Calibration method and calibration device for physiological index detector

Abstract

The present application discloses a calibration method and a calibration device for a physiological index detector, which relate to the technical field of instrument calibration, and include: testing biological samples of multiple different sample concentrations on a system to be calibrated respectively to obtain multiple corresponding original signal values, and testing each biological sample on a reference system respectively to obtain multiple corresponding reference concentration values; establishing a corresponding functional relationship according to the original signal values ​​and reference concentration values ​​corresponding to the same sample concentration to obtain a first function, and substituting each original signal value into the first function for calculation to obtain multiple initial concentration values; establishing a corresponding functional relationship according to the initial concentration values ​​and reference concentration values ​​corresponding to the same sample concentration to obtain a second function; substituting the first function into the second function to obtain a third function, and using the third function as a concentration calculation function of the system to be calibrated to complete the calibration of the physiological index detector, thereby reducing the situation where high and low values ​​deviate from the standard calibration curve.

Description

Technical Field

[0001] The invention relates to the technical field of instrument calibration, and in particular to a calibration method and a calibration device for a physiological index detector. Background Art

[0002] At present, the physiological index detectors on the market, such as blood glucose meters, uric acid meters, immunoanalyzers, chemiluminescence detectors, etc., in the process of physiological index detection, these detectors substitute the signals generated by the detected samples and reaction reagents into the preset calibration function to calculate the concentration parameters of the physiological indexes. The preset calibration function in the detector is built-in by the manufacturer before leaving the factory. Therefore, the accuracy of the calibration function is related to the accuracy of the final physiological index parameters. The existing method for determining the calibration function generally measures multiple calibration products on the detector system, and performs function fitting on the detected reaction signals and the concentrations of the calibration products to obtain the calibration function. However, after the calibration function obtained in this way is applied to the detector as a preset calibration function, the detection results will deviate greatly from the calibration function when the concentration of the analyte is high or low, resulting in inaccurate detection results in some cases. Therefore, the current detector calibration method still needs to be improved. Summary of the invention

[0003] In view of this, the purpose of the present invention is to provide a calibration method and a physiological indicator detector, which can accurately generate a marker concentration curve and improve the accuracy of the test results. The specific scheme is as follows:

[0004] In a first aspect, the present application discloses a calibration method for a physiological indicator detector, comprising:

[0005] Testing a plurality of biological samples with different sample concentrations on the system to be calibrated to obtain a plurality of corresponding original signal values, and testing each of the biological samples on the reference system to obtain a plurality of corresponding reference concentration values;

[0006] Establishing a corresponding functional relationship according to the original signal value and the reference concentration value corresponding to the same sample concentration to obtain a first function, and substituting each of the original signal values ​​into the first function for calculation to obtain a plurality of initial concentration values;

[0007] A corresponding function relationship is established according to the initial concentration value and the reference concentration value corresponding to the same sample concentration to obtain a second function;

[0008] The first function is substituted into the second function to obtain a third function, and the third function is used as a concentration calculation function of the system to be calibrated to complete the calibration of the physiological index detector.

[0009] Optionally, the signal type corresponding to the original signal value is any one or more of an electrical signal, an optical signal, an acoustic signal, and a magnetic signal.

[0010] Optionally, the step of testing a plurality of biological samples with different sample concentrations on the system to be calibrated to obtain a plurality of corresponding original signal values ​​includes:

[0011] Loading each target biological sample into a detection kit to be calibrated in the system to be calibrated, respectively, so that the detection kit to be calibrated reacts chemically with the target biological sample;

[0012] Each reaction signal is captured and measured by the system to be calibrated to obtain each reaction signal as an original signal value.

[0013] Optionally, the biological samples are tested separately on a reference system to obtain a plurality of corresponding reference concentration values, including:

[0014] loading each of the biological samples into a reference detection kit in the reference system, so that the reference detection kit reacts with the biological sample;

[0015] Capturing and measuring each of the reaction signals by the reference system;

[0016] The manufacturer's calibration algorithm built into the reference system is used to perform signal calculation on each of the reaction signals to obtain a plurality of corresponding reference concentration values ​​under the reference system.

[0017] Optionally, the function types of the first function and the second function are any one or more of a linear function type, a quadratic polynomial function type, a piecewise function type, and an exponential function type.

[0018] Optionally, the first function is a linear function of one variable.

