Clinical laboratory performance verification intelligent system
By introducing an integrated and automated smart performance verification system in clinical laboratories, the accuracy problems caused by manual operations in the existing technology are solved, and more efficient and accurate performance verification results are achieved.
Patent Information
- Application Number
- CN202411647974.9
- Authority / Receiving Office
- CN · China
- Patent Type
- Applications(China)
- Current Assignee / Owner
- Filing Date
- 2024-11-18
- Publication Date
- 2025-04-29
AI Technical Summary
Existing clinical laboratory performance verification methods are highly dependent on manual operations and are susceptible to human factors, resulting in the limitation of the accuracy of verification results.
It provides a smart system for clinical laboratory performance verification, integrating five functional modules: comparison analysis, precision analysis, linear analysis, dilution verification and reference interval verification. Each module automatically performs analysis and verification to reduce artificial factors.
Through automated analysis and verification, the accuracy and efficiency of clinical laboratory performance verification is significantly improved, the complexity and error of manual operations are reduced, and the ability to quickly generate standardized verification reports is provided.
Smart Images
Figure CN119905218A_ABST
Abstract
Description
Technical Field
[0001] The present invention relates to the field of medical detection technology, and in particular to an intelligent system for clinical laboratory performance verification. Background Art
[0002] With the continuous improvement of medical testing requirements, strict requirements are placed on clinical laboratories. Therefore, the performance of clinical laboratories needs to be verified.
[0003] The existing clinical laboratory performance verification process is usually as follows: (1) Specimen collection: Manually collect samples to ensure that the quality and quantity of the samples meet the analysis requirements; (2) Data collection: During the experiment, manually record various experimental data to ensure the integrity and accuracy of the data; (3) Data analysis: Professionals perform statistical analysis on the collected data by writing codes or using analysis software; (4) Report generation: Analysts organize the analysis results and generate detailed statistical analysis reports.
[0004] Since existing clinical laboratory performance verification methods are highly dependent on manual operations and are easily affected by human factors, the accuracy of verification results is limited. Summary of the invention
[0005] The present invention provides a clinical laboratory performance verification intelligent system to solve the defect of poor accuracy of clinical laboratory performance verification in the prior art and to improve the accuracy of clinical laboratory performance verification.
[0006] The present invention provides a clinical laboratory performance verification intelligent system, including: a comparison analysis module, a precision analysis module, a linear analysis module, a dilution verification module and a reference interval verification module; The comparison analysis module is used to obtain the comparison strategy formulated by the user according to the comparison analysis template; select the target comparison sample according to the comparison strategy and the sample data distribution map; execute the comparison strategy on the target comparison sample and generate a comparison report; The precision analysis module is used to obtain a first data file uploaded by a user according to a preset precision analysis template, perform precision analysis on the first data file, and generate a precision analysis report; The linear analysis module is used to obtain a second data file uploaded by a user according to a preset linear analysis template, automatically perform linear analysis on the second data file, and generate a linear analysis report; The dilution verification module is used to obtain a third data file uploaded by a user according to a preset dilution verification template, automatically perform dilution verification analysis on the third data file, and generate a dilution verification report; The reference interval verification module obtains a fourth data file uploaded by a user according to a preset reference interval verification template, automatically performs reference interval verification analysis on the fourth data file, and generates a reference interval verification report.
[0007] In some embodiments, the precision analysis module is used to perform precision analysis on the first data file and generate a precision analysis report, including: The precision analysis module is used to remove abnormal values in the first data file based on the Grubbs method, and calculate precision-related parameters for the remaining data in the first data file; Compare the calculated precision-related parameters with the precision-related parameters claimed by the reagent manufacturer, and determine whether the precision verification has been passed based on the comparison results; In the case where the precision verification fails, the UVL value of the claimed precision-related parameters is automatically calculated based on the preset precision parameter table; Whether the precision verification is passed is determined based on the calculated precision-related parameters and the UVL value.
