Critical reviews in clinical laboratory sciences最新文献

{"title":"Sustainability and waste reduction in clinical laboratories.","authors":"Adetoun A Ejilemele, Ila R Singh","doi":"10.1080/10408363.2026.2687509","DOIUrl":"https://doi.org/10.1080/10408363.2026.2687509","url":null,"abstract":"<p><p>Hospitals are major generators of waste, producing an estimated 5.9 million tons of solid waste annually in the United States alone. This burden contributes to environmental pollution, rising operational costs, and downstream health impacts. While operating rooms, food services, and imaging departments have received increasing scrutiny as waste-intensive sectors, clinical laboratories, despite their high energy use, dependence on single-use plastics, and central role in every diagnostic decision, remain comparatively understudied in sustainability research. In this review, we argue that integrating environmental impact into laboratory practice represents the next evolution of quality in laboratory medicine. We propose a workflow-based framework to evaluate waste generation across the full testing continuum, including test ordering, specimen collection, transport, analysis, post-analytical practices, procurement, and accreditation. Drawing on current evidence, case studies, and emerging sustainability programs, we identify practical intervention points and critical knowledge gaps, including the lack of standardized environmental metrics such as waste-per-test, energy-per-test and water-per-test. By treating environmental performance as measurable, comparable and improvable, clinical laboratories can help lead healthcare's broader transition toward high-value, environmentally responsible care while maintaining diagnostic quality and patient-centered care.</p>","PeriodicalId":10760,"journal":{"name":"Critical reviews in clinical laboratory sciences","volume":" ","pages":"1-14"},"PeriodicalIF":6.2,"publicationDate":"2026-06-27","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148338183","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Aptamer-based biosensing strategies for influenza virus detection: a systematic and critical review of electrochemical and optical platforms.","authors":"Amir Hossein Esfandiari, Hamed Afarande, Vahid Reza Amini, Behnaz Hatamluyi, Zahra Meshkat, Aida Gholoobi","doi":"10.1080/10408363.2026.2688519","DOIUrl":"https://doi.org/10.1080/10408363.2026.2688519","url":null,"abstract":"<p><p>Influenza virus remains a major global health challenge due to its genetic variability and frequent emergence of novel strains. Subtyping is determined by the diverse arrangements of hemagglutinin (HA) and neuraminidase (NA) glycoproteins, with HA frequently serving as the molecular target for diagnostic assays. Conventional detection methods, however, are labor-intensive, require specialized expertise, and often lack adaptability to rapidly evolving viral variants. Aptamer-based biosensing technologies have emerged as promising alternatives. Aptamers, synthetic single-stranded DNA or RNA oligonucleotides generated via the Systematic Evolution of Ligands by Exponential Enrichment (SELEX) process, exhibit exceptional specificity and high binding affinity, enabling precise recognition of viral proteins. This systematic and critical review synthesizes recent advances in aptamer-integrated biosensing platforms, focusing on electrochemical and optical detection strategies for influenza virus. By comparing sensitivity, specificity, operational simplicity, and translational potential, this review highlights that electrochemical platforms are better suited for point-of-care use due to their speed and simpler instrumentation, while optical platforms offer superior sensitivity for reference laboratory settings. A key finding is that despite two decades of research and remarkable analytical sensitivity (reaching fg/mL levels), the vast majority of platforms have not been validated on authentic clinical specimens or compared with gold-standard molecular methods, explaining why none have entered routine diagnostic workflows. The analysis provides evidence-based insights into which biosensing strategies are most suitable for the development of rapid, reliable, and scalable diagnostic tools against influenza virus, thereby informing future research directions and clinical translation.</p>","PeriodicalId":10760,"journal":{"name":"Critical reviews in clinical laboratory sciences","volume":" ","pages":"1-25"},"PeriodicalIF":6.2,"publicationDate":"2026-06-23","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148301221","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Advancing patient safety through laboratory quality indicators in clinical pathology.","authors":"Jieli Li","doi":"10.1080/10408363.2026.2678823","DOIUrl":"https://doi.org/10.1080/10408363.2026.2678823","url":null,"abstract":"<p><p>Quality indicators (QIs) are widely used in clinical laboratories to support quality management, patient safety, and regulatory compliance. Although regulatory and accreditation frameworks emphasize the use of QIs across the total testing process, published literature has often focused on analytical performance or discipline-specific approaches. Less attention has been