[0019] Optionally, the second function is a quadratic polynomial function.

[0020] In a second aspect, the present application discloses a calibration device for a physiological indicator detector, comprising:

[0021] A first acquisition module is used to acquire a plurality of original signal values ​​of biological samples of different sample concentrations respectively tested on the system to be calibrated; and to acquire a plurality of reference concentration values ​​of each of the biological samples respectively tested on the reference system;

[0022] A first function building module is used to establish a corresponding function relationship according to the original signal value and the reference concentration value corresponding to the same sample concentration to obtain a first function;

[0023] A second function building module is used to substitute each of the original signal values ​​into the first function for calculation, obtain multiple initial concentration values, and establish a corresponding function relationship according to the initial concentration values ​​and reference concentration values ​​corresponding to the same sample concentration to obtain a second function;

[0024] The third function building module is used to substitute the first function into the second function to obtain the third function.

[0025] It can be seen that the present application provides a calibration method for a physiological indicator detector, including: testing a plurality of biological samples with different sample concentrations on a system to be calibrated to obtain a plurality of corresponding original signal values, and testing each of the biological samples on a reference system to obtain a plurality of corresponding reference concentration values; establishing a corresponding functional relationship according to the original signal value and the reference concentration value corresponding to the same sample concentration to obtain a first function, and substituting each of the original signal values ​​into the first function for calculation to obtain a plurality of initial concentration values; establishing a corresponding functional relationship according to the initial concentration value and the reference concentration value corresponding to the same sample concentration to obtain a second function; substituting the first function into the second function to obtain a third function, and using the third function as the concentration calculation function of the system to be calibrated to complete the calibration of the physiological indicator detector. It can be seen that by preparing a plurality of biological samples with different sample concentrations. Test these samples on the detection system to be calibrated to obtain a plurality of original signal values; at the same time, test these same samples on a system as a reference standard to obtain a plurality of corresponding reference concentration values. Then, for the original signal value and the reference concentration value corresponding to each same sample concentration, a functional relationship is established, which is the first function. Substitute each of the previously obtained original signal values ​​into the first function for calculation, thereby obtaining multiple initial concentration values. Next, for each initial concentration value and reference concentration value corresponding to the same sample concentration, establish a functional relationship, which is the second function. Finally, substitute the first function into the second function to obtain the third function. This third function is determined as the function used by the system to be calibrated to calculate the concentration, thus completing the calibration of the physiological indicator detector. In this way, by testing multiple different sample concentrations and establishing multiple functional relationships for calibration, the measurement deviation of the system to be calibrated can be corrected more accurately, thereby significantly improving the accuracy of physiological indicator detection. Taking into account the multiple corresponding relationships between the original signal value and the reference concentration value, a plurality of functions are comprehensively established, which effectively reduces the influence of a single factor or accidental error on the calibration result. Furthermore, since multiple different sample concentrations are used for testing and calibration, it can adapt to sample detection in different concentration ranges, thereby improving the versatility of the detector in various practical application scenarios, avoiding the situation where the test results deviate significantly from the calibration function when the concentration of the analyte is high or low, and reducing the deviation of high and low values ​​from the standard calibration curve, thereby reducing a large number of false positive or false negative cases caused by inaccurate calculation of marker concentrations, and being able to give diagnostic values ​​more correctly, providing a more reliable basis for medical diagnosis. BRIEF DESCRIPTION OF THE DRAWINGS

[0026] In order to more clearly illustrate the embodiments of the present invention or the technical solutions in the prior art, the drawings required for use in the embodiments or the description of the prior art will be briefly introduced below. Obviously, the drawings described below are only embodiments of the present invention. For ordinary technicians in this field, other drawings can be obtained based on the provided drawings without paying creative work.

[0027] Figure 1 A flow chart of a calibration method for a physiological index detector disclosed in the present application;

[0028] Figure 2 A display result diagram of deviation data before secondary calibration disclosed in the present application;

[0029] Figure 3 A calibration data point result diagram of a secondary calibration algorithm disclosed in this application;

[0030] Figure 4 A secondary calibration curve data result diagram disclosed in this application;

[0031] Figure 5 This is a schematic diagram of a calibration device for a physiological indicator detector disclosed in this application. DETAILED DESCRIPTION

[0032] The following will be combined with the drawings in the embodiments of the present application to clearly and completely describe the technical solutions in the embodiments of the present application. Obviously, the described embodiments are only part of the embodiments of the present invention, not all of the embodiments. Based on the embodiments of the present invention, all other embodiments obtained by ordinary technicians in this field without making creative work are within the scope of protection of the present invention.

