CLINICA CHIMICA ACTA临床化学学报
CLINICA CHIMICA ACTA(英文缩写 CLIN CHIM ACTA),ISSN 0009-8981,eISSN 1873-3492,中文译名:临床化学学报 是一本学术期刊。本页汇总该期刊的最新影响因子、分区信息以及最新收录于 PubMed 的文献,帮助您快速了解期刊全貌。
发文量统计区间：2025-11-01 至 2026-10-31，按本站收录文献的发表日期统计。
期刊介绍
历年影响因子趋势
| JCR 数据年份 | 影响因子 | JCR 分区 |
|---|---|---|
| 2021 | 6.315 | Q1 |
| 2022 | 5.000 | Q1 |
| 2023 | 3.200 | Q2 |
| 2024 | 2.900 | Q2 |
| 2025 | 4.100 | Q1 |
CLINICA CHIMICA ACTA 最新收录文献
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1. Impact of ISO/TS 20914-based measurement uncertainty on HbA1c diagnostic classification: A real-world comparison of two analytical systems.
PMID:日期:2026-10-04HbA1c is interpreted using fixed clinical decision limits, but measurement uncertainty (MU) may affect analytical interpretation of results near these thresholds. This study estimated ISO/TS 20914-based MU for two HbA1c analytical systems and evaluated the patient-level impact of including calibration- and traceability-related uncertainty. In this retrospective two-center study, 30,791 routine HbA1c results from independent patient cohorts were obtained using Roche cobas c501 and Adams HA-8180 V systems. MU was estimated from within-laboratory reproducibility uncertainty (uRw), calibration- and traceability-related standard uncertainty (ucal), and uncertainty associated with the IFCC-to-NGSP master equation (uME). Decision-limit-specific coverage intervals were calculated at 5.7% and 6.5% HbA1c using a calibration-included MU model (uRw, ucal, and uME) and a calibration-excluded sensitivity analysis (uRw and uME). Patient-level reclassification was evaluated using McNemar's test with Holm adjustment. Roche showed higher uRw than Adams, whereas ucal was higher for Roche (2.35% vs 1.75%). Calibration-included standard MU was 3.77% and 3.76% for Roche at 5.7% and 6.5%, respectively, and 2.47% and 2.45% for Adams. Inclusion of ucal increased the proportion of results within MU coverage intervals from 38.81% to 48.05% for Roche at 5.7%, from 15.45% to 20.76% at 6.5%, and from 10.69% to 15.90% for Adams at 6.5% (all Holm-adjusted P < 0.001). No reclassification occurred for Adams at 5.7%. Inclusion of calibration- and traceability-related uncertainty materially affected analytical interpretation around clinical decision limits in three of four system-threshold analyses. Patient-level impact depended on both MU budget composition and the distribution of results around the relevant threshold.
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2. From promise to practice: Assessing middleware characteristics in autoimmune diagnostics.
2. 从承诺到实践：评估自身免疫诊断中的中间件特性PMID:日期:2026-10-03Middleware systems connect analytical instruments with laboratory information systems and may support workflow control, result review, and data management. We conducted a nationwide descriptive survey to characterize middleware adoption, reported functionality, and user perceptions in Italian autoimmune diagnostic laboratories affiliated with the Autoimmunology Study Group of the Italian Society of Clinical Pathology and Laboratory Medicine. The questionnaire was administered in January 2026. Of 38 invited laboratories, 36 responded and 33 reported using middleware. Thirty laboratories provided complete Yes/No/I-don't-know responses for 24 detailed functionality items. Cross-vendor interoperability was reported in 20 of 29 records (69.0%); six reported no interoperability and three were nonresponses. Reported capabilities varied: worklist generation (70.0%), previous-result display (86.7%), personalized comments (80.0%), remote assistance (83.3%), and online updates (80.0%) were common, whereas warehouse management (3.3%), access to the clinical question (6.7%), delta-check flagging (13.3%), redundant-test cancellation (20.0%), and automated dilution suggestions (20.0%) were less common. Agreement (Likert scores 4-5) with perceived benefits ranged from 54.2% for reduction of reporting errors to 88.5% for improved diagnostic quality. These findings describe respondent-reported capabilities and perceived benefits; they do not demonstrate objective improvements in quality, turnaround time, error rates, or patient outcomes. The results identify potential priorities for interoperability, configurable rules, user training, and future objective evaluation.
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3. Liquid biopsy for early detection and biomarker applications in gynecological cancers: current status and future directions.
