中文简体First global report｜AI-PBRTQC Realize intelligent real-time quality control of Tang sieve detection
Source of the article: Journal of Clinical Laboratory Analysis, 2024; 0: e25019
author: Yang Xuran Chen Qianlan Pan Zhifeng Cheng Jingmao Zheng Wenting Liang Yingliang Chen Hui Wang Wandang*
Corresponding author email: wangwandang@126. com
summary
Recommended points
This study is based on Senxu Medical AI of PBRTQC Intelligent real-time quality control platform, Establish the most advanced artificial intelligence based system PBRTQC model, The system is capable of real-time operation, Accuracy and stability of five key serum analytes in dynamic monitoring of pregnant women's serum screening results. This study demonstrates the application of artificial intelligence PBRTQC The performance of the model in serum screening for Down syndrome, traditional PBRTQC Compared to models, Based on artificial intelligence PBRTQC The model has higher sensitivity and accuracy in identifying and analyzing quality errors. This innovative method not only improves the quality of serum screening for Down syndrome, It also provides new ideas for quality control of other quantitative laboratory projects.
Research through collection 2021 year 1 moon 4 Solstice 9 moon 7 Measurement data and related routine indoor quality control of Down syndrome serum screening project in Japan (IQC) data, Professor team from Zhongshan Xiaolan People's Hospital discusses artificial intelligence based PBRTQC The model has undergone a comprehensive evaluation. The research results indicate that, By combining with traditional indoor quality control methods, Based on artificial intelligence PBRTQC EWMA The model can reflect the quality risk of detection in a real and timely manner, Becoming a good supplementary quality control tool for Down syndrome serum screening and testing projects. Moreover, This model can also quickly identify instrument faults, Quality risks caused by issues with the quality of quality control products, Realize intelligent monitoring and early warning throughout the entire time period. These achievements are attributed to Sen Xu AI-MA The widespread application of intelligent real-time quality control platform in clinical laboratory quality management has laid a solid foundation.
Research Background
Down syndrome (DS) , also known as 21 Trisomy syndrome, It is the most common chromosomal aneuploidy disease among live born infants, The birth incidence rate rate worldwide is about 1%, And there is currently no effective treatment method available. Therefore, Prenatal serum screening has become an important means of detecting Down syndrome fetuses. Indoor quality control isThe most common quality control tool, Used for monitoring routine experimentsPerformance of. however, Traditional indoor quality control methods have many limitations in monitoring and analyzing quality, Like matrix effect, Non interchangeability, poor stability, Inappropriate detection range and discontinuous quality monitoring, etc, This may result in false positives or inability to quickly detect the true alarm, The final impact on the accuracy of the detection results.
Hoffman and Waid Early on 1965 It is recommended to PBRTQC AON Supplementary quality control methods for clinical testing, But many clinical laboratories do not use this method, Mainly because establishing these specific programs is considered complex, And if there is no software with specific functions, It cannot be applied in practice. However, given the importance of maternal serum screening, In this study, we attempted for the first time to use artificial intelligence software to construct a PBRTQC program, To continuously monitor the quality of maternal serum screening testing, Thus, by combining with indoor quality control methods, the accuracy of maternal serum screening can be improved.
Real time quality control based on patient data (PBRTQC) It is a method of using patient clinical specimen testing results in real-time, continuous, Quality control methods for dynamic monitoring and analysis of quality errors and analytical performance throughout the entire process. IFCC International guidelines suggest that clinical laboratories should be widely used PBRTQC Innovative methods, It's traditionalIQCA good supplement to the method, It is a new quality control strategy based on patient risk management. International Federation of Clinical Chemistry (IFCC) Laboratory Medicine PBRTQC The working group suggests using it in medical laboratories PBRTQC method, traditionalIQCCompared to other methods, PBRTQC Has many advantages: Continuous quality control of the entire testing system, No matrix effect, No additional cost, More sensitive to identifying pre analysis errors, Can be used for monitoring the detection of materials without quality control, etc.
Research purpose
This study aims to utilize artificial intelligence technology to construct real-time quality control based on patient data (PBRTQC) program, To continuously monitor the quality of maternal serum screening testing, Thus, through andIQCCombining methods to improve detection accuracy, This study is conducted by Sen Xu AI-MA The practical application of intelligent real-time quality control platform in monitoring quality risks in clinical laboratories provides strong data support and practical experience.
research findings
1, This study is conducted in Senxu AI-MA The optimal real-time quality control platform has been established on the intelligent platform PBRTQC EWMA and MA model. The comparison results show that, Under the rules of intelligent monitoring platform EWMA The program has the best quality control efficiency (See figure 1, picture 2)
picture 1: AI-MA Joint intelligent real-time quality control platform PBRTQC EWMA Quality control chart and indoor quality control chart of quality control products Z Score chart.
picture 2: based on AI-MA The construction of an intelligent real-time quality control platform PBRTQC Exponential weighted moving average method (EWMA) And the moving average method (MA) Comparison of Programs.
