CN117517629A - Sample analyzer, method for producing calibration curve of sample analyzer, and storage medium - Google Patents
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- 238000011088 calibration curve Methods 0.000 title claims abstract description 45
- 238000004519 manufacturing process Methods 0.000 title claims abstract description 18
- 238000003860 storage Methods 0.000 title claims abstract description 16
- 238000001514 detection method Methods 0.000 claims abstract description 103
- 238000012360 testing method Methods 0.000 claims abstract description 70
- 238000005259 measurement Methods 0.000 claims abstract description 46
- 238000000034 method Methods 0.000 claims abstract description 35
- 239000003153 chemical reaction reagent Substances 0.000 abstract description 5
- 238000004364 calculation method Methods 0.000 abstract description 4
- 238000010586 diagram Methods 0.000 description 4
- 239000012895 dilution Substances 0.000 description 4
- 238000010790 dilution Methods 0.000 description 4
- 239000000243 solution Substances 0.000 description 4
- 230000008878 coupling Effects 0.000 description 3
- 238000010168 coupling process Methods 0.000 description 3
- 238000005859 coupling reaction Methods 0.000 description 3
- 238000012545 processing Methods 0.000 description 3
- 238000004891 communication Methods 0.000 description 2
- 238000002835 absorbance Methods 0.000 description 1
- 238000004458 analytical method Methods 0.000 description 1
- 230000009286 beneficial effect Effects 0.000 description 1
- 210000004369 blood Anatomy 0.000 description 1
- 239000008280 blood Substances 0.000 description 1
- 210000001124 body fluid Anatomy 0.000 description 1
- 239000010839 body fluid Substances 0.000 description 1
- 238000011161 development Methods 0.000 description 1
- 238000003745 diagnosis Methods 0.000 description 1
- 238000005516 engineering process Methods 0.000 description 1
- 238000000338 in vitro Methods 0.000 description 1
- 238000012417 linear regression Methods 0.000 description 1
- 230000003287 optical effect Effects 0.000 description 1
- 238000002360 preparation method Methods 0.000 description 1
- 238000013102 re-test Methods 0.000 description 1
- 210000002700 urine Anatomy 0.000 description 1
Abstract
The application provides a sample analyzer and a method for manufacturing a calibration curve thereof, and a storage medium, wherein the manufacturing method comprises the following steps: obtaining calibration samples of a plurality of concentrations; obtaining the test times of each calibration sample, wherein the test times of at least one calibration sample are more than 1; based on the test times, testing each calibration sample through a sample analyzer so that each calibration sample correspondingly obtains at least one first detection value; obtaining a measurement value of each calibration sample based on the first detection value of each calibration sample, wherein when the number of tests of the calibration sample is confirmed to be greater than 1, the measurement value of the calibration sample is obtained by calculation based on at least two of all the first detection values of the calibration sample; a calibration curve of the sample analyzer is prepared based on the measured values of the plurality of calibration samples. The method for manufacturing the calibration curve can reduce consumption of the calibration sample and the reagent, and the accuracy of the drawn calibration curve is high.
Description
Technical Field
The present disclosure relates to the field of medical devices, and in particular, to a sample analyzer, a method for manufacturing a calibration curve of the sample analyzer, and a storage medium.
Background
The in vitro diagnosis is a detection technology with great potential, has the advantages of rapidness, simplicity, convenience, high efficiency, low cost, short detection period, small specimen dosage and the like, and has been widely applied to clinic. Sample analyzers have been rapidly developed in recent years as a new development direction.
In the existing blood, urine or body fluid detection analyzers, the instrument needs to be calibrated before use, and the accuracy of the result of the instrument is confirmed.
The current sample analyzer is usually made by adopting a calibration curve making mode that a calibrator instrument is automatically provided with dilution ratio or manually provided with a plurality of calibrators with different dilution ratios for testing, when the test result of a certain test point does not meet the requirement, the single test point can be retested until the test result meeting the condition is obtained, but when the test result meeting the legal curve cannot be detected by repeated tests, the current calibration is abandoned, and the calibrator and the reagent are wasted.
Disclosure of Invention
The technical problem that this application mainly solves is to provide a sample analysis appearance and calibration curve's preparation method, storage medium to among the solution prior art, when calibration curve draws, cause extravagant technical problem of calibrator and reagent easily.