given to how QIs are selected, interpreted, and sustained across the full range of clinical pathology subspecialties in routine practice. This critical review examines the role of quality indicators within clinical pathology laboratories, with emphasis on their selection, implementation, interpretation, and integration into quality management systems. Regulatory and accreditation expectations from CLIA, CAP, ISO 15189, and the Joint Commission are used as contextual anchors. We describe a decision-oriented lifecycle for quality indicators that emphasizes risk-based prioritization, feasibility, actionability, and governance integration. Practical examples of quality indicators spanning the pre-analytical, analytical, and post-analytical phases are presented across multiple subspecialties. Approaches to quality indicator data analysis are discussed, with particular focus on longitudinal, within-laboratory monitoring as a practical strategy for identifying meaningful trends and guiding improvement in diverse practice settings. Quality indicators are most effective when used as adaptive management tools rather than static compliance measures. Their value depends on thoughtful selection aligned with patient risk and laboratory scope, consistent interpretation within local context, and sustained linkage to corrective and preventive action. By adopting a discipline-aware, practice-focused approach, clinical pathology laboratories can use quality indicators to support continuous improvement, enhance patient safety, and meet regulatory and accreditation expectations across evolving healthcare environments.</p>","PeriodicalId":10760,"journal":{"name":"Critical reviews in clinical laboratory sciences","volume":" ","pages":"1-11"},"PeriodicalIF":5.5,"publicationDate":"2026-06-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148155826","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Omics-based computational approaches for biomarker identification, prediction, and treatment of Long COVID.","authors":"Sindy Pinero, Xiaomei Li, Junpeng Zhang, Marnie Winter, Sang Hong Lee, Thin Nguyen, Lin Liu, Jiuyong Li, Thuc Duy Le","doi":"10.1080/10408363.2025.2583083","DOIUrl":"10.1080/10408363.2025.2583083","url":null,"abstract":"&lt;p&gt;&lt;p&gt;Long COVID, or post-acute sequelae of COVID-19 (PASC), is a major global health problem, with cumulative estimates suggesting that around 400 million people worldwide have been affected. It is characterized by persistent or new symptoms such as fatigue, cognitive impairment, and breathlessness lasting beyond four weeks after acute infection. Diverse clinical manifestations, chronic course, and incompletely understood pathophysiology-including hypotheses involving viral persistence, immune dysregulation, autoimmunity, endothelial dysfunction, and metabolic reprogramming-impede the development of diagnostic criteria, biomarkers, and targeted therapies. We conducted a critical review of 101 Long COVID omics studies, focusing on the computational methods used and their methodological quality. Using standardized criteria, we evaluated study design, statistical rigor, reproducibility, and clinical relevance across genomics, epigenomics, transcriptomics, proteomics, metabolomics, and multiomics integration, and mapped these findings onto regulatory and translational frameworks. Despite substantial methodological heterogeneity, convergent biological signals emerged. Genomic studies implicate risk loci in immune and cardiopulmonary pathways. Epigenomic analyses identify differentially methylated regions in immune and circadian genes. Transcriptomic studies reveal persistent dysregulation of innate immune and coagulation pathways, as well as reproducible molecular endotypes. Proteomic studies consistently show abnormalities in the complement cascade and coagulation, with a small panel of complement proteins showing highly reproducible changes across independent cohorts. Metabolomic studies demonstrate sustained mitochondrial dysfunction and altered cellular bioenergetics for up to two years after infection. Multiomics integration supports at least two major endotypes, characterized by predominant inflammatory versus metabolic dysregulation, and provides a basis for patient stratification and computational treatment discovery. Machine learning models frequently achieve high classification performance, but are rarely externally validated. Critical limitations restrict clinical translation. Most studies are underpowered relative to analytical complexity, use heterogeneous case definitions and controls, and report platform-specific signatures with limited overlap. External validation, preregistered analysis plans, and regulatory-aligned assay development are uncommon. To date, no regulatory-approved diagnostic assay or evidence-based therapeutic intervention has directly emerged from these computational findings. Future progress requires harmonized phenotyping protocols, adequately powered longitudinal cohorts with external validation, integration of spatial omics and explainable artificial intelligence, and early engagement with regulatory and health-technology assessment pathways. This review provides a critical assessment and a