; then, a processing circuit calculates a first correlation value of the sample according to the current variation signal.
In summary, in the embodiments of the present disclosure, the expected first correlation value can be accurately detected by detecting the instantaneous current change of the sample when the sample is subjected to different detection voltages, so as to improve the detection efficiency and accuracy.
Drawings
FIG. 1 is a schematic view of a detection device shown in accordance with some embodiments of the present disclosure.
FIG. 2 is a schematic view of a test strip according to some embodiments of the present disclosure.
Fig. 3A and 3B are diagrams of detected voltage waveforms according to some embodiments of the present disclosure.
Fig. 4A and 4B are diagrams illustrating waveforms of the detection current according to some embodiments of the disclosure.
FIG. 5 is a graph illustrating linear regression data according to some embodiments of the present disclosure.
Fig. 6 is a flow chart illustrating a detection method according to some embodiments of the present disclosure.
Description of reference numerals:
100 detection device
110 power supply circuit
120 conversion circuit
130 processing circuit
131A/D conversion unit
132 memory cell
140 connection circuit
150 detection circuit
160 control circuit
200 test strip
210 substrate layer
211 reaction part
220 working electrode
230 intermediate layer
231 injection part
240 upper cover layer
300 display
400 blood detector
t1 first time period
t10 first moment in time
t2 second time period
t20 second moment in time
t3 third time period
P1-P3 detection current
P10 recovery current
i1 first moment current
i2 second moment current
S601-S609 step
Detailed Description
In the following description, numerous implementation details are set forth in order to provide a thorough understanding of the present invention. It should be understood, however, that these implementation details should not be taken to limit the invention. That is, in some embodiments of the invention, such implementation details are not necessary. In addition, some conventional structures and elements are shown in the drawings in a simple schematic manner for the sake of simplifying the drawings.
When an element is referred to as being "connected" or "coupled," it can be referred to as being "electrically connected" or "electrically coupled. "connected" or "coupled" may also be used to indicate that two or more elements are in a coordinated operation or interaction with each other. Moreover, although the terms first, second, …, etc. may be used herein to describe various elements, these terms are only used to distinguish one element or operation from another element or operation described by the same technical terms. Unless the context clearly dictates otherwise, the terms do not specifically refer or imply an order or sequence nor are they intended to limit the invention.
Referring to fig. 1, fig. 1 is a schematic diagram of a detection apparatus according to some embodiments of the present disclosure, in one embodiment, the detection apparatus 100 includes a blood detector 400, the blood detector 400 at least includes a power supply circuit 110, a conversion circuit 120 and a processing circuit 130, the power supply circuit 110 is configured to provide a first detection voltage and a second detection voltage, which are continuous, and when a sample (e.g., a blood sample) is applied with the first detection voltage and the second detection voltage, the current changes. In one embodiment, the first detection voltage provided by the power supply circuit 110 is a positive voltage with a magnitude between 0.2 volts and 1 volt, and the second detection voltage is either a positive voltage or a negative voltage, but its absolute value must be smaller than the absolute value of the first detection voltage, i.e., there is a sudden voltage change between the first detection voltage and the second detection voltage. Referring to fig. 3A, in one embodiment, the first detection voltage may be 1 volt and the second detection voltage may be 0.3 volt, and in another embodiment, referring to fig. 3B, the first detection voltage may be 1 volt and the second detection voltage may be-0.3 volt.
The converting circuit 120 is used for detecting the current change on the sample, and when the first detecting voltage is switched to the second detecting voltage, the converting circuit 120 can output a current change signal according to the current change in the sample. In one embodiment, the detecting device 100 further includes a control circuit 160, and the control circuit 160 is used for controlling the manner in which the converting circuit 120 detects the current variation. For example, the conversion circuit 120 can detect a current change slope only for the instant current change when the first detection voltage is switched to the second detection voltage, i.e., the current change slope is related to the current change of the sample. In other embodiments, the conversion circuit 120 may also detect a current change in a time segment, convert the current change into a current change graph, and obtain a current change slope.
