CN118758924B - Calibration method and calibration device of physiological index detector - Google Patents
Calibration method and calibration device of physiological index detector Download PDFInfo
- Publication number
- CN118758924B CN118758924B CN202411245107.2A CN202411245107A CN118758924B CN 118758924 B CN118758924 B CN 118758924B CN 202411245107 A CN202411245107 A CN 202411245107A CN 118758924 B CN118758924 B CN 118758924B
- Authority
- CN
- China
- Prior art keywords
- function
- concentration
- calibrated
- calibration
- value
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
- Active
Links
Classifications
-
- G—PHYSICS
- G01—MEASURING; TESTING
- G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
- G01N21/00—Investigating or analysing materials by the use of optical means, i.e. using sub-millimetre waves, infrared, visible or ultraviolet light
- G01N21/75—Systems in which material is subjected to a chemical reaction, the progress or the result of the reaction being investigated
- G01N21/76—Chemiluminescence; Bioluminescence
-
- G—PHYSICS
- G01—MEASURING; TESTING
- G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
- G01N33/00—Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
- G01N33/48—Biological material, e.g. blood, urine; Haemocytometers
-
- G—PHYSICS
- G01—MEASURING; TESTING
- G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
- G01N33/00—Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
- G01N33/48—Biological material, e.g. blood, urine; Haemocytometers
- G01N33/50—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing
- G01N33/72—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing involving blood pigments, e.g. haemoglobin, bilirubin or other porphyrins; involving occult blood
- G01N33/721—Haemoglobin
- G01N33/723—Glycosylated haemoglobin
-
- G—PHYSICS
- G06—COMPUTING; CALCULATING OR COUNTING
- G06F—ELECTRIC DIGITAL DATA PROCESSING
- G06F17/00—Digital computing or data processing equipment or methods, specially adapted for specific functions
- G06F17/10—Complex mathematical operations
-
- G—PHYSICS
- G16—INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR SPECIFIC APPLICATION FIELDS
- G16C—COMPUTATIONAL CHEMISTRY; CHEMOINFORMATICS; COMPUTATIONAL MATERIALS SCIENCE
- G16C20/00—Chemoinformatics, i.e. ICT specially adapted for the handling of physicochemical or structural data of chemical particles, elements, compounds or mixtures
- G16C20/10—Analysis or design of chemical reactions, syntheses or processes
Landscapes
- Engineering & Computer Science (AREA)
- Life Sciences & Earth Sciences (AREA)
- Health & Medical Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Physics & Mathematics (AREA)
- General Physics & Mathematics (AREA)
- Analytical Chemistry (AREA)
- Immunology (AREA)
- Hematology (AREA)
- Theoretical Computer Science (AREA)
- Biomedical Technology (AREA)
- Pathology (AREA)
- General Health & Medical Sciences (AREA)
- Biochemistry (AREA)
- Urology & Nephrology (AREA)
- Molecular Biology (AREA)
- Mathematical Physics (AREA)
- Medicinal Chemistry (AREA)
- Data Mining & Analysis (AREA)
- Food Science & Technology (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Mathematical Analysis (AREA)
- Bioinformatics & Computational Biology (AREA)
- Crystallography & Structural Chemistry (AREA)
- Mathematical Optimization (AREA)
- Biotechnology (AREA)
- Cell Biology (AREA)
- Software Systems (AREA)
- Microbiology (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Databases & Information Systems (AREA)
- General Engineering & Computer Science (AREA)
- Computing Systems (AREA)
- Pure & Applied Mathematics (AREA)
- Computational Mathematics (AREA)
- Algebra (AREA)
- Plasma & Fusion (AREA)
- Investigating Or Analysing Biological Materials (AREA)
Abstract
The application discloses a calibration method and a calibration device of a physiological index detector, which relate to the technical field of instrument calibration and comprise the steps of respectively 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, respectively testing each biological sample on a reference system to obtain a plurality of corresponding reference concentration values, establishing a corresponding function relation according to the original signal values and the reference concentration values corresponding to the same sample concentration to obtain a first function, respectively substituting each original signal value into the first function to calculate to obtain a plurality of initial concentration values, establishing a corresponding function relation according to the initial concentration values and the 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 taking the third function as a concentration calculation function of the system to be calibrated to finish the calibration of the physiological index detector, thereby reducing the condition that the high and low values deviate from a standard calibration curve.
Description
Technical Field
The invention relates to the technical field of instrument calibration, in particular to a calibration method and a calibration device of a physiological index detector.