translational roadmap, ","PeriodicalId":10760,"journal":{"name":"Critical reviews in clinical laboratory sciences","volume":" ","pages":"332-358"},"PeriodicalIF":5.5,"publicationDate":"2026-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145713614","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Uncovering hidden connections: the role of the male reproductive system microbiome and gut microorganisms in implantation: a critical review.","authors":"Magdalena Jendraszak, Mirosław Andrusiewicz","doi":"10.1080/10408363.2025.2562894","DOIUrl":"10.1080/10408363.2025.2562894","url":null,"abstract":"&lt;p&gt;&lt;p&gt;Recent advancements in sequencing technologies have uncovered complex and diverse microbial communities inhabiting various niches of the human body, including the reproductive system. This review explores the significance of the male genital and gut microbiomes in maintaining reproductive health, focusing on their potential roles in embryo implantation and pregnancy outcomes. A comprehensive literature search was conducted using MEDLINE, Web of Science, and Scopus for articles published between 2004 and 2024. Search terms included \"microbiome,\" \"implantation,\" \"inflammation,\" \"male reproductive system,\" \"recurrent miscarriage,\" \"recurrent implantation failure,\" and \"probiotics.\" From an initial pool of 1,091 articles, 107 were selected after applying filters for clinical, comparative, and observational studies. Ultimately, 21 articles met the quality criteria and were included in the review. While the female genital microbiome has been extensively studied and its role in implantation and embryo development well established, research on the male genital microbiome remains limited, and its influence is not yet fully understood. Nevertheless, emerging data suggest that the male reproductive tract harbors its own distinct microbial community, which may affect fertility, implantation, and pregnancy outcomes. The presence of certain bacteria and leukocytes in semen has been associated with sperm DNA damage, potentially compromising fertility and embryo development. Moreover, microbial exchange between partners during intercourse may alter the composition of the female reproductive microbiome, potentially influencing implantation success. The male and female reproductive tracts are colonized by microbial communities that play crucial roles in preventing infections and supporting reproductive health. Disruptions in these ecosystems have been linked to infertility, miscarriage, and preterm birth. Additionally, the gut microbiome is believed to interact with the reproductive system, possibly influencing implantation through immune and metabolic pathways. A deeper understanding of these connections is essential for identifying new preventive and therapeutic strategies for individuals experiencing recurrent pregnancy loss or implantation failure. Identifying specific microbial patterns associated with dysbiosis is critical for the development of targeted interventions. Potential therapeutic approaches include probiotics, prebiotics, and antibiotics, which may help restore microbial balance, enhance fertility, and reduce the risk of miscarriage. Antibiotic treatment may also prove beneficial in addressing infections that disrupt implantation. As microbial exchange, sperm DNA integrity, and immune regulation are all influenced by the microbiome, further research is necessary to understand its role in reproductive outcomes fully. Microbiome-targeted therapies represent a promising frontier in reproductive medicine. However, their clinical efficacy must be","PeriodicalId":10760,"journal":{"name":"Critical reviews in clinical laboratory sciences","volume":" ","pages":"359-389"},"PeriodicalIF":5.5,"publicationDate":"2026-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145231647","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Parallelism in neurodegenerative biomarker tests: hidden errors and the risk of misconduct.","authors":"A Petzold, Joachim Pum, David P Crabb","doi":"10.1080/10408363.2025.2583078","DOIUrl":"10.1080/10408363.2025.2583078","url":null,"abstract":"<p><p>Biomarkers are critical tools in the diagnosis and monitoring of neurodegenerative diseases. Reliable quantification depends on assay validity, especially the demonstration of parallelism between diluted biological samples and the assay's standard curve. Inadequate parallelism can lead to biased concentration estimates, jeopardizing both clinical and research applications. Here, we systematically review the evidence of analytical parallelism in body fluid (serum, plasma, cerebrospinal fluid) biomarker assays for neurodegeneration and evaluate the extent, reproducibility, and reporting quality of partial parallelism. This systematic review was registered on PROSPERO (CRD42024568766) and conducted in accordance with PRISMA guidelines. We included studies published between December 2010 to July 2024 without language restrictions. Eligible studies included original research assessing biomarker concentrations in body fluids with data suitable for evaluating serial dilution and standard curve parallelism. The data extraction for interrogating parallelism included dilution