Clinical chemistry and laboratory medicine最新文献

{"title":"Urine-derived light chain sequencing enables serum-based MRD monitoring in multiple myeloma.","authors":"Luciano H Di Stefano, Charissa Wijmands, Joannes F M Jacobs, Vincent Bonifay, Caroline Rougé Dubroc","doi":"10.1515/cclm-2026-1061","DOIUrl":"https://doi.org/10.1515/cclm-2026-1061","url":null,"abstract":"","PeriodicalId":10390,"journal":{"name":"Clinical chemistry and laboratory medicine","volume":" ","pages":""},"PeriodicalIF":4.4,"publicationDate":"2026-10-08","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"149126893","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":"An LR-based risk stratification framework for assessing interlaboratory variability in HEp-2 IFA pattern interpretation.","authors":"Chaochao Zhang, Yingxin Dai, Dan Cao, Rong Chen, Zhiyuan Gao, Yifan Gong, Anni Guo, Xiaowei Huang, Aiping Liu, Tiantian Liu, Ce Shi, Yi Sun, Wenjuan Wang, Hongkun Wu, Jing Yang, Yiwen Yao, Lei Yu, Ying Zhang, Haiyin Zheng, Kaimin Mao, Min Li, Bing Zheng","doi":"10.1515/cclm-2026-1012","DOIUrl":"https://doi.org/10.1515/cclm-2026-1012","url":null,"abstract":"<p><strong>Objectives: </strong>Interlaboratory variability in HEp-2 indirect immunofluorescence assay (IFA) interpretation remains a major challenge. Conventional agreement metrics quantify disagreement but do not distinguish discrepancies by diagnostic relevance. We aimed to develop a likelihood ratio (LR)-based framework for clinically informed assessment of interpretation variability.</p><p><strong>Methods: </strong>Pattern-specific positive LRs were derived from 33,690 routine HEp-2 IFA records and used to classify patterns into four risk tiers. A pattern discrepancy score (PDS) was developed to quantify discrepancies according to risk-tier displacement. Interlaboratory variability was assessed using a standardized 200-specimen panel tested by 18 laboratories, and diagnostic performance was explored in six laboratories.</p><p><strong>Results: </strong>Pattern disagreement rates ranged from 17.5 to 50.0 %. PDS strongly correlated with disagreement rate (Spearman's ρ=0.936, p<0.001), but laboratories with similar disagreement rates differed in cross-tier discrepancy distribution. Most discrepancies remained within the same risk tier; among discordant interpretations involving high-risk reference patterns, 20.4 % crossed into another tier. Pattern concordance varied markedly, while titer agreement was moderate to almost perfect (weighted κ, 0.569-0.821). Across six laboratories, diagnostic performance varied (Youden Index, 0.391-0.617), but was not significantly associated with interpretation consistency.</p><p><strong>Conclusions: </strong>HEp-2 IFA interpretation variability differs in both frequency and potential diagnostic relevance. The LR-based framework and PDS complement conventional agreement measures by identifying discrepancies that alter diagnostic risk classification, potentially supporting risk-oriented proficiency assessment and targeted quality improvement.</p>","PeriodicalId":10390,"journal":{"name":"Clinical chemistry and laboratory medicine","volume":" ","pages":""},"PeriodicalIF":4.4,"publicationDate":"2026-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"149079959","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":"Semen analysis external quality assessment: a paradigm shift from statistical consensus to biological variation-based analytical quality specifications.","authors":"Xiyan Wu, Weina Li","doi":"10.1515/cclm-2026-0896","DOIUrl":"https://doi.org/10.1515/cclm-2026-0896","url":null,"abstract":"<p><p>Semen analysis is the primary diagnostic tool for male fertility evaluation, yet its subjective nature introduces substantial interlaboratory variation that compromises result reliability; despite over three decades of external quality assessment (EQA) practice, coefficients of variation (CV) for core semen parameters remain unacceptably high worldwide. Synthesising evidence from 34 years of global EQA programmes, this review documents interlaboratory CVs of 12.7-138.0 %, 17.0-127.0 %, and 7-375 % for concentration, motility, and morphology, and identifies three structural dilemmas: (1) peer self-referencing bias in assigned value determination, (2) disconnection of allowable total error (TEa) from clinical need, (3) a cognitive threshold effect in morphological interpretation. The principal international schemes - CAP (USA), UK NEQAS, NCCL (China), and QUIP (Germany) - diverge markedly in specimen type, assigned value strategy, and acceptance criteria. We critically evaluate the transition from state-of-the-art to biological variation (BV)-based analytical quality specifications (APS), examine performance differentials between assisted reproductive technology (ART) centres and general clinical laboratories, and