Background
Currently, physiological index detectors such as blood glucose meters, uric acid meters, immune analyzers, chemiluminescent detectors and the like are used for calculating concentration parameters of physiological indexes by substituting signals generated by detected samples and reaction reagents into preset calibration functions in the physiological index detection process. And the calibration function preset in the detector is built in by a manufacturer before leaving the factory. Thus, the accuracy of the calibration function is related to the accuracy of the final physiological index parameter. In the existing calibration function determining method, a plurality of calibration materials are measured on a detector system, and the detected reaction signals and the concentration of the calibration materials are subjected to function fitting to obtain a calibration function. However, after the calibration function obtained in this way is applied to the detector as a preset calibration function, the detection result of the detector deviates from the calibration function greatly when the concentration of the object to be detected is high or low, so that the phenomenon of inaccurate detection result occurs in some cases. Thus, there remains a need for improvements in current detector calibration methods.
Disclosure of Invention
Therefore, the invention aims to provide a calibration method of a physiological index detector and the physiological index detector, which can accurately generate a marker concentration curve and improve the accuracy of a detection result. The specific scheme is as follows:
In a first aspect, the application discloses a method for calibrating a physiological index detector, comprising the following steps:
Respectively 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 respectively testing each biological sample on a reference system to obtain a plurality of corresponding reference concentration values;
establishing a corresponding function relation according to an original signal value and a reference concentration value corresponding to the same sample concentration to obtain a first function, and substituting each original signal value into the first function to calculate to obtain a plurality of initial concentration values;
Establishing a corresponding function relation according to an initial concentration value and a 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 taking the third function as a concentration calculation function of the system to be calibrated to finish the calibration of the physiological index detector.
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.
Optionally, the testing the biological samples with different sample concentrations on the system to be calibrated to obtain a plurality of corresponding original signal values includes:
respectively loading each target biological sample into a detection kit to be calibrated in a system to be calibrated so that the detection kit to be calibrated and the target biological sample perform chemical reaction;
capturing and measuring each reaction signal through the system to be calibrated so as to obtain each reaction signal as an original signal value.
Optionally, the testing each biological sample on the reference system to obtain a plurality of corresponding reference concentration values includes:
Loading each biological sample into a reference detection kit in the reference system respectively so that the reference detection kit reacts with the biological sample;
capturing and measuring each of the reaction signals by the reference system;
and calculating the signals of each reaction signal by using a manufacturer calibration algorithm built in the reference system so as to obtain a plurality of corresponding reference concentration values under the reference system.
Optionally, the function types of the first function and the second function are any one or more of a unitary linear function type, a unitary quadratic polynomial function type, a piecewise function type and an exponential function type.
Optionally, the first function is a unitary linear function.
Optionally, the second function is a unitary quadratic polynomial function.
In a second aspect, the present application discloses a calibration device for a physiological index detector, comprising:
the system comprises a first acquisition module, a first calibration module, a second acquisition module and a first calibration module, wherein the first acquisition module is used for acquiring a plurality of original signal values of a plurality of biological samples with different sample concentrations respectively tested on a system to be calibrated;
the first function construction module is used for establishing a corresponding function relation according to an original signal value and a reference concentration value corresponding to the same sample concentration so as to obtain a first function;
The second function construction module is used for substituting each original signal value into the first function calculation to obtain a plurality of initial concentration values, and establishing a corresponding function relation according to the initial concentration value and the reference concentration value corresponding to the same sample concentration to obtain a second function;
And the third function construction module is used for substituting the first function into the second function to obtain a third function.
The application provides a calibration method of a physiological index detector, which comprises the steps of respectively 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, respectively testing each biological sample on a reference system to obtain a plurality of corresponding reference concentration values, establishing a corresponding function relation according to the original signal values and the reference concentration values corresponding to the same sample concentration to obtain a first function, respectively substituting each original signal value into the first function to calculate to obtain a plurality of initial concentration values, establishing a corresponding function relation according to the initial concentration values and the 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 taking the third function as a concentration calculation function of the system to be calibrated to finish the calibration of the physiological index detector. It can be seen that by preparing a plurality of biological samples having different sample concentrations. And simultaneously, testing the same samples on a system serving as a reference standard to obtain a plurality of corresponding reference concentration values. Then, a functional relationship is established for the original signal value and the reference concentration value corresponding to each identical sample concentration, which is the first function. And substituting each original signal value obtained before into a first function to calculate so as to obtain a plurality of initial concentration values. Then, a functional relationship is established for the initial concentration value and the reference concentration value corresponding to each identical sample concentration, which is a second function. And finally, substituting the first function into the second function to obtain a third function. This third function is determined as a function of the concentration calculated by the system to be calibrated, thus completing the calibration of the physiological index detector. Therefore, the measurement deviation of the system to be calibrated can be corrected more accurately by testing different sample concentrations for a plurality of times and establishing a plurality of functional relations for calibration, so that the accuracy of the detection of the physiological index is improved remarkably. And the multiple corresponding relations between the original signal value and the reference concentration value are considered, and multiple functions are comprehensively established, so that the influence of single factors or accidental errors on the calibration result is effectively reduced. Furthermore, as a plurality of different sample concentrations are used for testing and calibrating, the method can adapt to sample detection in different concentration ranges, improves the universality of the detector in various practical application scenes, avoids the situation that the detection result of the detector deviates from a calibration function greatly when the concentration of the object to be detected is high or low, reduces the situation that the high or low value deviates from a standard calibration curve, further reduces a large number of false positive or false negative cases caused by inaccurate calculation of the marker concentration, can give out a diagnosis value more accurately, and provides more reliable basis for medical diagnosis.
