Critical reviews in clinical laboratory sciences最新文献

{"title":"Diagnostic workout of glandular malignant lesions of the bladder according to the 5th WHO classification.","authors":"Francesca Sanguedolce, Angelo Cormio, Magda Zanelli, Andrea Palicelli, Maurizio Zizzo, Ugo Giovanni Falagario, Roberta Mazzucchelli, Andrea Benedetto Galosi, Giuseppe Carrieri, Luigi Cormio","doi":"10.1080/10408363.2025.2464248","DOIUrl":"https://doi.org/10.1080/10408363.2025.2464248","url":null,"abstract":"<p><p>Glandular lesions involving the bladder are less common than conventional urothelial carcinoma, and they are often diagnostically challenging diseases, carrying different clinical outcomes. As a group, they encompass both primary and secondary neoplasms, with sometimes overlapping morphological features. In this scenario, proper clinical information is important, in that secondary involvement of the bladder may occur by direct extension or lymphatic/hematogenous spread from carcinomas at other sites, comprising prostate, colon, cervix, breast, and lung. According to the 5th edition of the WHO Classification of urological tumors, glandular morphology is a major hallmark of the following entities: urothelial carcinoma with glandular differentiation, adenocarcinoma, NOS, urachal carcinoma, and tumors of Mullerian type. The distinction among these entities, and between primary and secondary tumors, heavily relies on their biological and immunophenotypical features. This article will review glandular neoplasms of the bladder, highlighting their main immunophenotypical markers. Furthermore, molecular data associated with their pathogenesis, prognosis, and treatment will be described. The aim of this study is to provide a practical and comprehensive up-to-date overview of this complex topic.</p>","PeriodicalId":10760,"journal":{"name":"Critical reviews in clinical laboratory sciences","volume":" ","pages":"1-12"},"PeriodicalIF":6.6,"publicationDate":"2025-03-09","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143584983","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":"Within-subject biological variation estimated using real-world data strategies (RWD): a systematic review.","authors":"Fernando Marques-García, Ana Nieto-Librero, Xavier Tejedor-Ganduxe, Cristina Martinez-Bravo","doi":"10.1080/10408363.2025.2464244","DOIUrl":"https://doi.org/10.1080/10408363.2025.2464244","url":null,"abstract":"&lt;p&gt;&lt;p&gt;Biological variation (BV) is defined as the variation in the concentration of a measurand around the homeostatic set point. This is a concept introduced by Fraser and Harris in the second part of the twentieth century. BV is divided into two different estimates: within-subject BV (CV&lt;sub&gt;I&lt;/sub&gt;) and between-subject BV (CV&lt;sub&gt;G&lt;/sub&gt;). Biological variation studies of biomarkers have been gaining importance in recent years due to the potential practical application of these estimates. The main applications of BV in the clinical laboratory include: the establishment of Analytical Performance Specifications (APS), estimation of the individual's homeostatic set point (HSP), calculation of Reference Change Value (RCV), estimation of individuality index calculation (II), and establishment of personalized reference intervals (prRI). The classic models for obtaining BV estimates have been the most used to date. In these studies, a target population (\"normal\" population), a sampling frequency and time, and a number of samples per individual, among other factors, are defined. The Biological Variation Data Critical Appraisal Checklist (BIVAC) established by the Task Group-Biological Variation Database (TG-BVD) of the European Federation of Clinical Chemistry and Laboratory Medicine (EFLM) represents a guide for the evaluation and performance of these direct studies. These methods have limitations because they are laborious, expensive, invasive, and are based on an ideal population. In recent years, models have been proposed to obtain BV estimates based on the Real-World Data (RWD) strategy. In this case, we move from a model with a low number of individuals (direct methods) to a population model using the data stored in the Laboratory Information System (LIS). RWD methods are presented as an alternative to overcome the limitations of direct methods. Currently, there is little scientific evidence on the application of RWD models since only five papers have been published. In these papers, three different working algorithms are proposed (Loh et al., Jones et al., and Marques-Garcia et al.). These algorithms are divided into three fundamental stages for their development: patient data and study design, database(s) cleaning, and statistical strategies for obtaining BV estimates. When working with large amounts of data, RWD methods allow us to subdivide the population and thus obtain estimates into subgroups, what would be more difficult using direct methods. Of the three algorithms proposed, the algorithm developed in the Spanish