Method for distinguishing quality control liquid and biological sample

Abstract

The invention discloses a method for distinguishing a quality control solution from a biological sample, and belongs to the technical field of electrochemical detection. The method comprises the following steps: enabling a working electrode to be in contact with a to-be-detected sample, the working electrode being a blank electrode or being covered with an inert substance which does not chemically react with a biological sample; an excitation signal sequence is input to the working electrode, the excitation signal sequence comprises at least two continuous or discontinuous input signals, and each input signal is a constant value; and respectively measuring output signal sequences of the quality control liquid and the biological sample in response to the excitation signal sequence so as to distinguish the quality control liquid from the biological sample. The electrode type blood detection device solves the problems that in the quality control process of an existing electrode type blood detection device, manual adjustment of a quality control liquid mode may cause misoperation, and mode setting of a quality control liquid sample or a biological sample does not need to be conducted in actual use, so that the use convenience is improved, bad results caused by misoperation are avoided, and the detection efficiency is improved. And the method has no special requirements on quality control liquid and is convenient to apply and popularize.

Description

Technical Field

[0001] The present application relates to a method for distinguishing a quality control solution from a biological sample, and belongs to the technical field of biological sample analysis. Background Art

[0002] Quantitatively determining the concentrations of important substances in human blood, such as the concentrations of blood glucose, blood ketone, blood lactic acid, cholesterol, uric acid, triglyceride, etc., is very important for clinical diagnosis and health management. Currently, an electrochemical test system is mainly used to determine the concentration of a target analyte in blood. The target analyte in blood is selectively recognized by a biomolecule (such as an enzyme) modified on the electrode surface, and the biological recognition signal is converted into an electrical signal (oxidation or reduction current) that can be collected and measured in a blood detection device to achieve quantitative detection of the target analyte.

[0003] To ensure the reliability and accuracy of the electrochemical test system for determining the concentration of the target analyte in blood, it is necessary to regularly perform quality control tests on the electrochemical test system to determine whether the test system can work properly. For example, common blood glucose test systems are equipped with blood glucose quality control solutions. After a certain period of time, the operator needs to use the blood glucose test system to measure the blood glucose quality control solution. If the measured value exceeds the quality control concentration range of the blood glucose quality control solution, it indicates that the reliability of the blood glucose test system has decreased and it cannot be used for clinical detection.

[0004] The quality control measurement mode of a common electrochemical test system is that the operator manually selects the quality control solution measurement mode on the electrochemical tester, installs the electrode of the electrochemical test device into the electrochemical measuring instrument, and adds the quality control solution to the electrode of the electrochemical test device to achieve it. In this operation mode, the operator needs to manually switch the tester between the two measurement modes of the quality control solution or the actual sample (such as blood, urine). If the actual sample is measured in the quality control solution mode, or the quality control solution is measured in the actual sample measurement mode without changing the test mode, there may be a risk that the instrument inspection result and the test result are inaccurate, affecting the operator's correct clinical judgment. In addition, when the measurer manages the measured values, the measurement results of the quality control solution that are not required in the management data will be mixed together, and the measured values cannot be properly managed.

[0005] Chinese Patent CN116165252A discloses a method, application and device for automatically identifying a quality control solution and a sample. It discloses applying an alternating voltage to the electrode and detecting the impedance value of the sample to be measured to determine whether the sample to be measured is a quality control solution or a sample. However, the method provided by this patent requires that the quality control solution must contain lithium salt, and even has requirements for the mass concentration of the lithium salt, which causes certain limitations to daily applications. Summary of the Invention

[0006] To solve the above problems, a method for distinguishing a quality control liquid from a biological sample is provided. An excitation signal sequence is input to a blank electrode or a working electrode covered with an inert substance that does not chemically react with the biological sample. By measuring the output signal sequence of the excitation signal sequence, the quality control liquid and the biological sample are distinguished. The purpose is to solve the problem that in the quality control process of existing electrode-type blood detection devices, manual adjustment of the quality control liquid mode may lead to operation errors. In actual use, it will no longer be necessary to set the mode of the quality control liquid sample or the biological sample, improving the convenience of use, thus avoiding adverse results caused by misoperation, and having no special requirements for the quality control liquid, which is convenient for application and promotion.

