Critical reviews in clinical laboratory sciences最新文献

{"title":"Machine learning models for acute kidney injury prediction and management: a scoping review of externally validated studies.","authors":"Aqeeb Ur Rehman, Javier A Neyra, Jin Chen, Lama Ghazi","doi":"10.1080/10408363.2025.2497843","DOIUrl":"10.1080/10408363.2025.2497843","url":null,"abstract":"<p><p>Despite advancements in medical care, acute kidney injury (AKI) remains a major contributor to adverse patient outcomes and presents a significant challenge due to its associated morbidity, mortality, and financial cost. Machine learning (ML) is increasingly being recognized for its potential to transform AKI care by enabling early prediction, detection, and facilitating an individualized approach to patient management. This scoping review aims to provide a comprehensive analysis of externally validated ML models for the prediction, detection, and management of AKI. We systematically searched for relevant literature from inception to 15 February 2024, using four databases-MEDLINE, EMBASE, Web of Science, and Scopus. We focused solely on models that had undergone external validation, employed Kidney Disease Improving Global Outcomes (KDIGO) definitions for AKI, and utilized ML models (excluding logistic regression models). A total of 44 studies encompassing 161 ML models for AKI prediction, severity assessment, and outcomes in both adult and pediatric populations were included in the review. These studies encompassed 4,153,424 patient admissions, with 1,209,659 in the development and internal validation cohorts and 2,943,765 in the external validation cohorts. The ML models demonstrated significant variability in performance owing to differing clinical settings, populations, and predictors used. Most of the included models were developed in specialized patient populations, such as those in intensive care units, post-surgical settings, and specific disease states (e.g. congestive heart failure, traumatic brain injury, etc.). Moreover, only a few models incorporated dynamic predictors of AKI which are crucial for improving clinical utility in rapidly evolving clinical conditions like AKI. The variable performance of these models when applied to external validation cohorts highlights the challenges of reproducibility and generalizability in implementing ML models in AKI care. Despite acceptable performance metrics, none of the models assessed in this review underwent validation or implementation in real-world clinical workflows. These findings underscore the need for standardized performance metrics and validation protocols to enhance the generalizability and clinical applicability of these models. Future efforts should focus on enhancing model adaptability by incorporating dynamic predictors and unstructured data and by ensuring that models are developed in diverse patient populations. Moreover, collaboration between clinicians and data scientists is critical to ensure the development of models that are clinically relevant, fair, and tailored to real-world healthcare environments.</p>","PeriodicalId":10760,"journal":{"name":"Critical reviews in clinical laboratory sciences","volume":" ","pages":"454-476"},"PeriodicalIF":5.5,"publicationDate":"2025-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143982756","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":"Laboratory test utilization and effect on clinical outcomes in a pediatric setting.","authors":"Ridwan B Ibrahim, Anil K Chokkalla, Adetoun A Ejilemele, Sridevi Devaraj","doi":"10.1080/10408363.2025.2494614","DOIUrl":"10.1080/10408363.2025.2494614","url":null,"abstract":"<p><p>Given recent economic concerns, there has been pressure on the health-care system to improve efficiency, quality and reduce cost. The clinical laboratory is now under close scrutiny to adopt \"practicing to value\" which involves shifting its focus from performing many tests to performing only necessary tests. To achieve this, clinical laboratories have been implementing strategies for effective laboratory test utilization and participating in health outcome studies to provide evidenced-based insights on test utilization, clinical decision-making and policy improvements. It is essential to highlight the full spectrum of this additional role of the clinical laboratory to administrators, policy makers and other health-care stakeholders, as clinical laboratories are an easy target for economic restrictions. This review highlights how strategic stewardship implementation by a clinical laboratory improves clinical outcomes in a pediatric setting.