Drawings
In order to more clearly illustrate the embodiments of the present invention or the technical solutions in the prior art, the drawings that are required to be used in the embodiments or the description of the prior art will be briefly described below, and it is obvious that the drawings in the following description are only embodiments of the present invention, and that other drawings can be obtained according to the provided drawings without inventive effort for a person skilled in the art.
FIG. 1 is a flow chart of a method for calibrating a physiological index detector according to the present application;
FIG. 2 is a graph showing the result of the secondary calibration of the present application;
FIG. 3 is a graph of the results of calibrating data points using a secondary calibration algorithm according to the present disclosure;
FIG. 4 is a graph of the data results of a secondary calibration curve according to the present disclosure;
fig. 5 is a schematic diagram of a calibration device of a physiological index detector according to the present disclosure.
Detailed Description
The following description of the embodiments of the present application will be made clearly and completely with reference to the accompanying drawings, in which it is apparent that the embodiments described are only some embodiments of the present application, but not all embodiments. All other embodiments, which can be made by those skilled in the art based on the embodiments of the application without making any inventive effort, are intended to be within the scope of the application.
Currently, physiological index detectors such as blood glucose meters, uric acid meters, immune analyzers, chemiluminescent detectors and the like are used for calculating concentration parameters of physiological indexes by substituting signals generated by detected samples and reaction reagents into preset calibration functions in the physiological index detection process. And the calibration function preset in the detector is built in by a manufacturer before leaving the factory. Thus, the accuracy of the calibration function is related to the accuracy of the final physiological index parameter. In the existing calibration function determining method, a plurality of calibration materials are measured on a detector system, and the detected reaction signals and the concentration of the calibration materials are subjected to function fitting to obtain a calibration function. However, after the calibration function obtained in this way is applied to the detector as a preset calibration function, the detection result of the detector deviates from the calibration function greatly when the concentration of the object to be detected is high or low, so that the phenomenon of inaccurate detection result occurs in some cases. Thus, there remains a need for improvements in current detector calibration methods.
Therefore, the invention provides a portable detection analyzer calibration scheme, which can accurately generate a marker concentration curve and improve the accuracy of a detection result.
Referring to fig. 1, an embodiment of the present invention discloses a method for calibrating a physiological index detector, including:
step S11, respectively 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 respectively testing each biological sample on a reference system to obtain a plurality of corresponding reference concentration values.
In this embodiment, the system to be calibrated is a physiological index detector to be calibrated. It should be noted that the calibration method of the present invention is suitable for calibrating any physiological index detector, such as any type of device, such as a blood glucose meter, a uric acid meter, an immunochromatography, a turbidimetry detector, a chemiluminescent detector, etc.
In the embodiment, each target biological sample is loaded to a detection kit to be calibrated in a system to be calibrated, so that the detection kit to be calibrated and the target biological sample perform chemical reaction, and each reaction signal is captured and measured by the system to be calibrated to obtain each reaction signal as an original signal value. It will be appreciated that taking a chemiluminescent detector for detecting glycated hemoglobin as an example, a plurality of blood samples of different sample concentrations are obtained, and that the glycated hemoglobin concentration of these blood samples should cover a common detection range, e.g., evenly distributed from low concentration to high concentration. And then preprocessing the blood sample, which can comprise centrifugation, dilution, reagent addition and other operations, so as to obtain target blood samples meeting detection requirements, and then respectively placing the prepared target blood samples with different concentrations into a glycosylated hemoglobin detector to be calibrated for detection, so as to obtain a plurality of corresponding reaction signals. The glycosylated hemoglobin detector to be calibrated is a chemiluminescent detector, so that the signal type of the reaction signal is an optical signal, and the obtained original signal value is a 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 types corresponding to the original signal values are any one or more of electric signals, optical signals, acoustic signals and magnetic signals.
In this embodiment, the testing the biological samples on the reference system to obtain the corresponding multiple reference concentration values includes loading the biological samples into the reference detection kit in the reference system so that the reference detection kit reacts with the biological samples, capturing and measuring the reaction signals by the reference system, and calculating the signals of the reaction signals by using a calibration algorithm built in the reference system to obtain the corresponding multiple reference concentration values under the reference system. It can be understood that the concentration test is performed on the target biological samples with different sample concentrations in the same batch by using the reference system, and because the reference system is internally provided with the corresponding calibration algorithm in advance, the concentration test can be performed on the original signal value detected by the reference system to obtain a plurality of corresponding reference concentration values under the reference system.
