CN112345748A - Sample analyzer and calibration method thereof - Google Patents

Sample analyzer and calibration method thereof Download PDF

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Publication number
CN112345748A
CN112345748A CN201910736383.1A CN201910736383A CN112345748A CN 112345748 A CN112345748 A CN 112345748A CN 201910736383 A CN201910736383 A CN 201910736383A CN 112345748 A CN112345748 A CN 112345748A
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China
Prior art keywords
calibration
retest
tests
test
fails
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Pending
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CN201910736383.1A
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Chinese (zh)
Inventor
邓爱华
罗森
谢良
王丽
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Shenzhen Mindray Bio Medical Electronics Co Ltd
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Shenzhen Mindray Bio Medical Electronics Co Ltd
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Priority to CN201910736383.1A priority Critical patent/CN112345748A/en
Publication of CN112345748A publication Critical patent/CN112345748A/en
Pending legal-status Critical Current

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    • 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
    • GPHYSICS
    • G01MEASURING; TESTING
    • G01NINVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N35/00Automatic analysis not limited to methods or materials provided for in any single one of groups G01N1/00 - G01N33/00; Handling materials therefor

Abstract

The embodiment of the application provides a sample analyzer and a calibration method thereof, wherein the sample analyzer comprises the following steps: setting calibration test information; carrying out calibration tests according to the set calibration test information, wherein the calibration tests comprise calibration tests for calibrators with different concentrations; if the calibration fails, the calibration failed part is subjected to calibration retest application; and within a preset time, performing calibration retesting on the part which fails in the calibration test. Therefore, the time for calibrating and retesting can be reduced, and the consumption of the calibrator and the reagent is reduced.