</p>","PeriodicalId":10760,"journal":{"name":"Critical reviews in clinical laboratory sciences","volume":" ","pages":"429-436"},"PeriodicalIF":5.5,"publicationDate":"2025-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143976606","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":"The current state in liquid chromatography-mass spectrometry methods for quantifying kynurenine pathway metabolites in biological samples: a systematic review.","authors":"Md Munnaf Hossen, Bobbi Fleiss, Rosita Zakaria","doi":"10.1080/10408363.2025.2495160","DOIUrl":"10.1080/10408363.2025.2495160","url":null,"abstract":"<p><p>Kynurenine pathway (KP) metabolites are implicated in various disorders, including Alzheimer's disease, schizophrenia, and adverse pregnancy outcomes. Simultaneous measurement of multiple KP metabolites offers valuable insight into the pathway's role in health and disease, would improve this relatively undeveloped field. This systematic review aim was to summarize the state of the art for measuring the eight key KP metabolites, using liquid chromatography-mass spectrometry (LC-MS), explicitly focusing on whether methods were validated using established guidelines with superior sensitivity and selectivity. We undertook a comprehensive review of the literature using the PRISMA guidelines. Our search uncovered 66 publications, and 39 qualified the defined key criteria. We summarized each publication's method development parameters, analytical design, and method performance specifications. We found notable variability in sample preparation techniques and analytical design across biological matrices, underscoring a lack of universally established and validated methods for KP metabolite quantification. We also identified significant gaps in the basic method evaluation. Our findings highlight that no single method has been evaluated for quantifying the eight key KP metabolites across three or more biological sample types, revealing a critical gap in the field. Our review emphasizes the need for robust analytical methods to quantify KP metabolites across multiple biological matrices, facilitating a better understanding of their roles in health and disease. Given the diversity of disorders involving the KP in the clinical testing lab, developing such methods will reduce diagnostic errors and advance KP metabolite research, supporting more precise, and personalized medical care.</p>","PeriodicalId":10760,"journal":{"name":"Critical reviews in clinical laboratory sciences","volume":" ","pages":"437-453"},"PeriodicalIF":5.5,"publicationDate":"2025-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143977776","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":"Deep learning algorithms and Raman spectroscopy in the clinical laboratory setting.","authors":"Charlotte Delrue, Marijn M Speeckaert, Sander De Bruyne","doi":"10.1080/10408363.2025.2549305","DOIUrl":"https://doi.org/10.1080/10408363.2025.2549305","url":null,"abstract":"<p><p>Raman spectroscopy is an important diagnostic method that extracts molecular-level information from biological specimens, with distinct potential for disease diagnoses. However, its clinical application has been limited by the challenges associated with spectral interpretation. Deep learning (DL) represents an important new approach in which selected Raman spectroscopy experiments can be automated, offering the potential for higher classification accuracy. This paper highlights recent efforts toward the integration of Raman spectroscopy and DL for medical applications and elaborates on key DL models, including Convolutional Neural Networks (CNNs), Long Short-Term Memory (LSTMs), and Generative Adversarial Networks (GANs), which can collect relevant features, denoise spectra, and provide enhanced diagnostic value from biological specimens. The use of DL in Raman spectroscopy has produced impressive results in cancer diagnosis, bacterial identification, and viral diagnostics. Therefore, this paper provides an organized introduction to explore existing DL architectures used in Raman spectroscopy, their advantages and limitations, and opportunities for clinical applications. Collectively, DL with Raman spectroscopy provides a unique approach for noninvasive and reliable diagnostics.