Correction method of function detection system, equipment and program product

Abstract

The invention relates to the field of intelligent medical treatment, in particular to a correction method and device of a function detection system and a program product. Comprising the following steps: acquiring a serum sample and correction liquid of a to-be-detected person; the correction liquid is a sample diluent of the toxoplasma gondii antibody detection reagent; mixing the serum sample with a correction solution to obtain a mixed solution; the mixed solution is conveyed into the function detection system to be corrected to obtain the corrected function detection system, the method is simple and rapid in function system correction, a doctor can directly understand a detection result, and the method has good readability and has good clinical application value.

Description

Technical Field

[0001] The present application relates to the field of intelligent medical treatment, and specifically to a correction method, device, program product and computer-readable storage medium for a function detection system. Background Art

[0002] There are two or more methods (reagents, instruments) for the same test in the laboratory department, and sometimes the results are very different. For example, the Yahuilong equipment is used as the main testing instrument to test six endocrine items, which is inconsistent with the clinical diagnosis. The test result of the estradiol project is too high. The Abbott equipment is used as an auxiliary comparison instrument to conduct parallel comparisons on samples with high estradiol projects. The results of the two instruments are quite different, which has an adverse effect on clinical diagnosis. Referring to the requirements for quality assessment in the US Clinical Laboratory Amendments (CLIA'88), the laboratory department should have specific measures to make the reports of different measurement methods for the same project comparable. Summary of the invention

[0003] In view of the above problems, the present invention provides a calibration method for a function detection system, which specifically includes: Obtaining a serum sample and a calibration solution from a subject to be tested; the calibration solution is a sample dilution solution of a Toxoplasma gondii antibody detection reagent; Mixing the serum sample and the calibration solution to obtain a mixed solution; The mixed solution is transferred to the functional detection system to be calibrated to obtain a calibrated functional detection system.

[0004] The calibration solution is diluted to obtain a diluted calibration solution, and the serum sample and the diluted calibration solution are mixed to obtain a mixed solution, wherein the dilution is 2-5 times dilution.

[0005] The correction fluid is: the correction fluid is a sample diluent of the Toxoplasma IgG antibody detection reagent.

[0006] The correction solution is replaced with: a first mixed solution of a fresh serum sample and a sample diluent of a Toxoplasma antibody detection reagent, the first mixed solution is mixed with the serum sample to obtain a second mixed solution, and the second mixed solution is transferred to the functional detection system to be calibrated to obtain a calibrated functional detection system.

[0007] Or the correction solution is replaced by: a second mixed solution of a fresh serum sample and a sample diluent of a Toxoplasma IgG antibody detection reagent, the second mixed solution is mixed with the serum sample to obtain a third mixed solution, and the third mixed solution is transferred to the functional detection system to be calibrated to obtain a calibrated functional detection system.

[0008] The method also includes a correction judgment, obtaining the item detection values ​​of the first function detection system and the second function detection system; using the item detection values ​​of the first function detection system as a benchmark, comparing the item detection values ​​of the first function detection system and the second function detection system, and when the item detection values ​​of the two are greater than the error judgment standard, correcting the second function detection system.

[0009] The first functional detection system includes one or more of the following: Roche Elecsys 2010, Elecsys2020, Cobas e411, Cobas e601, Abbott Architect i1000SR, i2000SR, Siemens Centaur XP / XPTPlus, Beckman Coulter Access 2, DxI 600 / 800, UniCel DxI 600 SR, DxI 800.

[0010] The second functional detection system includes one or more of the following: Aeon iFlash 3000, iFlash3000C, iFlash 1800, Mindray Medical CL-6000i / CL-8000i, Antu Biotech AutoLumo A2000 Plus / A2000Pro, and MyBiotech Pylon 3000.

[0011] The items detected by the detection system include one or more of the following: thyroid hormone TSH, thyroid hormone FT3, thyroid hormone FT4, gonadal hormone LH, gonadal hormone FSH, gonadal hormone E2, gonadal hormone PRL, pituitary hormone GH, pituitary hormone ACTH, luteinizing hormone, follicle-stimulating hormone, testosterone, and estradiol.