The processing circuit 130 is electrically connected to the converting circuit 120 for calculating a first correlation value of the sample according to the current variation signal. In one embodiment, the first correlation value is a hematocrit index (Hct index), and the hematocrit index can be accurately calculated by increasing and changing the current generated by the sample during the voltage change of the sudden drop, thereby correcting the blood glucose level. In one embodiment, the detecting device 100 further includes a display device 300 for displaying the hematocrit index or the corrected blood glucose value.
The present disclosure is to determine a first correlation value (i.e., hematocrit index) in a sample by a current change instantaneously occurring in a voltage drop state in the sample when a high or low continuous detection voltage is applied to the sample. Referring to fig. 3A and 3B, fig. 3A and 3B are schematic diagrams of voltages applied by the power supply circuit 110 according to different embodiments, respectively. The power supply circuit 110 applies a first detection voltage during a first time period t1, and applies a second detection voltage during a second time period t2 immediately after the first detection voltage is applied, so as to generate an instantaneous recovery current on the sample, wherein the duration of the first time period t1 and the duration of the second time period t2 are both between 0.2 seconds and 5 seconds. Referring to fig. 4A and 4B, fig. 4A is a current variation graph generated after the sample is subjected to the detection voltage, and fig. 4B is a partial enlarged view of the current variation because the instantaneous variation trend of the current is not easy to be seen in fig. 4A. When the sample is subjected to the first detection voltage and the second detection voltage, the sample has a high detection current P1 and a low detection current P2, respectively, and between the detection currents P1 and P2, a transient recovery current P10 appears on the sample due to a sudden voltage state, and the slope of the recovery current is related to a first related value of the sample, namely, a hematocrit index in the present embodiment, so that the detection accuracy of the hematocrit index can be increased by detecting the transient change and the slope of the current from the first transient current i1 to the second transient current i2 in the period from the first transient time t10 to the second transient time t 20.
In one embodiment, the detecting device further comprises a test strip 200, fig. 2 is a schematic view of an embodiment of the test strip 200, the test strip 200 comprises a substrate layer 210, at least two working electrodes 220, an intermediate layer 230 and a top cover layer 240, the substrate layer 210 is provided with a reaction portion 211 for carrying a sample; the working electrodes 220 are respectively disposed on the substrate layer 210, and one end of each working electrode 220 at least partially contacts the reaction portion 211. The intermediate layer 230 is disposed on the working electrode 220 and the substrate layer 210, and an injection part 231 is disposed on the intermediate layer 230 at a position corresponding to the reaction part 211, so that the sample can be injected onto the reaction part 211 through the injection part 231. The cap layer 240 is disposed on the middle layer 230.
In one embodiment, the detecting device 100 further includes a connecting circuit 140 and a detecting circuit 150, the connecting circuit 140 is electrically connected to the working electrode 220 of the test strip 200 and the converting circuit 120, respectively, so that the converting circuit 120 measures the voltage or current change on the test strip 200 through the connecting circuit 140. 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 converting circuit 120 and the connecting circuit 150. In other embodiments, the power supply circuit 110 can also apply a voltage directly to the test strip 200 without the conversion circuit 120 and the connection circuit 140. The test circuit 150 is used to determine whether the test strip 200 is connected to the connection circuit 140.
In one embodiment, the power supply circuit 110 is further configured to apply a third detection voltage to the sample, the third detection voltage is also a positive voltage and is between 0.2 v and 1 v, as shown in fig. 3A to 4B, the third time period t3 of the third detection voltage may be between 0.2 s and 5 s, and the sample has a detection current P3 when receiving the third detection voltage. The conversion circuit 120 is used to detect the voltage variation when the third detection voltage is applied to the sample, so as to output a voltage variation signal, and the processing circuit 130 can calculate a second correlation value (e.g. an initial blood glucose value) according to the voltage variation signal.
The processing circuit 130 can correct the second correlation value according to the first correlation value after calculating the first correlation value and the second correlation value. For example, the processing circuit 130 can correct the initial blood glucose level according to the hematocrit index, and since the initial blood glucose level is affected by the hematocrit index and deviates from the actual condition, the corrected actual blood glucose level can actually reflect the actual blood glucose state of the user.