2, optimal PBRTQC EWMA The law accurately provides warning signals before instrument malfunctions occur. Sen Xu AI-MA Intelligent real-time quality control platform detected 2021 year 6 moon 18 day-23 Early screening of serological indicators with negative bias warning. Reviewing the analysis, it was found that the reagent dispensing robotic arm on the left side of the machine is 2021 year 6 moon 18 Daily malfunction, Causing interruption of the experiment; 6 moon 23 day, Mechanical arm repair, But poor sealing was found when adding reagents, therefore 6 moon 23 Change the experimental procedure in the future, Change to using the right robotic arm to add reagents, The alarm signal is subsequently released. at the same time, Discovered during the experiment 2021 year 6 moon 24 Solstice 7 moon 1 There are early risk warning signals for serological indicators during mid-term screening between days, Analysis shows that, The sample probe has positional deviation and wear blockage, in 7 moon 8 After installing a new sample probe and readjusting the testing program parameters, The deviation has been corrected. Combining actual warning events, Sen Xu AI-MA The intelligent real-time quality control platform can provide accurate warning signals. Moreover, During the warning period, IQC No quality alert triggered, This also proves PBRTQC Can be used as a traditional IQC Supplementary quality control tools, Used for monitoring and analyzing the stability of performance analysis throughout the entire process (See figure 3) .
picture 3: AI-MA The best intelligent real-time quality control platform PBRTQC EWMA The program can intelligently warn of system error results.
3, inAI-MA Application in Intelligent Real time Quality Control Platform PBRTQC EWMA Method helps to monitor and detect quality when traditional quality control products are unstable, Ensure the effectiveness of decision-making. In the actual experimental process, There will be instances where the quality control product level exceeds the standard 1-3S The situation of quality control rules, But in subsequent comparative experiments, it was found that, The patient's experimental results are good. Investigation and discovery, The loss of control of such quality control products may be due to the packaged quality control products being-30°C Errors caused by prolonged storage time, But PBRTQC EWMA The law can truly reflect the stability of the detection system during this process, Help clinical quickly judge the quality of testing, Improve the speed of report review (See figure 4) .
picture 4: PAPP-A Indoor quality control (IQC) The point of losing control is z Display in the score chart, Represented by the triangle circled in red IQC The point of losing control.
4, AI-MA In the intelligent real-time quality control platform PBRTQC EWMA The method helps to monitor the accuracy of detection results when the concentration of traditional quality control products is inappropriate. In this study, The laboratory is used for prenatal screening during the second trimester of pregnancy m-β-HCG The clinical concentration range is 3. 5 to 29. 5ng/ml, The corresponding minimum concentration level for quality control products is about 80ng/mL, latest batch (89400) Even up to 120ng/mL, And based on patient dataAI-MA The intelligent real-time quality control platform has become a great tool for supplementing quality control products, The concentration range that cannot be monitored by quality control products, Helps to conduct genuine monitoring and reflect the quality of testing (See figure 5) .
picture 5: The actual concentration distribution range of patient detection data and corresponding indoor quality control (IQC) Concentration distribution of data. The actual patient (A) m-β-HCG and (B) uE3 The concentration frequency distribution chart. Corresponding to quality control products (C) m-β-HCG and (D) uE3 Level concentration; L1, L2 and L3 represent IQC The three concentration levels; Lot. 1 and Lot. 2 Each represents the indoor quality control batch number 39190 and 89400. (E) m-β-HCG and (F) uE3 in AI-MA The optimal one established in the platform PBRTQC EWMA program z Score chart.