In order to solve the technical problems, one technical scheme adopted by the application is as follows: provided is a method for manufacturing a calibration curve of a sample analyzer, the method comprising: obtaining calibration samples of a plurality of concentrations; obtaining the test times of each calibration sample, wherein the test times of at least one calibration sample are more than 1; based on the test times, testing each calibration sample through a sample analyzer so that each calibration sample correspondingly obtains at least one first detection value; obtaining a measurement value of each calibration sample based on the first detection value of each calibration sample, wherein when the number of tests of the calibration sample is confirmed to be greater than 1, the measurement value of the calibration sample is obtained by calculation based on at least two of all the first detection values of the calibration sample; a calibration curve of the sample analyzer is prepared based on the measured values of the plurality of calibration samples.
Further, when the number of tests of the calibration sample is confirmed to be greater than 1, calculating a measurement value of the calibration sample based on at least two of all the first detection values of the calibration sample, including, when the number of tests of the calibration sample is confirmed to be greater than 1, finding out the first detection values meeting a preset condition from all the first detection values of the calibration sample; and calculating the average value of all the first detection values meeting the preset condition to obtain the measured value of the calibration sample.
Further, calculating the measurement value of the calibration sample based on at least two of all the first detection values of the calibration sample includes calculating an average of all the first detection values of the calibration sample to obtain the measurement value of the calibration sample.
Further, the number of tests for different calibration samples may be the same or different.
Further, after the step of obtaining the measurement value of each calibration sample based on the first detection value of each calibration sample, the manufacturing method further includes determining whether the measurement value of each calibration sample satisfies a curve drawing condition; if not, at least one calibration sample is obtained from the plurality of calibration samples, and the obtained at least one calibration sample is retested for a plurality of times through a sample analyzer, so that a plurality of second detection values are obtained; based on a number of second detection values of the at least one calibration sample, a measurement value of the at least one calibration sample is updated.
Further, updating the measured value of the at least one calibration sample based on the number of second detection values of the at least one calibration sample includes updating the measured value of the at least one calibration sample based on an average of at least one or both of the number of second detection values.
Further, updating the measured value of the at least one calibration sample based on the number of second detection values of the at least one calibration sample includes obtaining the measured value of the at least one calibration sample based on at least two of all first detection values and all second detection values of the at least one calibration sample.
Further, obtaining a measurement value of the at least one calibration sample based on at least two of all first detection values and all second detection values of the at least one calibration sample includes calculating an average of all first detection values and all second detection values of the at least one calibration sample to obtain a measurement value of the at least one calibration sample.
In order to solve the technical problems, one technical scheme adopted by the application is as follows: there is provided a sample analyzer comprising a memory and a processor coupled to each other, the processor being configured to execute program instructions stored in the memory to implement the method of producing a calibration curve according to any of the above embodiments.
In order to solve the technical problems, one technical scheme adopted by the application is as follows: there is provided a computer readable storage medium having stored thereon program instructions which, when executed by a processor, implement the method of producing a calibration curve of any of the above embodiments.
The beneficial effects of this application are: different from the situation of the prior art, the method for manufacturing the calibration curve of the sample analyzer provided by the application comprises the following steps: obtaining calibration samples of a plurality of concentrations; obtaining the test times of each calibration sample, wherein the test times of at least one calibration sample are more than 1; based on the test times, testing each calibration sample through a sample analyzer so that each calibration sample correspondingly obtains at least one first detection value; obtaining a measurement value of each calibration sample based on the first detection value of each calibration sample, wherein when the number of tests of the calibration sample is confirmed to be greater than 1, the measurement value of the calibration sample is obtained by calculation based on at least two of all the first detection values of the calibration sample; a calibration curve of the sample analyzer is prepared based on the measured values of the plurality of calibration samples. In the method for manufacturing the calibration curve, the test times of each calibration sample can be flexibly set, so that the calibration curve can be drawn more flexibly.
Drawings
FIG. 1 is a flow chart of an embodiment of a method for fabricating a calibration curve of a sample analyzer according to the present application;
FIG. 2 is a flow chart of an embodiment of the step S14 in FIG. 1;
FIG. 3 is a flow chart of another embodiment of a method for fabricating a calibration curve of a sample analyzer provided herein;
FIG. 4 is a schematic diagram of a frame of an embodiment of a sample analyzer provided herein;
FIG. 5 is a schematic diagram of a framework of one embodiment of a computer readable storage medium provided herein.
