CN114184605A - Measuring system and method of chemiluminescence immunoassay analyzer - Google Patents

Measuring system and method of chemiluminescence immunoassay analyzer Download PDF

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CN114184605A
CN114184605A CN202210140695.8A CN202210140695A CN114184605A CN 114184605 A CN114184605 A CN 114184605A CN 202210140695 A CN202210140695 A CN 202210140695A CN 114184605 A CN114184605 A CN 114184605A
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fitting
curve
calibration data
standard curve
calibration
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胡程煜
唐峰
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Ningbo Haiyi Biotechnology Co ltd
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Ningbo Haiyi Biotechnology Co ltd
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    • GPHYSICS
    • G01MEASURING; TESTING
    • G01NINVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N21/00Investigating or analysing materials by the use of optical means, i.e. using sub-millimetre waves, infrared, visible or ultraviolet light
    • G01N21/75Systems in which material is subjected to a chemical reaction, the progress or the result of the reaction being investigated
    • G01N21/76Chemiluminescence; Bioluminescence
    • GPHYSICS
    • G01MEASURING; TESTING
    • G01NINVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N33/00Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
    • G01N33/48Biological material, e.g. blood, urine; Haemocytometers
    • G01N33/50Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing
    • G01N33/53Immunoassay; Biospecific binding assay; Materials therefor

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Abstract

The invention belongs to the technical field of chemiluminescence immunoassay, and provides a measuring system and a measuring method of a chemiluminescence immunoassay analyzer, which comprises the following steps: the calibration parameter reading module is used for acquiring calibration data; a curve fitting parameter obtaining module for obtaining a parameter of curve fitting; the parameters of the curve fitting comprise a starting point of the segment fitting and a curve fitting mode of each segment. The curve fitting module is used for performing curve segmentation fitting according to the calibration data and the curve fitting parameters to generate a standard curve required by detection of the analyzer; and the detection module is used for calculating the concentration of the measured object through the standard curve according to the brightness value obtained by the reaction of the measured object through the analyzer. The method has the advantages that the curve fitting and back calculation precision is improved by setting curve fitting modes of various models and combining the sectional fitting mode, and the accuracy and precision of the final measurement result are further improved.