research findings
In recent years, With the continuous improvement of laboratory information systems and artificial intelligence+The development of big data technology, target, aim at, address, focus on, in response to PBRTQC The professional software for the model has been developed and improved, promoted PBRTQC Application in clinical quality management. however, PBRTQC The application still faces many challenges in reality, as PBRTQC Selection and establishment of programs, Performance validation and optimization, And how to achieve dynamic and continuous monitoring. Therefore, Badrick Suggestions from others, It is necessary to transform the statistical process into artificial intelligence methods, Applied to PBRTQC. Rossum Also suggested, When IQC inefficient, Should be used PBRTQC Method for inspection and testing. Research shows, AI-MA Intelligent real-time quality control platform, In case of instrument malfunction, Unstable quality control products, When the concentration range of quality control products cannot be monitored, it helps to monitor the quality of testing, thanHigher program efficiency under traditional quality control rules, Can truly and timely reflect the quality risks of testing, It is a good quality control supplement tool for serum screening of Down syndrome, In general, PBRTQC The application can more effectively establish and select the best model for the laboratory. Successful Practice of Xiaolan People's Hospital in Clinical Laboratory Quality Control in Zhongshan City, Further promoted PBRTQC Widely used, It also provides valuable experience and reference for quality management and technological innovation in clinical laboratories. With the continuous development of artificial intelligence technology, The field of medical testing is gradually moving towards a new stage, The quality control revolution led by artificial intelligence will bring higher quality medical services to patients. Expert team of Xiaolan People's Hospital in Zhongshan City
Professor Chen Hui, Director of the Science and Education Department of Xiaolan People's Hospital in Zhongshan City
Chief Technician, Formerly served as the director of the laboratory department, Current Director of Science and Education Department. Engaged in medical laboratory work 23 year, Established with PCR technology, high-throughput sequencing , Precision Medicine Center with Nucleic Acid Mass Spectrometry Technology and Liquid Phase Chip Technology as the Main Platforms, Promote the rapid development of hospital scientific research work. Member of the Medical Genomics and Bioinformatics Professional Committee of the China Medical Education Association, Member of the Molecular Diagnosis Professional Committee of the Laboratory Medicine Branch of the Norman Bethune Spirit Research Association, Vice President of the Smart Inspection Branch of Guangdong Health Information Network Association, Member of the Standing Committee of the Laboratory Medicine Professional Committee of Guangdong Clinical Medical Association, Executive Committee Member of the Laboratory Medicine Professional Committee of Guangdong Medical Education Association, Member of the Standing Committee of the Precision Testing Branch of Guangdong Precision Medicine Application Society, Executive Committee Member of the Inspection Professional Committee of Guangdong Grassroots Medical Association, Vice Chairman of the Clinical Laboratory Management Professional Committee of Zhongshan Hospital Association, etc, Host and participate in the province, More than ten municipal level scientific research projects, Published over 20 professional academic papers as first author and corresponding author, Participate in the writing of monographs 1 ministry, Group Standard 2 item, Hosted at the national level, Nearly ten provincial and municipal continuing education projects.
Professor Zheng Wenting, Director of the Laboratory Department of Xiaolan People's Hospital in Zhongshan City
Chief Technician, Testing physician, Director of Laboratory Department, Xiaolan People's Hospital, Zhongshan City, National Youth Civilization Leader, Member of the Maternal and Child Health Management Branch of the Chinese Eugenics Association, Executive Committee Member of the Smart Inspection Branch of Guangdong Health Information Network Association, Executive Committee Member of the Laboratory Medicine Transformation and Innovation Professional Committee of Guangdong Preventive Medicine Association, Executive member of the Innovation and Transformation Professional Committee of Laboratory Medicine of Guangdong Health Management Society, Member of the Maternal and Child Prevention and Treatment Group of the Laboratory Medicine Branch of Guangdong Medical Association, Member of the Inspection Professional Committee Branch of Guangdong Medical Association, Executive Committee Member of the Prenatal Diagnosis Professional Committee of Zhongshan Medical Association, Executive Committee Member of the Inspection Professional Committee Branch of Zhongshan Medical Association, Executive Committee Member of Clinical Laboratory Management Professional Committee of Zhongshan Hospital Association, Member of the Expert Database for the Supervision of Xiaolan Town Medical Security Fund. Participated in national and provincial inspections multiple times, Prenatal Diagnosis Seminar, Publish professional papers 17 remaining articles, Lead or participate in scientific research projects 7 item. Certified Medical Practitioner, Genetic counseling, Maternal and Child Health Care (Cellular Genetics) , Pre marital and pre pregnancy health care work, Laboratory Biosafety Officer, Medical laboratory auditor, National Resident Physician Training Backbone Teachers, HIV Technical operation and other qualification certificates. In Cytogenetics, Clinical biochemical testing, Has rich experience in laboratory tests such as clinical immunological testing and clinical applications, Proficient in various theoretical knowledge of clinical medical laboratory testing techniques.