[0008] In some embodiments, the reference interval verification module is used to automatically perform reference interval verification analysis on the fourth data file and generate a reference interval verification report, including: The reference interval verification module is used to automatically identify and remove outliers in the fourth data file based on the Tukey method; Calculate the ratio of the remaining data in the fourth data file to the inside and outside reference intervals; A reference interval verification report is generated based on the ratio inside and outside the reference interval.
[0009] In some embodiments, the system is developed using Java and R languages.
[0010] In some embodiments, the system is further configured to: Modify data according to the parameters entered by the user and automatically generate the corresponding R language code text; The R language code is called by a Java program to analyze the R language code text and dynamically adjust parameters.
[0011] In some embodiments, the R language code structure is templated.
[0012] In some embodiments, the system adopts a B / S+C / S architecture.
[0013] The clinical laboratory performance verification intelligent system provided by the present invention integrates five major functional modules: comparison analysis, precision analysis, linear analysis, dilution verification and reference interval verification, and each functional module automatically performs analysis and verification. It reduces human factors on the basis of providing comprehensive performance verification services, thereby improving the accuracy of clinical laboratory performance verification. BRIEF DESCRIPTION OF THE DRAWINGS
[0014] In order to more clearly illustrate the technical solutions in the present invention or the prior art, the following briefly introduces the drawings required for use in the embodiments or the description of the prior art. Obviously, the drawings described below are some embodiments of the present invention. For ordinary technicians in this field, other drawings can be obtained based on these drawings without paying creative work.
[0015] Figure 1 It is a structural schematic diagram of the clinical laboratory performance verification intelligent system provided by the present invention. DETAILED DESCRIPTION
[0016] In order to make the purpose, technical solution and advantages of the present invention clearer, the technical solution of the present invention will be clearly and completely described below in conjunction with the drawings of the present invention. Obviously, the described embodiments are part of the embodiments of the present invention, not all of the embodiments. Based on the embodiments of the present invention, all other embodiments obtained by ordinary technicians in this field without creative work are within the scope of protection of the present invention.
[0017] Figure 1 Schematic diagram of the structure of the clinical laboratory performance verification intelligent system provided by the present invention. Figure 1 As shown, the present invention provides a clinical laboratory performance verification intelligent system, including a comparison analysis module, a precision analysis module, a linear analysis module, a dilution verification module and a reference interval verification module.
[0018] The comparison analysis module is used to obtain the comparison strategy formulated by the user according to the comparison analysis template; select the target comparison sample according to the comparison strategy and the sample data distribution map; execute the comparison strategy on the target comparison sample and generate a comparison report; The precision analysis module is used to obtain a first data file uploaded by a user according to a preset precision analysis template, perform precision analysis on the first data file, and generate a precision analysis report; The linear analysis module is used to obtain a second data file uploaded by a user according to a preset linear analysis template, automatically perform linear analysis on the second data file, and generate a linear analysis report; The dilution verification module is used to obtain the third data file uploaded by the user according to the preset dilution verification template, automatically perform dilution verification analysis on the third data file, and generate a dilution verification report; The reference interval verification module obtains the fourth data file uploaded by the user according to the preset reference interval verification template, automatically performs reference interval verification analysis on the fourth data file, and generates a reference interval verification report.
[0019] Specifically, the clinical laboratory performance verification method mainly includes 5 parts: comparison analysis, precision analysis, linear analysis, dilution verification and reference interval verification. Therefore, the clinical laboratory performance verification intelligent system provided by the present invention includes a comparison analysis module, a precision analysis module, a linear analysis module, a dilution verification module and a reference interval verification module.
[0020] In the comparison analysis module, users can formulate comparison strategies according to the comparison analysis template on the system page, and select appropriate target comparison samples based on the comparison strategy and the sample data distribution map in the server. The comparison strategy is executed on the target comparison sample, and a comparison report is generated according to the standard comparison file (such as EP9-A3 file). During the comparison process, users can observe the comparison progress in real time.
[0021] The comparison analysis module can also calculate bias or percentage bias based on user-maintained cut-point segments.
[0022] In the comparison analysis module, appropriate comparison samples are automatically selected through user settings, reducing human intervention, improving the accuracy of comparison sample selection, reducing errors and workload of human operations, and thus improving the efficiency and accuracy of comparison analysis.