Description

Measuring system and method of chemiluminescence immunoassay analyzer
Technical Field
The invention relates to the technical field of chemiluminescence immunoassay, in particular to a measuring system and a measuring method of a chemiluminescence immunoassay analyzer.
Background
Chemiluminescence immunoassay is an analytical technique for quantitatively detecting various antigens, haptens, antibodies, hormones, enzymes, fatty acids, vitamins, drugs and the like by combining a chemiluminescence assay method with high sensitivity and an immunoreaction method with high specificity.
The current analytical detection process generally includes: firstly, respectively placing a sample and a reagent into a sample storage module and a reagent storage module, then adding the sample and the reagent into a reaction cup, respectively carrying out certain treatment on the reaction cup, and finally, enabling the reaction cup to enter a measurement module for result measurement. The chemiluminescence immunoassay method is to calculate the content of a detected object by using a standard curve according to the relation between a chemiluminescence marker and the luminous intensity. Therefore, fitting and back-calculation of the concentration curve are particularly important in establishing the standard curve.
Disclosure of Invention
The invention aims to provide a measuring system and a measuring method of a chemiluminescence immunoassay analyzer, which are used for solving the problem of high-precision fitting of a concentration curve.
In order to achieve the purpose, the invention adopts the technical scheme that:
a measurement system of a chemiluminescent immunoassay analyzer comprising:
the calibration parameter reading module is used for acquiring calibration data;
a curve fitting parameter obtaining module for obtaining a parameter of curve fitting; the parameters of the curve fitting comprise a starting point of the sectional fitting and a curve fitting mode of each section;
the curve fitting module is used for performing curve segmentation fitting according to the calibration data and the curve fitting parameters to generate a standard curve required by detection of the analyzer;
and the detection module is used for calculating the concentration of the measured object through the standard curve according to the brightness value obtained by the reaction of the measured object through the analyzer.
Further, the curve fitting mode comprises straight line fitting, polynomial fitting, broken line fitting, cubic spline fitting, Lagrangian fitting, exponential logarithm fitting and Logistic model fitting.
Further, the method also comprises the following steps: and the two-point calibration module is used for carrying out deviation correction on the formed standard curve according to the two groups of calibration data.
Further, the two-point scaling module comprises:
a calibration parameter obtaining unit for obtaining calibration data;
the calibration method selection unit is used for acquiring a method for correcting the deviation of the calibration data;
and the calibration effect output unit is used for carrying out deviation correction on the formed standard curve according to the acquired calibration data by the acquired deviation correction method and displaying the fitting correlation coefficient and the deviation data of the deviation correction method.
Further, the deviation correction method comprises absolute deviation correction, relative deviation correction, logarithmic absolute deviation correction, logarithmic relative deviation correction and mapping scaling correction.
The invention also provides a measuring method of the chemiluminescence immunoassay analyzer, which comprises the following steps:
s1, acquiring multiple groups of calibration data and parameters required by curve fitting, wherein the parameters of the curve fitting comprise a starting point of the sectional fitting and a curve fitting mode of each section;
s2, performing curve segmentation fitting according to the calibration data and the curve fitting parameters to generate a standard curve required by the detection of the analyzer;
and S3, calculating the concentration of the measured object through the standard curve according to the brightness value obtained by the reaction of the measured object through the analyzer.
Further, the method also comprises the following steps:
and S4, performing deviation correction on the standard curve between the two points according to the two groups of calibration data.
Further, the step of correcting the deviation of the standard curve comprises:
s41, acquiring two groups of calibration data;
s42, acquiring a method for correcting the deviation of the calibration data selected by the user;
and S43, performing deviation correction on the formed standard curve according to the acquired calibration data by a deviation correction method selected by a user, and displaying a fitting correlation coefficient and deviation data of the deviation correction method.
Compared with the prior art, the invention at least comprises the following beneficial effects:
(1) by setting curve fitting modes of various models and combining a segmented fitting mode, the curve fitting and back calculation precision is improved, the accuracy and precision of a final measurement result are further improved, and the whole measurement process is stably and reliably carried out;
(2) under the condition that a standard curve is formed through multiple measurements, data of two points in the standard curve are selected, and deviation correction is performed on the fitted curve in a two-point calibration mode, so that the accuracy of the standard curve is further guaranteed.
Drawings
FIG. 1 is a block diagram of a system according to an embodiment of the present invention;
FIG. 2 is a block diagram of a two-point scaling module according to an embodiment of the present invention;
FIG. 3 is a flow chart of a measurement method according to a second embodiment of the present invention;
fig. 4 is a flowchart of performing deviation correction on a standard curve according to a second embodiment of the present invention.
Detailed Description
It should be noted that all the directional indicators (such as up, down, left, right, front, and rear … …) in the embodiment of the present invention are only used to explain the relative position relationship between the components, the movement situation, etc. in a specific posture (as shown in the drawing), and if the specific posture is changed, the directional indicator is changed accordingly.
Moreover, descriptions of the present invention as relating to "first," "second," "a," etc. are for descriptive purposes only and are not to be construed as indicating or implying relative importance or implicit ly indicating a number of technical features indicated. Thus, a feature defined as "first" or "second" may explicitly or implicitly include at least one such feature. In the description of the present invention, "a plurality" means at least two, e.g., two, three, etc., unless specifically limited otherwise.
In the present invention, unless otherwise expressly stated or limited, the terms "connected," "secured," and the like are to be construed broadly, and for example, "secured" may be a fixed connection, a removable connection, or an integral part; can be mechanically or electrically connected; they may be directly connected or indirectly connected through intervening media, or they may be connected internally or in any other suitable relationship, unless expressly stated otherwise. The specific meanings of the above terms in the present invention can be understood by those skilled in the art according to specific situations.
In addition, the technical solutions in the embodiments of the present invention may be combined with each other, but it must be based on the realization of those skilled in the art, and when the technical solutions are contradictory or cannot be realized, such a combination of technical solutions should not be considered to exist, and is not within the protection scope of the present invention.
The following are specific embodiments of the present invention, and the technical solutions of the present invention will be further described with reference to the drawings, but the present invention is not limited to these embodiments.
Example one
As shown in fig. 1, the measurement system of a chemiluminescence immunoassay analyzer of the present invention includes a calibration parameter reading module, a curve fitting parameter obtaining module, a curve fitting module, and a detection module.