Detailed Description
The following description of the technical solutions in the embodiments of the present application will be made clearly and completely with reference to the accompanying drawings in the embodiments of the present application, and it is apparent that the described embodiments are only some embodiments of the present application, not all embodiments. All other embodiments, which can be made by one of ordinary skill in the art without undue burden from the present disclosure, are within the scope of the present disclosure.
In the description of the present application, the meaning of "a plurality of" means at least two, for example, two, three, etc., unless explicitly specified otherwise.
Referring to fig. 1, fig. 1 is a schematic flow chart of an embodiment of a method for manufacturing a calibration curve of a sample analyzer, and specifically, the method includes:
s11: calibration samples of a plurality of concentrations are obtained.
When a calibration curve of a sample analyzer is prepared, a plurality of concentration calibration samples are obtained first, and specifically, a dilution ratio can be automatically prepared by using a calibrator instrument so as to obtain the plurality of concentration calibration samples. Or a plurality of calibration samples with different dilution ratios are manually prepared. The plurality of calibration samples herein refers to at least two calibration samples, for example, 4 calibration samples may be obtained, and the concentrations of the 4 calibration samples are different. The number of calibration samples may also be 2, 3 or 5, etc. The setting may be specifically performed according to actual conditions, and is not particularly limited herein.
S12: and obtaining the test times of each calibration sample, wherein the test times of at least one calibration sample are more than 1.
After a plurality of calibration samples are obtained, a number of tests may be set for each calibration sample, wherein the number of tests for at least one calibration sample is greater than 1. For example, the number of tests of at least one calibration sample may be set to 2, 3, 4, or more than 4, etc.
For example, 4 calibration samples are obtained, and the number of tests of two of the calibration samples may be set to 3 and the number of tests of the other two calibration samples may be set to 1. Alternatively, the number of tests per calibration sample may be set to be multiple.
The number of tests per calibration sample may be the same or different. The user may manually select the number of tests for different calibration samples. In this way, the detection of the calibration sample can be made more flexible.
S13: based on the test times, each calibration sample is tested through a sample analyzer, so that each calibration sample correspondingly obtains at least one first detection value.
After obtaining a plurality of calibration samples and the test times of each calibration sample, testing each calibration sample through a sample analyzer based on the test times so that each calibration sample correspondingly obtains at least one first detection value. The number of the first detection values corresponding to each calibration sample is the same as the test times of the calibration sample. For example, if the number of tests of a certain calibration sample is 2, the first detection value corresponding to the calibration sample is 2.
Since the number of tests of at least one calibration sample is greater than 1, the at least one calibration sample corresponds to a plurality of first detection values.
Preferably, a plurality of tests may be performed on each calibration sample by the sample analyzer such that each calibration sample obtains a plurality of first test values. Multiple tests herein refer to at least two tests. The first detection value may be absorbance or time, etc.
S14: and obtaining a measurement value of each calibration sample based on the first detection value of each calibration sample, wherein when the test times of the calibration sample are confirmed to be more than 1, the measurement value of the calibration sample is calculated based on at least two of all the first detection values of the calibration sample.
A measurement value of each calibration sample is obtained based on the first detection value of the calibration sample, and the measurement value of the calibration sample is used to draw a calibration curve.
It will be appreciated that when the calibration sample corresponds to only one first detection value, then the first detection value is the measurement value of the calibration sample.
When it is confirmed that the number of tests of the calibration sample is greater than 1, that is, the calibration sample corresponds to a plurality of first detection values, the measurement value of the calibration sample may be calculated based on at least two of all the first detection values of the calibration sample when the measurement value of the calibration sample is calculated. For example, since a certain calibration sample is tested 3 times, the calibration sample has 3 first detection values, the measurement value of the calibration sample may be obtained based on two first detection values of the calibration sample, or the measurement value of the calibration sample may be obtained based on three first detection values of the calibration sample.