assess emerging technologies including AI-assisted morphology assessment and digital EQA platforms. The field is undergoing a paradigm shift from statistical peer consensus toward clinically driven BV-based APS, derived from intra-individual (CV1) and inter-individual (CVG) variation of semen parameters; However, AI systems exhibit systematic analytical bias compared with manual microscopy, which stems from training-set composition, annotator subjectivity, and visual fatigue caused by high-throughput workloads. Independent calibration and version-control validation should be completed prior to clinical application. Priority efforts encompass EQA framework harmonisation aligned with WHO Sixth Edition (2021) and ISO 23162:2021, measurement uncertainty incorporation into TEa derivation, prospective AI algorithm validation, split-sample parallel testing, and disaggregation of morphological APS by defect category (head, midpiece, and tail).</p>","PeriodicalId":10390,"journal":{"name":"Clinical chemistry and laboratory medicine","volume":" ","pages":""},"PeriodicalIF":4.4,"publicationDate":"2026-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"149079993","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":"Population-specific pediatric reference intervals for complete blood count in Vietnamese children and their impact on clinical classification.","authors":"Dien Minh Tran, Anh Quynh Mai, Phuc Huu Phan, Tung Viet Cao, Mai Thi Chi Tran, Ronda F Greaves, Tze Ping Loh, Duyen Thi Nguyen","doi":"10.1515/cclm-2026-0766","DOIUrl":"https://doi.org/10.1515/cclm-2026-0766","url":null,"abstract":"<p><strong>Objectives: </strong>To establish age- and sex-specific reference intervals (RI) for complete blood count (CBC) parameters in healthy Vietnamese children aged 0 to <19 years and assess the impact of applying locally derived vs. non-local pediatric RI on abnormal flagging and clinical classification.</p><p><strong>Methods: </strong>A community-based cross-sectional study included 3,885 healthy Vietnamese children aged 0 to <19 years recruited through school-based health screening programs between April 2024 and November 2025. Peripheral venous blood samples were analyzed using the Sysmex XN-9000 hematology analyzer under standardized pre-analytical and analytical conditions with internal and external quality control. Outliers were excluded using the Tukey interquartile range method. Age and sex partitions were established through an integrated assessment of visual inspection, the Mann-Whitney U test, Cliff's delta, the Harris-Boyd method, and biological and clinical considerations. Reference intervals were established according to CLSI EP28-A3c using a nonparametric approach (2.5-97.5th percentiles), with 90 % confidence intervals estimated by bootstrap.</p><p><strong>Results: </strong>All CBC parameters showed age-related variation, supporting age-specific RI. Sex differences were limited to erythrocyte parameters, including red blood cell count, hemoglobin, and hematocrit, emerging after puberty; sex partitioning was unnecessary for most analytes. Application of the Vietnamese vs. CALIPER reference intervals in an outpatient cohort resulted in bidirectional reclassification, with 0.0-32.6 % of CALIPER-abnormal results reclassified as normal and 0.0-24.4 % of CALIPER-normal results reclassified as abnormal, depending on the analyte.</p><p><strong>Conclusions: </strong>This study establishes population-based pediatric CBC RI for Vietnamese children. Non-local pediatric RI may alter abnormal flagging and result interpretation in routine practice.</p>","PeriodicalId":10390,"journal":{"name":"Clinical chemistry and laboratory medicine","volume":" ","pages":""},"PeriodicalIF":4.4,"publicationDate":"2026-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"149080010","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":"Target product profiles in laboratory medicine: a framework for defining test requirements and supporting outcome-based performance specifications.","authors":"Alison F Smith, Paola Cocco, Kile Green, Aisling Ponzo, Kerrie A Davies, Katy Bell, Bethany Shinkins, Mariska Leeflang, Gail Hayward, Mike Messenger","doi":"10.1515/cclm-2026-0956","DOIUrl":"https://doi.org/10.1515/cclm-2026-0956","url":null,"abstract":"<p><p>Despite rapid advances in diagnostics, many tests fail to deliver meaningful clinical or system value because their intended use, performance requirements, and implementation context were not clearly articulated early in development. Target product profiles (TPPs) offer a structured, consensus-based framework to define intended use, outline minimal and desirable performance specifications, and set operational expectations for testing technologies. This paper introduces the topic of TPPs, summarising their purpose, structure, and typical