[0023] In the precision analysis module, the user can download the preset precision analysis template from the system page, and fill in and upload the first data file according to the format of the preset precision analysis template. After obtaining the first data file, the first data file is automatically batch-precision analyzed to generate a precision analysis report.
[0024] In the precision analysis module, by automatically performing precision analysis on the first data file, human intervention is reduced, the automation and accuracy of the precision analysis are improved, and the difficulty of operation is reduced.
[0025] In the linear analysis module, users can download the preset linear analysis template from the system page, and fill in and upload the second data file according to the format of the preset linear analysis template. After obtaining the second data file, the linear analysis is automatically performed on the second data file according to the standard of the EP file, the regression parameters and correlation coefficients are calculated, and a linear analysis report is generated.
[0026] In the linear analysis module, automatic analysis is performed according to the standards of the EP file to ensure the authority and consistency of the linear analysis results, simplify the linear analysis process, and improve the linear analysis speed and the accuracy of the linear analysis results.
[0027] In the dilution verification module, users can download the preset dilution verification template from the system page, and fill in and upload the third data file according to the format of the preset dilution verification template. After obtaining the third data file, the dilution verification analysis is automatically performed on the third data file according to the standard of the EP file, the recovery rate and deviation of the diluted sample are calculated, and the dilution verification report is generated.
[0028] In the dilution verification module, manual calculation errors are reduced, the efficiency and accuracy of dilution verification are improved, and the consistency and reliability of dilution verification results are ensured.
[0029] In the reference interval verification module, users can download the preset reference interval verification template from the system page, and fill in and upload the fourth data file in the format of the preset reference interval verification template. According to the standard of the EP file, the reference interval verification analysis is automatically performed on the fourth data file, the ratio of the reference interval inside and outside the verification data is calculated, and the reference interval verification report is generated.
[0030] In the reference interval verification module, manual intervention and operational complexity are reduced, and the accuracy and efficiency of reference interval verification are improved.
[0031] The clinical laboratory performance verification intelligent system provided by the present invention integrates five major functional modules: comparison analysis, precision analysis, linear analysis, dilution verification and reference interval verification, and each functional module automatically performs analysis and verification. It reduces human factors on the basis of providing comprehensive performance verification services, thereby improving the accuracy of clinical laboratory performance verification.
[0032] In some embodiments, the precision analysis module is used to perform precision analysis on the first data file and generate a precision analysis report, including: The precision analysis module is used to remove abnormal values in the first data file based on the Grubbs method, and calculate precision-related parameters for the remaining data in the first data file; Compare the calculated precision-related parameters with the precision-related parameters claimed by the reagent manufacturer, and determine whether the precision verification has been passed based on the comparison results; In the case of failure of precision verification, the UVL value of the claimed precision-related parameters is automatically calculated based on the preset precision parameter table; According to the calculated precision-related parameters and UVL value, determine whether the precision verification has passed.
[0033] Specifically, in the precision analysis module, the Grubbs method is first automatically used to remove outliers in the first data file, and precision-related parameters (such as parameters such as intra-laboratory imprecision and repeatability) are calculated for the remaining data in the first data file.
[0034] Then, the calculated precision-related parameters are automatically compared with the precision-related parameters claimed by the reagent manufacturer obtained from the reagent manual, and whether the precision verification is passed is determined based on the comparison results; if the precision verification fails, the upper verification limit (UVL) value of the claimed precision-related parameters is automatically calculated based on the preset precision parameter table (such as the built-in EP15-A3 parameter table), that is, the claimed precision-related parameters are multiplied by the coefficient F to obtain the UVL value, where the table of coefficient F is built into the R script and automatically extracted according to the precision scheme selected by the user.
[0035] Finally, based on the relationship between the UVL value and the calculated precision-related parameters, determine whether the precision verification has passed and generate a precision analysis report.
[0036] The clinical laboratory performance verification intelligent system provided by the present invention automatically eliminates abnormal values by adopting the Grubbs method to ensure the accuracy and reliability of data, and reduces the complexity of manual calculation by automatically calculating the UVL value, thereby improving the automation and accuracy of precision analysis.