As shown in fig. 2, in a specific embodiment, when it is confirmed that the number of tests of the calibration sample is greater than 1, the step of calculating the measured value of the calibration sample based on at least two of all the first detection values of the calibration sample includes,
s141: when the number of tests of the calibration sample is confirmed to be greater than 1, finding out first detection values meeting the preset condition from all first detection values of the calibration sample.
When the number of tests of a certain calibration sample is confirmed to be greater than 1, the calibration sample is correspondingly provided with a plurality of (a plurality of means at least two of) first detection values, and the first detection values meeting the preset conditions can be found out from the plurality of first detection values. The preset condition may be: within a given reasonable range, or a preset condition is greater than or less than a predetermined threshold, etc. For example, when the first detection value is time, the preset condition may be: in the range of 3s-6s, therefore, the first detection value in the range of 3s-6s can be found from the first detection values. For example, a certain calibration sample is tested 3 times, and the number of first detection values obtained is 3, 5 and 7s respectively. The preset condition is in the range of 3s-6s, and therefore, from the 3 first detection values, the first detection values satisfying the preset condition are obtained as 3s and 5s.
S142: and calculating the average value of all the first detection values meeting the preset condition to obtain the measured value of at least one calibration sample.
After obtaining the first detection value of a certain calibration sample meeting the preset condition, the average value of all the first detection values meeting the preset condition can be calculated to obtain the measurement value of the calibration sample.
For example, in a specific embodiment, the first detection value is time, and the first detection values satisfying the preset condition are 3s and 5s, so that an average value of the two first detection values can be calculated, and the measurement value of the calibration sample is 4s.
By the method, the error in the first detection value, which is larger, can be removed, and the test error is reduced, so that the accuracy of the measured value of the calibration sample is improved.
It will be appreciated that when the calibration sample corresponds to a plurality of first detection values, the average value of all the first detection values may be directly calculated to obtain a measurement value of the calibration sample. In this way, the calculation process of the measured value of the sample is simpler, and the accuracy of the measured value of the calibration sample can be improved.
S15: a calibration curve of the sample analyzer is prepared based on the measured values of the plurality of calibration samples.
After obtaining the measurement values of the plurality of calibration samples, a calibration curve is prepared based on the measurement values of the plurality of calibration samples. Specifically, the concentrations of a plurality of calibration samples are taken as the abscissa, and the measured value corresponding to each calibration sample is taken as the ordinate to draw a calibration curve. The method of drawing the calibration curve through a plurality of points is within the purview of those skilled in the art, for example, the calibration curve may be fitted by a linear regression method, and will not be described in detail herein.
In the method for manufacturing the calibration curve of the embodiment, the test times of each calibration sample can be flexibly set, so that the calibration curve can be drawn more flexibly.
Referring to fig. 3, fig. 3 is a flow chart of an embodiment of a method for manufacturing a calibration curve of a sample analyzer according to the present application, where the method for manufacturing a calibration curve includes:
s21: calibration samples of a plurality of concentrations are obtained.
Step S21 is the same as step S11, and will not be described here again.
S22: and obtaining the test times of each calibration sample, wherein the test times of at least one calibration sample are more than 1.
Step S22 is the same as step S12, and will not be described here again.
S23: based on the test times, each calibration sample is tested through a sample analyzer, so that each calibration sample correspondingly obtains at least one first detection value.
Step S23 is the same as step S13, and will not be described again here.
S24: and obtaining a measurement value of each calibration sample based on the first detection value of each calibration sample, wherein when the test times of the calibration sample are confirmed to be more than 1, the measurement value of the calibration sample is calculated based on at least two of all the first detection values of the calibration sample.
Step S24 is the same as step S14, and will not be described here again.
S25: and judging whether the measured value of each calibration sample meets the curve drawing condition.
After obtaining the measured values of the plurality of calibration samples, judging whether the measured values of the calibration samples obtained by the first setting meet the requirement of drawing a curve. If so, step S28 is executed, that is, if the obtained measurement values of the plurality of calibration samples satisfy the drawing requirement of the calibration curve, step S28 is executed to draw the calibration curve from the measurement values of the plurality of calibration samples.
S26: if not, at least one calibration sample is obtained from the plurality of calibration samples, and the obtained at least one calibration sample is retested for a plurality of times through a sample analyzer, so that a plurality of second detection values are obtained.