development pathways. We describe a three-phase development process of scoping, drafting, and consensus-building, and use real-world examples to illustrate how evidence, stakeholder input, and contextual constraints shape the specification of performance requirements. We highlight how TPPs can support the shift toward outcome-based performance specifications by providing a transparent mechanism to link test analytical and clinical performance with downstream clinical decision-making, patient outcomes, and system-level impact. We also propose strategies to strengthen the methodological robustness and transparency of TPPs and emphasise the essential role laboratory professionals play in ensuring feasibility and clinical relevance of TPP content. When developed collaboratively, including essential laboratory input, TPPs serve as practical tools that guide upstream test research and design and support ongoing verification, validation and life-cycle management, helping to ensure that tests are clinically meaningful, operationally implementable, and responsive to real-world healthcare needs. Ultimately, the integration of well-designed TPPs into test development pipelines has the potential to accelerate innovation that delivers real clinical value and strengthens the role of laboratory medicine in improving patient outcomes.</p>","PeriodicalId":10390,"journal":{"name":"Clinical chemistry and laboratory medicine","volume":" ","pages":""},"PeriodicalIF":4.4,"publicationDate":"2026-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"149104558","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":"Garbage in, (mis)diagnosis out: making laboratory measurement bias visible and actionable across clinical algorithm outputs.","authors":"Niels van Noort, Marith van Schrojenstein Lantman, Mathie P G Leers, Remy J H Martens, Volkher Scharnhorst, Marc H M Thelen, Arjen-Kars Boer","doi":"10.1515/cclm-2026-1156","DOIUrl":"10.1515/cclm-2026-1156","url":null,"abstract":"<p><strong>Objectives: </strong>Clinical algorithms increasingly combine multiple laboratory measurands to support diagnosis, prognosis, and treatment decisions. Yet, measurement bias arising from differences in calibration, reagent lots, or analytical platforms can propagate through such algorithms in non-linear ways, shifting outputs and altering clinical classifications. Existing external quality assessment (EQA) programmes evaluate measurands individually and do not capture the cumulative effect of bias on algorithm behaviour. We present a framework that extends EQA to quantify and communicate the impact of laboratory-specific measurement bias on clinical algorithm outputs.</p><p><strong>Methods: </strong>Bias estimates derived from EQA results are injected into a representative patient cohort and propagated through the algorithm; when clinical outcomes are available, output shifts are translated into changes in clinically interpretable performance characteristics. Measurand-specific what-if analyses estimate the expected benefit of correcting individual bias. The framework is illustrated using the Fibrosis-4 (FIB-4) index and scalability is demonstrated on the ten-input CoLab COVID-19 severity score.</p><p><strong>Results: </strong>Participant-facing reports were developed that summarise deviation from a zero-bias reference, position each laboratory within the peer distribution, and identify which input measurands offer the greatest potential for performance recovery. Applied to FIB-4, the reports demonstrate how laboratories can locate themselves relative to clinically desired performance thresholds and receive actionable, measurand-specific guidance to prioritise corrective efforts.</p><p><strong>Conclusions: </strong>By translating bias-propagation analysis into interpretable laboratory reports, this framework bridges the gap between measurand-level analytical performance and clinical algorithm performance. It supports post-deployment monitoring, cross-laboratory comparability and verification, targeted quality improvement, and is applicable to any transparent formula-based clinical algorithm.</p>","PeriodicalId":10390,"journal":{"name":"Clinical chemistry and laboratory medicine","volume":" ","pages":""},"PeriodicalIF":4.4,"publicationDate":"2026-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"149079998","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":"Clinical evaluation of an intelligent venipuncture robotic system: performance, patient acceptance, and pre-analytical outcomes.","authors":"Bo Wang, Yao Yao, Liangping Ye, Dan Wu, Hong Zhao, Meijuan Zheng, Yuanhong Xu, Min Zhang, Jinxing Xia, Anyong Wang","doi":"10.1515/cclm-2026-0833","DOIUrl":"https://doi.org/10.1515/cclm-2026-0833","url":null,"abstract":"<p><strong>Objectives: </strong>In high-throughput outpatient settings, manual venipuncture is frequently constrained by extreme time pressure and inherent human operator variability, which collectively exacerbate pre-analytical errors and diminish operational efficiency. To address these clinical challenges, we conducted a retrospective study of an intelligent venipuncture robot using 13,803 clinical encounters collected over 18 months in a high-volume outpatient clinic.