In a real worldIn one embodiment, the processing circuit 130 may correct the initial blood glucose level according to the following equation: "G1 ═ G0 × (Hct index) f In this case, Hct index is an index of hematocrit, and can be replaced by a current change slope or a hematocrit. G0 is the initial blood glucose value, f is a weight constant between 0.5-2.0, 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 storage unit 132, wherein the analog-to-digital unit 131 is used for performing analog-to-digital conversion on the current variation signal and the voltage variation signal transmitted from the conversion circuit 120; the storage unit 132 stores therein first correlation value determination data and second correlation value determination data. In one embodiment, the first correlation value determination data may be a corresponding relationship between a hematocrit index and a current change slope; the second correlation value determination data may be a corresponding relationship between the initial blood glucose level and the voltage variation signal, so that the processing unit can calculate the hematocrit index and the initial blood glucose level according to the received current variation signal and the voltage variation signal.
In one embodiment, the processing circuit 130 corrects the second correlation value according to a linear regression data and the first correlation value. When the first correlation value is the hematocrit index, the processing circuit 130 can determine a corresponding hematocrit value according to the linear regression data stored in the storage unit 132, and then correct the initial blood glucose value (i.e., the second correlation value) according to the hematocrit value. Please refer to fig. 5, which is a schematic diagram of the linear regression data, the linear regression data is a linear relationship established by respectively detecting actual hematocrit ratios of a blood sample under different hematocrit indexes for a standard blood sample, for example: when the hematocrit index is 15.2, the hematocrit is 22%; when the hematocrit index is 13, the hematocrit proportion is 43%. Accordingly, when the processing circuit 130 calculates the hematocrit index as 14, the hematocrit index can be calculated as 38% based on the linear regression data.
Referring to fig. 6, fig. 6 is a flowchart illustrating a detection method according to some embodiments of the disclosure. For convenience and clarity of illustration, the following detection method is described with reference to the embodiments shown in fig. 1 to 5, but the invention is not limited thereto, and various changes and modifications can be made by those skilled in the art without departing from the spirit and scope of the present disclosure. As shown in fig. 6, the control method includes steps S610 to S609.
First, in step S601, the power supply circuit 110 provides a first detection voltage and a second detection voltage, which are applied to the working electrode 220 of the test strip 200 through the conversion circuit 120 and the connection circuit 140, so as to generate current and voltage variations in the sample.
In step S602, the converting circuit 120 detects the current change on the test strip 200, for example, the converting circuit 120 can have a galvanometer to detect the current on the working electrode 220, and in step S603, the converting circuit 120 outputs a current change signal to the processing circuit 130
In step S604, the processing circuit 130 determines a current change slope generated instantaneously according to the current change signal, performs an analog-to-digital conversion process through the analog-to-digital conversion unit 131, and calculates a first correlation value, i.e., a hematocrit index, according to a first correlation value determination data stored in the storage unit 132.
In step S605, the power supply circuit 110 applies a third detection voltage to the sample to generate a voltage change in the sample, in step S606, the conversion circuit 120 detects the voltage change on the test strip 200, and in step S607, outputs a voltage change signal, for example: the conversion circuit 120 can detect the operating voltage 220 or the voltage value of the connection unit 140 through a voltmeter.
In step S608, the analog-to-digital conversion unit 131 performs analog-to-digital conversion on the voltage variation signal, and calculates a second correlation value, that is, an initial blood glucose level, according to a second correlation value determination data stored in the storage unit 132.
In step S609, after the processing circuit 130 calculates the blood volume ratio index and the initial blood glucose level, the initial blood glucose level can be corrected based on the blood volume ratio index to calculate the actual blood glucose level.
In the above embodiment, the detection apparatus 100 applies the first detection voltage and the second detection voltage successively to calculate the hematocrit index, and then applies the third detection voltage to calculate the initial blood glucose level. In addition, the detecting device 100 can continuously apply the first detecting voltage, the second detecting voltage and the third detecting voltage without a pause time; the detection apparatus 100 may calculate the initial blood glucose level by applying the first detection voltage and the second detection voltage successively to calculate the hematocrit index and then applying the third detection voltage. That is, as shown in fig. 3A and 3B, there may be an interval or no interval between the time periods t 1-t 2 and the third time period t 3.
Although the present disclosure has been described with reference to exemplary embodiments, it will be understood by those skilled in the art that various changes and modifications may be made without departing from the spirit and scope of the present disclosure, and therefore, the scope of the present disclosure is to be determined by the terms of the appended claims.