The calibration parameter reading module is used for acquiring calibration data. The curve fitting parameter obtaining module is used for obtaining the parameters of curve fitting. The parameters of the curve fitting include the starting point of the segment fitting and the curve fitting manner of each segment.
And the curve fitting module is used for performing curve segmentation fitting according to the calibration data and the curve fitting parameters to generate a standard curve required by the detection of the analyzer. The curve fitting mode comprises straight line fitting, polynomial fitting, broken line fitting, cubic spline fitting, Lagrangian fitting, exponential logarithm fitting and Logistic model fitting.
The polynomial fitting is to approximate the calibration data points by using a polynomial model curve, and a corresponding linear equation can be obtained by using the principle of a least square method, and the result can be obtained by directly solving.
The method of the broken line fitting is to connect the calibration data points by straight lines, i.e. to calculate the values outside the calibration points by using the equation of the straight line between the two points.
Cubic spline fitting is that calibration data points are connected by a curve, and only one straight line can be determined between two points, so that a segmented curve is introduced and smoothness constraint is met, namely the first derivative and the second derivative of the point are equal at the front end and the rear end of the segmented point.
The detection module is used for calculating the concentration of the measured object through the standard curve according to the brightness value obtained by the measured object through the reaction of the analyzer.
When the standard curve is generated, a user can select a segmented curve fitting mode, and different curve fitting modes are selected according to the distribution condition of the calibration data points, so that the accuracy of the finally generated standard curve is improved.
The chemiluminescence immunoassay method is to calculate the content of a detected object by using a standard curve according to the relation between a chemiluminescence marker and the luminous intensity. Therefore, the process of generating a calibration curve from the calibration data is critical to the accuracy of the subsequent sample detection.
The invention improves the curve fitting and back calculation precision by setting curve fitting modes of various models and combining the form of piecewise fitting, thereby improving the accuracy and precision of the final measurement result.
The invention also comprises a two-point calibration module which is used for carrying out deviation correction on the formed standard curve according to the two groups of calibration data.
As shown in fig. 2, the two-point calibration module includes:
a scaling parameter obtaining unit for obtaining the scaling data.
And the calibration method selection unit is used for acquiring a method for correcting the deviation of the calibration data.
The deviation correction method comprises absolute deviation correction, relative deviation correction, logarithm absolute deviation correction, logarithm relative deviation correction and mapping scaling correction.
And the calibration effect output unit is used for carrying out deviation correction on the formed standard curve according to the acquired calibration data through the acquired deviation correction method and displaying the fitting correlation coefficient and the deviation data of the deviation correction method.
The deviation is the difference between the individual measured value and the measured average value, and can be used to measure the precision of the measurement result. Because the standard curve is crucial to the accuracy of the subsequent sample detection, the average value of data obtained by multiple tests is usually used as calibration data when the original curve is fitted, but the calibration data is deviated by using the average value, and deviation correction needs to be performed by using two sets of calibration data. And the deviation correction is to correct the curve between the two groups of calibration data according to the value obtained by the calibration data and the average value according to a preset algorithm. And displaying a calibration effect on the interface after the deviation correction is carried out, wherein the calibration effect comprises fitting correlation coefficients and deviation data, a user can judge a deviation correction result of the standard curve through the data displayed on the interface, and if a large data difference occurs, the deviation correction needs to be carried out on the curve again.
The absolute deviation correction is to obtain absolute deviation data after the difference is made between the point data and the calibration data on the standard curve, calculate the deviation slope and the correction value in the deviation function according to the absolute deviation data, and perform deviation correction on the generated standard curve through the deviation function.
The relative deviation correction is to calculate the deviation slope and the correction value of the deviation function according to the percentage data of the absolute deviation data in the point data on the standard curve, and to perform deviation correction on the generated standard curve through the deviation function.
The log absolute deviation correction and the log relative deviation correction are based on the absolute deviation correction and the relative deviation correction, and are performed with a logarithmic operation when calculating a deviation slope and a correction value, and then deviation correction is performed on the generated standard curve through a deviation function.
The mapping scaling correction is to scale the point data on the standard curve according to the proportion of the calibration data point so as to correct the deviation of the fitted curve.
Under the condition that a standard curve is formed through multiple measurements, data of two points in the standard curve are selected, and deviation correction is performed on the fitted curve in a two-point calibration mode, so that the accuracy of the standard curve is further guaranteed.
Example two
As shown in fig. 3, the measurement method of a chemiluminescence immunoassay analyzer of the present invention comprises the steps of:
and S1, acquiring multiple groups of calibration data and parameters required by curve fitting, wherein the parameters of the curve fitting comprise a starting point of the segment fitting and a curve fitting mode of each segment.
And S2, performing curve segmentation fitting according to the calibration data and the curve fitting parameters to generate a standard curve required by the detection of the analyzer.
And S3, calculating the concentration of the measured object through the standard curve according to the brightness value obtained by the reaction of the measured object through the analyzer.
And S4, performing deviation correction on the formed standard curve according to the two groups of calibration data.
As shown in fig. 4, the step of performing deviation correction on the standard curve includes:
s41, acquiring two groups of calibration data;
s42, acquiring a method for correcting the deviation of the standard curve selected by the user;
and S43, performing deviation correction on the formed standard curve according to the acquired calibration data by a deviation correction method selected by a user, and displaying a fitting correlation coefficient and deviation data of the deviation correction method.
According to the method, different curve fitting modes are selected according to the distribution condition of calibration data points in the fitting process of the standard curve, so that the accuracy of the finally generated standard curve is improved. And after the standard curve is generated, the deviation correction is carried out on the formed standard curve according to the calibration data of two points in the standard curve and the calibration method selected by the user, so that the accuracy of the standard curve is further ensured.
The specific embodiments described herein are merely illustrative of the spirit of the invention. Various modifications or additions may be made to the described embodiments or alternatives may be employed by those skilled in the art without departing from the spirit or ambit of the invention as defined in the appended claims.