steps, measured concentrations, and sample types. For each study, we generated parallelism plots in a uniform and comparable way. These graphs were used to come to a balanced decision on whether parallelism or partial parallelism was present. The risk of bias was assessed based on sample preparation, buffer consistency, and methodological transparency. Of 44 eligible studies, 19 provided sufficient data for generating 49 partial parallelism plots. Only 7 plots (14%) demonstrated clear partial parallelism. Partial parallelism was typically achieved over a narrow dilution range of about three doubling steps. Most assays deviated from parallelism, risking over- or underestimation of biomarker levels if determined at different dilution steps. A high risk of bias was identified in 9 studies using spiked or artificial samples, inconsistent dilution buffers, or incomplete reporting. Several studies assessed sample-to-sample parallelism rather than sample-to-standard, contrary to guidelines by regulatory authorities. In conclusion, partial parallelism was infrequently observed and inconsistently reported in most biomarker assays for neurodegeneration. Narrow dilution ranges and variable methodologies limit generalizability. Transparent reporting of dilution protocols and adherence to established analytical validation guidelines are needed. This systematic review has practical implications for clinical trial design, regulatory approval processes, and the reliability of biomarker-based diagnostics.</p>","PeriodicalId":10760,"journal":{"name":"Critical reviews in clinical laboratory sciences","volume":" ","pages":"305-331"},"PeriodicalIF":5.5,"publicationDate":"2026-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145556393","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Pleural fluid biochemical analyses: a state-of-the-art review.","authors":"Wen-Qi Zheng, José M Porcel, Y C Gary Lee, Zhi-De Hu","doi":"10.1080/10408363.2025.2577984","DOIUrl":"10.1080/10408363.2025.2577984","url":null,"abstract":"<p><p>Pleural fluid biochemical analyses are of great value in verifying the etiology of undiagnosed pleural effusions. The preanalytical phase of pleural fluid biochemical analyses refers to the potential errors associated with specimen collection procedures, transportation, and sample stability. The analytical phase refers to the matrix effects and interference. The post-analytical phase refers to the clinical interpretation of the biochemical analyses. This review summarizes the preanalytical, analytical, and postanalytical phases of pleural fluid biochemical analyses. Evidence regarding potential preanalytical errors (e.g. stability, interference, and effects of anticoagulants on biomarker results) was summarized. In addition, we compiled evidence on the clinical interpretation of pleural fluid biomarkers, particularly from systematic reviews and meta-analyses. Finally, we discuss the future directions of biochemical analyses of pleural fluid.</p>","PeriodicalId":10760,"journal":{"name":"Critical reviews in clinical laboratory sciences","volume":" ","pages":"287-304"},"PeriodicalIF":5.5,"publicationDate":"2026-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145488109","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Pleural fluid biomarkers for the diagnosis and management of malignant pleural effusions: a clinical review.","authors":"Jose Diego Santotoribio","doi":"10.1080/10408363.2025.2559697","DOIUrl":"10.1080/10408363.2025.2559697","url":null,"abstract":"<p><p>Initial pleural fluid analysis is a fundamental step in the evaluation of suspected malignant pleural effusion (MPE). Most MPEs present as exudates, often hemorrhagic, with mononuclear cell predominance. Basic biochemical parameters-glucose, total protein, LDH, ADA, and pH-help distinguish MPE from other causes and offer prognostic information. Low glucose and pH, and elevated LDH, are associated with higher tumor burden and poorer outcomes. Flow cytometry can detect high-fluorescence cells suggestive of malignancy, while additional markers like CRP, cholesterol, amylase, and lipids provide complementary diagnostic value, especially when interpreted alongside tumor markers (TMs). Among TMs in pleural fluid, CEA is the most validated and widely used, showing high specificity for MPE. Others-such as CA 15.3, CYFRA 21-1, CA 125, CA 19.9, NSE, and HE4-offer variable sensitivity and specificity depending on tumor type and clinical context. False positives can occur in benign or inflammatory conditions, emphasizing the need for cautious interpretation. Other cancer biomarkers in pleural fluid-such as VEGF, Apolipoprotein E, calprotectin, endostatin, and homocysteine-may enhance diagnostic and prognostic capabilities. VEGF and endostatin reflect tumor angiogenesis and may also serve as therapeutic targets, while homocysteine shows promise in detecting MPEs not identified by conventional TMs. Multimarker strategies significantly improve diagnostic accuracy. Combinations of two pleural fluid TMs, such as CEA with CA 15.3, or diagnostic models like the MPER score (CEA + homocysteine), have shown excellent performance. Panels with three or more markers, including inflammatory or metabolic