</p>","PeriodicalId":10760,"journal":{"name":"Critical reviews in clinical laboratory sciences","volume":" ","pages":"1-29"},"PeriodicalIF":5.5,"publicationDate":"2025-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144945868","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":"New insight in early detection and precision medicine in small cell lung cancer: liquid biopsy as innovative clinical tool.","authors":"Sara Santamaria, Barbara Cardinali, Matteo Rovere, Silvia Marconi, Simone Nardin, Gianluca Sacco, Lucrezia Barcellini, Lucia Del Mastro, Carlo Genova, Simona Coco","doi":"10.1080/10408363.2025.2493121","DOIUrl":"10.1080/10408363.2025.2493121","url":null,"abstract":"<p><p>Small cell lung cancer (SCLC) is one of the deadliest types of lung cancer, with most cases being diagnosed at advanced stages. The gold standard approach in SCLC treatment has been chemotherapy, although it has been associated with limited efficacy and significant toxicity. In recent years, the integration of immunotherapies coupled with traditional chemotherapy has expanded the treatment landscape for SCLC. Nevertheless, a major challenge remains in accurately predicting which patients will benefit from these treatment strategies. However, the paucity of available tumor tissue in some patients requires the exploration of alternative approaches. In this context, liquid biopsy provides a minimally invasive tool for earlier diagnosis and treatment decision-making. Peripheral blood contains several tumor-derived elements, such as circulating tumor cells (CTCs), circulating tumor DNA (ctDNA), extracellular vesicles (EVs), and platelets, which provide real-time insights into the tumor, offering a dynamic alternative to traditional tissue biopsies. This article aims to comprehensively review the latest research on the application of liquid biopsy in SCLC. Specifically, the studies reviewed here focus on the detection, counting, and profiling of CTCs and the genomic, fragmentomic, and methylomic patterns of ctDNA across various patient cohorts and treatment settings. These studies reported promising results, particularly in the areas of early diagnosis and prognosis, suggesting that liquid biopsies could significantly enhance the management of SCLC patients. Additionally, emerging biomarkers such as serum/plasma-derived EV proteins and miRNA signatures, and the platelet-lymphocyte ratio have shown potential, however, their clinical application is still in the early stages. Although the findings regarding liquid biopsy-based markers are encouraging, their translation into the clinics is not yet achieved, mainly due to the low number and high variability of enrolled patients along with the lack of universal isolation strategies and univocal cut-offs for diagnosis and prognosis. Thus, large-scale, multi-institutional studies are essential to validate these markers and explore their integration into comprehensive multi-parameter scores. Finally, <i>in-vitro/in-vivo</i> CTC-derived cell lines/xenografts (CDX) might be used as pre-clinical \"tumor-twin\" models to understand SCLC biology as well as to test therapeutic options and comprehend the mechanisms of drug resistance, resulting in the expansion of alternative tools to improve precision medicine of this lethal neoplasm.</p>","PeriodicalId":10760,"journal":{"name":"Critical reviews in clinical laboratory sciences","volume":" ","pages":"404-428"},"PeriodicalIF":5.5,"publicationDate":"2025-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144141702","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":"Contribution of the medical laboratory in case of suspected insulin overdose.","authors":"Charline Bottinelli, Nathalie Cartiser, Fabien Bévalot, Laurent Fanton, Jérôme Guitton","doi":"10.1080/10408363.2025.2528877","DOIUrl":"10.1080/10408363.2025.2528877","url":null,"abstract":"<p><p>Insulins (human insulin and insulin analogues), widely used as hypoglycemic agents in the treatment of diabetes, can cause unexplained glycemic disorder. The medical laboratory then has a major role in determining and quantifying insulins. However, this is challenging, since pre-analytic and analytic aspects are specific, and appropriate interpretation is complex. This paper covers the various steps, and their pitfalls, for measuring insulins in blood samples. It provides a practical tool to apply in medical laboratories in case of suspected insulin overdose. Analytic strategy is presented, comparing immunoassays and chromatographic methods coupled to mass spectrometry. Tables summarize the appropriate standardized pre-analytic steps, from sampling to storage, to guarantee reliable measurement, a list of commercial immunoassays that measure insulins (with detailed cross-reactivity and sensitivity), and key parameters for interpretation of results in various unexplained glycemic events. Insulins degradation, adsorption, technical analytic limitations and variability in insulins kinetics are some of the pitfalls in insulins measurement. To avoid misinterpretation of results, a good mastery of the total testing process is required. The role of the medical laboratory is therefore central to provide the essential information to avoid the many pre-analytic and analytic pitfalls associated with the quantification of insulin and its analogues in blood. Finally, the article shows the importance of clinical-biological dialogue in interpreting results.