Clinica Chimica Acta最新文献

英文中文

Plasma non-targeted metabolomics unveils the metabolic signatures of trans-right ventricle in pulmonary arterial hypertension associated with atrial septal defect 血浆非靶向代谢组学揭示了肺动脉高压伴房间隔缺损患者经右心室的代谢特征。

IF 2.9 3区医学 Q2 MEDICAL LABORATORY TECHNOLOGY

Clinica Chimica Acta

Pub Date : 2026-01-21 DOI: 10.1016/j.cca.2026.120849

Xifeng Qian , Yuanrui Deng , Tingting Guo , Xin Huang , Chaowu Yan , Xin Gao , Yan Wu , Song Hu , Jiangshan Tan , Lingtao Chong , Shengsong Zhu , Mingjie Ma , Mengting Ye , Xiaojian Wang , Jian Cao , Lu Hua

Background

Understanding metabolic evolution of right ventricle (RV) of pulmonary arterial hypertension associated with atrial septal defect (PAH-ASD) helps elucidate the underlying pathobiology and reveal disease-specific biomarkers. However, the exact metabolic profile of RV of PAH-ASD is scarce.

Objectives

This study aimed to unveil precisely the metabolic signatures of trans-RV of PAH-ASD through non-targeted metabolomics.

Methods

Participants with PAH-ASD were recruited and their blood samples were obtained from superior vena cava (SVC) and pulmonary artery (PA) through right cardiac catheterization. Non-targeted metabolomics analysis on the basis of UHPLC-MS/MS was utilized to generate the metabolomic signature of trans-RV by comparing the metabolites change from SVC to PA.

Results

1060 metabolites were detected from blood samples from 40 PAH-ASD participants. A total of 44 differential metabolites were identified based on screening criteria after flowing through the RH, including 10 metabolites with decreased levels and 34 metabolites with increased levels. Among them, phosphatidylcholines, sphingomyelins, AICARP, XMP, inosine 5’-Monophosphate, prostaglandin A1, oleoyl ethanolamide, tyramine, 2-phenylethylamine, 23-nordeoxycholic acid, LPI 20:4, and LPE 22:6 were discovered. Moreover, distinct metabolic perturbations, such as the change of sphingomyelins, inosine 5’-Monophosphate and LPE 22:6, was correlated with the significant clinical variables indicating RV dysfunction in clinical association analysis.

Conclusion

Our study correctly defined metabolic signatures indicating towards a metabolic pathogenesis of trans-RV of PAH-ASD, emphasizing the importance of these metabolites in promoting of RV dysfunction and devising therapeutic strategies.

背景：了解肺动脉高压合并房间隔缺损（PAH-ASD）右心室（RV）的代谢演变有助于阐明潜在的病理生物学和揭示疾病特异性生物标志物。然而，PAH-ASD中RV的确切代谢谱尚不清楚。目的：本研究旨在通过非靶向代谢组学精确揭示PAH-ASD反式rv的代谢特征。方法：招募PAH-ASD患者，通过右心导管从上腔静脉（SVC）和肺动脉（PA）采集血样。利用UHPLC-MS/MS基础上的非靶向代谢组学分析，通过比较SVC和PA的代谢物变化，生成trans-RV的代谢组学特征。结果：从40名PAH-ASD参与者的血液样本中检测到1060种代谢物。经过RH后，根据筛选标准共鉴定出44种差异代谢物，其中10种代谢物水平降低，34种代谢物水平升高。其中发现磷脂酰胆碱、鞘磷脂、AICARP、XMP、肌苷5′-单磷酸、前列腺素A1、油基乙醇酰胺、酪胺、2-苯乙胺、23-去氧胆酸、LPI 20:4、LPE 22:6。此外，在临床关联分析中，不同的代谢扰动，如鞘磷脂、肌苷5′-单磷酸和LPE 22:6的变化，与提示RV功能障碍的重要临床变量相关。结论：本研究正确定义了PAH-ASD反式右心室代谢机制的代谢特征，强调了这些代谢物在促进右心室功能障碍中的重要性，并制定了治疗策略。

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引用次数: 0

ALT-triggered reflex AST testing in health check-ups: A decision curve analysis 健康检查中alt触发反射性AST检测：决策曲线分析。

IF 2.9 3区医学 Q2 MEDICAL LABORATORY TECHNOLOGY

Clinica Chimica Acta

Pub Date : 2026-01-20 DOI: 10.1016/j.cca.2026.120848

Shu-Mei Bai , Xu-Xiao Guo , Guo-Ming Zhang

Background

Aspartate aminotransferase (AST) is frequently co-ordered with alanine aminotransferase (ALT) in routine health check-ups, although universal AST testing may have a low clinical yield in asymptomatic individuals. We evaluated ALT-triggered reflex AST testing via decision curve analysis (DCA) to identify implementable screening policies.