3. 液体活检在妇科癌症早期检测和生物标志物应用中的现状与未来方向PMID:日期:2026-10-03Liquid biopsy is a minimally invasive approach to early detection and biomarker assessment in gynecological cancers. This structured review synthesizes evidence on circulating tumor DNA (ctDNA), circulating tumor cells (CTCs), exosomal non-coding RNAs, epigenetic markers (methylation and fragmentation), and multi-omics signatures across ovarian, endometrial, cervical, vulvar, and vaginal malignancies. A structured search of PubMed/MEDLINE, Embase, Scopus, Web of Science, and the Cochrane Library identified studies evaluating early detection, predictive and prognostic performance, therapy monitoring, minimal residual disease (MRD) detection, resistance mechanisms, and clinical implementation; each quantitative estimate was assigned an evidence tier reflecting study design and validation status. Multi-omics integration outperforms single-analyte approaches, with a prospective gynecological cohort reporting approximately 82% sensitivity at 97-99% specificity. ctDNA methylation and fragmentomics exceed CA125 in ovarian and endometrial cancers, and cfHPV-DNA shows high specificity in cervical disease. ctDNA dynamics are associated with PARP inhibitor response, MRD status and BRCA reversion-mediated resistance, and detect recurrence before imaging. Reported hazard ratios vary widely but differ in cohort, assay platform and sampling timepoint, and are not directly comparable. Almost all detection estimates derive from retrospective or case-control designs that overestimate performance, and none has been externally and prospectively validated; circulating HPV DNA in cervical cancer is the only marker with prospective trial-level prognostic support. No liquid biopsy assay holds an FDA or EMA indication for any gynecological cancer; pan-tumor clearances exist, but no gynecology-specific companion diagnostic, and no major oncology society recommends use outside clinical trials. Liquid biopsy complements but cannot replace tissue biopsy for diagnosis, subtyping and grading. Randomized trials controlling for lead-time bias are required to establish clinical utility.
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4. A novel γ-chain Tyr306Asn missense mutation causes congenital dysfibrinogenemia.
4. 一种新型γ链Tyr306Asn错义突变导致先天性异常纤维蛋白原血症PMID:日期:2026-10-03Congenital dysfibrinogenemia is an inherited disorder caused by fibrinogen gene defects, leading to structural and functional abnormalities of the protein. We identified a novel heterozygous γTyr306Asn mutation in a 26-year-old woman and aimed to elucidate its pathogenic mechanism. The study used coagulation assays, genetic analysis, sodium dodecyl sulfate-polyacrylamide gel electrophoresis, liquid chromatography-tandem mass spectrometry, fibrin polymerization, fibrin clot dissolution, cross-linking, sequence conservation analysis, bioinformatics analysis, and molecular modeling. The proband's fibrinogen levels were 1.66 g/L by the Clauss assay and 5.38 g/L by the PT-derived method. Sequencing identified a novel heterozygous γTyr306Asn mutation in the fibrinogen gene. Mass spectrometry detected both normal and mutant fibrinogen peptides in patient plasma. Amino acid sequence alignment revealed that γTyr306 is highly conserved across homologous species. Furthermore, multiple online bioinformatics tools consistently predicted that this mutation would significantly impair protein structure or function. Molecular modeling analysis revealed that the γTyr306Asn mutation alters the spatial conformation and electrostatic interactions of the amino acid, resulting in structural distortion of the local β-sheet. This perturbation was predicted to alter the local β-sheet conformation and may interfere with D:D-mediated fibrin assembly. Fibrin polymerization confirmed that the proband's fibrinogen had a decreased aggregation rate and defective fibrin aggregation. Clot lysis and cross-linking remained unaffected. The novel γTyr306Asn variant was associated with impaired fibrin polymerization. The combined structural and functional findings support a pathogenic mechanism involving disturbed D:D-mediated fibrin assembly.
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5. Liquid biopsy in head and neck tumors: novel approaches and clinical applications.
PMID:日期:2026-10-02Head and neck cancers (HNCs) represent one of the most prevalent and lethal types of cancer, accounting for 4.7% of annual cancer new cases and 4.9% of cancer-related mortalities. These high prevalence and mortality rates have positioned HNCs as a global health issue. Despite advances in disease treatment methods, the prognosis of patients with advanced or recurrent diseases remains poor. The difficulty of early-stage diagnosis of HNCs is one of the primary contributors to this reduced long-term survival. Currently available diagnostic and disease-monitoring tools, such as tissue biopsy and imaging techniques, are associated with several limitations, including invasiveness, limited repeatability, and limited sensitivity for detecting minimal residual disease (MRD) and microscopic metastases. In recent years, liquid biopsy has emerged as a promising approach, enabling minimally invasive detection of tumor-related biomarkers in body fluids. This review aims to provide a comprehensive overview of the progress and pitfalls of liquid biopsy in the context of HNCs. In this regard, we discuss the principles of liquid biopsy, applicable biomarker types, sample sources, and advanced detection methods. Furthermore, the current status of liquid biopsy in clinical trials of HNCs and the challenges of its clinical translation are also comprehensively explored.