multicenter project &lt;i&gt;BiVaBiDa&lt;/i&gt; is the most complete, as it overcomes the limitations of the other two, including the possibility of calculating the confidence interval of the BV estimate. RWD methods also have limitations such as the anonymization of data and the standardization of electronic medical records, as well as the statistical complexity associated with data analysis. It is necessary to continue working on the deve","PeriodicalId":10760,"journal":{"name":"Critical reviews in clinical laboratory sciences","volume":" ","pages":"1-13"},"PeriodicalIF":6.6,"publicationDate":"2025-03-09","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143584986","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":"Cardiovascular disease lipids and lipoproteins biomarker standardization.","authors":"Alicia N Lyle, Uliana Danilenko, Otoe Sugahara, Hubert W Vesper","doi":"10.1080/10408363.2025.2462817","DOIUrl":"https://doi.org/10.1080/10408363.2025.2462817","url":null,"abstract":"<p><p>Cardiovascular disease (CVD) is the leading cause of mortality in the United States and globally. This review describes changes in CVD lipid and lipoprotein biomarker measurements that occurred in line with the evolution of clinical practice guidelines for CVD risk assessment and treatment. It also discusses the level of comparability of these biomarker measurements in clinical practice. Comparable and reliable measurements are achieved through assay standardization, which not only depends on correct test calibration but also on factors such as analytical sensitivity, selectivity, susceptibility to factors that can affect the analytical measurement process, and the stability of the test system over time. The current status of standardization for traditional and newer CVD biomarkers is discussed, as are approaches to setting and achieving standardization goals for low-density lipoprotein cholesterol (LDL-C), high-density lipoprotein cholesterol (HDL-C), total cholesterol (TC), triglycerides (TG), lipoprotein(a) (Lp(a)), apolipoproteins (apo) A-I and B, and non-HDL-C. Appropriate levels of standardization for blood lipids are maintained by the Centers for Disease Control and Prevention's (CDC) CVD Biomarkers Standardization Program (CDC CVD BSP) using the analytical performance goals recommended by the National Cholesterol Education Program. The level of measurement agreement that can be achieved is dependent on the characteristics of the analytes and differences in measurement principles between reference measurement procedures and clinical assays. The technical and analytical limitations observed with traditional blood lipids are not observed with apolipoproteins. Additionally, apoB and Lp(a) may more accurately capture CVD risk and residual CVD risk, respectively, than traditional lipids, thus prompting current guidelines to recommend apolipoprotein measurements. This review further discusses CDC's approach to standardization and describes the analytical performance of traditional blood lipids and apoA-I and B observed over the past 11 years. The reference systems for apoA-I and B, previously maintained by a single laboratory, no longer exist, thus requiring the creation of new systems, which is currently underway. This situation emphasizes the importance of a collaborative network of laboratories, such as CDC's Cholesterol Reference Methods Laboratory Network (CRMLN), to ensure standardization sustainability. CDC is supporting the International Federation of Clinical Chemistry and Laboratory Medicine's (IFCC) work to establish such a network for lipoproteins. Ensuring comparability and reliability of CVD biomarker measurements through standardization remains critical for the effective implementation of clinical practice guidelines and for improving patient care. Utilizing experience gained over three decades, CDC CVD BSP will continue to improve the standardization of traditional and emerging CVD biomarkers together with stakeholders.</p>","PeriodicalId":10760,"journal":{"name":"Critical reviews in clinical laboratory sciences","volume":" ","pages":"1-22"},"PeriodicalIF":6.6,"publicationDate":"2025-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143531230","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":"Genetic variants of accessory proteins and G proteins in human genetic disease.","authors":"Miles D Thompson, Peter Chidiac, Pedro A Jose, Alexander S Hauser, Caroline M Gorvin","doi":"10.1080/10408363.2024.2431853","DOIUrl":"10.1080/10408363.2024.2431853","url":null,"abstract":"<p><p>We present a series of three articles on the genetics and pharmacogenetics of G protein- coupled receptors (GPCR). In the first article, we discuss genetic variants of the G protein subunits and accessory proteins that are associated with human phenotypes; in the second article, we build upon this to discuss \"G protein-coupled receptor (GPCR) gene variants and human genetic disease\" and in the third article, we survey \"G protein-coupled receptor pharmacogenomics\". In