[0033] At present, the physiological index detectors on the market, such as blood glucose meters, uric acid meters, immunoanalyzers, chemiluminescence detectors, etc., in the process of physiological index detection, these detectors substitute the signals generated by the detected samples and reaction reagents into the preset calibration function to calculate the concentration parameters of the physiological indexes. The preset calibration function in the detector is built-in by the manufacturer before leaving the factory. Therefore, the accuracy of the calibration function is related to the accuracy of the final physiological index parameters. The existing method for determining the calibration function generally measures multiple calibration products on the detector system, and performs function fitting on the detected reaction signals and the concentrations of the calibration products to obtain the calibration function. However, after the calibration function obtained in this way is applied to the detector as a preset calibration function, the detection results will deviate greatly from the calibration function when the concentration of the analyte is high or low, resulting in inaccurate detection results in some cases. Therefore, the current detector calibration method still needs to be improved.

[0034] To this end, the present invention provides a portable detection analyzer calibration solution, which can achieve accurate generation of marker concentration curves and improve the accuracy of detection results.

[0035] Reference Figure 1 As shown, an embodiment of the present invention discloses a calibration method for a physiological indicator detector, comprising:

[0036] Step S11: testing a plurality of biological samples with different sample concentrations on the system to be calibrated to obtain a corresponding plurality of original signal values, and testing each of the biological samples on the reference system to obtain a corresponding plurality of reference concentration values.

[0037] In this embodiment, the system to be calibrated is a physiological indicator detector to be calibrated. It should be noted that the calibration method of the present invention is applicable to the calibration of any physiological indicator detector, such as blood glucose meter, uric acid meter, immunocolorimeter, turbidimeter, chemiluminescence detector and any other similar equipment.

[0038] In this embodiment, each target biological sample is loaded into the detection kit to be calibrated in the system to be calibrated, so that the detection kit to be calibrated reacts chemically with the target biological sample; each reaction signal is captured and measured by the system to be calibrated to obtain each reaction signal as the original signal value. It can be understood that, taking the chemiluminescence detector for detecting glycated hemoglobin as an example, a plurality of blood samples with different sample concentrations are obtained, and the glycated hemoglobin concentrations of these blood samples should cover the common detection range, such as uniform distribution from low concentration to high concentration. Then, the above-mentioned blood samples are pre-processed, which may include operations such as centrifugation, dilution, and adding reagents to obtain target blood samples that meet the detection requirements, and then the prepared target blood samples of different concentrations are respectively placed in the glycated hemoglobin detector to be calibrated for detection to obtain the corresponding multiple reaction signals. Among them, because the glycated hemoglobin detector to be calibrated is a chemiluminescence detector, the signal type of the reaction signal is an optical signal, and accordingly, the original signal value obtained is the corresponding optical signal. In addition, for different types of detection instruments, the signal types corresponding to the corresponding original signal values ​​are also different types, wherein the signal type corresponding to the original signal value is any one or more of electrical signals, optical signals, acoustic signals, and magnetic signals.

[0039] In this embodiment, the biological samples are tested separately on the reference system to obtain multiple corresponding reference concentration values, including: loading each biological sample into a reference detection kit in the reference system so that the reference detection kit reacts with the biological sample; capturing and measuring each reaction signal by the reference system; and performing signal calculation on each reaction signal using a calibration algorithm built into the reference system to obtain multiple corresponding reference concentration values ​​under the reference system. It can be understood that the reference system is used to perform concentration tests on target biological samples of different sample concentrations of the same batch. Since the reference system has a corresponding calibration algorithm built into it in advance, the original signal value detected by the reference system can be tested for concentration to obtain multiple corresponding reference concentration values ​​under the reference system.

[0040] Step S12: establishing a corresponding function relationship according to the original signal value and the reference concentration value corresponding to the same sample concentration to obtain a first function, and substituting each of the original signal values ​​into the first function for calculation to obtain a plurality of initial concentration values.