And step S12, establishing a corresponding function relation 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 original signal value into the first function to calculate so as to obtain a plurality of initial concentration values.
In this embodiment, a corresponding functional relationship between an original signal value corresponding to the same sample concentration and a reference concentration value is constructed to obtain a first function. The function type of the first function is any one or more of a unitary linear function type, a unitary quadratic polynomial function type, a piecewise function type and an exponential function type.
When the first function is a unitary linear function, the corresponding function expression is: Wherein, the method comprises the steps of, wherein, 、A parameter representing a unitary linear function of one degree,The value of the original signal is represented by,Representing the initial concentration value.
It will be appreciated that the first function is obtained by first fitting continuously according to the correspondence between the reference concentration value and the original signal value of each pair, specifically by taking the original signal value as the X value and the reference concentration value as the Y value, and labeling the fitting in a rectangular coordinate system,、Each pair of reference concentration value and original signal value is obtained in the fitting process, and each original signal value is respectively substituted into unitary linear functionAnd obtaining the corresponding initial concentration values respectively, and outputting the corresponding initial concentration values according to the input of the original signal value by the finally obtained first function. It can be seen that the first function is constructed in a simple form using a unitary linear function form, which is easy to understand and calculate. When the relation between the original signal value and the reference concentration value is initially established, the approximately linear trend between the original signal value and the reference concentration value can be rapidly captured as initial approximation and estimation. Since there may be a major linear correlation trend between the raw signal value and the reference concentration value, this major law of variation can be grasped first using a unitary linear function.
And S13, establishing a corresponding function relation according to the initial concentration value and the reference concentration value corresponding to the same sample concentration so as to obtain a second function.
In this embodiment, as well, the second function is constructed based on the correspondence between the initial concentration value and the reference concentration value of the biological sample at each sample concentration of the same batch. The function type of the second function is any one or more of a unitary linear function type, a unitary quadratic polynomial function type, a piecewise function type and an exponential function type.
When the second function is a unitary quadratic polynomial function, the corresponding function expression is: Wherein, the method comprises the steps of, wherein, 、、Parameters representing a unitary quadratic polynomial function,Representing the initial concentration value.
It will be appreciated that after preliminary modeling of the first function, some non-linear deviations or errors are found to exist. The unitary quadratic polynomial function has more flexibility, can better capture and correct the nonlinear characteristics, improves the calibration precision, and can have a plurality of quadratic change rules on the basis of the primary linear trend, for example, acceleration or deceleration change in a specific concentration range, so that the unitary quadratic polynomial function can better describe the complex relationship. Therefore, a second function is further constructed, specifically, the initial concentration value is taken as an X value, the reference concentration value is taken as a Y value, and the second function is obtained by marking and fitting in a rectangular coordinate system, wherein the second function is obtained by marking and fitting、、Are obtained during the fitting process by each pair of reference concentration values and initial concentration values.
And S14, substituting the first function into the second function to obtain a third function, and taking the third function as a concentration calculation function of the system to be calibrated to finish the calibration of the physiological index detector.
In the present embodiment, the first functionSubstitution into a second functionTo obtain a third function. It will be appreciated that by substituting the first function into the second function, a composite function, i.e. a third function, is obtained which reflects to some extent the basic measurement characteristics of the system to be calibrated, since the first function is established based on a preliminary relationship of the original signal values and the reference concentration values. However, this preliminary function may not describe the complex relationship between the two exactly and there may be some deviation or unaccounted for. 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 differences and laws between the first function calculation result and the actual reference value. When substituting the first function into the second function to obtain the third function, the information and the relationship of the two stages are integrated. The third function can more fully and accurately reflect the real 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 first function calculation result and the overall difference from the reference concentration value.
In this embodiment, after the third function is obtained, in order to verify that the third function can be used as a concentration calculation function of a system to be calibrated, error verification is performed on the third function, specifically, concentration detection is performed on biological test samples with different sample concentrations by using the system to be calibrated with the built-in third function to obtain a corresponding first concentration fitting curve, concentration detection is performed on the biological test samples with different sample concentrations by using the reference system of a built-in calibration algorithm to obtain a corresponding second concentration fitting curve, and whether the accuracy of the current third function as the concentration calculation function of the system to be calibrated meets the requirement is determined according to curve deviation between the first concentration fitting curve and the second concentration fitting curve. The method comprises the steps of determining whether the accuracy of a current third function serving as a concentration calculation function of a system to be calibrated meets the requirement according to curve deviation between a first concentration fitting curve and a second concentration fitting curve, judging whether the curve deviation between the first concentration fitting curve and the second concentration fitting curve meets a preset deviation condition, if so, enabling the accuracy of the current third function serving as the concentration calculation function of the system to be calibrated to meet the requirement, and if not, enabling the accuracy of the current third function serving as the concentration calculation function of the system to be calibrated to not meet the requirement.