[0012] The object of the present invention is to provide a computer program product, which includes a computer program or instructions, and the computer program or instructions are executed by a processor to implement the correction method of the above-mentioned function detection system.

[0013] The object of the present invention is to provide a computer device, which includes a memory, a processor and a computer program or instructions stored in the memory, wherein the computer program or instructions are executed by the processor to implement the correction method of the above-mentioned function detection system.

[0014] An object of the present invention is to provide a computer-readable storage medium having a computer program or instructions stored thereon, wherein the computer program or instructions are executed by a processor to implement the correction method of the above-mentioned function detection system.

[0015] Advantages of the present invention: In view of the problem that the inconsistency of test results between different systems leads to reduced readability and usability of test reports, the present invention proposes to use correction fluid for correction, so that the test results obtained by the corrected system are more readable and usable, thereby improving the reliability of the functional detection system.

[0016] 2 It is proposed to use the sample diluent in the Toxoplasma IgG antibody detection reagent as a calibration fluid to calibrate the functional detection system, which can simply and conveniently complete the calibration of the functional detection system.

[0017] 3. The functional detection system is calibrated by using a mixture of the sample diluent in the Toxoplasma IgG antibody detection reagent and the fresh serum sample as a calibration solution. This has the advantages of simple and efficient calibration of the functional detection system, and allows physicians to directly apply the test report after using the functional detection system, which has good practical clinical application value. BRIEF DESCRIPTION OF THE DRAWINGS

[0018] In order to more clearly illustrate the technical solutions in the embodiments of the present invention, the drawings required for use in the description of the embodiments will be briefly introduced below. Obviously, the drawings described below are only some embodiments of the present invention. For those skilled in the art, other drawings can be obtained based on these drawings without creative work.

[0019] Figure 1 A schematic diagram of a flow chart of a calibration method for a function detection system provided by an embodiment of the present invention; Figure 2 A schematic diagram of a correction system of a function detection system provided by an embodiment of the present invention; Figure 3 A schematic diagram of a calibration device for a function detection system provided by an embodiment of the present invention; Figure 4 Correlation between different functional detection systems before adding correction fluid provided by the embodiment of the present invention; Figure 5 Correlation between different functional detection systems after adding correction fluid provided by the embodiment of the present invention; Figure 6 The embodiment of the present invention provides a correlation between sample data that does not contain a correction fluid and meets the consistency requirements and sample data that meets the consistency requirements and contains a correction fluid. DETAILED DESCRIPTION

[0020] In order to enable those skilled in the art to better understand the solutions of the present invention, the technical solutions in the embodiments of the present invention will be clearly and completely described below in conjunction with the accompanying drawings in the embodiments of the present invention.

[0021] In some of the processes described in the specification and claims of the present invention and the above-mentioned figures, multiple operations that appear in a specific order are included, but it should be clearly understood that these operations may not be executed in the order in which they appear in this article or executed in parallel. The sequence numbers of the operations, such as S101, S102, etc., are only used to distinguish between different operations, and the sequence numbers themselves do not represent any execution order. In addition, these processes may include more or fewer operations, and these operations may be executed in sequence or in parallel. It should be noted that the descriptions of "first", "second", etc. in this article are used to distinguish different messages, devices, modules, etc., do not represent the order of precedence, and do not limit the "first" and "second" to be different types.

[0022] Figure 1 A schematic diagram of a calibration method for a function detection system provided by an embodiment of the present invention specifically includes: S101: Obtaining a serum sample and a calibration solution from a subject; the calibration solution is a sample dilution solution of a Toxoplasma gondii antibody detection reagent; In one embodiment, the correction solution is replaced with: sample diluent of Toxoplasma gondii IgG antibody detection reagent.

[0023] In one embodiment, the correction solution is replaced with: a first mixed solution of a fresh serum sample and a sample diluent of a Toxoplasma antibody detection reagent, the first mixed solution is mixed with the serum sample to obtain a second mixed solution, and the second mixed solution is input into the functional detection system to be calibrated to obtain a calibrated functional detection system.

[0024] In one embodiment, the correction solution is replaced with: a second mixed solution of a fresh serum sample and a sample diluent of a Toxoplasma IgG antibody detection reagent, the second mixed solution is mixed with the serum sample to obtain a third mixed solution, and the third mixed solution is input into the functional detection system to be calibrated to obtain a calibrated functional detection system.