[0041] In this embodiment, a corresponding functional relationship between the original signal value corresponding to the same sample concentration and the reference concentration value is constructed to obtain a first function, wherein the function type of the first function is any one or more of a linear function type, a quadratic polynomial function type, a piecewise function type, and an exponential function type.

[0042] When the first function is a linear function of one variable, the corresponding function expression is: ,in, , represents the parameters of a linear function of one variable, represents the original signal value, Indicates the initial concentration value.

[0043] It can be understood that first, according to the corresponding relationship between each pair of reference concentration value and original signal value, fitting is continuously performed, specifically, the original signal value is used as the X value and the reference concentration value is used as the Y value, and the fitting is marked in the rectangular coordinate system to obtain the first function, wherein, , All of them are obtained through the fitting process of each pair of reference concentration value and original signal value; each original signal value is substituted into the one-variable linear function , then the corresponding initial concentration values ​​are obtained, and the first function finally obtained can output the corresponding initial concentration value according to the original signal value as input. It can be seen that the form of constructing the first function in the form of a one-dimensional linear function is simple, easy to understand and calculate. When the relationship between the original signal value and the reference concentration value is initially established, the approximate linear trend between the two can be quickly captured as a preliminary approximation and estimate. Since there may be a major linear correlation trend between the original signal value and the reference concentration value, the use of a one-dimensional linear function can first grasp this major change pattern.

[0044] Step S13: establishing a corresponding function relationship according to the initial concentration value and the reference concentration value corresponding to the same sample concentration to obtain a second function.

[0045] In this embodiment, similarly, a second function is constructed based on the correspondence between the initial concentration values ​​and the reference concentration values ​​of the biological samples of each sample concentration in the same batch, wherein the function type of the second function is any one or more of a linear function type, a quadratic polynomial function type, a piecewise function type, and an exponential function type.

[0046] When the second function is a quadratic polynomial function, the corresponding function expression is: ,in, , , represents the parameters of a quadratic polynomial function, Indicates the initial concentration value.

[0047] It is understandable that after the initial modeling of the first function, some nonlinear deviations or errors were found. The quadratic polynomial function has more flexibility and can better capture and correct these nonlinear characteristics, thereby improving the accuracy of calibration. The relationship between the original signal value and the reference concentration value may have some quadratic change rules on the basis of the initial linear trend, such as: acceleration or deceleration changes within a specific concentration range. The quadratic polynomial function can better describe this complex relationship. Therefore, the second function was further constructed, specifically using the initial concentration value as the X value and the reference concentration value as the Y value, and marking the fitting in the rectangular coordinate system to obtain the second function; wherein, the second function , , They are all obtained through each pair of reference concentration value and initial concentration value in the fitting process.

[0048] Step S14: Substitute the first function into the second function to obtain a third function, and use the third function as the concentration calculation function of the system to be calibrated to complete the calibration of the physiological indicator detector.

[0049] In this embodiment, the first function Substitute into the second function , to obtain the third function . It can be understood that by substituting the first function into the second function, a composite function, namely the third function, is obtained. Since the first function is established based on the preliminary relationship between the original signal value and the reference concentration value, it reflects the basic measurement characteristics of the system to be calibrated to a certain extent. However, this preliminary function may not be able to fully and accurately describe the complex relationship between the two, and there may be some deviations or unconsidered factors. The second function is established based on the relationship between the initial concentration value calculated by the first function and the true reference concentration value. It further captures the difference and regularity between the calculation result of the first function and the actual reference value. When the first function is substituted into the second function to obtain the third function, it actually combines the information and relationship of the above two stages. The third function can more comprehensively and accurately reflect the true relationship between the original signal value and the final reference concentration value. It takes into account the preliminary measurement characteristics of the system to be calibrated, the deviation of the calculation result of the first function, and the overall difference from the reference concentration value.

[0050] In this embodiment, after obtaining the third function, in order to verify that the third function can be used as the concentration calculation function of the system to be calibrated, the third function is firstly error verified. Specifically, the system to be calibrated with the built-in third function is used to perform concentration detection on biological test samples with different sample concentrations to obtain a corresponding first concentration fitting curve; the reference system with the built-in calibration algorithm is used to perform concentration detection on the biological test samples with different sample concentrations to obtain a corresponding second concentration fitting curve; and the accuracy of the current third function as the concentration calculation function of the system to be calibrated is determined according to the curve deviation between the first concentration fitting curve and the second concentration fitting curve. Wherein, determining whether the accuracy of the current third function as the concentration calculation function of the system to be calibrated meets the requirements according to the curve deviation between the first concentration fitting curve and the second concentration fitting curve includes: judging whether the curve deviation between the first concentration fitting curve and the second concentration fitting curve meets the preset deviation condition; if so, the accuracy of the current third function as the concentration calculation function of the system to be calibrated meets the requirements; if not, the accuracy of the current third function as the concentration calculation function of the system to be calibrated does not meet the requirements.