[0007] In one aspect of the present application, a method for distinguishing a quality control liquid from a biological sample is provided, wherein the working electrode contacts the sample to be tested, and the working electrode is a blank electrode or is covered with an inert substance that does not chemically react with the biological sample;

[0008] An excitation signal sequence is input to the working electrode, and the excitation signal sequence includes at least two consecutive or non-consecutive input signals, and each of the input signals is a constant value;

[0009] The output signal sequence of the sample to be tested in response to the excitation signal sequence is measured to distinguish the quality control liquid and the biological sample.

[0010] Optionally, the excitation signal sequence includes at least two consecutively applied input signals, and the output voltage of the excitation signal sequence continuously increases or continuously decreases, and the voltage range is 0.1 - 3V; preferably, the excitation signal sequence includes 4 - 8 consecutive input signals.

[0011] Specifically, this form of input signal can obtain multi-data feedback of the working electrode, reduce errors, save detection steps, and reduce the test difficulty.

[0012] Optionally, the excitation signal sequence includes 5 consecutive input signals, and the voltage values of the 5 consecutive input signals are 0.3V, 0.8V, 1.2V, 1.7V, and 2.0V respectively.

[0013] Optionally, the excitation signal sequence includes at least two non-consecutively applied input signals, and the output voltage of the excitation signal sequence non-continuously increases or non-continuously decreases, and the voltage range is 0.1 - 3V; preferably, the excitation signal sequence includes 4 - 8 non-consecutive input signals.

[0014] Optionally, the excitation signal sequence includes 6 non-consecutive input signals, and the voltage values of the 6 non-consecutive input signals are 0.3V, 0.8V, 0.6V, 1.1V, 1.0V, and 1.8V respectively.

[0015] Optionally, the total application time of the excitation signal sequence is at least 1 s, and the voltage range is 0.2 - 2.2 V.

[0016] Specifically, the shorter total application time of the excitation signal sequence can improve the test efficiency.

[0017] Optionally, the application time of each input signal in the excitation signal sequence is 0.1 - 0.3 s; preferably, the application time of each input signal in the excitation signal sequence is equal, all being 0.2 s.

[0018] Optionally, at least one parameter is calculated from the output signal sequence of the working electrode, and the sample being tested is determined to be a quality control solution or a biological sample according to a predetermined critical value for detecting the quality control solution.

[0019] Optionally, at least two parameters are calculated from the output signal sequence of the working electrode, and the sample being tested is determined to be a quality control solution or a biological sample according to a predetermined two-dimensional critical value for detecting the quality control solution.

[0020] Optionally, at least two different sets of parameter groups are calculated from the output signal sequence of the working electrode, and the sample being tested is determined to be a quality control solution or a biological sample according to a predetermined two-dimensional critical value for detecting two sets of quality control solutions.

[0021] Optionally, the biological sample includes samples such as blood, urine, saliva, bile, gastric juice, lymph fluid, etc.

[0022] The beneficial effects of this application include but are not limited to:

[0023] 1. According to the method for distinguishing a quality control solution from a biological sample of this application, an excitation signal sequence is input to a blank electrode or a working electrode covered with an inert substance that does not chemically react with the biological sample, and the output signal sequence of the excitation signal sequence is measured to distinguish the quality control solution from the biological sample; the purpose is to solve the problem that manual adjustment of the quality control solution mode may lead to operation errors during the quality control process of the existing electrode-type blood detection device. In actual use, it will no longer be necessary to set the mode of the quality control solution sample or the biological sample, improving the ease of use, thus avoiding adverse results caused by misoperation, and having no special requirements for the quality control solution, which is convenient for application and promotion.