[0025] S102: mixing the serum sample and the calibration solution to obtain a mixed solution; In one embodiment, the calibration solution is diluted to obtain a diluted calibration solution, and the serum sample and the diluted calibration solution are mixed to obtain a mixed solution, and the dilution is 2-5 times dilution.

[0026] In a specific embodiment, the Yahuilong device was used as the main detection instrument to detect six endocrine items, which were inconsistent with the clinical diagnosis, among which the test result of the estradiol item was high. The Abbott device was used as an auxiliary comparison instrument to conduct parallel comparisons on samples with high estradiol items. The results of the two instruments were quite different, and the Abbott result was more in line with clinical needs. For samples with high estradiol results, the Yahuilong device was calibrated, auxiliary reagents were added and diluted 2-5 times, and the comparison was performed on the above two instruments at the same time. After the results were analyzed, a good linear relationship was shown.

[0027] S103: The mixed solution is transferred to the function detection system to be calibrated to obtain a calibrated function detection system.

[0028] In one embodiment, the method also includes a correction judgment, obtaining the item detection values ​​of the first function detection system and the second function detection system; using the item detection values ​​of the first function detection system as a benchmark, comparing the item detection values ​​of the first function detection system and the second function detection system, and when the item detection values ​​of the two are greater than the error judgment standard, calibrating the second function detection system.

[0029] In one embodiment, the first functional detection system includes one or more of the following: Roche Elecsys2010, Elecsys 2020, Cobas e411, Cobas e601, Abbott Architect i1000SR, i2000SR, Siemens Centaur XP / XPT Plus, Beckman Coulter Access 2, DxI 600 / 800, UniCel DxI 600 SR, DxI800.

[0030] In one embodiment, the second function detection system includes one or more of the following: Aeon iFlash3000, iFlash 3000C, iFlash 1800, Mindray Medical CL-6000i / CL-8000i, Antu Biotech AutoLumoA2000 Plus / A2000 Pro, and MyBiotech Pylon 3000.

[0031] In one embodiment, the items detected by the detection system include one or more of the following: thyroid hormone TSH, thyroid hormone FT3, thyroid hormone FT4, gonadal hormone LH, gonadal hormone FSH, gonadal hormone E2, gonadal hormone PRL, pituitary hormone GH, pituitary hormone ACTH, luteinizing hormone, follicle stimulating hormone, testosterone, and estradiol.

[0032] In one embodiment, the error standard is 1 / 2 of the total error allowed by the Clinical Laboratory Improvement Amendments Proficiency Testing (CLIA88) of the United States.

[0033] In one embodiment, the range of X and the regression equation are tested. The range of X and the regression equation are tested by performing correlation and regression analysis on y and X, and using the correlation coefficient (r) to estimate whether the distribution range of X is appropriate. If r ≥ 0.975 or r 2 If ≥0.95, the specimen selection is considered appropriate and the linear regression equation result is reliable. Calculate the linear regression equation: Y=bX+a.

[0034] In one embodiment, the comparability evaluation and expected bias estimation between two detection systems. Substitute the given medical decision level concentration (Xc) of the comparison project into the equation to calculate the acceptable error (Ea): Ea=1 / 2CLIA'88 total error (TEa)*Xc; expected deviation (Bc) Bc=a+(b-1)Xc, b is the slope, a is the intercept; 95% confidence interval. Result judgment standard: The acceptable error (Ea) is based on 1 / 2 of the allowable error (TEA) of the US Clinical Laboratory Amendment (CLIA'88) for inter-laboratory quality assessment. ① The acceptable error (Ea) falls within the Bc95% confidence interval, indicating that the bias of the two systems is acceptable and the test results of the two detection systems are comparable, otherwise they are not comparable; ② The acceptable error (Ea) is greater than the upper limit of the Bc95% confidence interval, indicating that there is a 97.5% probability that the results obtained by the two systems are consistent, the bias is acceptable, and the test results of the two detection systems are comparable, otherwise they are not comparable; ③ The acceptable error (Ea) is less than the lower limit of the Bc95% confidence interval, indicating that there is a 97.5% probability that the results obtained by the two systems are inconsistent, the bias is unacceptable, and the test results of the two detection systems are not comparable.