the present article, we review the processes of ligand binding, GPCR activation, inactivation, and receptor trafficking to the membrane in the context of human genetic disease resulting from pathogenic variants of accessory proteins and G proteins. Pathogenic variants of the genes encoding G protein α and β subunits are examined in diverse phenotypes. Variants in the genes encoding accessory proteins that modify or organize G protein coupling have been associated with disease; these include the contribution of variants of the regulator of G protein signaling (RGS) to hypertension; the role of variants of activator of G protein signaling type III in phenotypes such as hypoxia; the contribution of variation at the <i>RGS10</i> gene to short stature and immunological compromise; and the involvement of variants of G protein-coupled receptor kinases (GRKs), such as GRK4, in hypertension. Variation in genes that encode proteins involved in GPCR signaling are outlined in the context of the changes in structure and function that may be associated with human phenotypes.</p>","PeriodicalId":10760,"journal":{"name":"Critical reviews in clinical laboratory sciences","volume":" ","pages":"113-134"},"PeriodicalIF":6.6,"publicationDate":"2025-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11854058/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142913856","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Human telomere length detected by quantitative fluorescent in situ hybridization: overlooked importance and application.","authors":"Xinling Li, Dongsheng Hu, Ming Zhang, Wei Wang","doi":"10.1080/10408363.2024.2441733","DOIUrl":"10.1080/10408363.2024.2441733","url":null,"abstract":"<p><p>The technique of Quantitative Fluorescence <i>in Situ</i> Hybridization (Q-FISH) plays a crucial role in determining the length of telomeres for studies in molecular biology and cytogenetics. Throughout the years, the use of Q-FISH for measuring telomere length has made substantial contributions to research in aging, cancer, and stem cells. The objective of this analysis is to delineate the categorization, fundamental concepts, pros and cons, and safety measures of Q-FISH in telomere length analysis, encapsulate, and anticipate its principal uses across diverse human biomedical research fields.</p>","PeriodicalId":10760,"journal":{"name":"Critical reviews in clinical laboratory sciences","volume":" ","pages":"135-147"},"PeriodicalIF":6.6,"publicationDate":"2025-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142892747","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 role of immunophenotyping in common variable immunodeficiency: a narrative review.","authors":"Jana Neirinck, Malicorne Buysse, Ciel De Vriendt, Mattias Hofmans, Carolien Bonroy","doi":"10.1080/10408363.2024.2404842","DOIUrl":"10.1080/10408363.2024.2404842","url":null,"abstract":"<p><p>Common variable immunodeficiency (CVID) is a heterogeneous primary immunodeficiency (PID) characterized by an impaired immunoglobulin production, in association with an increased susceptibility to infections and a diversity of clinical manifestations. This narrative review summarizes immunophenotypic abnormalities in CVID patients and their relevance for diagnosis and disease classification. A comprehensive search across four databases - PubMED, Web of Science, EMBASE and Google Scholar - yielded 170 relevant studies published between 1988 and April 31, 2023. Over the past decades, the role of immunophenotyping in CVID diagnosis has become evident by identifying \"hallmark\" immunophenotypic aberrancies in patient subsets, with some now integrated in the consensus diagnostic criteria. Furthermore, the role of immunophenotyping in subclassifying CVID in relation to clinical presentation and prognosis has been extensively studied. Certain immunophenotypic patterns consistently correlate with clinical manifestations and/or subsets of CVID, particularly those associated with noninfectious complications (i.e. low switched memory B cells, shifts in follicular helper T cell subsets, low naïve CD4⁺ T cells, low regulatory T cells, and expansion of CD21low B cells, often associated with autoimmunity and/or splenomegaly). Also, efforts to associate subset levels of innate immune cells, such as Natural Killer (NK) cells, invariant (i)NKT cells, innate lymphoid cells (ILCs), and dendritic cells (DCs) to CVID complications are evident albeit in a lesser degree. However, inconsistencies regarding the role of flow cytometry in classification and prognosis persist, reflecting the disease complexity, but probably also cohort variations and methodological differences between published studies. This underscores the need for collaborative efforts to integrate emerging concepts, such as standardized flow cytometry and computational tools, for a more precise CVID classification approach. Additionally, recent studies suggest a potential value of (epi)genetic-based molecular assays to this effort.