Professor Wang Wandang from the Laboratory Department of Xiaolan People's Hospital in Zhongshan City
Associate Chief Technologist, Master's degree candidate, United States UIC visiting scholar, 2019 I went to Guangdong Maternal and Child Health Hospital for further studies in molecular genetics, Serving as the Teaching Director of the Laboratory Teaching and Research Office at Xiaolan People's Hospital in Zhongshan City. Since starting work, I have mainly been engaged in precision medicine laboratory diagnosis, Good at molecular diagnosis of infectious diseases, Prenatal genetic molecular diagnosis and immune function assessment, etc. In the past five years, as the first or communication author PNAS, MI, Frontiers in Immunology Waiting for publication in journals SCI research article 10 remaining articles. Hosted or primarily participated in the establishment of the Guangdong Medical Research Fund 1 item, Guangdong Province Teaching Reform Project Approval 1 item, Major Projects of Zhongshan Science and Technology Bureau 1 item, General Projects of Zhongshan Science and Technology Bureau 3 item, Research project approved by Zhongshan Health Bureau 3 item.
Yang Xuran, Department of Laboratory Medicine, Xiaolan People's Hospital, Zhongshan City
Senior Technician, Master's degree candidate, Teaching Secretary of the Laboratory Teaching and Research Office of Xiaolan People's Hospital in Zhongshan City. Since starting work, I have mainly been engaged in laboratory work related to Down syndrome screening, Yu 2018 I went to Guangdong Maternal and Child Health Hospital for further studies on newborn genetic metabolic disease screening and prenatal screening. In the past five years, as the first author MOLECULAR IMMUNOLOGY, Frontiers in Bioengineering and Biotechnology Waiting for publication in journals SCI paper 5 piece, Hosted and primarily participated in scientific research projects 3 item.
Zhongshan Xiaolan People's Hospital, Sen Xu AI-MA Clinical application of intelligent real-time quality control platform
Professor Chen Hui, Director of the Science and Education Department at Xiaolan People's Hospital in Zhongshan City, Under the leadership of Professor Zheng Wenting, Director of the Laboratory Department, Based on Senxu AI-MA The intelligent real-time quality control platform has been established: ※23 platforminstrument ※3 aprofessional group ※247 aproject ※494 abased on AI of PBRTQC Real time quality control intelligent monitoring model ※896 abased on AI of PBRTQC Intelligent comparison model Based on Senxu AI-PBRTQC Intelligent real-time quality control is used to analyze the performance stability of various professional groups' testing systems in the entire laboratory, Real time intelligent monitoring of the consistency of instrument inspection results and patient quality risk analysis throughout the entire process. Hospitals have found in clinical applications, Sen Xu AI-MA The intelligent real-time quality control platform demonstrates its advantages in laboratory quality risk management, The system can more accurately identify potential quality risks, And achieve early warning, This greatly improves the reliability and accuracy of the detection results. Sen Xu AI-MA The intelligent real-time quality control platform not only improves the overall inspection and testing level, It also provides solid technical support for building high-quality clinical laboratories, Hospitals have taken a solid step on the road to improving the quality of medical services.
Introduction to the Laboratory Department of Xiaolan People's Hospital in Zhongshan City
Department of Laboratory Medicine, Xiaolan People's Hospital, Zhongshan City, awarded "National Youth Civilization Number" , Guangdong Advanced Standardized Laboratory for Sexually Transmitted Diseases, Guangdong Province "Model of the May Fourth Red Flag Youth League Branch" Zhongshan City "Key medical specialties during the 14th Five Year Plan period" Waiting for titles, is "National Bacterial Resistance Testing Network Testing Unit" , "Monitoring units of the National Fungal Disease Monitoring Network" , "Guangdong Province Community Drug Resistance Monitoring Demonstration Base" , "The Pearl River Specialized Medical Alliance" , "Deaf gene testing base" and "Guangdong Medical Laboratory Clinical Medical Research Center County Regional Construction Unit" , Always uphold "Quality first, rigorous and truth-seeking, Enthusiastic Service" , Provide accurate and timely test results for clinical practice, Provide high-quality and professional services to the vast number of patients"As a guideline, Established a standardized and effective quality management system, Implemented the informatization of the entire inspection process, networked, intelligentization, Ensuring the accuracy of every result.
All members of the laboratory actively practice, explore PBRTQC The best model and its precise operation in clinical applications, This process not only deepened the team's understanding PBRTQC Theoretical understanding, It also promotes effective implementation in practical work, This demonstrates the excellent ability of the inspection team in technological innovation and their relentless pursuit of high-quality services. believe, With Senxu AI-MA Promotion and use of intelligent real-time quality control platform in clinical laboratories, Will enhance the overall level of the domestic medical testing industry, promote PBRTQC The recognition and development of concepts and technologies in China and even internationally.