[0051] In order to compare the accuracy of the concentration values ​​output by the reference system with a built-in reference concentration calculation function (corresponding to the second concentration fitting curve) and the system to be calibrated with a built-in common concentration calculation function before calibration, each data point output by the system to be calibrated is used as the test value, and the corresponding standard data point in the reference system is used as the reference value, and then the relative error of each data point is calculated according to the following relative error calculation formula:

[0052] ;

[0053] in, Indicates the test value, Indicates the reference value, Indicates relative error.

[0054] Relative error is used to measure the degree of deviation of the test value from the reference value, and the size of the error is expressed based on the reference value.

[0055] For example, if the reference value is 100 and the test value is 110, then the test value - reference value = 110 - 100 = 10, and its absolute value is 10. The relative error is 10 ÷ 100 = 0.1, or 10%.

[0056] Relative error is often used to evaluate the accuracy and reliability of measurement results and to help determine the precision of test methods or instruments.

[0057] Determine whether the relative error is greater than the preset error threshold to obtain the corresponding comparison result; it should be noted that when judging whether the relative error is greater than the preset error threshold, the preset error threshold is an error value set artificially based on historical error conditions. If it is greater than, it indicates that some of the data points output in the system to be calibrated have a large deviation from their own normal concentration calculation function; if it is less than or equal to, it indicates that some of the data points output in the system to be calibrated have a small deviation or no deviation from their own normal concentration calculation function. Take the glycated hemoglobin data sample as an example to analyze the relative error. The relevant data results before fitting and calibration are shown in Table 1 below:

[0058] Table 1

[0059]

[0060]

[0061]

[0062] It can be seen that 50 glycated hemoglobin data samples are selected in Table 1, their relative errors are calculated, and the curve deviation that is acceptable for relative errors that meet the calibration requirements is set to 10%. In this way, samples with reference values ​​below 5.0 and above 13.0 deviate from the corresponding own normal concentration calculation function, that is, when the curve segment to which the current data point belongs is the starting segment and the ending segment of the curve segment of the own normal concentration calculation function, a corresponding curve deviation will occur, thereby forming deviation data. It can be seen that the high and low values ​​in the curve of the own normal concentration calculation function are higher than those of the reference concentration calculation function in the reference system. Extended to the detection environment of different sample data corresponding to the test kit to be calibrated, it can be seen that the own normal concentration calculation function is offset from the reference concentration calculation function. As Figure 2 As shown, it can be clearly found Figure 2 The degree of deviation between the ordinary concentration calculation function formed by fitting each data point and the reference concentration calculation function as the dotted line, and the data points surrounded by the two black boxes are the deviation data.

[0063] In this embodiment, the final function expression of the third function is After multiple tests of experimental data, finally, .

[0064] It can be understood that the determination process of the third function depends on the first function and the second function, wherein in the selection of the function type of the first function and the second function, the order of the polynomial is first determined: according to the characteristics of the data and the purpose of fitting, the appropriate polynomial order is selected. Generally speaking, the higher the order, the higher the accuracy of the fitting, but it is also easy to cause overfitting. Therefore, this embodiment selects the polynomial order as 2nd order; constructs the system of equations and solves the system of equations. Finally, according to The biological test samples with different sample concentrations are tested for concentration to obtain a first concentration fitting curve.

[0065] Among them, the fitting effect of the first concentration fitting curve is as follows Figure 3 As shown, it can be seen that the obtained fitting results are better than the fitting results of other fitting algorithms (polynomial correction, piecewise correction, spline (spline fitting algorithm), etc.) based on the deviated data.