Description

Sample analyzer and calibration method thereof
Technical Field
The present application relates to the field of in vitro diagnostics and relates to, but is not limited to, a sample analyzer and a method of calibrating the same.
Background
Sample analyzers, such as immunoassays or biochemical analyzers, require calibration (i.e., calibration) of an analysis item to obtain calibration parameters for the item prior to sample analysis. The calibration method comprises the steps of introducing a calibration product and a main curve before calibration, then selecting calibration items and reagents, applying for calibration test, starting to execute a calibration detection program, detecting to obtain a luminous value of the calibration product, and adjusting the main curve according to the actually-measured luminous value of the calibration product to obtain calibration parameters.
In the calibration test process, calibration failure may be caused by instrument failure, insufficient calibrator, insufficient reagent, forgetting to put calibrator with certain concentration, and the like. Generally, the processing after calibration failure is as follows: and reapplying for calibration and carrying out calibration test again. However, when the calibration test is performed again, the calibrators with different concentration levels need to be tested again from the beginning to obtain complete calibration data, but this method needs to consume more calibrators and reagents, consumes longer calibration time, and is inefficient.
Disclosure of Invention
In view of the above, embodiments of the present application provide a sample analyzer and a calibration method thereof to solve at least one problem in the related art.
In one aspect, an embodiment of the present invention provides a calibration method for a sample analyzer, including: setting calibration test information; performing calibration tests according to the set calibration test information, wherein the calibration tests comprise calibration tests performed on calibration products with different concentration levels; if the calibration fails, the calibration failed part is subjected to calibration retest application; and within a preset time, performing calibration retesting on the part which fails in the calibration test.
In an embodiment of the first aspect, the calibration test includes N calibration tests performed on a calibrator at N concentration levels, where N is a natural number not less than 2, and if any one of the N calibration tests fails, it is a calibration failure.
In an embodiment of the first aspect, the method further comprises: outputting calibration data of the N calibration tests; analyzing and comparing the calibration data of the N calibration tests; and judging whether a failed calibration test exists according to the calibration data of the N calibration tests.
In an embodiment of the first aspect, the performing calibration retesting on the calibration test failed part within the preset time includes: after the application of the calibration retest, if the calibration retest is carried out within the preset time, the calibration retest is carried out on the part which fails in the calibration test; and if the calibration retest is not carried out within the preset time, automatically canceling the application of the calibration retest.
In an embodiment of the first aspect, the method further includes providing a setup interface, where the setup interface includes options of partial calibration retest and full calibration retest, and if partial calibration retest is selected, performing calibration retest on the part that failed calibration after failure; if all calibration retests are selected, the calibration tests of different concentrations are all retested after the calibration fails.
In an embodiment of the first aspect, the method further includes setting the preset time at a setting interface.
In a second aspect, an embodiment of the present invention further provides a sample analyzer, which includes a control device, a testing device, and a transferring device. The control device is used for carrying out calibration tests according to the set calibration test information, and the calibration tests comprise calibration tests carried out on calibration products with different concentration levels; the test device is used for executing the calibration test and outputting corresponding calibration test data to the control device; the transfer device is used for transferring the mixed solution mixed with the calibrator and the reagent to the test device for calibration test; the control device is also used for judging whether the calibration test fails or not, and if the calibration fails, the calibration failed part is subjected to calibration retest application.
In an embodiment of the second aspect, the control device is further configured to determine whether to perform calibration retest within a preset time, and if so, control the test device to perform calibration retest on a part where the calibration test fails; and if the preset time is exceeded, automatically canceling the calibration retest application.
In an embodiment of the second aspect, the calibration test includes N calibration tests performed on a calibrator at N concentration levels, where N is a natural number not less than 2, and if any one of the N calibration tests fails, it is a calibration failure.
In an embodiment of the second aspect, the control device is further configured to: acquiring calibration data of N calibration tests; analyzing and comparing the calibration data of the N calibration tests; and judging whether a failed calibration test exists according to the calibration data of the N calibration tests.
In an embodiment of the second aspect, the sample analyzer further comprises a display device for outputting a setup interface including partial calibration retest and full calibration retest options.
In an embodiment of the second aspect, the control device is further configured to: if the partial calibration retest option is selected, after calibration fails, applying for calibration retest on the part which fails in calibration; and if all the calibration retest options are selected, after the calibration fails, all the calibration retest applications are carried out on the calibration tests with different concentrations.
In an embodiment of the second aspect, the sample analyzer further comprises an input device for inputting the value of the preset time.
