{"title":"The role of AI in pre-analytical phase - use cases.","authors":"Hikmet Can Çubukçu","doi":"10.1515/cclm-2025-1220","DOIUrl":null,"url":null,"abstract":"<p><p>The pre-analytical phase of laboratory testing, encompassing processes from test ordering to sample analysis, represents the most error-prone component of laboratory medicine, accounting for 68-98 % of laboratory mistakes. These errors compromise patient safety, increase healthcare costs, and disrupt operational efficiency. Artificial intelligence (AI) and machine learning (ML) technologies have emerged as promising solutions to address these challenges across multiple pre-analytical applications. This narrative review examines current AI research applications and commercial implementations across seven key pre-analytical domains: clot detection, wrong blood in tube (WBIT) error detection, sample dilution management, chemical manipulation detection in urine samples, serum quality assessment based on hemolysis/icterus/lipemia (HIL), test utilization optimization, and automated tube handling. Research studies demonstrate impressive performance, with neural networks achieving accuracies exceeding 95 % for clot detection, XGBoost models reaching 98 % accuracy for WBIT detection, and deep learning systems attaining AUCs above 0.94 for test recommendation systems. However, a significant translation gap persists between research prototypes and commercial deployment. Academic models excel at pattern recognition using curated datasets but face limitations including single-center validation, retrospective designs, and integration challenges. Commercial solutions prioritize deterministic controls, barcoding, and sensor-based approaches that ensure reliability and scalability, with limited explicit AI implementation. Successful clinical laboratory translation requires multicenter prospective validation, robust laboratory information system integration, regulatory compliance frameworks, and evaluation metrics focused on operational outcomes rather than solely statistical performance. As infrastructure and standards mature, strategic AI adoption in pre-analytical tasks offers measurable improvements in safety, efficiency, and cost-effectiveness.</p>","PeriodicalId":10390,"journal":{"name":"Clinical chemistry and laboratory medicine","volume":" ","pages":""},"PeriodicalIF":3.7000,"publicationDate":"2025-10-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"Clinical chemistry and laboratory medicine","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1515/cclm-2025-1220","RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q1","JCRName":"MEDICAL LABORATORY TECHNOLOGY","Score":null,"Total":0}
引用次数: 0
Abstract
The pre-analytical phase of laboratory testing, encompassing processes from test ordering to sample analysis, represents the most error-prone component of laboratory medicine, accounting for 68-98 % of laboratory mistakes. These errors compromise patient safety, increase healthcare costs, and disrupt operational efficiency. Artificial intelligence (AI) and machine learning (ML) technologies have emerged as promising solutions to address these challenges across multiple pre-analytical applications. This narrative review examines current AI research applications and commercial implementations across seven key pre-analytical domains: clot detection, wrong blood in tube (WBIT) error detection, sample dilution management, chemical manipulation detection in urine samples, serum quality assessment based on hemolysis/icterus/lipemia (HIL), test utilization optimization, and automated tube handling. Research studies demonstrate impressive performance, with neural networks achieving accuracies exceeding 95 % for clot detection, XGBoost models reaching 98 % accuracy for WBIT detection, and deep learning systems attaining AUCs above 0.94 for test recommendation systems. However, a significant translation gap persists between research prototypes and commercial deployment. Academic models excel at pattern recognition using curated datasets but face limitations including single-center validation, retrospective designs, and integration challenges. Commercial solutions prioritize deterministic controls, barcoding, and sensor-based approaches that ensure reliability and scalability, with limited explicit AI implementation. Successful clinical laboratory translation requires multicenter prospective validation, robust laboratory information system integration, regulatory compliance frameworks, and evaluation metrics focused on operational outcomes rather than solely statistical performance. As infrastructure and standards mature, strategic AI adoption in pre-analytical tasks offers measurable improvements in safety, efficiency, and cost-effectiveness.
期刊介绍:
Clinical Chemistry and Laboratory Medicine (CCLM) publishes articles on novel teaching and training methods applicable to laboratory medicine. CCLM welcomes contributions on the progress in fundamental and applied research and cutting-edge clinical laboratory medicine. It is one of the leading journals in the field, with an impact factor over 3. CCLM is issued monthly, and it is published in print and electronically.
CCLM is the official journal of the European Federation of Clinical Chemistry and Laboratory Medicine (EFLM) and publishes regularly EFLM recommendations and news. CCLM is the official journal of the National Societies from Austria (ÖGLMKC); Belgium (RBSLM); Germany (DGKL); Hungary (MLDT); Ireland (ACBI); Italy (SIBioC); Portugal (SPML); and Slovenia (SZKK); and it is affiliated to AACB (Australia) and SFBC (France).
Topics:
- clinical biochemistry
- clinical genomics and molecular biology
- clinical haematology and coagulation
- clinical immunology and autoimmunity
- clinical microbiology
- drug monitoring and analysis
- evaluation of diagnostic biomarkers
- disease-oriented topics (cardiovascular disease, cancer diagnostics, diabetes)
- new reagents, instrumentation and technologies
- new methodologies
- reference materials and methods
- reference values and decision limits
- quality and safety in laboratory medicine
- translational laboratory medicine
- clinical metrology
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