Claims (8)

1. A measurement system of a chemiluminescent immunoassay analyzer, comprising:
the calibration parameter reading module is used for acquiring calibration data;
a curve fitting parameter obtaining module for obtaining a parameter of curve fitting; the parameters of the curve fitting comprise a starting point of the sectional fitting and a curve fitting mode of each section;
the curve fitting module is used for performing curve segmentation fitting according to the calibration data and the curve fitting parameters to generate a standard curve required by detection of the analyzer;
and the detection module is used for calculating the concentration of the measured object through the standard curve according to the brightness value obtained by the reaction of the measured object through the analyzer.
2. The measurement system of a chemiluminescent immunoassay analyzer of claim 1 wherein the curve fitting means comprises straight line fitting, polynomial fitting, polyline fitting, cubic spline fitting, lagrange fitting, exponential log fitting and Logistic model fitting.
3. The measurement system of a chemiluminescent immunoassay analyzer of claim 1, further comprising: and the two-point calibration module is used for carrying out deviation correction on the formed standard curve according to the two groups of calibration data.
4. The measurement system of a chemiluminescent immunoassay analyzer of claim 3 wherein the two point calibration module comprises:
a calibration parameter obtaining unit for obtaining calibration data;
the calibration method selection unit is used for acquiring a method for correcting the deviation of the calibration data;
and the calibration effect output unit is used for carrying out deviation correction on the formed standard curve according to the acquired calibration data by the acquired deviation correction method and displaying the fitting correlation coefficient and the deviation data of the deviation correction method.
5. The measurement system of a chemiluminescent immunoassay analyzer of claim 4 wherein the bias correction method comprises absolute bias correction, relative bias correction, log absolute bias correction, log relative bias correction and map scaling correction.
6. A measurement method of a chemiluminescence immunoassay analyzer, based on the measurement system of the chemiluminescence immunoassay analyzer of claim 1, characterized by comprising the steps of:
s1, acquiring multiple groups of calibration data and parameters required by curve fitting, wherein the parameters of the curve fitting comprise a starting point of the sectional fitting and a curve fitting mode of each section;
s2, performing curve segmentation fitting according to the calibration data and the curve fitting parameters to generate a standard curve required by the detection of the analyzer;
and S3, calculating the concentration of the measured object through the standard curve according to the brightness value obtained by the reaction of the measured object through the analyzer.
7. The measurement method of a chemiluminescent immunoassay analyzer of claim 6 further comprising the steps of:
and S4, performing deviation correction on the formed standard curve according to the two groups of calibration data.
8. The measurement method of a chemiluminescent immunoassay analyzer of claim 7 wherein the step of bias correcting the standard curve comprises:
s41, acquiring two groups of calibration data;
s42, acquiring a method for correcting the deviation of the standard curve selected by the user;
and S43, performing deviation correction on the formed standard curve according to the acquired calibration data by a deviation correction method selected by a user, and displaying a fitting correlation coefficient and deviation data of the deviation correction method.
CN202210140695.8A 2022-02-16 2022-02-16 Measuring system and method of chemiluminescence immunoassay analyzer Pending CN114184605A (en)