If the measured value of the calibration sample obtained by the first setting does not meet the requirement of drawing the calibration curve, the user can select at least one measured point on the calibration curve for retesting, namely retesting the obtained at least one calibration sample for a plurality of times through the sample analyzer. Wherein. Several times including testing 1, 2, 3 or more than 3 times, etc. The retested calibration sample corresponds to a plurality of second detection values.
S27: based on a number of second detection values of the at least one calibration sample, a measurement value of the at least one calibration sample is updated.
Based on a number of second detection values of the retested calibration sample, the measurement value of the calibration sample is updated.
Alternatively, the measured value of at least one calibration sample may be updated based on an average of at least one or both of the number of second detection values. For example, when the second detection value is 1, the second detection value may be used as a measurement value of a calibration sample to update a measurement value of a previously determined sample. Alternatively, when the second detection value is plural, the measurement value of the calibration sample may be updated based on an average value of at least two of the plural second detection values. Preferably, the measured value of the calibration sample may be updated based on an average of all second detected values of the calibration sample.
Optionally, the measured value of the at least one calibration sample is derived based on at least two of all first detection values and all second detection values of the at least one calibration sample. Preferably, the average of all the first detection values and all the second detection values of at least one calibration sample may be calculated, resulting in a measured value of at least one calibration sample. In this way, the accuracy of the measurement value of the calibration sample can be improved.
S28: a calibration curve of the sample analyzer is prepared based on the measured values of the plurality of calibration samples.
Step S28 is the same as step S15, and will not be described here again.
In the above embodiment, if the obtained result is set for the first time to fail to meet the requirement of drawing the curve, the user may select a certain measurement point on the curve to retest, and then take the average value of all the test results or a certain value or the average value of several results at the point as the measured value to draw the curve. By the method, a legal calibration curve can be obtained more flexibly, and the consumption of calibration samples and reagents is reduced.
The present application further provides a sample analyzer, as shown in fig. 4, fig. 4 is a schematic diagram of a frame of an embodiment of the sample analyzer provided in the present application, where the sample analyzer 40 includes a memory 41 and a processor 42 coupled to each other, and the processor 42 is configured to execute program instructions stored in the memory 41 to implement the method for manufacturing a calibration curve according to any one of the above embodiments.
The processor 42 may also be referred to as a CPU (Central Processing Unit ). The processor 42 may be an integrated circuit chip having signal processing capabilities. The processor 42 may also be a general purpose processor, a digital signal processor (Digital Signal Processor, DSP), an application specific integrated circuit (Application Specific Integrated Circuit, ASIC), a Field programmable gate array (Field-Programmable Gate Array, FPGA) or other programmable logic device, discrete gate or transistor logic device, discrete hardware components. The general purpose processor may be a microprocessor or the processor 42 may be any conventional processor or the like. In addition, the processor 42 may be commonly implemented by an integrated circuit chip.
The sample analyzer of the embodiment can obtain a legal calibration curve more flexibly, and reduce the consumption of calibration samples and reagents.
The present application further provides a computer readable storage medium, please refer to fig. 5, fig. 5 is a schematic diagram of an embodiment of a computer readable storage medium according to the present application. The computer-readable storage medium 50 stores program instructions 51 executable by the processor, the program instructions 51 for implementing the steps of the method for producing a calibration curve of any of the above embodiments.
Wherein the program instructions 51 may be stored in the form of a software product in the above-mentioned computer-readable storage medium 50, comprising instructions for causing an apparatus or processor to perform all or part of the steps of the methods of the various embodiments of the present application.
The computer-readable storage medium 50 is a medium in computer memory for storing some discrete physical quantity. Wherein the computer-readable storage medium 50 comprises: a U-disk, a removable hard disk, a Read-Only Memory (ROM), a random access Memory (RAM, random Access Memory), a magnetic disk or an optical disk, or other various media capable of storing the program instructions 51 code.
In the several embodiments provided in the present application, it should be understood that the disclosed methods and apparatus may be implemented in other manners. For example, the apparatus embodiments described above are merely illustrative, e.g., the division of modules or units is merely a logical functional division, and there may be additional divisions of actual implementation, e.g., units or components may be combined or integrated into another system, or some features may be omitted, or not performed. Alternatively, the coupling or direct coupling or communication connection shown or discussed with each other may be an indirect coupling or communication connection via some interfaces, devices or units, which may be in electrical, mechanical, or other forms.