In order to compare the accuracy of the concentration values respectively output by the reference system with the built-in reference concentration calculation function (corresponding to the second concentration fitting curve) and the to-be-calibrated system with the built-in common concentration calculation function before the calibration, respectively taking each data point output by the to-be-calibrated system as a test value, taking the standard data point corresponding to the data point in the reference system as a reference value, and then calculating the relative error of each data point according to the following relative error calculation formula:
;
wherein, The value of the test is indicated and,The reference value is represented by a reference value,Representing the relative error.
The relative error is used to measure the deviation degree of the test value from the reference value, and the magnitude of the error is represented by taking the reference value as a benchmark.
For example, the reference value is 100 and the test value is 110, then the test value-reference value=110-100=10, and the absolute value is 10. The relative error is 10++100=0.1, i.e. 10%.
The relative error is often used to evaluate the accuracy and reliability of the measurement results, helping to determine the accuracy of the test method or instrument.
And when judging whether the relative error is greater than the preset error threshold, the preset error threshold is a specific error value set by people according to the historical error condition. If the data points are larger than the normal concentration calculation function, and if the data points are smaller than or equal to the normal concentration calculation function, and the data points are smaller than or equal to the normal concentration calculation function. Taking glycosylated hemoglobin data samples as an example, analysis of relative errors was performed, and the results of the data before fitting and calibration are shown in table 1 below:
TABLE 1
It can be seen that 50 glycosylated hemoglobin data samples are selected in table 1, the relative error is calculated, and the curve deviation acceptable for the relative error meeting the calibration requirement is set to be 10%, so that the sample with the reference value of 13.0 or more is deviated from the corresponding common concentration calculation function, namely, when the curve section to which the current data point belongs is formed as the curve section initial section and the curve section end section of the common concentration calculation function, the corresponding curve deviation is generated, further deviation data is formed, and the common concentration calculation function is compared with the reference concentration calculation function in the reference system, and the high value and the low value in the curve are both in a higher condition. The method is expanded to detection environments of different sample data corresponding to the detection kit to be calibrated, and the fact that the common concentration calculation function of the method is offset from the reference concentration calculation function can be seen. As shown in fig. 2, it is clear that the degree of deviation between the common concentration calculation function of the self formed by fitting each data point and the reference concentration calculation function as a broken line in fig. 2 is found, and the data points framed by two black boxes are the deviation data.
In this embodiment, the final function expression of the third function isAfter the test of a plurality of experimental data, finally,。
It will be appreciated that the determination of the third function relies on the first and second functions, wherein in the choice of the function type of the first and second functions, the order of the polynomial is first determined, and the appropriate polynomial order is selected according to the nature of the data and the purpose of the fit. Generally, the higher the order, the higher the accuracy of the fit, but over-fitting is also easily caused. Therefore, the order of the selected polynomial is 2 nd order, and the system of equations is constructed and solved. Finally, according toAnd detecting the concentration of the biological test samples with different sample concentrations to obtain a first concentration fitting curve.
The fitting effect of the first concentration fitting curve is shown in fig. 3, and it can be seen that the obtained fitting result is better than the fitting result of other fitting algorithms (polynomial correction, piecewise correction, spline (spline fitting algorithm) and the like) on the basis of the deviation data.
And comparing the first concentration fitting curve with the second concentration fitting curve, judging whether the comparison result meets the curve comparison requirement or not, namely judging whether the relative error between the first concentration fitting curve and the second concentration fitting curve is smaller than or equal to a preset standard error or not, if the comparison result of all data points in the first concentration fitting curve and the standard data points of the second concentration fitting curve is smaller than or equal to the preset standard error, indicating that the calibration ending condition is reached at the moment, and determining the corresponding third function as a concentration calculation function. Taking the data of table 1 as an example, after performing the second fitting on the data points in table 1, the obtained correlation index results are shown in table 2 below:
TABLE 2
It can be seen that after the secondary calibration is performed according to the deviation data in table 2, the comparison result of all the data points in the first concentration fitting curve and the standard data points is less than or equal to 10% of the preset standard error, which indicates that the calibration end condition is reached at this time, and the accuracy of outputting the current third function as the concentration calculation function of the system to be calibrated meets the requirement. Thus, the output result is shown in fig. 4, and as can be seen from the curve display result in fig. 4, the test value of the whole linear range can be matched with the reference value, and the accuracy of the third function as the concentration calculation function of the system to be calibrated is further proved to be higher.