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Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN115145431A (en) * 2022-07-06 2022-10-04 中元汇吉生物技术股份有限公司 Sample processing method, system, device, readable medium and sample analyzer

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JPH063264A (en) * 1992-06-19 1994-01-11 Iseki & Co Ltd Method for forming calibration curve in near infrared analysis
JPH0763712A (en) * 1993-08-30 1995-03-10 Rigaku Ind Co Method and apparatus for bias correction in fluorescent x-ray analysis
JPH07134100A (en) * 1993-11-12 1995-05-23 Iseki & Co Ltd Near infrared spectral analysis method
CN107391909A (en) * 2017-06-28 2017-11-24 苏州卫宁精密仪器设备有限公司 The curve-fitting method based on Based on Interpolating Spline for chemiluminescence immunoassay detection
CN108680523A (en) * 2018-07-10 2018-10-19 北京北分瑞利分析仪器(集团)有限责任公司 It is connected the determinand assay method of standard curve using a variety of fit approach
CN109613283A (en) * 2018-11-15 2019-04-12 必欧瀚生物技术(合肥)有限公司 A kind of robot scaling equipment and calibrating method
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
CN112836176A (en) * 2021-02-02 2021-05-25 苏州玖物互通智能科技有限公司 Curve fitting optimization method, storage medium, electronic device and system

Patent Citations (8)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JPH063264A (en) * 1992-06-19 1994-01-11 Iseki & Co Ltd Method for forming calibration curve in near infrared analysis
JPH0763712A (en) * 1993-08-30 1995-03-10 Rigaku Ind Co Method and apparatus for bias correction in fluorescent x-ray analysis
JPH07134100A (en) * 1993-11-12 1995-05-23 Iseki & Co Ltd Near infrared spectral analysis method
CN107391909A (en) * 2017-06-28 2017-11-24 苏州卫宁精密仪器设备有限公司 The curve-fitting method based on Based on Interpolating Spline for chemiluminescence immunoassay detection
CN108680523A (en) * 2018-07-10 2018-10-19 北京北分瑞利分析仪器(集团)有限责任公司 It is connected the determinand assay method of standard curve using a variety of fit approach
CN109613283A (en) * 2018-11-15 2019-04-12 必欧瀚生物技术(合肥)有限公司 A kind of robot scaling equipment and calibrating method
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
CN112836176A (en) * 2021-02-02 2021-05-25 苏州玖物互通智能科技有限公司 Curve fitting optimization method, storage medium, electronic device and system

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN115145431A (en) * 2022-07-06 2022-10-04 中元汇吉生物技术股份有限公司 Sample processing method, system, device, readable medium and sample analyzer

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