The elements illustrated as separate elements may or may not be physically separate, and elements shown as elements may or may not be physical elements, may be located in one place, or may be distributed over network elements. Some or all of the units may be selected according to actual needs to achieve the purpose of the embodiment.
In addition, each functional unit in each embodiment of the present application may be integrated in one processing unit, or each unit may exist alone physically, or two or more units may be integrated in one unit. The integrated units may be implemented in hardware or in software functional units.
The integrated units, if implemented in the form of software functional units and sold or used as stand-alone products, may be stored in a computer readable storage medium. Based on such understanding, the technical solution of the present application may be embodied essentially or in part or all or part of the technical solution contributing to the prior art or in the form of a software product stored in a storage medium, including several instructions to cause a computer device (which may be a personal computer, a server, or a network device, etc.) or a processor (processor) to perform all or part of the steps of the methods of the embodiments of the present application.
The foregoing description is only of embodiments of the present application, and is not intended to limit the scope of the patent application, and all equivalent structures or equivalent processes using the descriptions and the contents of the present application or other related technical fields are included in the scope of the patent application.
Claims (10)
1. A method of making a calibration curve for a sample analyzer, the method comprising:
obtaining calibration samples of a plurality of concentrations;
obtaining the test times of each calibration sample, wherein the test times of at least one calibration sample are more than 1;
based on the test times, testing each calibration sample through a sample analyzer so that each calibration sample correspondingly obtains at least one first detection value;
obtaining a measurement value of each calibration sample based on the first detection value of each calibration sample, wherein when the number of tests of the calibration sample is confirmed to be greater than 1, the measurement value of the calibration sample is obtained based on at least two of all the first detection values of the calibration sample;
and based on the measured values of the plurality of calibration samples, preparing a calibration curve of the sample analyzer.
2. The method according to claim 1, wherein when the number of tests of the calibration sample is confirmed to be greater than 1, the measurement value of the calibration sample is calculated based on at least two of all the first detection values of the calibration sample, including,
when the test times of the calibration sample are confirmed to be more than 1, finding out first detection values meeting preset conditions from all the first detection values of the calibration sample;
and calculating the average value of all the first detection values meeting the preset condition to obtain the measurement value of the calibration sample.
3. The method of claim 1, wherein the calculating the measurement value of the calibration sample based on at least two of all the first detection values of the calibration sample comprises,
and calculating the average value of all the first detection values of the calibration sample to obtain the measured value of the calibration sample.
4. A method of manufacturing as claimed in any one of claims 1 to 3 wherein the number of tests for different of the calibration samples is the same or different.
5. The method of claim 1, wherein after the step of obtaining a measurement value for each of the calibration samples based on the first detection value for each of the calibration samples, the method further comprises,
judging whether the measured value of each calibration sample meets the curve drawing condition or not;
if not, at least one calibration sample is obtained from a plurality of calibration samples, and the obtained at least one calibration sample is retested for a plurality of times through the sample analyzer, so that a plurality of second detection values are obtained;
updating a measured value of at least one of the calibration samples based on a number of the second detection values of at least one of the calibration samples.
6. The method of claim 5, wherein updating the measured value of at least one of the calibration samples based on the plurality of second detection values of at least one of the calibration samples comprises,
updating a measured value of at least one of the calibration samples based on an average of at least one or both of the plurality of second detection values.
7. The method of claim 5, wherein updating the measured value of at least one of the calibration samples based on the plurality of second detection values of at least one of the calibration samples comprises,
obtaining a measured value of at least one of the calibration samples based on at least two of all the first detection values and all the second detection values of at least one of the calibration samples.
8. The method of claim 7, wherein said obtaining a measurement value of at least one of said calibration samples based on at least two of all of said first test values and all of said second test values of at least one of said calibration samples comprises,
and calculating the average value of all the first detection values and all the second detection values of at least one calibration sample to obtain the measured value of at least one calibration sample.
9. A sample analyzer comprising a memory and a processor coupled to each other, the processor configured to execute program instructions stored in the memory to implement the method of producing a calibration curve according to any one of claims 1-8.
10. A computer readable storage medium having stored thereon program instructions, which when executed by a processor, implement a method of producing a calibration curve according to any of claims 1-8.
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