</p><p><strong>Methods: </strong>We analyzed performance metrics and patient feedback across three consecutive phases to evaluate both the system's technical maturation and patient acceptance. Furthermore, we validated its clinical utility by comparing procedural success, failure causes, and specimen rejection rates against historical manual practice records.</p><p><strong>Results: </strong>The results demonstrated that the robotic success rate increased steadily over time (from 95.02 % to 97.57 %) alongside sustained high patient acceptance (up to 96.70 %). Most crucially, the robotic system demonstrated a remarkable full-period zero specimen rejection advantage, effectively eliminating the pre-analytical sample rejections that typically compromise manual phlebotomy. During the same observation window, the primary cause of failure shifted chronologically from device puncture errors (47.58 % in Phase I) to patient movement (57.14 % in Phase III).</p><p><strong>Conclusions: </strong>This study provides robust real-world data supporting the integration of intelligent venipuncture robotics. Given the evident shift in failure mechanisms toward human factors, future advancements must prioritize optimizing human-machine interaction design and implementing targeted pre-procedure psychological interventions to mitigate involuntary patient movements.</p>","PeriodicalId":10390,"journal":{"name":"Clinical chemistry and laboratory medicine","volume":" ","pages":""},"PeriodicalIF":4.4,"publicationDate":"2026-09-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"149073748","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":"Stability of 54 biochemical analytes in capped serum samples stored at 4-8 °C: a 72-h longitudinal evaluation.","authors":"Paula Tauler-Quetglas, María Sanz-Felisi, Sofía Durán-Espín, Teresa Escartín-Díez, Alicia Madurga, Ariadna Arbiol-Roca","doi":"10.1515/cclm-2026-0933","DOIUrl":"https://doi.org/10.1515/cclm-2026-0933","url":null,"abstract":"<p><strong>Objectives: </strong>To evaluate the stability of 54 biochemical analytes in blood samples that were centrifuged, capped, and stored at 4-8 °C for 24, 48, and 72 h.</p><p><strong>Methods: </strong>A prospective study was conducted with 588 serum samples using the Cobas^® 8000 modular analyzer and the Cobas^® p701 post-analytical unit (Roche Diagnostics). Analytes were measured at baseline and after 24, 48, and 72 h. Stability limits were determined by comparing percentage deviations against the maximum permissible instability criteria established.</p><p><strong>Results: </strong>The majority of the evaluated analytes showed acceptable analytical stability for up to 72 h. However, seven analytes remained stable for only up to 48 h (albumin, alkaline phosphatase, calcium, free prostatic specific-antigen, gamma-glutamyl transferase, potassium and total protein). Ten analytes showed reduced stability, remaining reliable for only 24 h (chloride, folate, parathyroid hormone, triglycerides and vitamin B12) or less (alanine aminotransferase, alpha-amylase, inorganic phosphate, troponin and uric acid).</p><p><strong>Conclusions: </strong>Refrigerated storage at 4-8 °C ensures the analytical stability of 38 out of 54 biochemical analytes for up to 72 h, validation that safely covers typical weekend operational delays and requests for add-on testing. Nonetheless, specific time restrictions must be strictly enforced for the unstable analytes identified to guarantee clinical accuracy.</p>","PeriodicalId":10390,"journal":{"name":"Clinical chemistry and laboratory medicine","volume":" ","pages":""},"PeriodicalIF":4.4,"publicationDate":"2026-09-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"149073719","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":"Multicenter evaluation of an innovative fully-automated molecular diagnostics system.","authors":"Yaping Ren, Chao Chen, Weizhong Wang, Zhengquan Yang, Zhonggang Fang, Ying Yu, Zhongyuan Xiang","doi":"10.1515/cclm-2026-0879","DOIUrl":"https://doi.org/10.1515/cclm-2026-0879","url":null,"abstract":"<p><strong>Objectives: </strong>To evaluate the analytical performance of a novel fully-automated molecular diagnostics system Molecision^® R8, together with its multiplex testing capability and compatibility with different types of analytes and samples.