</p>","PeriodicalId":10760,"journal":{"name":"Critical reviews in clinical laboratory sciences","volume":" ","pages":"1-9"},"PeriodicalIF":5.5,"publicationDate":"2025-08-19","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144871848","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":"Loop-mediated isothermal amplification (LAMP)-based microbial detection: a review of FDA-authorized tests and future perspectives.","authors":"Austin Jin, Maggie Deng, He S Yang, Zejuan Li","doi":"10.1080/10408363.2025.2542808","DOIUrl":"https://doi.org/10.1080/10408363.2025.2542808","url":null,"abstract":"<p><p>Loop-mediated isothermal amplification (LAMP) has emerged as a rapid and accessible alternative to traditional polymerase chain reactions (PCR) for nucleic acid amplification in research, significantly enhancing pathogen detection in infectious disease diagnostics. This review aims to bridge the gap in the literature regarding the real-world applications of LAMP assays and their potential to improve infectious disease diagnostics across various healthcare settings. We evaluated the current landscape of United States Food and Drug Administration (FDA)-authorized LAMP-based microbial tests, categorizing 30 such tests and detailing their regulatory pathways, such as 510(k) clearance and Emergency Use Authorization (EUA), particularly in response to the COVID-19 pandemic. We comprehensively examine the technical characteristics of LAMP assays, including sample collection, nucleic acid extraction, amplification processes, signal detection, device automation, and their analytical and clinical performance. We highlight the versatility of LAMP assays in diagnostic applications and their growing role in rapid infectious disease. We discuss the advantages and limitations of LAMP technology and identify future directions for its development in infectious disease diagnostics. By analyzing FDA-authorized LAMP-based microbial tests, this review aims to guide healthcare professionals and support future research and product development, ultimately improving patient care.</p>","PeriodicalId":10760,"journal":{"name":"Critical reviews in clinical laboratory sciences","volume":" ","pages":"1-23"},"PeriodicalIF":5.5,"publicationDate":"2025-08-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144834407","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":"Is screening for Alzheimer's disease ready for prime time? Ask Wilson and Jungner.","authors":"Miyo K Chatanaka, Maria Pascual Lorén, Eleftherios P Diamandis","doi":"10.1080/10408363.2025.2533860","DOIUrl":"10.1080/10408363.2025.2533860","url":null,"abstract":"<p><p>Population screening is an effective strategy for disease prevention, early diagnosis and treatment; however, the benefits and harms of disease screening need to be carefully evaluated before clinical implementation. Various national and international bodies, including the U.S. Preventive Services Task Force (USPSTF), periodically develop recommendations for screening after reviewing the available published evidence and, in some instances, expert opinions. In 1968, Wilson and Jungner formulated a set of 10 rules that must be considered and fulfilled before introducing screening for any disease into clinical practice. Alzheimer's disease (AD), a devastating chronic disease that affects millions of people worldwide and is the most common cause of dementia, has recently been reviewed in the context of population screening. Data and predictions show that the prevalence of AD is steadily increasing and will likely become one of the most common causes of death by 2060. Currently, there are no effective curative therapeutic options for this disease, but new developments have allowed earlier detection at asymptomatic and early symptomatic stages. New classes of disease-modifying therapeutics show promise of slowing the progression of the disease. These new developments prompted us to examine the near-future feasibility of screening for presymptomatic or early symptomatic AD by considering the general screening principles of Wilson and Jungner. In 2020, USPSTF published a guideline regarding screening for cognitive impairment, an AD symptom, and