biomarkers (ADA, CRP, and %polymorphonuclear leukocytes) further enhance sensitivity and specificity. Molecular analysis in pleural fluid has emerged as a promising approach for the diagnosis of MPE, enabling the detection of mRNA, DNA methylation patterns, lncRNAs, miRNAs, or circulating tumor DNA. Although these biomarkers have demonstrated good diagnostic accuracy, they are not yet implemented in routine clinical practice, and most studies have primarily focused on MPE due to lung cancer. In malignant pleural mesothelioma, where cytology has limited sensitivity, the most extensively investigated markers in pleural fluid are mesothelin and fibulin-3. Among conventional tumor markers, the pleural fluid CYFRA 21-1/CEA ratio has shown high diagnostic accuracy, further enhanced when combined with mesothelin. Pleural fluid fibulin-3 has also been identified as an independent prognostic factor for survival.</p>","PeriodicalId":10760,"journal":{"name":"Critical reviews in clinical laboratory sciences","volume":" ","pages":"237-260"},"PeriodicalIF":5.5,"publicationDate":"2026-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145111688","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Essential amino acids in celiac disease: key roles in immunogenicity, pathogenesis, and therapeutic approaches.","authors":"Sajjad Bakhtiari, Nastaran Asri, Andrea Masotti, Somayeh Jahani-Sherafat, Mostafa Rezaei Tavirani, Mohammad Rostami-Nejad","doi":"10.1080/10408363.2025.2551656","DOIUrl":"10.1080/10408363.2025.2551656","url":null,"abstract":"<p><p>Celiac disease (CD) is a chronic autoimmune disorder triggered by gluten ingestion, causing intestinal damage and systemic complications. Essential amino acids (EAAs) play crucial roles in immune function, intestinal integrity, and metabolic regulation; however, their malabsorption in CD contributes to disease progression. Tryptophan dysregulation may influence mood disorders in CD, while phenylalanine and lysine are linked to immune activation and gluten modification. Methionine impacts antioxidant defense and homocysteine metabolism, and disruptions in both pathways have been observed in CD patients. Branched-chain amino acids (BCAAs), crucial for muscle synthesis, remain deficient even in treated patients, suggesting long-term metabolic effects. Threonine, vital for gut barrier function, has been reported to show increased levels in CD, potentially reflecting altered metabolism and disease progression. Arginine metabolism shifts toward pro-inflammatory nitric oxide production, exacerbating intestinal damage. EAA imbalances may serve as biomarkers for disease activity, severity, and treatment response. Altered plasma and fecal amino acid profiles correlate with disease progression, offering diagnostic and monitoring potential. Addressing EAA deficiencies through targeted supplementation or dietary interventions could enhance intestinal healing, mitigate complications, and improve outcomes beyond a gluten-free diet (GFD). This review examines the interplay between EAAs and CD pathogenesis, highlighting their roles in immune modulation, gut barrier maintenance, systemic metabolic effects, and potential as disease biomarkers.</p>","PeriodicalId":10760,"journal":{"name":"Critical reviews in clinical laboratory sciences","volume":" ","pages":"204-219"},"PeriodicalIF":5.5,"publicationDate":"2026-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144999856","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Data analytics for error detection in clinical laboratories.","authors":"Clarence W Chan","doi":"10.1080/10408363.2025.2555261","DOIUrl":"10.1080/10408363.2025.2555261","url":null,"abstract":"<p><p>Errors inevitably occur in the practice of laboratory medicine. A cornerstone of clinical laboratory quality management is the detection of erroneous results and the assessment of imprecision, bias, and other performance limitations of clinical test methods, particularly those affecting patient care. Errors can arise in each of what has been conventionally regarded as the three key phases of testing: pre-analytical, analytical, and post-analytical. In this review, both the standard concepts and methods of quantifying uncertainty and error are introduced in the context of clinical laboratory operations. Method validation and verification studies are presented as opportunities for preemptive and anticipatory error assessment-before tests are implemented for patient testing. Quality control monitoring is a key internal quality assurance strategy, whereas proficiency testing forms the basis of most external quality assurance initiatives. Data analytic approaches for error detection are reviewed, highlighting quantitative and statistical concepts on which they are based, and emerging machine learning and artificial intelligence algorithms are presented as contemporary tools currently under development for error detection in the clinical laboratory.</p>","PeriodicalId":10760,"journal":{"name":"Critical reviews in clinical laboratory sciences","volume":" ","pages":"220-236"},"PeriodicalIF":5.5,"publicationDate":"2026-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145085200","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}