[0066] Compare the first concentration fitting curve with the second concentration fitting curve to determine whether the comparison result meets the curve comparison requirements, that is, determine whether the relative error between the two is less than or equal to the preset standard error. If the comparison results of all data points in the first concentration fitting curve and the standard data points of the second concentration fitting curve are less than or equal to the preset standard error, it indicates that the calibration end condition is reached at this time, and the corresponding third function is determined to be the concentration calculation function. Taking the data in Table 1 as an example, after performing a quadratic fit on the data points in Table 1, the relevant index results obtained are shown in Table 2 below:

[0067] Table 2

[0068]

[0069]

[0070]

[0071] It can be seen that after the secondary calibration according to the deviation data in Table 2, the comparison results of all data points in the first concentration fitting curve with the standard data points are less than or equal to the preset standard error of 10%, indicating that the calibration end condition has been reached at this time, and the accuracy of the output current third function as the concentration calculation function of the system to be calibrated meets the requirements. Therefore, the output result is as follows Figure 4 As shown, from Figure 4 It can be seen from the curve display results that the test values ​​in the entire linear range can match the reference values, further proving that the current third function is more accurate as the concentration calculation function of the system to be calibrated.

[0072] It can be seen that the present application provides a calibration method for a physiological indicator detector, including: testing a plurality of biological samples with different sample concentrations on a system to be calibrated to obtain a plurality of corresponding original signal values, and testing each of the biological samples on a reference system to obtain a plurality of corresponding reference concentration values; establishing a corresponding functional relationship according to the original signal value and the reference concentration value corresponding to the same sample concentration to obtain a first function, and substituting each of the original signal values ​​into the first function for calculation to obtain a plurality of initial concentration values; establishing a corresponding functional relationship according to the initial concentration value and the reference concentration value corresponding to the same sample concentration to obtain a second function; substituting the first function into the second function to obtain a third function, and using the third function as the concentration calculation function of the system to be calibrated to complete the calibration of the physiological indicator detector. It can be seen that by preparing a plurality of biological samples with different sample concentrations. Test these samples on the detection system to be calibrated to obtain a plurality of original signal values; at the same time, test these same samples on a system as a reference standard to obtain a plurality of corresponding reference concentration values. Then, for the original signal value and the reference concentration value corresponding to each same sample concentration, a functional relationship is established, which is the first function. Substitute each of the previously obtained original signal values ​​into the first function for calculation, thereby obtaining multiple initial concentration values. Next, for each initial concentration value and reference concentration value corresponding to the same sample concentration, establish a functional relationship, which is the second function. Finally, substitute the first function into the second function to obtain the third function. This third function is determined as the function used by the system to be calibrated to calculate the concentration, thus completing the calibration of the physiological indicator detector. In this way, by testing multiple different sample concentrations and establishing multiple functional relationships for calibration, the measurement deviation of the system to be calibrated can be corrected more accurately, thereby significantly improving the accuracy of physiological indicator detection. Taking into account the multiple corresponding relationships between the original signal value and the reference concentration value, a plurality of functions are comprehensively established, which effectively reduces the influence of a single factor or accidental error on the calibration result. Furthermore, since multiple different sample concentrations are used for testing and calibration, it can adapt to sample detection in different concentration ranges, thereby improving the versatility of the detector in various practical application scenarios, avoiding the situation where the test results deviate significantly from the calibration function when the concentration of the analyte is high or low, and reducing the deviation of high and low values ​​from the standard calibration curve, thereby reducing a large number of false positive or false negative cases caused by inaccurate calculation of marker concentrations, and being able to give diagnostic values ​​more correctly, providing a more reliable basis for medical diagnosis.

[0073] Reference Figure 5 As shown, the present invention also discloses a calibration device for a physiological index detector, comprising:

[0074] The first acquisition module 11 is used to acquire a plurality of original signal values ​​of biological samples with different sample concentrations respectively tested on the system to be calibrated; and to acquire a plurality of reference concentration values ​​of each of the biological samples respectively tested on the reference system;

[0075] A first function building module 12 is used to establish a corresponding function relationship according to the original signal value and the reference concentration value corresponding to the same sample concentration to obtain a first function;

[0076] A second function building module 13 is used to substitute each of the original signal values ​​into the first function for calculation, obtain multiple initial concentration values, and establish a corresponding function relationship according to the initial concentration values ​​and reference concentration values ​​corresponding to the same sample concentration to obtain a second function;

[0077] The third function building module 14 is used to substitute the first function into the second function to obtain a third function.