[0035] In one embodiment, the statistical processing statistical method calculates the linear regression equation, r and SE of the comparison items of the two detection systems, uses EXECL software to process the data, and uses SPSS13.0 statistical software as the statistical tool.

[0036] In a specific example, the Yahuilong device uses the immunochemiluminescence method to detect six endocrine (hormone) items. Since hormones are small molecules, they are difficult to capture and unstable, and there are also autoantibodies that affect the results, resulting in deviations. After adding auxiliary reagents, the interference of autoantibodies is eliminated, making the results more accurate.

[0037] Specifically, the present invention compared the first-generation reagents of the Yahuilong equipment, the second-generation reagents of the Yahuilong equipment, and the Abbott equipment, and the results were as follows: Figure 4 As shown, there are large differences in the results detected between the systems. 2 It does not meet the qualified standard of 0.95 or above and cannot be used in actual clinical practice. Before and after adding the calibration reagent, the results are as follows Figure 5 As shown, the systems show good linearity and r 2 It basically reaches the qualified standard of greater than or equal to 0.95, which is much better than the system test results before adding the calibration fluid, and the results obtained are more accurate and reliable.

[0038] In one embodiment, two different functional detection systems are tested for items, one of which is used as a detection benchmark, and the item test results are compared. When the test values ​​of both are greater than the error judgment standard, the other one is calibrated to obtain a correction fluid (a sample dilution fluid in a Toxoplasma IgG antibody detection reagent), and the correction fluid is added to the functional detection system to be calibrated to obtain a calibrated functional detection system, and the functional detection is performed using the calibrated functional detection system.

[0039] The two different function detection systems may be two function detection systems of different brands, or two function detection systems of different products of the same brand, or different reagents of the same product of the same brand.

[0040] In one embodiment, when the function detection system is known to need to be calibrated in the previous test items, in the subsequent test, the function detection system is first calibrated, and then the item test is performed. Specifically, a serum sample and a calibration solution (a sample diluent in the Toxoplasma IgG antibody detection reagent) are obtained, the serum sample and the calibration solution are mixed to obtain a mixed solution, the mixed solution is added to the function detection system to be calibrated to obtain a calibrated function detection system, and the calibrated function detection system is used to perform a function test. Redundant steps are removed to simplify the function detection process.

[0041] In one embodiment, when the function detection system is known to need to be calibrated in the previous detection project, in the subsequent detection, the function detection system is first calibrated and then the project detection is performed. Specifically, a serum sample and a calibration solution (a sample diluent in the Toxoplasma antibody detection reagent) are obtained, the calibration solution is diluted 2-5 times to obtain a diluted calibration solution, the serum sample and the diluted calibration solution are mixed to obtain a mixed solution, the mixed solution is added to the function detection system to be calibrated to obtain a calibrated function detection system, and the function detection is performed using the calibrated function detection system.

[0042] In one embodiment, when the function detection system is known to need to be calibrated in the previous detection project, in the subsequent detection, the function detection system is first calibrated and then the project detection is performed. Specifically, a serum sample and a calibration solution (a sample diluent in a Toxoplasma IgG antibody detection reagent) are obtained, the calibration solution is diluted 2-5 times to obtain a diluted calibration solution, the serum sample and the diluted calibration solution are mixed to obtain a mixed solution, the mixed solution is added to the function detection system to be calibrated to obtain a calibrated function detection system, and the calibrated function detection system is used to perform a function detection.

[0043] In one embodiment, when the function detection system is known to need to be calibrated in the previous detection project, in the subsequent detection, the function detection system is first calibrated and then the project detection is performed. Specifically, a serum sample and a calibration solution (a mixture of the sample diluent in the Toxoplasma IgG antibody detection reagent and fresh serum) are obtained, the calibration solution is diluted 2-5 times to obtain a diluted calibration solution, the serum sample and the diluted calibration solution are mixed to obtain a mixed solution, the mixed solution is added to the function detection system to be calibrated to obtain a calibrated function detection system, and the function detection is performed using the calibrated function detection system.