The application provides a calibration method of a physiological index detector, which comprises the steps of respectively 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, respectively testing each biological sample on a reference system to obtain a plurality of corresponding reference concentration values, establishing a corresponding function relation according to the original signal values and the reference concentration values corresponding to the same sample concentration to obtain a first function, respectively substituting each original signal value into the first function to calculate to obtain a plurality of initial concentration values, establishing a corresponding function relation according to the initial concentration values and the 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 taking the third function as a concentration calculation function of the system to be calibrated to finish the calibration of the physiological index detector. It can be seen that by preparing a plurality of biological samples having different sample concentrations. And simultaneously, testing the same samples on a system serving as a reference standard to obtain a plurality of corresponding reference concentration values. Then, a functional relationship is established for the original signal value and the reference concentration value corresponding to each identical sample concentration, which is the first function. And substituting each original signal value obtained before into a first function to calculate so as to obtain a plurality of initial concentration values. Then, a functional relationship is established for the initial concentration value and the reference concentration value corresponding to each identical sample concentration, which is a second function. And finally, substituting the first function into the second function to obtain a third function. This third function is determined as a function of the concentration calculated by the system to be calibrated, thus completing the calibration of the physiological index detector. Therefore, the measurement deviation of the system to be calibrated can be corrected more accurately by testing different sample concentrations for a plurality of times and establishing a plurality of functional relations for calibration, so that the accuracy of the detection of the physiological index is improved remarkably. And the multiple corresponding relations between the original signal value and the reference concentration value are considered, and multiple functions are comprehensively established, so that the influence of single factors or accidental errors on the calibration result is effectively reduced. Furthermore, as a plurality of different sample concentrations are used for testing and calibrating, the method can adapt to sample detection in different concentration ranges, improves the universality of the detector in various practical application scenes, avoids the situation that the detection result of the detector deviates from a calibration function greatly when the concentration of the object to be detected is high or low, reduces the situation that the high or low value deviates from a standard calibration curve, further reduces a large number of false positive or false negative cases caused by inaccurate calculation of the marker concentration, can give out a diagnosis value more accurately, and provides more reliable basis for medical diagnosis.
Referring to fig. 5, the invention also correspondingly discloses a calibration device of the physiological index detector, which comprises:
a first obtaining module 11, configured to obtain a plurality of original signal values of biological samples with different sample concentrations respectively tested on a system to be calibrated;
The first function construction module 12 is configured to establish a corresponding function relationship according to an original signal value and a reference concentration value corresponding to the same sample concentration, so as to obtain a first function;
The second function construction module 13 is configured to respectively substitute each of the original signal values into a first function to obtain a plurality of initial concentration values, and establish a corresponding function relationship according to the initial concentration value and a reference concentration value corresponding to the same sample concentration, so as to obtain a second function;
a third function construction module 14 is configured to substitute the first function into the second function to obtain a third function.
The application provides a method for obtaining a plurality of original signal values of biological samples with different sample concentrations, which are respectively tested on a system to be calibrated, and a method for obtaining a plurality of reference concentration values of each biological sample, which are respectively tested on a reference system, wherein a corresponding function relation is established according to the original signal values and the reference concentration values corresponding to the same sample concentration to obtain a first function, each original signal value is respectively substituted into the first function to be calculated to obtain a plurality of initial concentration values, a corresponding function relation is established according to the initial concentration values and the reference concentration values corresponding to the same sample concentration to obtain a second function, and the first function is substituted into the second function to obtain a third function. Therefore, by acquiring test values of a plurality of biological samples with different sample concentrations on the system to be calibrated and the reference system and establishing a first function, a second function and a third function relation to calibrate, inaccurate detection results caused by errors or deviations of the system to be calibrated can be remarkably reduced, and the detection results are more stable and reliable due to multiple rounds of function construction and calibration processes. Even when facing to complex biological samples or detecting environment changes, the application can maintain better detection performance so as to greatly improve the accuracy of the detection of the physiological indexes, and the physiological index detector provided by the application can cover most types of index detection instruments in the market to realize the detection of various different types of physiological indexes, so that a more accurate detection result can be obtained through the series of function construction and calibration steps as long as corresponding sample concentration data and original signal values can be obtained, and the physiological index detector has wide application prospects.
In this specification, each embodiment is described in a progressive manner, and each embodiment is mainly described in a different point from other embodiments, so that the same or similar parts between the embodiments are 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 points refer to the description of the method section.
Those of skill would further appreciate that the various illustrative elements and algorithm steps described in connection with the embodiments disclosed herein may be implemented as electronic hardware, computer software, or combinations of both, and that the various illustrative elements and steps are described above generally in terms of functionality in order to clearly illustrate the interchangeability of hardware and software. Whether such functionality is implemented as hardware or software depends upon the particular application and design constraints imposed on the solution. Skilled artisans may implement the described functionality in varying ways for each particular application, but such implementation decisions should not be interpreted as causing a departure from the scope of the present application. The steps of a method or algorithm described in connection with the embodiments disclosed herein may be embodied directly in hardware, in a software module executed by a processor, or in a combination of the two. The software modules may be disposed in 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 (Electric Erasable Programmable Read Only Memory), registers, hard disk, a removable disk, a CD-ROM (Compact Disc-Read Only Memory), or any other form of storage medium known in the art.