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6. Exhaled breath metabolomics: Clinical diagnostic applications, technological evolution and translational challenges.
6. 呼出气代谢组学：临床诊断应用、技术演进与转化挑战PMID:日期:2026-10-02Breathomics, the analysis of volatile organic compounds (VOCs) and other metabolites in exhaled breath, offers a non-invasive approach to disease screening, longitudinal monitoring and assessment of treatment response. Advances in gas chromatography-mass spectrometry, real-time mass spectrometry, electronic-nose (e-nose) sensors and machine-learning workflows have markedly improved the sensitivity and diagnostic performance of breath analysis. However, these gains have been demonstrated mainly in proof-of-concept and analytical validation studies, and remain insufficiently confirmed in prospective clinical cohorts. In this Review, we examine breathomics across the translational pathway, from breath sampling and pre-analytical standardization to analytical platforms, data processing, disease applications and clinical implementation. We focus on three clinically prominent areas, cancer, chronic respiratory disease and infectious disease, and use selected systemic disorders to illustrate the limited disease specificity of individual VOCs. Current evidence supports the presence of detectable disease-associated breath signatures, but most VOC panels remain insufficiently standardized, externally validated and mechanistically interpretable for routine clinical use. Translation will require harmonized sampling protocols, rigorous analytical validation, prospective multicenter cohorts, explainable models, regulatory approval, and evidence of clinical utility and cost-effectiveness.
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7. Performance assessment of a novel fully automated ELISA for anti-IA2 autoantibody detection in type 1 diabetes.
7. 一种用于1型糖尿病中抗IA2自身抗体检测的新型全自动ELISA的性能评估PMID:日期:2026-10-01Autoantibodies to insulinoma-associated antigen 2 (IA2) are well-established biomarkers of islet autoimmunity, supporting the diagnosis and risk stratification of type 1 diabetes (T1D). This study presents the analytical and clinical evaluation of a newly developed bridge-type Anti-IA2 ELISA (Euroimmun), which is CE-marked under the European In Vitro Diagnostic Regulation (IVDR) and compatible with fully automated processing platforms. The analytical performance was assessed through precision, detection capability, linearity, and interference studies. Diagnostic accuracy testing and method comparison with the predecessor ELISA and the Medipan CentAK anti-IA2 M radioimmunoassay were performed using serum samples from patients with T1D (median age at diagnosis: 11 years; median diabetes duration: 4 years), latent autoimmune diabetes in adults, or Addison's disease, as well as samples from non-T1D control groups and the Islet Autoantibody Standardization Program (IASP). The assay demonstrated low intra-/inter-lot imprecision (CVs ≤ 3.2%), detection limits in the low IU/mL range, linearity over the measuring range (10-2000 IU/mL), and no interference from hemolytic, lipemic, or icteric sample conditions. Sensitivity was 53.8% in the clinical T1D cohort (56.5% in newly diagnosed patients), and 76.0% in IASP case samples. Specificity in non-T1D controls reached 98.4%. Agreement with the predecessor ELISA was almost perfect (94.7%; κ = 0.873). Compared with the radioimmunoassay, substantial agreement (82.4-83.8%; κ ≥ 0.637) was observed, and the ELISA identified more anti-IA2-positive T1D samples. In conclusion, the new Anti-IA2 ELISA combines strong analytical and diagnostic performance with a fully automated workflow enabling standardized end-to-end processing. These features support implementation in high-throughput routine diagnostics. Prospective validation in larger and population-representative cohorts is warranted to further assess the assay's suitability for potential future use in large-scale screening aimed at improving early detection and risk assessment in autoimmune diabetes.
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8. Evaluation of external quality assessment results of 15 clinical laboratory quality indicators in China from 2019 to 2021.