[0078] It can be seen that the present application provides a method for obtaining a plurality of original signal values ​​of biological samples with different sample concentrations tested on a system to be calibrated respectively; and a plurality of reference concentration values ​​for obtaining each of the biological samples tested on a reference system respectively; establishing a corresponding functional relationship according to the original signal values ​​and reference concentration values ​​corresponding to the same sample concentration to obtain a first function; substituting each of the original signal values ​​into the first function for calculation to obtain a plurality of initial concentration values, establishing a corresponding functional relationship according to the initial concentration values ​​and reference concentration values ​​corresponding to the same sample concentration to obtain a second function; substituting the first function into the second function to obtain a third function. It can be seen that by obtaining the test values ​​of biological samples with different sample concentrations on a system to be calibrated and a reference system, and establishing the relationship between the first function, the second function, and the third function for calibration, the inaccurate detection results caused by the errors or deviations of the system to be calibrated itself can be significantly reduced, and multiple rounds of function construction and calibration processes make the detection results more stable and reliable. Even when faced with complex biological samples or changes in the detection environment, it can maintain good detection performance, thereby greatly improving the accuracy of physiological indicator detection. The physiological indicator detector proposed in the present invention can cover most types of indicator detection instruments on the market and realize various types of physiological indicator detection. As long as the corresponding sample concentration data and original signal values ​​can be obtained, more accurate detection results can be obtained through this series of function construction and calibration steps, which has broad application prospects.

[0079] In this specification, each embodiment is described in a progressive manner, and each embodiment focuses on the differences from other embodiments. The same or similar parts between the embodiments can be referred to each other. For the device disclosed in the embodiment, since it corresponds to the method disclosed in the embodiment, the description is relatively simple, and the relevant parts can be referred to the method part.

[0080] Professionals may further appreciate that the units and algorithm steps of each example described in conjunction with the embodiments disclosed herein can be implemented with electronic hardware, computer software, or a combination of the two. In order to clearly illustrate the interchangeability of hardware and software, the composition and steps of each example have been generally described in terms of function in the above description. Whether these functions are performed in hardware or software depends on the specific application and design constraints of the technical solution. Professional and technical personnel may use different methods to implement the described functions for each specific application, but such implementation should not be considered to be beyond the scope of this application. The steps of the method or algorithm described in conjunction with the embodiments disclosed herein can be implemented directly with hardware, a software module executed by a processor, or a combination of the two. The software module can be placed in a random access memory RAM (Random Access Memory), memory, read-only memory ROM (Read Only Memory), electrically programmable EPROM (Electrically Programmable Read Only Memory), electrically erasable programmable EEPROM (ElectricErasable Programmable Read Only Memory), register, hard disk, removable disk, CD-ROM (CompactDisc-Read Only Memory), or any other form of storage medium known in the technical field.

[0081] Finally, it should be noted that, in this article, relational terms such as first and second, etc. are only used to distinguish one entity or operation from another entity or operation, and do not necessarily require or imply any such actual relationship or order between these entities or operations. Moreover, the terms "include", "comprise" or any other variants thereof are intended to cover non-exclusive inclusion, so that a process, method, article or device including a series of elements includes not only those elements, but also other elements not explicitly listed, or also includes elements inherent to such process, method, article or device. In the absence of further restrictions, the elements defined by the sentence "comprise a ..." do not exclude the presence of other identical elements in the process, method, article or device including the elements.

[0082] The scheme provided by the present invention is introduced in detail above. Specific examples are used in this article to illustrate the principle and implementation mode of the present invention. The description of the above embodiments is only used to help understand the method of the present invention and its core idea. At the same time, for those skilled in the art, according to the idea of ​​the present invention, there will be changes in the specific implementation mode and application scope. In summary, the content of this specification should not be understood as limiting the present invention.