Methods

We retrospectively analysed adult health check-up records with paired ALT and AST results. Reflex strategies were simulated in which AST was measured only when ALT exceeded predefined thresholds (15–60 U/L). Pathological AST was defined via sex-specific upper reference limits (URL). Clinical utility was assessed via DCA, where threshold probability (pt) represents the trade-off between unnecessary testing and missed pathological results. The primary analysis prespecified pt. = 1%, with pt. = 1%–5% examined in sensitivity analyses.

Results

Among 46,059 participants (20,489 females; 25,570 males), AST ≥ URL was observed in 5.52% of females and 7.35% of males. At pt. = 1%, DCA supported sex-specific ALT triggers of ≥19 U/L for females and ≥ 26 U/L for males. These policies reduced AST testing to 34.8% and 46.7%, respectively, while maintaining sensitivities of 97.9% and 98.0%, respectively. The number of individuals with pathological AST who would be missed under the reflex policy was 11.7 and 14.9 per 10,000 screened. Across low pt. ranges, reflex strategies consistently achieved greater net benefits than did universal testing.

Conclusions

ALT-triggered reflex AST testing can substantially reduce low-yield AST measurements during health check-ups with minimal loss of screening sensitivity. The DCA provides a transparent framework for selecting sex-specific, screening-oriented policy thresholds.

背景：在常规健康检查中，谷草转氨酶（AST）经常与丙氨酸转氨酶（ALT）共序，尽管普遍的AST检测在无症状个体中可能有较低的临床产量。我们通过决策曲线分析（DCA）评估alt触发的反射性AST检测，以确定可实施的筛查政策。方法回顾性分析成人健康体检记录中ALT和AST的配对结果。模拟反射策略，仅当ALT超过预定义阈值（15-60 U/L）时测量AST。病理AST通过性别特异性参考上限（URL）定义。通过DCA评估临床效用，其中阈值概率（pt）代表不必要的测试和错过的病理结果之间的权衡。初步分析预先指定pt. = 1%，在敏感性分析中检查pt. = 1%-5%。结果：在46059名参与者中（女性20489人，男性25570人），5.52%的女性和7.35%的男性存在AST ≥ URL。在pt. = 1%时，DCA支持女性≥19 U/L和男性 ≥ 26 U/L的性别特异性ALT触发。这些政策将AST检测分别降低到34.8%和46.7%，同时保持了97.9%和98.0%的敏感性。在反射政策下，病理性AST个体的漏诊率分别为11.7 / 10000和14.9 / 10000。在低pt范围内，反射策略始终比通用测试获得更大的净收益。结论：alt触发的反射性谷草转氨酶检测可以显著降低健康检查中谷草转氨酶的低产率，同时使筛查敏感性损失最小。DCA为选择特定性别、面向筛选的政策阈值提供了一个透明的框架。

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引用次数: 0

Validating CALIPER pediatric reference intervals in a U.S. population using retrospective outpatient data and RefineR 使用回顾性门诊数据和RefineR在美国人群中验证CALIPER儿科参考间隔。

IF 2.9 3区医学 Q2 MEDICAL LABORATORY TECHNOLOGY

Clinica Chimica Acta

Pub Date : 2026-01-19 DOI: 10.1016/j.cca.2026.120846

Jillian Kodger , Thomas J.S. Durant , Nalan Yurtsever , Joe M. El-Khoury

Background

Accurate pediatric reference intervals (RIs) are critical for proper interpretation of laboratory results, yet their development is challenged by age-related physiological variation, limited sample sizes, and preanalytical variability. This study evaluates the applicability of the Canadian Laboratory Initiative on Pediatric Reference Intervals (CALIPER) RIs to a US-based, diverse pediatric outpatient population using both the RefineR inverse modeling approach and the Clinical and Laboratory Standards Institute (CLSI) EP28-A3c recommended approach.

Methods

Outpatient laboratory data from 51,863 patients under 19 years of age were collected from a single institution between January 2023 and December 2024. Nine commonly ordered chemistry analytes were evaluated. RIs were derived using both RefineR and CLSI guidelines with bootstrap resampling. These were compared to CALIPER RIs using a color-coded flagging system based on 95% confidence intervals and total allowable error (TAE).

Results

RefineR-based RIs aligned with CALIPER values in 86 out of 88 age- and gender-specific analyte groups, whereas CLSI-derived RIs aligned in 79 out of 88. Notable discrepancies involved alanine aminotransferase, aspartate aminotransferase, alkaline phosphatase, and blood urea nitrogen, often influenced by known preanalytical and physiological variables such as sample type, body mass index (BMI), and hydration status.

Conclusions

RefineR demonstrated superior alignment with CALIPER RIs compared to CLSI guidelines, highlighting its robustness in outpatient pediatric populations. Given its tolerance to mixed data and skewed distributions, RefineR offers a more practical and accurate method for deriving population-specific RIs in pediatric laboratory medicine, and helps verify the implementation of external RIs, such as CALIPER.