concluded that the current evidence is insufficient to assess the balance of benefits and harms and did not recommend screening for cognitive impairment in older adults. This was recapitulated in 2024 by the Canadian Task Force on Preventive Health Care (CTFPHC). After careful consideration, and despite the recent significant biological, diagnostic and therapeutic advances for AD, screening does not seem to be justified at present, due to numerous reasons, such as lack of trained professionals and specialized clinics to handle the anticipated highly increased workload, the huge cost, the ineffectiveness and side effects of current therapy, the lack of long-term therapy studies, and the disagreement among experts as to whom to test and treat and when (at either asymptomatic or early symptomatic stages).</p>","PeriodicalId":10760,"journal":{"name":"Critical reviews in clinical laboratory sciences","volume":" ","pages":"1-15"},"PeriodicalIF":5.5,"publicationDate":"2025-08-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144783682","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":"Cardiac troponin complexes and fragments: potential targets for improved clinical performance.","authors":"Sander A J Damen, Marc A Brouwer, Niels van Royen, Menko-Jan de Boer, Alan H B Wu, Xander M R van Wijk, G Etienne Cramer","doi":"10.1080/10408363.2025.2484954","DOIUrl":"10.1080/10408363.2025.2484954","url":null,"abstract":"<p><p>High-sensitivity assays for cardiac troponin (cTn) have improved rule-out algorithms for acute myocardial infarction (AMI). However, reduced specificity specifically to AMI posed new clinical challenges. Studies involving the composition of troponin released into the circulation after injury may provide insights to improve specificity. In MI patients, cTnI primarily exists of cTnIC and truncated cTnTIC complexes. Larger-sized cTnT forms, as part of the cTnTIC complex, predominate with shorter ischemic time windows. Over time, mildly and heavily truncated cTnT forms increase, whereas for cTnI this is less certain. Targeting the central part of cTnT, the current high-sensitivity assay also identifies heavily truncated forms as seen in end-stage renal disease and after exercise. This review on composition of circulating troponin covers different populations and outlines first initiatives toward more specific assays by targeting larger-sized troponin forms.</p>","PeriodicalId":10760,"journal":{"name":"Critical reviews in clinical laboratory sciences","volume":" ","pages":"313-326"},"PeriodicalIF":6.6,"publicationDate":"2025-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143971680","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":"The intersection of the laboratory and transgender care.","authors":"Kevin Jessen, Nilika Wijeratne, Ailie Connell","doi":"10.1080/10408363.2025.2488839","DOIUrl":"10.1080/10408363.2025.2488839","url":null,"abstract":"<p><p>Transgender and gender diverse (TGD) individuals seeking gender affirming treatment are an increasing demographic in today's society; such treatments include hormonal and surgical interventions aimed at alleviating gender dysphoria and increasing quality of life. A number of diagnostic pathology tests are provided to medical professionals with sex specific reference intervals (RIs) for interpretation, due to sex specific physiological differences, organ size and hormone levels for example. These tests may be reported with RIs that are not appropriate, and interpretation for the medical professional can be challenging. From the laboratory perspective, there are limitations in Laboratory Information Management Systems (LIMS) and the ability of these databases to record both sex and gender identifiers, as well as the reporting of appropriate RIs. The use of RIs derived from the transgender population is complex, studies generally have a low sample size and include adults with long established hormonal treatments. The age of an individual undergoing gender affirming therapy has decreased, and the use of Gonadotrophin Releasing Hormone analogues adds complexity. In this review, we will discuss the current challenges and perspectives regarding the reporting of reference intervals in the TGD population, the derivation of personalized or transgender specific RIs and interpretation of specific diagnostic tests.</p>","PeriodicalId":10760,"journal":{"name":"Critical reviews in clinical laboratory sciences","volume":" ","pages":"347-362"},"PeriodicalIF":6.6,"publicationDate":"2025-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144062545","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}