Claims

1. A calibration method for a physiological indicator detector, characterized in that: include: Testing a plurality of biological samples with different sample concentrations on the system to be calibrated to obtain a plurality of corresponding original signal values, and testing each of the biological samples on the reference system to obtain a plurality of corresponding reference concentration values; Establishing a corresponding functional relationship according to the original signal value and the reference concentration value corresponding to the same sample concentration to obtain a first function, and substituting each of the original signal values ​​into the first function for calculation to obtain a plurality of initial concentration values; A corresponding function relationship is established according to the initial concentration value and the reference concentration value corresponding to the same sample concentration to obtain a second function; Substituting the first function into the second function to obtain a third function, and using the third function as a concentration calculation function of the system to be calibrated to complete the calibration of the physiological index detector; Before using the third function as the concentration calculation function of the system to be calibrated, the method further includes: using the system to be calibrated with the built-in third function to perform concentration detection on biological test samples with different sample concentrations to obtain a corresponding first concentration fitting curve; using the reference system with a built-in calibration algorithm to perform concentration detection on the biological test samples with different sample concentrations to obtain a corresponding second concentration fitting curve; and determining whether the accuracy of the current third function as the concentration calculation function of the system to be calibrated meets the requirements according to the curve deviation between the first concentration fitting curve and the second concentration fitting curve; Among them, determining whether the accuracy of the current third function as the concentration calculation function of the system to be calibrated meets the requirements according to the curve deviation between the first concentration fitting curve and the second concentration fitting curve includes: judging whether the curve deviation between the first concentration fitting curve and the second concentration fitting curve meets the preset deviation condition; if so, the accuracy of the current third function as the concentration calculation function of the system to be calibrated meets the requirements; if not, the accuracy of the current third function as the concentration calculation function of the system to be calibrated does not meet the requirements.

2. The calibration method of the physiological index detector according to claim 1, characterized in that: The signal type corresponding to the original signal value is any one or more of an electrical signal, an optical signal, an acoustic signal, and a magnetic signal.

3. The calibration method of the physiological index detector according to claim 1, characterized in that: The method of testing a plurality of biological samples with different sample concentrations on the system to be calibrated to obtain a plurality of corresponding original signal values ​​includes: Loading each target biological sample into a detection kit to be calibrated in the system to be calibrated, respectively, so that the detection kit to be calibrated reacts chemically with the target biological sample; Each reaction signal is captured and measured by the system to be calibrated to obtain each reaction signal as an original signal value.

4. The calibration method of the physiological index detector according to claim 3, characterized in that: The biological samples are tested on the reference system to obtain corresponding multiple reference concentration values, including: loading each of the biological samples into a reference detection kit in the reference system, so that the reference detection kit reacts with the biological sample; Capturing and measuring each reaction signal by the reference system; The calibration algorithm built into the reference system is used to perform signal calculation on each of the reaction signals to obtain a plurality of corresponding reference concentration values ​​under the reference system.

5. The calibration method of the physiological index detector according to claim 1, characterized in that: The function types of the first function and the second function are any one or more of a linear function type, a quadratic polynomial function type, a piecewise function type, and an exponential function type.

6. The calibration method of the physiological index detector according to claim 5, characterized in that: The first function is a linear function of one variable.

7. The calibration method of the physiological index detector according to claim 5, characterized in that: The second function is a quadratic polynomial function.

8. A calibration device for a physiological index detector, characterized in that: include: A first acquisition module is used to acquire a plurality of original signal values ​​of biological samples with different sample concentrations respectively tested on the system to be calibrated; and for obtaining a plurality of reference concentration values ​​for each of the biological samples to be tested on a reference system; A first function building module is used to establish a corresponding function relationship according to the original signal value and the reference concentration value corresponding to the same sample concentration to obtain a first function; A second function building module is used to substitute each of the original signal values ​​into the first function for calculation, obtain multiple initial concentration values, and establish a corresponding function relationship according to the initial concentration values ​​and reference concentration values ​​corresponding to the same sample concentration to obtain a second function; A third function building module, used for substituting the first function into the second function to obtain a third function; The calibration device of the physiological index detector is used to perform concentration detection on biological test samples with different sample concentrations using the system to be calibrated with the third function built in, so as to obtain a corresponding first concentration fitting curve; Using the reference system with a built-in calibration algorithm to perform concentration detection on the biological test samples of different sample concentrations to obtain a corresponding second concentration fitting curve; determining whether the accuracy of the current third function as the concentration calculation function of the system to be calibrated meets the requirements according to the curve deviation between the first concentration fitting curve and the second concentration fitting curve; The calibration device of the physiological indicator detector is also used to determine whether the curve deviation between the first concentration fitting curve and the second concentration fitting curve meets the preset deviation condition; if so, the accuracy of the current third function as the concentration calculation function of the system to be calibrated meets the requirements; if not, the accuracy of the current third function as the concentration calculation function of the system to be calibrated does not meet the requirements.

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