[0037] In some embodiments, the reference interval verification module is used to automatically perform reference interval verification analysis on the fourth data file and generate a reference interval verification report, including: The reference interval verification module is used to automatically identify and eliminate outliers in the fourth data file based on the Tukey method; Calculate the ratio of the remaining data in the fourth data file to the inside and outside reference intervals; Generate a reference interval verification report based on the ratio inside and outside the reference interval.
[0038] Specifically, in the reference interval verification module, the Tukey method is used to automatically identify and eliminate outliers in the fourth data file, calculate the ratio of the remaining data in the fourth data file inside and outside the reference interval, and automatically generate a reference interval verification report that meets the standard (e.g., EP28-A3c) based on the ratio of the reference interval.
[0039] The process of calculating the proportion of the remaining data in the fourth data file that is inside and outside the reference interval is: after uploading the fourth file, a reference interval will be generated. The reference interval is an interval containing two endpoints. The reference interval can be used to determine the proportion of the remaining data in the fourth data file that falls inside and outside the reference interval.
[0040] The reference interval verification module can also dynamically adjust the calculation process of the ratio inside and outside the reference interval according to the parameters set by the user.
[0041] The clinical laboratory performance verification intelligent system provided by the present invention automatically eliminates outliers by adopting the Tukey method to ensure the accuracy and reliability of data, and reduces manual intervention and operation complexity by automatically calculating the ratio inside and outside the reference interval, thereby improving the accuracy and efficiency of reference interval verification.
[0042] In some embodiments, the clinical laboratory performance verification intelligent system provided by the present invention is developed using Java language and R language.
[0043] Specifically, the clinical laboratory performance verification intelligent system is developed using Java and R languages. Through the seamless integration of Java and R languages, the system can efficiently transmit and process data. Java is responsible for front-end parameter collection and back-end data management, while R focuses on complex data analysis and statistical calculations. The combination of the two not only improves the processing efficiency of the system, but also ensures the accuracy and reliability of the analysis results.
[0044] In some embodiments, the clinical laboratory performance verification intelligent system provided by the present invention is also used for: Modify data according to the parameters entered by the user and automatically generate the corresponding R language code text; The R language code is called by a Java program to analyze the R language code text and dynamically adjust parameters.
[0045] Specifically, when users modify parameters in the system front end, they modify data according to the parameters entered by the users, and the system will automatically generate corresponding R language code texts, which contain the parameters specified by the users, and dynamically call the R language code for analysis through the Java program in the background, thereby dynamically adjusting the parameters. This not only reduces the complexity of manual code writing and adjustment by users, but also improves the flexibility and accuracy of analysis.
[0046] The clinical laboratory performance verification intelligent system provided by the present invention realizes the automatic analysis and dynamic adjustment of parameters by calling the R language code through the Java program, which greatly improves the efficiency and accuracy of clinical laboratory performance verification, reduces human errors, and improves work efficiency and data processing quality.
[0047] In some embodiments, the code structure of the R language is templated.
[0048] Specifically, the system uses a templated R language code structure to automatically generate R language code text containing specific analysis logic according to different analysis requirements (such as comparison analysis, precision analysis, etc.). Users only need to enter relevant parameters, and the system will automatically generate and execute the corresponding R language code to complete data analysis and report generation.
[0049] In some embodiments, the system has built-in multiple performance verification standards (such as EP9-A3, EP15-A3, etc.), and these standards are parameterized. The system automatically selects the appropriate analysis method and executes the corresponding R language code based on the parameters and data entered by the user. The entire process does not require manual intervention, which greatly simplifies the operational process of performance verification.
[0050] In some embodiments, the system automatically generates industry-standard verification reports based on the analysis results of various performance verifications. These reports include detailed data analysis processes, statistical results, and chart displays to ensure that users can clearly understand and use the verification results.
[0051] In some embodiments, the clinical laboratory performance verification intelligent system provided by the present invention adopts the B / S+C / S architecture.