Finally, it is further noted that relational terms such as first and second, and the like are used solely to distinguish one entity or action from another entity or action without necessarily requiring or implying any actual such relationship or order between such entities or actions. Moreover, the terms "comprises," "comprising," or any other variation thereof, are intended to cover a non-exclusive inclusion, such that a process, method, article, or apparatus that comprises a list of elements does not include only those elements but may include other elements not expressly listed or inherent to such process, method, article, or apparatus. Without further limitation, an element defined by the phrase "comprising one does not exclude the presence of other like elements in a process, method, article, or apparatus that comprises an element.
While the foregoing has been provided to illustrate the principles and embodiments of the present invention, specific examples have been provided herein to assist in understanding the principles and concepts of the invention, and are intended to be in the spirit and scope of the invention as defined by the appended claims.
Claims (8)
1. A method of calibrating a physiological index detector, comprising:
Respectively 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 respectively testing each biological sample on a reference system to obtain a plurality of corresponding reference concentration values;
establishing a corresponding function relation according to an original signal value and a reference concentration value corresponding to the same sample concentration to obtain a first function, and substituting each original signal value into the first function to calculate to obtain a plurality of initial concentration values;
Establishing a corresponding function relation according to an initial concentration value and a 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 taking the third function as a concentration calculation function of the system to be calibrated to finish the calibration of the physiological index detector;
before the third function is used as the concentration calculation function of the system to be calibrated, the method further comprises the steps of detecting the concentration of biological test samples with different sample concentrations by using the system to be calibrated with the third function built in so as to obtain corresponding first concentration fitting curves, detecting the concentration of the biological test samples with different sample concentrations by using the reference system with built-in calibration algorithm so as to obtain corresponding second concentration fitting curves, and determining whether the accuracy of the current third function as the concentration calculation function of the system to be calibrated meets the requirement according to curve deviation between the first concentration fitting curves and the second concentration fitting curves;
The method comprises the steps of determining whether the accuracy of a current third function serving as a concentration calculation function of a system to be calibrated meets the requirement according to curve deviation between a first concentration fitting curve and a second concentration fitting curve, judging whether the curve deviation between the first concentration fitting curve and the second concentration fitting curve meets a preset deviation condition, if so, enabling the accuracy of the current third function serving as the concentration calculation function of the system to be calibrated to meet the requirement, and if not, enabling the accuracy of the current third function serving as the concentration calculation function of the system to be calibrated to not meet the requirement.
2. The method for calibrating a physiological index detector according to claim 1, wherein 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 method for calibrating a physiological index detector according to claim 1, wherein said testing a plurality of biological samples with different sample concentrations on a system to be calibrated to obtain a corresponding plurality of raw signal values comprises:
respectively loading each target biological sample into a detection kit to be calibrated in a system to be calibrated so that the detection kit to be calibrated and the target biological sample perform chemical reaction;
capturing and measuring each reaction signal through the system to be calibrated so as to obtain each reaction signal as an original signal value.
4. The method according to claim 3, wherein the testing each biological sample on the reference system to obtain a plurality of corresponding reference concentration values comprises:
Loading each biological sample into a reference detection kit in the reference system respectively so that the reference detection kit reacts with the biological sample;
Capturing and measuring each response signal by the reference system;
and performing signal calculation on each reaction signal by using a calibration algorithm built in the reference system to obtain a plurality of corresponding reference concentration values under the reference system.
5. The method according to claim 1, wherein the function types of the first function and the second function are any one or more of a unitary linear function type, a unitary quadratic polynomial function type, a piecewise function type, and an exponential function type.
6. The method of calibrating a physiological monitor according to claim 5, wherein said first function is a unitary linear function.
7. The method of calibrating a physiological monitor according to claim 5, wherein said second function is a unitary quadratic polynomial function.