[0044] In one embodiment, two different functional detection systems are tested for items, one of which is used as a detection benchmark, and the item test results are compared. When the test values ​​of both are greater than the error judgment standard, the other is calibrated to obtain a correction solution (a sample diluent in a Toxoplasma IgG antibody detection reagent), and the correction solution is diluted 2-5 times to obtain a diluted correction solution, which is added to the functional detection system to be calibrated to obtain a calibrated functional detection system, and the functional detection is performed using the calibrated functional detection system.

[0045] In one embodiment, two different functional detection systems are tested for items, one of which is used as a detection benchmark, and the item test results are compared. When the test values ​​of both are greater than the error judgment standard, the other is calibrated to obtain a correction solution (a mixture of the sample diluent in the Toxoplasma IgG antibody detection reagent and fresh serum), and the correction solution is diluted 2-5 times to obtain a diluted correction solution, which is added to the functional detection system to be calibrated to obtain a calibrated functional detection system, and the functional detection is performed using the calibrated functional detection system.

[0046] In one embodiment, the functional system correction method of the present invention is used to calibrate the functional test data using correction fluid when the functional test results of different test systems are inconsistent and the doctor is unable to interpret the data so that the functional item test results of the serum sample of the test subject are consistent with the test data results of the commonly used test system.

[0047] When the test data of the functional detection system are consistent, the test results after adding the correction solution of the present invention and the test results without adding the correction solution meet the linear correlation, and the results are as follows: Figure 6 As shown, therefore, the correction method of the present invention can correct inconsistent sample data after the detection data is inconsistent to obtain consistent sample data, and can also directly calibrate the functional detection system with the correction fluid and then perform functional detection on the sample data to obtain functional detection data.

[0048] The disclosed embodiments of the present invention further provide a computer program product or system, including a computer program, which implements the above-mentioned correction method steps of the function detection system when executed by a processor.

[0049] Figure 2 A schematic diagram of a correction system of a function detection system provided by an embodiment of the present invention specifically includes: Acquisition unit: acquires a serum sample and a calibration solution of a subject to be tested; the calibration solution is a sample dilution solution of a Toxoplasma gondii antibody detection reagent; Mixing unit: mixing the serum sample and the calibration solution to obtain a mixed solution; Calibration unit: The mixed solution is transferred to the functional detection system to be calibrated to obtain the calibrated functional detection system.

[0050] Figure 3 A schematic diagram of a calibration device of a function detection system provided by an embodiment of the present invention specifically includes: A memory and a processor; the memory is used to store program instructions; the processor is used to call program instructions, and when the program instructions are executed, any one of the above-mentioned correction methods for the function detection system is implemented.

[0051] The disclosed embodiment of the present invention further provides a computer-readable storage medium, wherein the computer-readable storage medium stores a computer program, and when the computer program is executed by a processor, any one of the above-mentioned correction methods for the function detection system is implemented.

[0052] The verification results of this verification embodiment show that assigning inherent weights to indications can improve the performance of the method relative to the default setting. Those skilled in the art can clearly understand that for the convenience and simplicity of description, the specific working processes of the systems, devices and units described above can refer to the corresponding processes in the aforementioned method embodiments, and will not be repeated here. In the several embodiments provided in this application, it should be understood that the disclosed systems, devices and methods can be implemented in other ways. For example, the device embodiments described above are only schematic, for example, the division of the units is only a logical function division, and there may be other division methods in actual implementation, such as multiple units or components can be combined or integrated into another system, or some features can be ignored or not executed. Another point is that the coupling or direct coupling or communication connection between each other shown or discussed can be through some interfaces, indirect coupling or communication connection of devices or units, which can be electrical, mechanical or other forms. The unit described as a separate component may or may not be physically separated, and the component displayed as a unit may or may not be a physical unit, that is, it may be located in one place, or it may be distributed on multiple network units. Some or all of the units can be selected according to actual needs to achieve the purpose of the scheme of this embodiment. In addition, each functional unit in each embodiment of the present invention may be integrated into one processing unit, or each unit may exist physically separately, or two or more units may be integrated into one unit. The above-mentioned integrated unit may be implemented in the form of hardware or in the form of software functional units. A person of ordinary skill in the art may understand that all or part of the steps in the various methods of the above-mentioned embodiments may be completed by instructing the relevant hardware through a program, and the program may be stored in a computer-readable storage medium, and the storage medium may include: a read-only memory (ROM), a random access memory (RAM), a disk or an optical disk, etc.