Claims (19)

1. A detection device, comprising:
a power supply circuit for providing a first detection voltage and a second detection voltage continuously, so that a sample has current variation according to the first detection voltage and the second detection voltage, wherein the second detection voltage is a positive voltage or a negative voltage;
a conversion circuit, configured to output a current variation signal according to an instantaneous current variation generated when the second detection voltage is applied to the sample when the first detection voltage is switched to the second detection voltage, wherein the conversion circuit is configured to detect a current variation slope of a detection test strip to output the current variation signal, and the current variation slope is related to a current variation of the sample; and
a processing circuit electrically connected to the converting circuit for calculating a hematocrit index of the sample according to the current variation signal.
2. The detecting device according to claim 1, wherein the detecting device further comprises the detecting test strip for carrying the sample, and the power supply circuit provides the first detecting voltage and the second detecting voltage to the detecting test strip.
3. The test device of claim 2, wherein the test strip comprises:
a substrate layer, which is provided with a reaction part for bearing the sample;
two working electrodes arranged on the substrate layer, wherein each working electrode partially contacts the reaction part;
the middle layer is arranged on the working electrode, and an injection part is arranged on the middle layer corresponding to the reaction part; and
an upper cover layer disposed on the middle layer.
4. The detecting device of claim 1, wherein the first detecting voltage provided by the power supply circuit is a positive voltage, and the absolute value of the second detecting voltage is smaller than the absolute value of the first detecting voltage.
5. The detecting device of claim 1, wherein the power supply circuit is further configured to apply a third detecting voltage to the sample; the conversion circuit is further used for detecting the voltage change of the sample when the third detection voltage is applied to the sample, and outputting a voltage change signal; the processing circuit calculates a second correlation value of the sample according to the voltage variation signal.
6. The test device according to claim 5, wherein the processing circuit corrects the second correlation value according to the hematocrit index.
7. The testing device according to claim 6, wherein the processing circuit corrects the second correlation value based on a linear regression data and the hematocrit index.
8. The detecting device of claim 1, wherein the first detecting voltage is between 0.2 volts and 1 volt.
9. The detecting device of claim 1, wherein the durations of the first and second detecting voltages are respectively between 0.2 seconds and 5 seconds.
10. A method of detection, comprising:
detecting current change in a sample on a test strip through a conversion circuit when a first detection voltage and a second detection voltage are continuously applied to the sample, and outputting a current change signal, wherein the conversion circuit is used for detecting a current change slope of the test strip to output the current change signal, the current change slope is related to the current change of the sample, and when the first detection voltage is switched to the second detection voltage, the current change signal is output according to instant current change of the sample generated when the second detection voltage is applied, and the second detection voltage is a positive voltage or a negative voltage; and
a processing circuit calculates a hematocrit index of the sample according to the current variation signal.
11. The detecting method of claim 10, wherein the first detecting voltage is a positive voltage, and an absolute value of the second detecting voltage is smaller than an absolute value of the first detecting voltage.
12. The detection method of claim 10, further comprising:
the first detection voltage and the second detection voltage are sequentially provided to the test strip through a power supply circuit.
13. The detection method of claim 12, further comprising:
applying a third detection voltage to the sample through the power supply circuit;
detecting the voltage change of the sample when the third detection voltage is applied through the conversion circuit, and converting a voltage change signal; and
and calculating a second correlation value of the sample according to the voltage change signal by the processing circuit.
14. The detection method of claim 13, further comprising:
the second correlation value is corrected by the processing circuit based on the hematocrit index.
15. The detecting method of claim 13, wherein the third detecting voltage is between 0.2 v and 1 v.
16. The detection method of claim 13, wherein the duration of the third detection voltage is between 0.2 seconds and 5 seconds.
17. The detecting method of claim 13, wherein the power supply circuit provides the first detecting voltage, the second detecting voltage, and the third detecting voltage sequentially.
18. The detecting method of claim 10, wherein the first detecting voltage is between 0.2 v and 1 v.
19. The detecting method of claim 10, wherein the durations of the first and second detecting voltages are between 0.2 seconds and 5 seconds, respectively.
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