</p>","PeriodicalId":10760,"journal":{"name":"Critical reviews in clinical laboratory sciences","volume":" ","pages":"65-84"},"PeriodicalIF":6.6,"publicationDate":"2025-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142371196","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":"Insight into metabolic dysregulation of polycystic ovary syndrome utilizing metabolomic signatures: a narrative review.","authors":"Aalaap Naigaonkar, Roshan Dadachanji, Manisha Kumari, Srabani Mukherjee","doi":"10.1080/10408363.2024.2430775","DOIUrl":"10.1080/10408363.2024.2430775","url":null,"abstract":"<p><p>Polycystic ovary syndrome (PCOS) is a complex multifactorial endocrinopathy affecting reproductive aged women globally, whose presentation is strongly influenced by genetic makeup, ethnic, and geographic diversity leaving these affected women substantially predisposed to reproductive and metabolic perturbations. Sophisticated techniques spanning genomics, proteomics, epigenomics, and transcriptomics have been harnessed to comprehensively understand the enigmatic pathophysiology of PCOS, however, conclusive markers for PCOS are still lacking today. Metabolomics represents a paradigm shift in biotechnological advances enabling the simultaneous identification and quantification of metabolites and the use of this approach has added yet another dimension to help unravel the strong metabolic component of PCOS. Reports dissecting the metabolic signature of PCOS have revealed disparate levels of metabolites such as pyruvate, lactate, triglycerides, free fatty acids, carnitines, branched chain and essential amino acids, and steroid intermediates in major biological compartments. These metabolites have been shown to be altered in women with PCOS overall, after phenotypic subgrouping, in animal models of PCOS, and also following therapeutic intervention. This review seeks to supplement previous reviews by highlighting the aforementioned aspects and to provide easy, coherent and elementary access to significant findings and emerging trends. This will in turn help to delineate the metabolic plot in women with PCOS in various biological compartments including plasma, urine, follicular microenvironment, and gut. This may pave the way to design additional studies on the quest of unraveling the etiology of PCOS and delving into novel biomarkers for its diagnosis, prognosis and management.</p>","PeriodicalId":10760,"journal":{"name":"Critical reviews in clinical laboratory sciences","volume":" ","pages":"85-112"},"PeriodicalIF":6.6,"publicationDate":"2025-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142853497","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 role of the clinical laboratory in diagnosing hyponatremia disorders.","authors":"Kenrick Berend, Micah Liam Arthur Heldeweg","doi":"10.1080/10408363.2025.2462814","DOIUrl":"https://doi.org/10.1080/10408363.2025.2462814","url":null,"abstract":"<p><p>In clinical medicine, hyponatremia is highly prevalent and frequently misdiagnosed, leading to substantial mismanagement and iatrogenic morbidity. Its differential diagnosis includes numerous diseases with diverse etiologies, making accurate assessment challenging. Despite extensive literature and guidelines on hyponatremia, most patients do not receive adequate evaluation due to the limitations of diagnostic algorithms, which rely on low-value clinical signs and are unable to identify concurrent conditions. In this review, we examine the range of laboratory tests available for hyponatremia assessment. Understanding renal mechanisms of solute and water exchange (e.g., fractional excretion) is essential for selecting appropriate tests and interpreting their diagnostic value. Additionally, detailed electrolyte and acid-base assessments remain critical for establishing a definitive diagnosis. We comprehensively discuss the selection of laboratory tests for specific differential diagnoses of hyponatremia. Importantly, in cases of acute hyponatremia, rapid correction should take precedence over a complete diagnostic workup. Ultimately, a thorough understanding of laboratory evaluation is crucial for accurately diagnosing hyponatremia. This paper critically reviews the available literature and explores relevant diseases in the context of associated laboratory parameters.