Clinical chemistry and laboratory medicine最新文献

{"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}

{"title":"Multiplex microblot array as an integrated approach to ANA screening and antigen-specific profiling in systemic autoimmune rheumatic diseases.","authors":"Maria Barrale, Nicola Bizzaro, Danilo Villalta, Ignazio Brusca","doi":"10.1515/cclm-2026-1223","DOIUrl":"https://doi.org/10.1515/cclm-2026-1223","url":null,"abstract":"","PeriodicalId":10390,"journal":{"name":"Clinical chemistry and laboratory medicine","volume":" ","pages":""},"PeriodicalIF":4.4,"publicationDate":"2026-09-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"149058942","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":"Refrigerated storage stability of 11 humoral parameters in two different venous blood collection tubes over a 7-day period.","authors":"Stijn De Koninck, Joren Hemelings, Simke Demeester","doi":"10.1515/cclm-2026-0962","DOIUrl":"https://doi.org/10.1515/cclm-2026-0962","url":null,"abstract":"<p><strong>Objectives: </strong>Humoral parameters like immunoglobulins, complement components, and free light chains (FLC) are vital for diagnosing immune and hematological disorders. To minimize pre-analytical errors and reduce turnaround time, this study evaluated the 7-day stability of 11 analytes (IgG, IgG subclasses 2-4, IgA, IgM, C1 esterase inhibitor, C3c, C4, and FLC Kappa/Lambda) to determine if manual aliquoting can be eliminated in favor of direct primary tube sampling.</p><p><strong>Methods: </strong>Blood from 27 healthy volunteers was collected into lithium heparin (LH) and LH-gel separator (LH-GS) tubes. Baseline measurements (Day 1) from aliquoted samples were compared against samples stored at 2-8 °C and re-tested on Days 3 and 7 using the Optilite^® analyzer. Stability was defined by the percent difference (%PD) against total error (TEa) limits.</p><p><strong>Results: </strong>IgG (and subclasses), IgA, IgM, and C4 remained highly stable through Day 7 in both tube types. FLCs (Kappa/Lambda) showed a progressive negative bias but stayed within acceptable limits. Conversely, C3c exhibited significant positive bias, exceeding stability limits by Day 7 (%PD 10.39 in LH); it was only stable up to Day 3. No interference from the gel separator was detected.</p><p><strong>Conclusions: </strong>Aliquoting can be safely omitted for most humoral parameters, allowing for direct primary tube sampling and streamlined workflows. While FLCs remain reliable for 7 days, C3c requires a strict 3-day window. Both LH and LH-GS tubes are suitable, supporting laboratory optimization and ISO 15189 compliance while maintaining analytical quality.</p>","PeriodicalId":10390,"journal":{"name":"Clinical chemistry and laboratory medicine","volume":" ","pages":""},"PeriodicalIF":4.4,"publicationDate":"2026-09-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"149058882","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":"Feasibility of self-sampling into capillary tubes at home in children with juvenile idiopathic arthritis: an observational study.","authors":"Martijn J H Doeleman, Gerrie C J W de Joode-Smink, Nico M Wulffraat, Wouter M Tiel Groenestege, Joost F Swart, Sytze de Roock","doi":"10.1515/cclm-2026-1104","DOIUrl":"https://doi.org/10.1515/cclm-2026-1104","url":null,"abstract":"","PeriodicalId":10390,"journal":{"name":"Clinical chemistry and laboratory medicine","volume":" ","pages":""},"PeriodicalIF":4.4,"publicationDate":"2026-09-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"149058780","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 utility of a dedicated vanishing twin analytical workflow in single-nucleotide variant-based non-invasive prenatal testing: a case report of resolving prolonged aneuploidy discordance.","authors":"Changhee Ha, Hanah Kim, Mina Hur, In-Sook Sohn","doi":"10.1515/cclm-2026-1330","DOIUrl":"https://doi.org/10.1515/cclm-2026-1330","url":null,"abstract":"","PeriodicalId":10390,"journal":{"name":"Clinical chemistry and laboratory medicine","volume":" ","pages":""},"PeriodicalIF":4.4,"publicationDate":"2026-09-23","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"149016000","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":"Season of sampling and the interpretation of serum homocysteine results: a within-person analysis of 268,877 health-screening examinations.","authors":"Seung-Hwan Kim, Jeong-Hwan Chae, Chang-Ho Chae","doi":"10.1515/cclm-2026-1304","DOIUrl":"https://doi.org/10.1515/cclm-2026-1304","url":null,"abstract":"<p><strong>Objectives: </strong>Serum total homocysteine (tHcy) is interpreted against fixed reference intervals and a decision limit. Whether the month of blood collection is a material source of variation, and whether it reflects the seasonal cycle of 25-hydroxyvitamin D [25(OH)D], is unresolved because earlier studies were cross-sectional or small.</p><p><strong>Methods: </strong>We analysed 268,877 health-screening examinations from 69,131 adults between January 2014 and December 2025 at a single Korean centre. Because no participant was examined twice in a calendar year, within-person seasonal contrasts span years; all models therefore combined person with calendar-year fixed effects. Seasonality was quantified by cosinor regression with cluster-robust standard errors.</p><p><strong>Results: </strong>The crude amplitude of tHcy (0.473 μmol/L) fell to 0.255 μmol/L under person fixed effects, so about half of the apparent seasonality reflected who attended. After the secular trend was also removed the within-person amplitude was 0.301 μmol/L (95 % CI 0.281-0.324), peaking in early November, and was unchanged by time-varying covariates. The 25(OH)D acrophase was in August, 2.6 months away, and adjustment for 25(OH)D did not attenuate the tHcy amplitude (retention 108.0 %); the rhythm persisted where within-person 25(OH)D barely varied. Spring examinations carried lower within-person odds of exceeding 15 μmol/L (odds ratio 0.699, 95 % CI 0.654-0.748).</p><p><strong>Conclusions: </strong>Month of sampling is a small but reproducible systematic source of within-person variation in tHcy that is not explained by 25(OH)D. It is modest relative to within-subject biological variation, but sufficient to alter classification near the decision limit and to bias reference intervals derived from seasonally unbalanced data.</p>","PeriodicalId":10390,"journal":{"name":"Clinical chemistry and laboratory medicine","volume":" ","pages":""},"PeriodicalIF":4.4,"publicationDate":"2026-09-23","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"149015964","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":"Availability and characteristics of external quality assessment (EQA) schemes for measurement of hemolysis, icterus and lipemia (HIL) in routine coagulation testing, a collaborative study from the European Organisation for External Quality Assurance in Laboratory Medicine (EQALM).","authors":"Ann Helen Kristoffersen, Martine J Hollestelle, Rachel Marrington, Gro Gidske, Ian Jennings, Claudia van Rijn, Piet Meijer","doi":"10.1515/cclm-2026-1130","DOIUrl":"https://doi.org/10.1515/cclm-2026-1130","url":null,"abstract":"","PeriodicalId":10390,"journal":{"name":"Clinical chemistry and laboratory medicine","volume":" ","pages":""},"PeriodicalIF":4.4,"publicationDate":"2026-09-21","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"149001370","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}