[0024] 2. According to the method for distinguishing a quality control solution from a biological sample of this application, this method can be used to determine the category of a sample, such as whether the sample is a whole blood sample or a quality control solution. The sample category is discriminated through one-dimensional or multi-dimensional parameter comparison, and the quality control solution is automatically separated from the whole blood sample database, so as to more accurately summarize and analyze different time periods of the whole blood sample, providing comprehensive data for disease treatment.

[0025] 3. According to the method for differentiating a quality control fluid from a biological sample in the present application, by setting the working electrode as a blank electrode or covering it with an inert substance that does not chemically react with the biological sample and having no chemical agent that can react with the analyte covered, at a low excitation potential (≤1.2 V), there are basically not many oxidizable substances present, so the output current is quite low. However, the attenuation rate of the output current varies depending on the different liquid qualities. At a high excitation potential (>1.2 V), the buffer components of the sample itself will become oxidizable, thereby giving different output currents. These intuitive manifestations can be reflected by extracting different parameters to differentiate the quality control fluid and the biological sample. BRIEF DESCRIPTION OF THE DRAWINGS

[0026] The drawings described herein are used to provide a further understanding of the present application and form a part of the present application. The schematic embodiments of the present application and their descriptions are used to explain the present application and do not constitute an improper limitation to the present application. In the drawings:

[0027] Figure 1 It is a schematic diagram of an excitation signal sequence of a working electrode according to an embodiment of the present application;

[0028] Figure 2 It is a schematic diagram of four different excitation waveforms of a staircase wave according to an embodiment of the present application;

[0029] Figure 3 It is an output signal diagram of a quality control fluid and a whole blood sample generated under staircase wave excitation according to an embodiment of the present application;

[0030] Figure 4 It is a two-dimensional parameter combination diagram of currents generated by extracting a working electrode from a whole blood sample and a quality control fluid according to Embodiment 1 of the present application;

[0031] Figure 5 It is a broken line diagram of the output signal current ratio and current ratio difference of a quality control fluid and blood generated under staircase wave excitation according to Embodiment 1 of the present application;

[0032] Figure 6 It is a two-dimensional parameter combination diagram of currents generated by extracting a working electrode from a whole blood sample and a quality control fluid according to Embodiment 2 of the present application;

[0033] Figure 7 It is a broken line diagram of the output signal current ratio and current ratio difference of a quality control fluid and blood generated under staircase wave excitation according to Embodiment 2 of the present application. DETAILED DESCRIPTION OF THE EMBODIMENTS

[0034] The present application will be described in detail below in conjunction with embodiments, but the present application is not limited to these embodiments.

[0035] Unless otherwise defined, all professional and scientific terms used herein have the same meaning as those familiar to persons skilled in the art. The reagents or raw materials used in the present invention can be obtained through conventional channels. Unless otherwise specified, the reagents or raw materials used in the present invention are used in accordance with the conventional methods in the art or in accordance with the product instructions. In addition, any methods and materials similar or equivalent to the described content can be applied to the method of the present invention. The preferred implementation methods and materials described in this patent are for illustrative purposes only.

[0036] Reference Figure 1 , embodiments of the present application disclose a working electrode excitation signal sequence. The time of each excitation in the excitation signal sequence can be between 0.05 and 0.5 seconds. It can be a continuous excitation sequence without intervals or a sequence composed of different excitation pulses with intervals. Preferably, the excitation signal sequence is a continuous excitation sequence without intervals. It can be understood that this continuous excitation sequence can be a continuously increasing excitation sequence, or an excitation sequence that first increases and then decreases, first increases and then decreases and then increases, etc. Preferably, this continuous excitation sequence is a continuously increasing excitation sequence. If the excitation signal sequence is a voltage, the voltage value is between 0.1 and 3V. Figure 1 The excitation series signal shown in [reference] includes 5 excitations. The excitation voltages of the 5 excitations are 0.3V, 0.8V, 1.2V, 1.7V, and 2.2V in sequence. And the time of each excitation can be 0.2 seconds. The duration of each excitation is 0.2 seconds, and the output current signal is synchronously measured at intervals of every 0.05 seconds. This excitation series signal can be called a "staircase wave".