The embodiment of the application provides a sample analyzer and a calibration method thereof, which can calibrate and retest a part which fails in calibration after the calibration fails, and do not need to do all calibration tests again from the beginning, so that the consumption of calibrators and reagents can be reduced, time can be saved, and the detection efficiency can be improved.
Drawings
FIG. 1 is a flow chart of a method of calibrating a sample analyzer according to a first embodiment of the present application;
FIG. 2 is a diagram of a correlation interface for outputting calibration data;
FIG. 3 is a diagram of a calibration operator interface providing a "retest" option;
FIG. 4 is a diagram of a calibration correlation interface providing a "calibration application";
FIG. 5 is a flow chart of a method of calibrating a sample analyzer according to a second embodiment of the present application;
FIG. 6 is a flow chart of a method of calibrating a sample analyzer according to a third embodiment of the present application;
fig. 7 is a block diagram of a sample analyzer according to a fourth embodiment of the present application.
Detailed Description
To make the objectives, technical solutions and advantages of the present application clearer, the present application will be described in further detail with reference to the accompanying drawings, the described embodiments should not be construed as limiting the present application, and all other embodiments obtained by a person of ordinary skill in the art without making creative efforts shall fall within the protection scope of the present application.
In the following description, reference is made to "some embodiments" which describe a subset of all possible embodiments, but it is understood that "some embodiments" may be the same subset or different subsets of all possible embodiments, and may be combined with each other without conflict.
Unless defined otherwise, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this application belongs. The terminology used herein is for the purpose of describing embodiments of the present application only and is not intended to be limiting of the application.
The first embodiment is as follows:
referring to fig. 1, an embodiment of the present invention provides a calibration method for a sample analyzer, including the following steps.
101: calibration test information is set, which may include inputting calibration items, calibrator information, reagent information, etc.
102: and performing calibration tests according to the set calibration test information, wherein the calibration tests comprise calibration tests performed on calibrators with different concentrations (such as three different concentration levels C0, C1 and C2).
103: and judging whether the calibration fails according to the calibration test result. In one embodiment, the calibration test may include N calibration tests performed on a calibrator at N concentration levels, where N is a natural number not less than 2, and if any one of the N calibration tests fails, it is a calibration failure. If the calibration tests for the calibrators of the N concentration levels are all successful, the calibration is successful. For example, if calibration tests are performed on 4 concentration levels of calibrators, wherein the data of the first three concentration levels of the calibrators meet a preset range or rule, and the data of the fourth concentration level of the calibrators fail to result (for example, the calibrators are insufficient or reagents are insufficient, which causes the calibration test not to be done) or the data of the calibration test is not in the preset range or does not meet the preset rule, the calibration is failed; if the calibration test data of the 4 concentration levels are all in the preset range or meet the preset rule, the calibration is successful. As shown in fig. 2, if the calibration tests of the concentration levels C0 and C1 succeeded (test data was normally output), and the latter calibration of the two calibration tests of the concentration level C2 failed, a calibration failure is displayed on the calibration result interface.
104: and if the calibration fails, performing calibration retest application on the part with failed calibration. As shown in fig. 3, if the calibration fails, a "retest" is selected on the calibration-related software interface, and a retest application can be applied to the calibration-failed part.
105: and performing calibration retesting on the part failing the calibration test within a preset time. After the application of the calibration retest, if the calibration retest is carried out within the preset time, the calibration retest is carried out on the part which fails in the calibration test; and if the calibration retest is not carried out within the preset time, automatically canceling the application of the calibration retest. Since the calibration test is performed continuously (calibration tests of calibrators with different concentrations are performed continuously) to ensure reliable results, if the calibration test is performed separately, to ensure the reliability of the results, the calibration retest application is required to be performed at intervals not exceeding a preset time (e.g., 12 hours), when the calibration retest application is performed, the user is prompted when the test is performed, and if the calibration application is not performed after the preset time (e.g., 12 hours), the calibration application is automatically cancelled. After the 'retest' is selected to conduct retest application on the part which fails in calibration, the software interface pops up a frame to prompt a user to place a sample in a preset time, and otherwise, the application is automatically cancelled.
106: and if the calibration is successful, outputting calibration detection data and/or a calibration curve.
Optionally, the method for determining whether the calibration fails may further include: outputting calibration data of the N calibration tests; analyzing and comparing the calibration data of the N calibration tests; and judging whether a failed calibration test exists according to the calibration data of the N calibration tests.
As shown in fig. 4, in an embodiment, a "calibration application" button may be further provided on the calibration-related software interface, and if an item (e.g., E2) is selected and then the calibration application is clicked, all calibration tests of the item may be retested, that is, the calibrators corresponding to the item with different concentration levels may be retested.