8. 2019年至2021年中国15项临床实验室质量指标外部质量评估结果评价PMID:日期:2026-10-01This study analyzed external quality assessment (EQA) results for 15 clinical laboratory quality indicators (QIs) in China from 2019 to 2021 to evaluate error-influencing factors, benchmark performance against international standards and inform preliminary quality specifications. Data for 15 QIs were collected via a web-based EQA system from 2019 to 2021. Variations across years were analyzed using descriptive statistics and Kruskal Wallis H test. Participation rates exceeded 75% for most indicators. Specimen acceptability indicators improved significantly over time. Pre-examination and intra-laboratory turnaround times (TATs) for routine and stat samples remained generally stable over the study period, except for a slight but significant increase in intra-laboratory TAT for stat samples (p < 0.001). The median rate of tests covered by an EQA-proficiency testing (PT) control reached 100%, whereas the rates of tests covered by internal quality control (IQC) and inter-laboratory comparison required improvement. The median rate of unacceptable performances in EQA-PT schemes from 2019 to 2021 was 0%, while the 75th percentile reached nearly 4%. This finding reveals considerable performance variation among individual laboratories. Reporting-related indicators yielded satisfactory results. Most laboratories achieved 100% for timely critical value notification, despite statistically significant inter-annual variations (p < 0.05). Overall laboratory quality improved from 2019 to 2021. Deficiencies in tests covered by IQC and inter-laboratory comparison require targeted improvements and sustained monitoring of quality indicators.
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9. Recent progress in the biomarkers of peripheral artery disease.
9. 外周动脉疾病生物标志物的研究进展PMID:日期:2026-10-01Peripheral artery disease (PAD) is a prevalent atherosclerotic disorder affecting over 113 million individuals worldwide, with its global burden projected to rise substantially amid population aging and increasing metabolic comorbidities, including type 2 diabetes mellitus (T2DM). Conventional diagnostic assessment, including the ankle-brachial index (ABI) as a non-invasive hemodynamic measurement and imaging-based techniques such as duplex ultrasonography, computed tomography angiography, magnetic resonance angiography, and digital subtraction angiography, has limited sensitivity for early disease detection and does not fully capture the multidimensional pathophysiological processes underlying disease progression, and ABI generates false-negative results in elderly and diabetic patients with medial arterial calcification, a critical unaddressed limitation in routine screening. Recent advances in multi-omics technologies have accelerated the discovery of circulating biomarkers that reflect distinct pathological axes-inflammation, oxidative stress, endothelial dysfunction, and metabolic dysregulation-underlying PAD pathogenesis. These novel biomarkers hold considerable promise for enhancing early diagnosis, risk stratification, prognostic assessment, therapeutic monitoring and postoperative restenosis prediction, and individualized precision intervention guidance. This review systematically summarizes the most recent advances in PAD biomarkers across these four pathophysiological categories, elucidating their mechanistic links to disease progression and critically evaluating their clinical utility and translational barriers; We further develop population-specific biomarker strategies for patients with diabetes mellitus, dialysis-dependent kidney disease, and chronic limb-threatening ischemia (CLTI), while considering disease-specific confounding factors and the current limitations of biomarker validation. We further discuss emerging biomarker classes, including extracellular vesicle-derived molecules and microRNAs, and highlight the superior diagnostic and predictive efficacy of multi-biomarker panels compared with single indicators, combined with machine learning modeling frameworks. Large-scale multi-center, multi-ethnic prospective validation studies, standardized pre-analytical and analytical detection protocols, and cost-effectiveness health economic evaluations remain essential prerequisites for full-scale clinical implementation.
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10. Advances in molecular techniques for detecting Mycobacterium leprae: A narrative review of progress, challenges, and future directions.
10. 检测麻风分枝杆菌分子技术的进展：关于进展、挑战和未来方向的叙述性综述PMID:日期:2026-10-01Leprosy is a neglected infectious disease where delayed diagnosis leads to disability and ongoing transmission, particularly in paucibacillary and pure neural forms. This narrative review summarizes molecular diagnostic approaches for Mycobacterium leprae, including polymerase chain reaction (PCR), isothermal nucleic acid amplification tests, clustered regularly interspaced short palindromic repeats (CRISPR)-Cas-based diagnostic systems, next-generation sequencing (NGS), microarrays, and biosensors. PCR remains the most established method, now expanded to multiplex, quantitative, and droplet digital formats for improved detection and antimicrobial resistance surveillance. Isothermal methods such as loop-mediated isothermal amplification (LAMP), recombinase polymerase amplification (RPA), and multiple cross displacement amplification (MCDA) offer rapid, field-deployable options but require further validation. Emerging platforms, including CRISPR-Cas diagnostics, targeted sequencing, and biosensors, show promise but are limited by cost and infrastructure needs. Overall, molecular approaches have substantially expanded the diagnostic and surveillance capacity for leprosy, particularly in paucibacillary, pure neural, and clinically ambiguous presentations where conventional methods lack sensitivity. Future advances should integrate optimized biomarkers, improved sample processing, and simplified platforms to further enable early diagnosis, treatment monitoring, and antimicrobial resistance surveillance, thereby supporting global leprosy control and elimination.