</p>","PeriodicalId":10760,"journal":{"name":"Critical reviews in clinical laboratory sciences","volume":" ","pages":"1-26"},"PeriodicalIF":6.6,"publicationDate":"2025-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143531234","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":"Analytical and clinical considerations of synovial fluid calprotectin in diagnosing periprosthetic joint infections.","authors":"Mohammed F Alkadhem, Paul C Jutte, Marjan Wouthuyzen-Bakker, Anneke C Muller Kobold","doi":"10.1080/10408363.2025.2463634","DOIUrl":"https://doi.org/10.1080/10408363.2025.2463634","url":null,"abstract":"<p><p>Calprotectin is a protein predominantly found in the cytosol of myeloid cells, such as neutrophils and monocytes. Calprotectin has several functions in innate immunity, such as attenuating bacteria, recruiting and activating immune cells, and aiding in the production of pro-inflammatory cytokines and reactive oxygen species. Due to its presence in inflammatory sites, it has been investigated as a biomarker for various medical conditions, especially Inflammatory bowel diseases (IBD), rheumatoid arthritis (RA), and has gained interest in the diagnosis of several infectious diseases, in particular for diagnosing periprosthetic joint infections (PJI). Synovial fluid calprotectin has demonstrated to be a sensitive and specific biomarker for both confirming as well as excluding PJI. Synovial fluid calprotectin can be measured using enzyme-linked immunosorbent assay (ELISA), immunoturbidimetry, and lateral flow methods. It is a generally stable biomarker, showing no significant decrease or increase in its levels despite blood or lipid contamination, storage duration, freeze-thaw cycles, and enzymatic pretreatments for viscosity reduction. This review discusses the biology and physiology of calprotectin, pathophysiology of PJI, and the clinical and analytical considerations surrounding its use in diagnosing PJI.</p>","PeriodicalId":10760,"journal":{"name":"Critical reviews in clinical laboratory sciences","volume":" ","pages":"1-12"},"PeriodicalIF":6.6,"publicationDate":"2025-02-19","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143448251","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 this test fit-for-purpose? Principles and a checklist for evaluating the clinical performance of a test in the new era of <i>in vitro</i> diagnostic (IVD) regulation.","authors":"S J Lord, A R Horvath, S Sandberg, P J Monaghan, C M Cobbaert, M Reim, A Tolios, R Mueller, P M Bossuyt","doi":"10.1080/10408363.2025.2453148","DOIUrl":"https://doi.org/10.1080/10408363.2025.2453148","url":null,"abstract":"<p><p>Recent changes in the regulatory assessment of <i>in vitro</i> medical tests reflect a growing recognition of the need for more stringent clinical evidence requirements to protect patient safety and health. Under current regulations in the United States and Europe, when needed for regulatory approval, clinical performance reports must provide clinical evidence tailored to the intended purpose of the test and allow assessment of whether the test will achieve the intended clinical benefit. The quality of evidence must be proportionate to the risk for the patient and/or public health. These requirements now cover both commercial and laboratory developed tests (LDT) and demand a sound understanding of the fundamentals of clinical performance measures and study design to develop and appraise the study plan and interpret the study results. However, there is a lack of harmonized guidance for the laboratory profession, industry, regulatory agencies and notified bodies on how the clinical performance of tests should be measured. The Working Group on Test Evaluation (WG-TE) of the European Federation of Clinical Chemistry and Laboratory Medicine (EFLM) is a multidisciplinary group of laboratory professionals, clinical epidemiologists, health technology assessment experts, and representatives of the <i>in vitro</i> diagnostic (IVD) industry. This guidance paper aims to promote a shared understanding of the principles of clinical performance measures and study design. Measures of classification performance, also referred to as discrimination, such as sensitivity and specificity are firmly established as the primary measures for evaluating the clinical performance for screening and diagnostic tests. We explain these measures are just as relevant for other purposes of testing. We outline the importance of defining the most clinically meaningful classification of disease so the clinical benefits of testing can be explicitly inferred for those correctly classified, and harm for those incorrectly classified. We introduce the key principles and a checklist for formulating the research objective and study design to estimate clinical performance: (1) the purpose of a test e.g. diagnosis, screening, risk stratification, prognosis, prediction of treatment benefit, and corresponding research objective for assessing clinical performance; (2) the target condition for clinically meaningful classification; (3) clinical performance measures to assess whether the test is fit-for-purpose; and (4) study design types. Laboratory professionals, industry, and researchers can use this checklist to help identify relevant published studies and primary datasets, and to liaise with clinicians and methodologists when developing a study plan for evaluating clinical performance, where needed, to apply for regulatory approval.</p>","PeriodicalId":10760,"journal":{"name":"Critical reviews in clinical laboratory sciences","volume":" ","pages":"1-16"},"PeriodicalIF":6.6,"publicationDate":"2025-02-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143254902","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}