In the embodiment of the invention, a plurality of tests containing a plurality of concentration levels are calibrated, and when the calibration is carried out again, the tests which are successfully carried out can be carried out without redoing, and only failed tests can be carried out; and the method supports the application of calibration retest, and only applies for failed calibration test, so that only failed calibration test can be performed. Therefore, consumption of a calibration product and a reagent can be reduced, time for calibration and test is shortened, and working efficiency of the sample analyzer is improved.
In addition, in the embodiment of the invention, the options of 'partial calibration retest' and 'full calibration retest' can be provided for the user, so that the user can conveniently select different retest modes according to the needs, and the method is convenient and flexible.
Example two:
referring to fig. 5, an embodiment of the invention provides a calibration method for a sample analyzer, including the following steps.
201: setting calibration test information; for example, an item to be calibrated, calibrator information, reagent information, or the like is input.
202: carrying out calibration tests according to the set calibration test information, wherein the calibration tests comprise calibration tests for calibrators with different concentrations; in one embodiment, the calibration test includes N calibration tests performed on a calibrator at N concentration levels, N being a natural number not less than 2.
203: calibration test data for each calibration test is acquired.
204: judging whether the calibration test is successful according to the calibration detection data of each calibration test; if any one of the N calibration tests fails, determining that the calibration fails; in one embodiment, the method for determining whether calibration fails may include: analyzing and comparing the calibration data of the N calibration tests; and judging whether a failed calibration test exists according to the calibration data of the N calibration tests.
205: and if the calibration is successful, outputting calibration detection data and/or a calibration curve.
206: and if the calibration fails, performing calibration retest application on the part with failed calibration.
207: and judging whether to perform calibration retest within a preset time.
208: and if the calibration retest is carried out within the preset time, carrying out the calibration retest on the part which fails in the calibration test.
209: and if the calibration retest is not carried out within the preset time, automatically canceling the application of the calibration retest.
Example three:
as shown in fig. 6, an embodiment of the present invention provides a calibration method for a sample analyzer, including the following steps.
301: setting calibration test information; for example, an item to be calibrated, reagent information, or calibrator information is input.
302: carrying out calibration tests according to the set calibration test information, wherein the calibration tests comprise calibration tests for calibrators with different concentrations; in one embodiment, the calibration test includes N calibration tests performed on a calibrator at N concentration levels, N being a natural number not less than 2.
303: acquiring calibration detection data of each calibration test;
304: judging whether the calibration test fails according to the calibration detection data of each calibration test; if any one of the N calibration tests fails, determining that the calibration fails; in one embodiment, the method for determining whether calibration fails may include: analyzing and comparing the calibration data of the N calibration tests; and judging whether a failed calibration test exists according to the calibration data of the N calibration tests.
305: if the calibration is successful, calibration detection data and/or a calibration curve may be output.
306: if the calibration fails, options of partial calibration and full calibration re-test are provided on a software interface related to the calibration.
307: if partial calibration retest is selected, the calibration retest is performed on the calibration failed part after the calibration failed.
308: if all calibration retests are selected, the recalibration products with different concentrations are retested after the calibration fails.
In an embodiment, the software interface related to calibration may further allow a user to set an effective calibration retest time (e.g., 12 hours), if a partial calibration retest is selected, because only a calibration failed part is retested, for example, calibration tests at 4 concentration levels are performed, the first 3 calibration test results are all valid, the 4 th test result is incorrect, only a 4 th concentration level calibration product is retested, it is required to ensure that the retest of the 4 th concentration level calibration product is performed within the effective time, otherwise, continuity of the calibration test and reliability of the result cannot be guaranteed.
Example four:
referring to fig. 7, the embodiment of the invention further provides a sample analyzer 400, which includes a control device 410, a testing device 420 and a transferring device 430. The control device 410 is configured to perform calibration tests according to the set calibration test information, where the calibration tests include calibration tests performed on calibrators with different concentrations; the testing device 420 is configured to perform the calibration test and output corresponding calibration test data to the control device 410; the transfer device 430 is configured to transfer the mixed solution in which the calibrator and the reagent are mixed to the test device 420 to perform a calibration test; the control device 410 is further configured to determine whether the calibration test fails, and if the calibration test fails, apply for a calibration retest on the calibration failed part, and control the test device 420 to retest the calibration failed part.
The control device 410 is further configured to determine whether to perform a calibration retest within a preset time after applying for a calibration retest on the calibration failed part, and if so, control the test device 420 to perform the calibration retest on the calibration test failed part; and if the preset time is exceeded, automatically canceling the calibration retest application.
The calibration test may include N calibration tests performed on a calibrator at N concentration levels, where N is a natural number not less than 2, and if any one of the N calibration tests fails, it is a calibration failure.