[0053] A person of ordinary skill in the art can understand that all or part of the steps in the above-mentioned embodiment method can be implemented by instructing related hardware through a program, and the program can be stored in a computer-readable storage medium. The above-mentioned medium storage can be a read-only memory, a disk or an optical disk, etc.

[0054] The above is a detailed introduction to a computer device provided by the present invention. For a person skilled in the art, according to the concept of the embodiments of the present invention, there may be changes in the specific implementation method and application scope. In summary, the content of this specification should not be understood as limiting the present invention.

Claims

1. A calibration method for a functional detection system, characterized in that: include: Obtaining serum samples and calibration fluid from subjects; The correction solution is a sample diluent of the Toxoplasma gondii antibody detection reagent; Mixing the serum sample and the calibration solution to obtain a mixed solution; The mixed solution is transferred to the functional detection system to be calibrated to obtain a calibrated functional detection system.

2. The calibration method of the functional detection system according to claim 1, characterized in that: The calibration solution is diluted to obtain a diluted calibration solution, and the serum sample and the diluted calibration solution are mixed to obtain a mixed solution, wherein the dilution is 2-5 times dilution.

3. The calibration method of the function detection system according to claim 1, characterized in that: The correction solution is replaced with: sample diluent of Toxoplasma gondii IgG antibody detection reagent.

4. The calibration method of the function detection system according to claim 1, characterized in that: The correction solution is replaced with: a first mixed solution of a fresh serum sample and a sample diluent of a Toxoplasma antibody detection reagent, the first mixed solution is mixed with the serum sample to obtain a second mixed solution, and the second mixed solution is transferred to the functional detection system to be calibrated to obtain a calibrated functional detection system; Or it can be replaced by: a second mixed solution of a fresh serum sample and a sample diluent of a Toxoplasma IgG antibody detection reagent, the second mixed solution is mixed with the serum sample to obtain a third mixed solution, and the third mixed solution is transferred to the functional detection system to be calibrated to obtain a calibrated functional detection system.

5. The calibration method of the function detection system according to claim 1, characterized in that: The method also includes a correction judgment, obtaining the item detection values ​​of the first function detection system and the second function detection system; using the item detection values ​​of the first function detection system as a benchmark, comparing the item detection values ​​of the first function detection system and the second function detection system, and when the item detection values ​​of the two are greater than the error judgment standard, correcting the second function detection system.

6. The calibration method of the function detection system according to claim 5, characterized in that: The first functional detection system includes one or more of the following: Roche Elecsys 2010, Elecsys 2020, Cobas e411, Cobas e601, Abbott Architect i1000SR, i2000SR, Siemens Centaur XP / XPT Plus, Beckman Coulter Access 2, DxI 600 / 800, UniCel DxI 600 SR, DxI 800; the second functional detection system includes one or more of the following: Aeon iFlash 3000, iFlash 3000C, iFlash 1800, Mindray Medical CL-6000i / CL-8000i, Antu Biotech AutoLumo A2000 Plus / A2000 Pro, and Mike Biotech Pylon 3000.

7. The calibration method of the function detection system according to claim 1, characterized in that: The items detected by the detection system include one or more of the following: thyroid hormone TSH, thyroid hormone FT3, thyroid hormone FT4, gonadal hormone LH, gonadal hormone FSH, gonadal hormone E2, gonadal hormone PRL, pituitary hormone GH, pituitary hormone ACTH, luteinizing hormone, follicle-stimulating hormone, testosterone, and estradiol.

8. A computer program product comprising a computer program or instructions, characterized in that: The computer program or instructions are executed by a processor to implement the correction method of the function detection system according to any one of the claims.

9. A computer device comprising a memory, a processor and a computer program or instruction stored in the memory, characterized in that: The computer program or instructions are executed by a processor to implement the correction method of the function detection system according to any one of the claims.

10. A computer-readable storage medium having a computer program or instruction stored thereon, characterized in that: The computer program or instructions are executed by a processor to implement the correction method of the function detection system according to any one of the claims.

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