[0052] Specifically, the clinical laboratory performance verification smart system adopts the architecture of browser / server (B / S) and client / server (C / S). Among them, the B side is mainly used for data management and result display; the S side is mainly responsible for business logic processing, data storage and interface support for the B side and C side; the C side mainly obtains verification plan information from the S side, and automatically retrieves samples that meet the plan requirements according to the plan data, then automatically sends the sample verification experiment task, and automatically drives the assembly line instruments to perform verification experiments.
[0053] The entire process only requires experimental design on the B side. The subsequent process of screening samples, driving instruments to conduct experiments, acquiring and analyzing experimental result data, and generating verification reports can be completed automatically by the system without human intervention.
[0054] The clinical laboratory performance verification intelligent system provided by the present invention has the following technical advantages: (1) Improved the efficiency of performance verification and reduced manual operation time
[0055] The system greatly shortens the cycle of laboratory performance verification through automated and intelligent data processing and analysis. Users only need to set parameters and upload data on the system, and the rest of the analysis and report generation are automatically completed by the system, significantly reducing manual operation time.
[0056] (2) Reduce the impact of human factors on verification results and improve the accuracy and reliability of verification results
[0057] Through automated data analysis and standardized processing procedures, the system effectively reduces the impact of human operation errors and subjective judgment on verification results. The use of R language for complex data calculation and analysis ensures the scientificity and consistency of the results and improves the accuracy and reliability of the verification results.
[0058] (3) Rapidly generate standardized verification reports to facilitate laboratory management and review
[0059] The system can automatically generate detailed reports that meet industry standards based on the analysis results of various performance verifications. These reports include data analysis process, statistical results and chart presentations, with standardized and unified formats, which facilitates laboratory management and review, and improves work efficiency and information transparency.
[0060] (4) Integrate multiple performance verification functions to provide a one-stop solution
[0061] The system integrates five functional modules: comparison analysis, precision analysis, linear analysis, dilution verification and reference interval verification, providing comprehensive performance verification services. Users can complete all verification work on one system without using multiple software and tools, which greatly simplifies the operation process and improves overall work efficiency.
[0062] (5) Flexible parameter adjustment and dynamic analysis capabilities
[0063] The system uses Java programs to call R language codes and uses text generation to dynamically modify variable parameters, achieving flexible parameter adjustment and real-time analysis. Users can quickly adjust the verification plan according to actual needs, and the system automatically updates the analysis logic and results to ensure the flexibility and adaptability of the verification process.
[0064] (6) Optimizing the use of experimental resources
[0065] The system automatically selects appropriate samples and drives the experimental instruments for verification, maximizing the use of experimental resources and reducing the waste of samples and reagents. At the same time, the automated process ensures the precise execution of each step, improving the efficiency of the use of experimental resources.
[0066] In summary, the clinical laboratory performance verification intelligent system provided by the present invention significantly improves the efficiency and accuracy of performance verification through integrated, automated and intelligent design, reduces the complexity and errors of manual operations, provides a convenient and fast one-stop solution, and greatly optimizes the laboratory management and audit process.
[0067] The clinical laboratory performance verification intelligent system provided by the present invention has high flexibility and scalability, and can integrate other performance verification functions to meet a wider range of laboratory needs. The following are some feasible expansion solutions: (1) Methodological comparison: The system can integrate methodological comparison functions to evaluate the consistency and comparability between different detection methods. Through automated data collection and analysis, a detailed comparison report is generated, including parameters such as bias, precision, and linear range of each method, to help laboratories select the most suitable detection method.
[0068] (2) Measurement uncertainty assessment: The system can integrate the measurement uncertainty assessment function to automatically calculate the measurement uncertainty of each test item. It uses standardized methods to perform uncertainty analysis and generate detailed assessment reports to help laboratories understand and control measurement uncertainty and improve the reliability of test results.
[0069] (3) Customized verification function modules: According to user needs, the system can customize and develop different verification function modules to provide personalized solutions. Users can submit customized requirements through the system interface, and the development team will develop and integrate modules according to the requirements to realize the automated verification process for specific laboratory needs and improve work efficiency and data processing capabilities.