[0037] Reference Figure 2 , in addition to Figure 1 the excitation signal sequence applied to the working electrode shown in [reference], other different excitation series signals, that is, staircase waves, can also be implemented. Figure 2 Here are several different staircase wave cases: Figure 2 A is Case 2, that is, Staircase Wave 2: After the excitation voltage of the excitation signal continuously increases by three steps, it drops by one step and then continuously increases by four steps. The voltages of the excitation signals are 0.3V, 0.7V, 1.1V, 0.9V, 1.2V, 1.5V, 1.9V, and 2.3V in sequence. The voltage of each excitation signal lasts for 0.15 seconds; Figure 2 B is Case 3, that is, Staircase Wave 3: After the excitation voltage of the excitation signal continuously increases by three steps, it drops by one step, then continuously increases by three steps and then drops by one step, and then continuously increases by three steps. The voltages of the excitation signals are 0.3V, 0.6V, 0.9V, 0.8V, 1.1V, 1.4V, 1.7V, 1.6V, 1.9V, 2.3V, and 2.7V in sequence. The voltage of each excitation signal lasts for 0.15 seconds; Figure 2C is Case 4, i.e., Step Wave 4: The growth amplitudes of the first few and the last few excitation signals in the excitation signal sequence are different. The voltages of the excitation signals are 0.3V, 0.5V, 0.7V, 0.9V, 1.2V, 1.6V, 2.0V, 2.4V in sequence, and each voltage lasts for 0.15 seconds. Figure 2 D is Case 5, i.e., Step Wave 5: The excitation signal sequence is a discontinuous excitation signal, and each excitation pulse signal is separated by a short open-circuit time, and the interval time does not exceed 50% of the pulse excitation time. The voltages of the excitation signals are 0.3V, 0.8V, 1.2V, 1.7V, 2.2V in sequence, each excitation pulse lasts for 0.15 seconds, and there is an open-circuit interval of 0.05 seconds between pulses.

[0038] For Case 2, Case 3, and Case 4 of the excitation signal sequence, the output signals at relatively low excitation intensities and relatively high excitation intensities can be collected. For example, when the input signal is potential, the range of 0.3 - 1.2V is more suitable for determining the more common chemicals in the sample, while when the input signal is between 1.2 - 3.0V, the chemicals that require high-intensity excitation, such as hematocrit value, will be excited. Finally, the discontinuous interval pulse excitation series signals will generate relatively different output signals.

[0039] Figure 3 It is the output signal diagram generated by the quality control solution and the whole blood sample under step wave excitation. According to the order in which the output current signals appear, the current signal values can be compiled as i n,m , where n is the nth excitation in the step wave, and m is the mth current signal output under the nth excitation. The object of the step wave is the working electrode, and the working electrode is a blank electrode or covered with an inert substance that does not chemically react with the biological sample, and there is no chemical agent covering that can react with the analyte. Therefore, the current signal generated by the step wave comes entirely from other oxidizable substances in the sample. Figure 3 The current shown comes from a 50mg / dL whole blood sample and a 50mg / dL quality control solution. At low excitation potentials (≤1.2V), there are basically not many oxidizable substances present, so the output current is quite low, but the attenuation rate of the output current is different due to different liquid qualities. At high excitation potentials (>1.2V), the buffer components in the sample itself will become oxidizable, thus giving different output currents. These intuitive manifestations can be reflected by extracting different parameters.