</p><p><strong>Methods: </strong>Precision, limit of detection (LoD) and linearity were evaluated based on respective guidelines. Method comparisons were conducted between Molecision^® R8 and two commercially available systems Sansure and Hybribio, using four assays for use with each system - hepatitis B virus (HBV) RNA, <i>Chlamydia trachomatis</i> (CT) DNA, <i>Ureaplasma urealyticum</i> (UU) DNA, and <i>Neisseria gonorrhoeae</i> (NG) DNA.</p><p><strong>Results: </strong>Molecision^® R8 demonstrated excellent analytical performance: within-lab coefficient of variation (CV) was ≤1.55 %, with 100 % detectable rates at claimed LoD and strong linearity with correlation coefficient of 0.9998. In HBV RNA comparison between Molecision^® R8 and Sansure system, the 95 % confidence interval of the slope and the intercept in Passing-Bablok regression contained 1 and 0 respectively, and mean bias was -0.05 lg IU/mL in Bland-Altman analysis. Over 95 % agreement rates were found between R8 and Hybribio system in CT DNA, UU DNA and NG DNA detection, except for the negative agreement rate of UU DNA.</p><p><strong>Conclusions: </strong>Excellent analytical characteristics were verified in various analyte and sample types for Molecision^® R8. Clinical safety and effectiveness of R8 were substantiated by its strong consistency with other polymerase chain reaction (PCR) platforms in routine clinical use. With sample-in-result-out workflow, Molecision^® R8 could further improve the efficacy of clinical molecular laboratories.</p>","PeriodicalId":10390,"journal":{"name":"Clinical chemistry and laboratory medicine","volume":" ","pages":""},"PeriodicalIF":4.4,"publicationDate":"2026-09-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"149073657","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":"Preanalytical stability of aPTT and anti-Xa levels for therapeutic unfractionated heparin monitoring: a systematic review and critical appraisal using CRESS criteria.","authors":"Annabelle Dupont, Isabelle Gouin-Thibault, Thomas Lecompte, François Mullier","doi":"10.1515/cclm-2026-1257","DOIUrl":"https://doi.org/10.1515/cclm-2026-1257","url":null,"abstract":"<p><strong>Introduction: </strong>The preanalytical stability of activated partial thromboplastin time (aPTT) and anti-factor Xa (anti-Xa) levels is critical for reliable monitoring of therapeutic unfractionated heparin (UFH). However, current recommendations regarding acceptable preanalytical delays are based on limited and heterogeneous evidence. We systematically reviewed the literature on the preanalytical stability of aPTT and anti-Xa levels in patients receiving therapeutic UFH and assessed study quality using the Checklist for Reporting Stability Studies (CRESS), with studies graded from A (best quality) to D (fail).</p><p><strong>Content: </strong>A systematic review was conducted according to the PRISMA 2020 guidelines. Studies evaluating the preanalytical stability of aPTT and/or anti-Xa levels in patients receiving therapeutic UFH were identified through a systematic literature search. Study quality and reporting were assessed using the 20-item CRESS checklist.</p><p><strong>Summary: </strong>Nine studies published between 1983 and 2025 met the inclusion criteria. Marked heterogeneity was observed in study design, preanalytical conditions, analytical methods, stability criteria, and statistical analyses. According to the CRESS, seven studies were graded C or D, while only two achieved grade B. Reported stability limits varied widely according to sample type, collection tube (citrate vs. CTAD), analytical reagent, storage conditions, and study methodology. Delayed centrifugation and delayed analysis were consistently associated with decreases in aPTT and anti-Xa levels. CTAD tubes and dextran sulphate-containing anti-Xa assays did not demonstrate a consistent stability advantage. Importantly, studies evaluating patient-level outcomes reported clinically relevant patient reclassification despite apparently acceptable analytical stability.</p><p><strong>Outlook: </strong>Evidence regarding the preanalytical stability of aPTT and anti-Xa levels remains limited by methodological heterogeneity, inconsistent stability criteria, and incomplete reporting. Based on the available evidence, centrifugation within 1 hour after blood collection followed by prompt analysis should remain the reference approach for therapeutic UFH monitoring. Future stability studies should comply with CRESS recommendations, use standardized acceptability criteria, and incorporate clinically relevant outcomes, including patient reclassification, to establish evidence-based recommendations for UFH monitoring.</p>","PeriodicalId":10390,"journal":{"name":"Clinical chemistry and laboratory medicine","volume":" ","pages":""},"PeriodicalIF":4.4,"publicationDate":"2026-09-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"149069392","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}