[0070] (4) Advanced data analysis and reporting functions: The system can integrate advanced data analysis functions, such as multivariate regression analysis, cluster analysis, etc., to meet more complex analysis needs. It provides a variety of report generation options, including custom report templates, charts and visualization tools, and supports multiple data export formats, which facilitates users to conduct further analysis and data sharing.
[0071] (5) Real-time monitoring and early warning system: The system can integrate real-time monitoring functions to track the experimental process and data changes in real time. An early warning mechanism is established to automatically send early warning information when abnormal test results appear, helping laboratories to discover and solve problems in a timely manner and improve the safety and reliability of the test process.
[0072] (6) Cross-system integration and data sharing: The system supports integration with other laboratory information management systems (LIMS) and electronic medical records (EMR) to achieve seamless data transmission and sharing. It provides an API interface to facilitate integration with other systems, promote data interoperability and collaborative work, and improve the laboratory's data management level.
[0073] Finally, it should be noted that the above embodiments are only used to illustrate the technical solutions of the present invention, rather than to limit it. Although the present invention has been described in detail with reference to the aforementioned embodiments, those skilled in the art should understand that they can still modify the technical solutions described in the aforementioned embodiments, or make equivalent replacements for some of the technical features therein. However, these modifications or replacements do not deviate the essence of the corresponding technical solutions from the spirit and scope of the technical solutions of the embodiments of the present invention.
Claims
1. A clinical laboratory performance verification intelligent system, characterized in that: include: Comparison analysis module, precision analysis module, linear analysis module, dilution verification module and reference interval verification module; The comparison analysis module is used to obtain the comparison strategy formulated by the user according to the comparison analysis template; select the target comparison sample according to the comparison strategy and the sample data distribution map; execute the comparison strategy on the target comparison sample and generate a comparison report; The precision analysis module is used to obtain a first data file uploaded by a user according to a preset precision analysis template, perform precision analysis on the first data file, and generate a precision analysis report; The linear analysis module is used to obtain a second data file uploaded by a user according to a preset linear analysis template, automatically perform linear analysis on the second data file, and generate a linear analysis report; The dilution verification module is used to obtain a third data file uploaded by a user according to a preset dilution verification template, automatically perform dilution verification analysis on the third data file, and generate a dilution verification report; The reference interval verification module obtains a fourth data file uploaded by a user according to a preset reference interval verification template, automatically performs reference interval verification analysis on the fourth data file, and generates a reference interval verification report.
2. The clinical laboratory performance verification intelligent system according to claim 1, characterized in that: The precision analysis module is used to perform precision analysis on the first data file and generate a precision analysis report, including: The precision analysis module is used to remove abnormal values in the first data file based on the Grubbs method, and calculate precision-related parameters for the remaining data in the first data file; Compare the calculated precision-related parameters with the precision-related parameters claimed by the reagent manufacturer, and determine whether the precision verification has been passed based on the comparison results; In the case where the precision verification fails, the UVL value of the claimed precision-related parameters is automatically calculated based on the preset precision parameter table; Whether the precision verification is passed is determined based on the calculated precision-related parameters and the UVL value.
3. The clinical laboratory performance verification intelligent system according to claim 1, characterized in that: The reference interval verification module is used to automatically perform reference interval verification analysis on the fourth data file and generate a reference interval verification report, including: The reference interval verification module is used to automatically identify and remove outliers in the fourth data file based on the Tukey method; Calculate the ratio of the remaining data in the fourth data file to the inside and outside reference intervals; A reference interval verification report is generated based on the ratio inside and outside the reference interval.
4. The clinical laboratory performance verification intelligent system according to claim 1, characterized in that: The system is developed using Java and R languages.
5. The clinical laboratory performance verification intelligent system according to claim 4, characterized in that: The system is also used to: Modify data according to the parameters entered by the user and automatically generate the corresponding R language code text; The R language code is called by a Java program to analyze the R language code text and dynamically adjust parameters.
6. The clinical laboratory performance verification intelligent system according to claim 4, characterized in that: The code structure of the R language is templated.
7. The clinical laboratory performance verification intelligent system according to claim 1, characterized in that: The system adopts the B / S+C / S architecture.