[0040] In addition, the parameters that can be extracted from the output current of the step wave are defined as follows:

[0041] Step wave: The first, second, third, fourth, and fifth step waves are defined as tp1, tp2, tp3, tp4, tp5 respectively;

[0042] Endpoint current ratio: The endpoint current ratio of each step voltage is defined as: RT1 = i1,4 / i 1,1 , RT2 = i 2,4 / i 2,1 , RT3 = i 3,4 / i 3,1 , RT4 = i 4,4 / i 4,1 , RT5 = i 5,4 / i 5,1 ;

[0043] Front-end two-current ratio: The front two-current ratio of each step is defined as: RT12 = i 1,2 / i 1,1 , RT22 = i 2,2 / i 2,1 , RT32 = i 3,2 / i 3,1 , RT42 = i 4,2 / i 4,1 , RT52 = i 5,2 / i 5,1 ;

[0044] Back-end two-current ratio: The back two-current ratio of each step is defined as: RT14 = i 1,4 / i 1,3 , RT24 = i 2,4 / i 2,3 , RT34 = i 3,4 / i 3,3 , RT44 = i 4,4 / i 4,3 , RT54 = i 5,4 / i 5,3 ;

[0045] Back-end front-end current ratio difference: RT14 - RT12, RT24 - RT22, RT34 - RT32, RT44 - RT42, RT54 - RT52. From the above-defined parameters, select the parameters that can be used to distinguish whole blood samples from quality control fluids.

[0046] Example 1

[0047] Input 5 consecutive input signals to the working electrode in sequence. The voltage values of the 5 input signals are 0.3V, 0.8V, 1.2V, 1.7V, and 2.0V respectively. The application times of the 5 input signals are equal, each being 0.2s. These 5 consecutive input signals are the excitation signal sequence. Measure the output current to obtain the step current ratio and current difference (RTx). This RTx is the output sequence signal;

[0048] The voltage values of the 5 input signals are 0.3V, 0.8V, 1.2V, 1.7V, and 2.0V respectively. There are four sampling points in each voltage application stage. When the voltage value of 0.3V is input, it is the first stage, and the sampling values are i 11 , i 12 , i 13 , i 14 ; when the voltage value of 0.8V is input, it is the second stage, and the sampling values are i 21 , i 22 , i 23 , i 24 ; when the voltage value of 1.2V is input, it is the third stage, and the sampling values are i 31 , i 32 , i 33 , i 34 ; when the voltage value of 1.7V is input, it is the fourth stage, and the sampling values are i 41 , i 42 , i 43 , i 44 ; when the voltage value of 2.0V is input, it is the fifth stage, and the sampling values are i 51 , i 52 , i 53 , i 54 .

[0049] Endpoint current ratio: The endpoint current ratio of each voltage segment is defined as: RT1 = i 14 / i 11 , RT2 = i 24 / i 21 , RT3 = i 34 / i 31 , RT4 = i 44 / i 41 , RT5 = i 54 / i 51 .

[0050] Front-end two-current ratio: The front-end two-current ratio of each voltage segment is defined as: RT12 = i 12 / i 11 , RT22 = i 22 / i 21 , RT32 = i 32 / i 31 , RT42 = i 42 / i 41 , RT52 = i 52 / i 51 .

[0051] Back-end two-current ratio: The back-end two-current ratio of each voltage segment is defined as: RT14 = i 14 / i 13 , RT24 = i24 / i 23 ,RT34 = i 34 / i 33 ,RT44 = i 44 / i 43 ,RT54 = i 54 / i 53 。

[0052] Back-end to front-end current ratio difference: RT14 - RT12, RT24 - RT22, RT34 - RT32, RT44 - RT42, RT54 - RT52.

[0053] Figure 4 This is a two-dimensional parameter combination diagram of the current generated by the working electrode extracted from whole blood samples and quality control solutions in this embodiment. The two-dimensional parameter combination diagram extracted from the output signal is used to distinguish the analysis samples of whole blood samples and quality control solutions. From Figure 4 A, Figure 4 B, Figure 4 C, it can be seen that the current signals generated by the staircase wave can form multiple groups of two-dimensional parameters to distinguish quality control solutions and biological samples.