8. A calibration device for a physiological index detector, comprising:
the system comprises a first acquisition module, a first calibration module, a second acquisition module and a first calibration module, wherein the first acquisition module is used for acquiring a plurality of original signal values of a plurality of biological samples with different sample concentrations respectively tested on a system to be calibrated;
the first function construction module is used for establishing a corresponding function relation according to an original signal value and a reference concentration value corresponding to the same sample concentration so as to obtain a first function;
The second function construction module is used for substituting each original signal value into the first function calculation to obtain a plurality of initial concentration values, and establishing a corresponding function relation according to the initial concentration value and the reference concentration value corresponding to the same sample concentration to obtain a second function;
The third function construction module is 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 for detecting the concentration of biological test samples with different sample concentrations by using the system to be calibrated with the built-in third function so as to obtain a corresponding first concentration fitting curve; determining whether the accuracy of a current third function as a concentration calculation function of the system to be calibrated meets the requirement according to curve deviation between the first concentration fitting curve and the second concentration fitting curve;
The calibration device of the physiological index detector is further used for judging whether curve deviation between the first concentration fitting curve and the second concentration fitting curve meets a preset deviation condition or not, if so, the accuracy of the current third function serving as a concentration calculation function of the system to be calibrated meets the requirement, and if not, the accuracy of the current third function serving as the concentration calculation function of the system to be calibrated does not meet the requirement.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN202411245107.2A CN118758924B (en) | 2024-09-06 | 2024-09-06 | Calibration method and calibration device of physiological index detector |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN202411245107.2A CN118758924B (en) | 2024-09-06 | 2024-09-06 | Calibration method and calibration device of physiological index detector |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| CN118758924A CN118758924A (en) | 2024-10-11 |
| CN118758924B true CN118758924B (en) | 2025-03-11 |
Family
ID=92951760
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN202411245107.2A Active CN118758924B (en) | 2024-09-06 | 2024-09-06 | Calibration method and calibration device of physiological index detector |
Country Status (1)
| Country | Link |
|---|---|
| CN (1) | CN118758924B (en) |
Family Cites Families (7)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| KR20110019555A (en) * | 2009-08-20 | 2011-02-28 | 삼성전자주식회사 | How to calibrate test results for testers that use reagents and an analytical device that performs them |
| US8620590B2 (en) * | 2010-09-30 | 2013-12-31 | Bio-Rad Laboratories, Inc. | Dose surface method for determination of analyte ratios |
| CN110426436B (en) * | 2013-03-14 | 2022-08-19 | 安晟信医疗科技控股公司 | Systematic error compensation for analyte concentration determination |
| CN106596613B (en) * | 2017-02-16 | 2019-08-27 | 武汉泛洲中越合金有限公司 | A method of road detection elements content is scanned using Xray fluorescence spectrometer |
| CN110968833A (en) * | 2019-12-10 | 2020-04-07 | 上海艾临科智能科技有限公司 | Calibration function relation obtaining method and device for analog quantity calibration |
| CN112462078A (en) * | 2020-11-16 | 2021-03-09 | 三诺生物传感股份有限公司 | Method for calibrating inter-platform difference of fluorescence immunoassay analyzer |
| EP4519885A1 (en) * | 2022-05-04 | 2025-03-12 | F. Hoffmann-La Roche AG | Method for establishing metrological traceability for at least one in vitro diagnostic medical device |
-
2024
- 2024-09-06 CN CN202411245107.2A patent/CN118758924B/en active Active
Also Published As
| Publication number | Publication date |
|---|---|
| CN118758924A (en) | 2024-10-11 |
Similar Documents
| Publication | Publication Date | Title |
|---|---|---|
| CN105466927B (en) | Method for identifying, correcting and alarming abnormal reaction curve of turbidimetry | |
| CN102959401B (en) | Calibration method for the prospective calibration of a measuring device | |
| US7949473B2 (en) | Method for detecting erroneous measurement results obtained with ion-selective electrodes | |
| EP1394546A1 (en) | Method and system for determining the acceptability of signal data collected from a prothrombin time test strip | |
| EP0453036A2 (en) | Analytical instrument and method of calibrating an analytical instrument | |
| CN111679035A (en) | Data compensation method, device, equipment and medium for gas analyzer | |
| Kristiansen | Description of a generally applicable model for the evaluation of uncertainty of measurement in clinical chemistry | |
| CN114755558A (en) | Data compensation method of radio frequency chip | |
| JP6776319B2 (en) | Detecting temporary errors in body fluid samples | |
| US6596153B1 (en) | Method for analyzing a gas sample | |
| CN118758924B (en) | Calibration method and calibration device of physiological index detector | |
| CN110441509B (en) | Calibration method and device for immunoreactant detection and terminal equipment | |
| CN117929418B (en) | Integrated circuit defect detection method and system | |
| CN109030801B (en) | Automatic biochemical analyzer for clinical samples | |
| CN117761124A (en) | Pressure product correction method and device with temperature compensation | |
| CN115060666B (en) | Calibration method of water quality parameter sensor and water quality parameter measuring method and device | |
| JP3647105B2 (en) | Analysis method and analyzer | |
| CN116429837B (en) | Method and system for correcting hematocrit and electrochemical measurement system | |
| CN111982195A (en) | Building safety performance monitoring devices | |
| CN111561968A (en) | Sensor-based environmental parameter detection method and device and data processing equipment | |
| CN116933979A (en) | A standard sample value determination method based on Bayesian algorithm | |
| JP3174188B2 (en) | Gas identification device | |
| CN115639335A (en) | Water quality monitoring data calibration method, system and computer readable storage medium | |
| US20080087818A1 (en) | Ion trap mobility spectrometer calibration method and system | |
| CN112257017A (en) | Unitary linear point-by-point analysis method, system and device of standardized residual error detection method |
Legal Events
| Date | Code | Title | Description |
|---|---|---|---|
| PB01 | Publication | ||
| PB01 | Publication | ||
| SE01 | Entry into force of request for substantive examination | ||
| SE01 | Entry into force of request for substantive examination | ||
| GR01 | Patent grant | ||
| GR01 | Patent grant |