The control device 410 is further configured to: acquiring calibration data of N calibration tests; analyzing and comparing the calibration data of the N calibration tests; and judging whether a failed calibration test exists according to the calibration data of the N calibration tests. The sample analyzer 400 also includes a display device 440 for outputting a setup interface, the setup interface 440 providing partial calibration retest options and full calibration retest options.
The control device 410 is further configured to: if the partial calibration retest option is selected, after the calibration fails, applying for calibration retest on the part with failed calibration, for example, retesting only on the calibrator with a certain concentration level with failed calibration; and if all the calibration retest options are selected, after the calibration fails, all the calibration retest applications are carried out on the calibration tests with different concentrations.
The sample analyzer 400 further includes an input device 450, which is configured to input a valid calibration retest time (e.g., 12 hours) on the setting interface, and if a partial calibration retest is selected, because only the calibration failed part is retested, for example, calibration tests at 4 concentration levels are performed, the first 3 calibration test results are valid, the 4 th calibration test results are not obtained, and only the 4 th calibration product is retested, it is required to ensure that the retest of the 4 th calibration product is performed within the valid time, otherwise, continuity and result reliability of the calibration test cannot be ensured. The input device 450 may be a keyboard, a mouse, or a touch screen, which can input information or instructions.
In the embodiment of the present invention, the sample analyzer 400 may be an immunoassay analyzer, a biochemical analyzer, a blood analyzer, or the like, and when performing a calibration test, the sample analyzer calibrates a plurality of tests including a plurality of concentration levels, and if a part of the calibration test results are incorrect or fail to result, the tests that have been successfully performed may not be redone and only failed tests may be performed when performing a calibration again; and support the application of calibration retest (such as automatic application), only apply for the calibration test that fails, just so can do the calibration test that fails. Therefore, consumption of a calibration product and a reagent can be reduced, time for calibration and test is shortened, and working efficiency of the sample analyzer is improved.
The above description of the sample analyzer embodiment is similar to the description of the method embodiment described above, with similar beneficial effects as the method embodiment. For technical details not disclosed in the embodiments of the sample analyzer according to the invention, reference is made to the description of the embodiments of the method according to the invention.
It should be appreciated that reference throughout this specification to "one embodiment" or "an embodiment" means that a particular feature, structure or characteristic described in connection with the embodiment is included in at least one embodiment of the present application. Thus, the appearances of the phrases "in one embodiment" or "in an embodiment" in various places throughout this specification are not necessarily all referring to the same embodiment. Furthermore, the particular features, structures, or characteristics may be combined in any suitable manner in one or more embodiments. It should be understood that, in the various embodiments of the present application, the sequence numbers of the above-mentioned processes do not mean the execution sequence, and the execution sequence of each process should be determined by its function and inherent logic, and should not constitute any limitation to the implementation process of the embodiments of the present application. The above-mentioned serial numbers of the embodiments of the present application are merely for description and do not represent the merits of the embodiments.
It should be noted that, in this document, 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 an … …" does not exclude the presence of other like elements in a process, method, article, or apparatus that comprises the element.
In the several embodiments provided in the present application, it should be understood that the disclosed apparatus and method may be implemented in other ways. The above-described device embodiments are merely illustrative, for example, the division of the unit is only a logical functional division, and there may be other division ways in actual implementation, such as: multiple units or components may be combined, or may be integrated into another system, or some features may be omitted, or not implemented. In addition, the coupling, direct coupling or communication connection between the components shown or discussed may be through some interfaces, and the indirect coupling or communication connection between the devices or units may be electrical, mechanical or other forms.
Those of ordinary skill in the art will understand that: all or part of the steps for realizing the method embodiments can be completed by hardware related to program instructions, the program can be stored in a computer readable storage medium, and the program executes the steps comprising the method embodiments when executed; and the aforementioned storage medium includes: various media that can store program codes, such as a removable Memory device, a Read Only Memory (ROM), a magnetic disk, or an optical disk.
Alternatively, the integrated units described above in the present application may be stored in a computer-readable storage medium if they are implemented in the form of software functional modules and sold or used as independent products. Based on such understanding, the technical solutions of the embodiments of the present application may be embodied in the form of a software product, which is stored in a storage medium and includes several instructions for causing a terminal to execute all or part of the methods described in the embodiments of the present application. And the aforementioned storage medium includes: a removable storage device, a ROM, a magnetic or optical disk, or other various media that can store program code.
The above description is only for the embodiments of the present application, but the scope of the present application is not limited thereto, and any person skilled in the art can easily conceive of changes or substitutions within the technical scope of the present application, and all such changes or substitutions should be covered by the present application.