[0054] The steps of Example 1 are taken to test the blood and quality control solutions. Two groups of experiments are carried out on the blood, namely b1 and b2, and sixteen groups of experiments are carried out on the quality control solution for calculation, namely c11, c12, c13, c14, c15, c16, c17, c18, c21, c22, c23, c24, c25, c26, c27 and c28. Record RT1, RT2, RT3, RT4, RT5, RT34 - RT32 for each group. The results are shown in Figure 5 。 Figure 5 This is a data diagram of the output signals generated by the quality control solution and blood under the excitation of the staircase wave. According to Figure 5 the data in, it can be known that for blood and quality control solutions, the differences in the above four parameters of RT2, RT4, RT5, and RT34 - RT32 are the largest, and blood and quality control solutions can be clearly distinguished according to these four parameters.

[0055] Example 2

[0056] Six non - continuous input signals are sequentially input to the working electrode. The voltage values of the six non - continuous input signals are 0.3V, 0.8V, 0.6V, 1.1V, 1.0V, and 1.8V respectively. The application time of the six input signals is equal, each being 0.2s, and the interval time is 0.1 second. These six non - continuous input signals are the excitation signal sequence. Measure the output current to obtain the staircase current ratio and current difference (RTx). This RTx is the output sequence signal;

[0057] The voltage values of the 6 input signals are 0.3V, 0.8V, 0.6V, 1.1V, 1.0V, and 1.8V respectively. There are four sampling points in each voltage application stage. When the voltage value of 0.3V is input, it is the first stage, and the sampling values are i11, i12, i13, i14 in sequence; when the voltage value of 0.8V is input, it is the second stage, and the sampling values are i21, i22, i23, i24 in sequence; when the voltage value of 0.6V is input, it is the third stage, and the sampling values are i31, i32, i33, i34 in sequence; when the voltage value of 1.1V is input, it is the fourth stage, and the sampling values are i41, i42, i43, i44 in sequence; when the voltage value of 1.0V is input, it is the fifth stage, and the sampling values are i51, i52, i53, i54 in sequence; when the voltage value of 1.8V is input, it is the sixth stage, and the sampling values are i61, i62, i63, i64 in sequence.

[0058] Endpoint current ratio: The endpoint current ratio of each voltage segment is defined as: RT1 = i14 / i11, RT2 = i24 / i21, RT3 = i34 / i31, RT4 = i44 / i41, RT5 = i54 / i51, RT6 = i64 / i61.

[0059] Front-end two-current ratio: The front-end two-current ratio of each segment is defined as: RT12 = i12 / i11, RT22 = i22 / i21, RT32 = i32 / i31, RT42 = i42 / i41, RT52 = i52 / i51; RT62 = i62 / i61.

[0060] Back-end two-current ratio: The back-end two-current ratio of each segment is defined as: RT14 = i14 / i13, RT24 = i24 / i23, RT34 = i34 / i33, RT44 = i44 / i43, RT54 = i54 / i53, RT64 = i64 / i63.

[0061] Back-end front-end current ratio difference: RT14 - RT12, RT24 - RT22, RT34 - RT32, RT44 - RT42, RT54 - RT52, RT64 - RT62.

[0062] Figure 6 This is a two-dimensional parameter combination diagram of the current generated by the working electrode extracted from the whole blood sample and the quality control solution in this embodiment. The two-dimensional parameter combination diagram extracted from the output signal is used to distinguish the analysis samples of the whole blood sample and the quality control solution. From Figure 6 A, Figure 6 B, Figure 6 C and Figure 6 D, it can be seen that the current signals generated by the staircase wave can form multiple groups of two-dimensional parameters to distinguish the quality control solution and biological samples.

[0063] The steps of Example 2 were taken to test the blood and the quality control solution. Two groups of experiments were conducted on the blood, namely b1 and b2, and sixteen groups of experiments were calculated for the quality control solution, namely c11, c12, c13, c14, c15, c16, c17, c18, c21, c22, c23, c24, c25, c26, c27, and c28. The RT2, RT3, RT4, RT5, RT6, RT54 - RT52, and RT44 - RT42 of each group were recorded. The results are shown in Figure 7 . Figure 7 It is a data graph of the output signals generated by the quality control solution and the blood under the stepped wave excitation. According to Figure 7 the data in, for the blood and the quality control solution, the differences in the above five parameters of RT2, RT3, RT6, RT54 - RT52, and RT44 - RT42 are the largest, and the blood and the quality control solution can be clearly distinguished according to the above four parameters.