Introduction to Xiaolan People's Hospital in Zhongshan City
Zhongshan Xiaolan People's Hospital (Zhongshan Fifth People's Hospital) Located in the beautiful northwest of Zhongshan City "Jucheng" - Xiaolan, was built in 1907 year, It is a century old institution, It is also a medical institution, teaching, A comprehensive tertiary Grade A hospital integrating scientific research and preventive healthcare. 2011 In the year, the hospital became the first town owned hospital in China "top three" hospital, 2022 year 9 moon, The hospital has been identified as the Zhongshan Regional Central Hospital, 2023 year 8 moon, Formally became the Fifth People's Hospital of Zhongshan City. The hospital is responsible for the northwest region of Zhongshan City and Jiangmen, Shunde and other surrounding cities, Near the town area 130 Urgent and critical illness affecting tens of thousands of people, complex, Difficult disease treatment task, It is a trustworthy large hospital in the mouths of the common people. The hospital occupies a total area of land 173 mu, Gross floor area approximately 22 ten thousand㎡, Established internally, outside, woman, Wait, wait 7 large system, establish 10 An internal institution and 64 A business department, "the 14th Five-Year Plan" Having obstetrics during this period, Department of Neurology, Inspection department, etc 3 Key specialized colleges in a city, Municipal characteristic specialty 19 a, Open beds approximately 1350 Zhang, Annual usage rate exceeds 95%. 2023 Annual outpatient and emergency service volume 182. 32 Ten thousand people, discharge 6. 75 Ten thousand people, Inpatient surgery 4. 11 Ten thousand people, among which CD Proportion of Type A Cases 74. 41%, Proportion of third - and fourth level surgeries 44. 64%. Hospitals integrate disciplinary advantages, Emphasis has been placed on building a national level chest pain center, Stroke Center, Trauma Center, Critical Maternal and Child Care Center, Five major centers including the Critical Care Children and Neonatal Treatment Center, Comprehensive strength ranks among the top in the city. In terms of medical technology, The hospital is equipped with 256 Spiral arrangement CT, SPECT/CT, 3. 0T Nuclear Magnetic Resonance, linear accelerator, Digital subtraction angiography system (DSA) Waiting for equipment, Successively carried out radioactive particle implantation technology, Extracorporeal membrane oxygenation (ECMO) technology, Structural tissue transplantation technology of allogeneic motor system, Multiple national level restricted technologies such as tumor ablation therapy, Interventional therapy techniques, Endoscopic diagnosis and treatment technology, Multiple Guangdong Province restricted technologies such as arthroscopy and joint replacement surgery. 2024 year 6 The Heart Center was established in the month, Breaking down the disciplinary barriers of various specialties within the institution, Establish including pre hospital facilities, In the courtyard, Integration after the hospital, Full lifecycle medical service model, with "one-stop" Hybrid surgical mode for treating coronary heart disease, chd , Heart diseases such as aortic disease and arrhythmia, Currently underway 30 Example of cardiac surgery, Immediate extubation rate after surgery 96%, cure rate 100%, Filling the gap in cardiac surgery in the northwest region of Zhongshan City. In the past two years, Our hospital is developing new technologies, New project agreement 260 item. In terms of scientific and educational construction, The hospital has been approved as a national standardized training collaborative base for physicians, Precision medicine centers and clinical trial institutions (GCP) The progress of various projects carried out is good. In the past five years, the hospital has received scientific research projects at all levels 286 item, Utility model patent 36 item, Publish papers in domestic core journals 249 piece, SCI Journal paper 40 piece, Accumulated impact factors reach 286. 17. In terms of talent development, Hospital staff on duty 2039 person, Senior Professional Title Expert 440 name, Master's degree or above 219 name, Chief Expert 6 name, senior expert 1 name. Multiple people have obtained it successively "National Labor Medal " "National Women's Merit Model" "Exemplary individual of National Health System" "Exemplary individual of National Quality Nursing" "Excellent management cadres of hospitals in Guangdong Province" "Guangdong Physician Award" "Famous doctors in Lingnan" "Good doctors in southern Guangdong" Waiting for honorary titles, The hospital has also won numerous awards "Top 100 Excellent Baby Friendly Hospitals in China" "National Youth Civilization Number" "County level counties in Guangdong Province (district) Excellent hospital management team" Waiting for Honor. Passing on the torch from generation to generation for a hundred years, Continuing the journey of progress. On a new journey, The hospital will focus on infrastructure, talent pool, medical technology, Research level, Continuously strengthen service capabilities and other aspects, Strive to provide comprehensive services for the people, Health services throughout the entire lifecycle.