Claims (15)

1. A method of calibrating a sample analyzer, comprising:
setting calibration test information;
carrying out calibration tests according to the set calibration test information, wherein the calibration tests comprise calibration tests for calibrators with different concentrations;
if the calibration fails, the calibration failed part is subjected to calibration retest application; and
and performing calibration retesting on the part failing the calibration test within a preset time.
2. The method of claim 1, wherein the calibration test comprises N calibration tests performed on a calibrator at N concentration levels, N being a natural number not less than 2, and a calibration failure if any one of the N calibration tests fails.
3. The method of claim 2, further comprising:
outputting calibration data of the N calibration tests;
analyzing and comparing the calibration data of the N calibration tests; and
and judging whether a failed calibration test exists according to the calibration data of the N calibration tests.
4. The method of claim 1, wherein: and outputting a calibration result or a calibration curve if the calibration is successful.
5. The method of claim 1, wherein the performing calibration retesting on the failed calibration test part within the preset time comprises: after the application of the calibration retest, if the calibration retest is performed within the preset time, the calibration retest is performed on the part which fails in the calibration test.
6. The method of claim 1 or 5, further comprising automatically canceling the calibration retest application if the calibration retest is not performed within a predetermined time after the calibration retest application is performed.
7. The method of claim 1, further comprising providing a setup interface, wherein the setup interface includes options for partial calibration retest and full calibration retest, and if partial calibration retest is selected, performing calibration retest on the calibration failed portion after the calibration failed; if all calibration retests are selected, the calibration tests of different concentrations are all retested after the calibration fails.
8. The method of claim 1 or 7, further comprising setting the preset time at a setup interface.
9. A sample analyzer, comprising:
the control device is used for carrying out calibration tests according to the set calibration test information, and the calibration tests comprise calibration tests carried out on calibration products with different concentrations;
the test device is used for executing the calibration test and outputting corresponding calibration test data to the control device;
a transfer device for transferring the mixed solution mixed with the calibrator and the reagent to the test device for calibration test;
the control device is also used for judging whether the calibration test fails or not, and if the calibration fails, the calibration failed part is subjected to calibration retest application.
10. The sample analyzer of claim 9, wherein: the control device is also used for judging whether to perform calibration retest within preset time, and if so, controlling the test device to perform calibration retest on the part which fails in the calibration test; and if the preset time is exceeded, automatically canceling the calibration retest application.
11. The sample analyzer of claim 9, wherein the calibration test includes N calibration tests performed on a calibrator at N concentration levels, N being a natural number not less than 2, and a calibration failure if any one of the N calibration tests fails.
12. The sample analyzer of claim 11, wherein the control device is further configured to:
acquiring calibration data of N calibration tests;
analyzing and comparing the calibration data of the N calibration tests; and
and judging whether a failed calibration test exists according to the calibration data of the N calibration tests.
13. The sample analyzer of claim 9 further comprising a display device for outputting a setup interface including partial calibration retest and full calibration retest options.
14. The sample analyzer of claim 13, wherein the control device is further configured to: if the partial calibration retest option is selected, after calibration fails, applying for calibration retest on the part which fails in calibration; and if all the calibration retest options are selected, after the calibration fails, all the calibration retest applications are carried out on the calibration tests with different concentrations.
15. The sample analyzer of claim 10 or 13 further comprising an input device for inputting the value of the preset time.
CN201910736383.1A 2019-08-09 2019-08-09 Sample analyzer and calibration method thereof Pending CN112345748A (en)

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CN109557292A (en) * 2017-09-26 2019-04-02 豪夫迈·罗氏有限公司 Calibration method
CN110967511A (en) * 2018-09-28 2020-04-07 希森美康株式会社 Calibration curve creation method, analysis device, and nonvolatile storage medium

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US6080364A (en) * 1997-04-10 2000-06-27 Hitachi, Ltd. Automatic analyzer and support system therefor
JP2015072287A (en) * 2015-01-19 2015-04-16 株式会社日立ハイテクノロジーズ Automatic analyzer
CN109557292A (en) * 2017-09-26 2019-04-02 豪夫迈·罗氏有限公司 Calibration method
CN110967511A (en) * 2018-09-28 2020-04-07 希森美康株式会社 Calibration curve creation method, analysis device, and nonvolatile storage medium

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Application publication date: 20210209