[0064] As mentioned above, it is only the embodiment of the present application. The protection scope of the present application is not limited by these specific embodiments, but is determined by the claims of the present application. For those skilled in the art, various changes and modifications can be made to the present application. Any modification, equivalent replacement, improvement, etc. made within the technical idea and principle of the present application shall be included within the protection scope of the present application.

Claims

1. A method for differentiating a quality control liquid from a biological sample, characterized in that, Bring the working electrode into contact with the sample to be tested, where the working electrode is a blank electrode or is coated with an inert substance that does not chemically react with biological samples; Input an excitation signal sequence to the working electrode, where the excitation signal sequence includes at least two consecutive or non-consecutive input signals, and each input signal is a constant value; Measure the output signal sequence of the sample to be tested in response to the excitation signal sequence to distinguish between the quality control solution and biological samples.

2. The method for differentiating a quality control liquid from a biological sample according to claim 1, wherein, The excitation signal sequence includes at least two consecutively applied input signals, and the output voltage of the excitation signal sequence increases or decreases continuously, with a voltage range of 0.1 - 3V; preferably, the excitation signal sequence includes 4 - 8 consecutive input signals.

3. A method for differentiating a quality control fluid from a biological sample according to claim 2, characterized in that, The excitation signal sequence includes 5 consecutive input signals, and the voltage values of the 5 consecutive input signals are 0.3V, 0.8V, 1.2V, 1.7V, and 2.0V respectively.

4. A method for differentiating a quality control liquid from a biological sample according to claim 1, characterized in that, The excitation signal sequence includes at least two non-consecutively applied input signals, and the output voltage of the excitation signal sequence increases or decreases discontinuously, with a voltage range of 0.1 - 3V; preferably, the excitation signal sequence includes 4 - 8 non-consecutive input signals.

5. A method for differentiating a quality control fluid from a biological sample according to claim 4, characterized in that, The excitation signal sequence includes 6 non-consecutive input signals, and the voltage values of the 6 non-consecutive input signals are 0.3V, 0.8V, 0.6V, 1.1V, 1.0V, and 1.8V respectively.

6. A method for differentiating a quality control liquid from a biological sample according to claim 1, wherein, The total application time of the excitation signal sequence is at least 1s, and the voltage range is 0.2 - 2.2V.

7. A method for differentiating a quality control fluid from a biological sample according to claim 6, characterized in that, The application time of each input signal in the excitation signal sequence is 0.1 - 0.3s; preferably, the application time of each input signal in the excitation signal sequence is equal, both being 0.2s.

8. A method for differentiating a quality control fluid from a biological sample according to claim 1, wherein Calculate at least one parameter from the output signal sequence of the working electrode, and determine whether the tested sample is a quality control solution or a biological sample according to the predetermined critical value for quality control solution detection.

9. A method for differentiating a quality control liquid from a biological sample according to claim 1, characterized in that, Calculate at least two parameters from the output signal sequence of the working electrode, and determine whether the tested sample is a quality control solution or a biological sample according to the predetermined two-dimensional critical value for quality control solution detection.

10. A method for differentiating a quality control fluid from a biological sample according to claim 1, characterized in that, Calculate at least two different parameter sets from the output signal sequence of the working electrode, and determine whether the tested sample is a quality control solution or a biological sample according to the predetermined two-dimensional critical values for two sets of quality control solution detection.

11. A method for differentiating a quality control fluid from a biological sample according to claim 1, characterized in that, The biological samples include samples such as blood, urine, saliva, bile, gastric juice, lymph fluid, etc.

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