背景：准确的儿科参考区间（RIs）对于正确解释实验室结果至关重要，但其发展受到年龄相关生理变化、有限样本量和分析前变异性的挑战。本研究使用RefineR逆建模方法和临床与实验室标准协会（CLSI） EP28-A3c推荐方法，评估加拿大儿科参考区间RIs （CALIPER）实验室倡议在美国不同儿科门诊人群中的适用性。方法：2023年1月至2024年12月，从一家机构收集51863例年龄在19岁以下 患者的门诊实验室数据。对9种常用化学分析物进行了评价。RIs是使用RefineR和CLSI指南和自举重采样得到的。使用基于95%置信区间和总允许误差（TAE）的颜色编码标记系统将这些与CALIPER RIs进行比较。结果：基于refiner的RIs在88个年龄和性别特定分析组中有86个与CALIPER值一致，而clsi衍生的RIs在88个组中有77个与CALIPER值一致。显著差异包括丙氨酸转氨酶、天冬氨酸转氨酶、碱性磷酸酶和血尿素氮，通常受到已知的分析前和生理变量的影响，如样品类型、体重指数（BMI）和水合状态。结论：与CLSI指南相比，RefineR与CALIPER RIs的一致性更好，突出了其在门诊儿科人群中的稳健性。鉴于RefineR对混合数据和偏态分布的容忍，它为儿科检验医学中获得人群特异性RIs提供了一种更实用、更准确的方法，并有助于验证外部RIs（如CALIPER）的实施。

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引用次数: 0

Exosome biosensors for detection of Lung cancer 肺癌检测的外泌体生物传感器。

IF 2.9 3区医学 Q2 MEDICAL LABORATORY TECHNOLOGY

Clinica Chimica Acta

Pub Date : 2026-01-19 DOI: 10.1016/j.cca.2026.120847

Obaid Afzal , Pavan Goud , Kavita Goyal , Ali Altharawi , Mubarak A. Alamri , Manal A. Alossaimi , Abdulmalik S.A. Altamimi , Surya Nath Pandey

Lung cancer is the leading cause of cancer-related mortality worldwide. It is frequently diagnosed at an advanced stage and exhibits significant morphological and molecular heterogeneity, encompassing both small- and non-small-cell types, as well as major histological variations. Conventional imaging and tissue biopsies are invasive and may fail to reflect dynamic tumor biology. Exosomes (30-150 nm, extracellular vesicles that are products of the endosome) are present in plasma, serum, saliva, and urine and contain tumor-reflective proteins, lipids, and RNAs. This review summarizes the strategies used in biosensors to detect exosomes in lung cancer using various approaches, including electrochemical, optical, microfluidic, and nanomaterial-assisted biosensors, which detect various markers, such as PD-L1, EGFR, and oncogenic miRNAs/lncRNAs. Exosomes possess inherent biocompatibility, intrinsic cargo protection, and the ability to target tumors (homing capabilities), attributes that synthetic nanocarriers, such as liposomes, polymeric, and inorganic nanoparticles, lack. These characteristics render exosomes advantageous for biosensing and delivery applications. We also discuss exosome-enabled therapeutic directions, such as drug- and nucleic-acid-loaded exosomes and immunomodulatory cargos, and indicate the new clinical-study environment. The most important obstacles are the non-uniformity of vesicles, variability in isolation/quantification, and lack of standardization. The discussion concludes with an examination of the practice performance standards, reporting priorities, and emerging trends. These include AI-assisted analysis and the use of portable point-of-care devices, which aim to expedite the development of clinically deployable exosome platforms for lung cancer diagnosis. We examined the integration of a sample into an answer, validation of assays on cohorts, and conceptual implications of regulatory considerations for reproducible measurements. This approach facilitates practical applications, such as screening, treatment monitoring, and early relapse detection.

肺癌是全球癌症相关死亡的主要原因。它经常在晚期被诊断出来，并表现出明显的形态学和分子异质性，包括小细胞和非小细胞类型，以及主要的组织学变异。传统的成像和组织活检是侵入性的，可能无法反映动态的肿瘤生物学。外泌体（30- 150nm，胞外囊泡，是内泌体的产物）存在于血浆、血清、唾液和尿液中，含有肿瘤反射蛋白、脂质和rna。本文综述了生物传感器用于检测肺癌外泌体的各种方法，包括电化学、光学、微流体和纳米材料辅助生物传感器，用于检测各种标记物，如PD-L1、EGFR和致癌miRNAs/lncRNAs。外泌体具有固有的生物相容性、固有的货物保护和靶向肿瘤的能力（归巢能力），这些都是合成纳米载体（如脂质体、聚合物和无机纳米颗粒）所缺乏的。这些特性使得外泌体有利于生物传感和传递应用。我们还讨论了外泌体的治疗方向，如药物和核酸负载的外泌体和免疫调节货物，并指出了新的临床研究环境。最重要的障碍是囊泡的不均匀性、分离/定量的可变性以及缺乏标准化。讨论以对实践绩效标准、报告优先级和新兴趋势的检查结束。其中包括人工智能辅助分析和便携式护理点设备的使用，其目的是加快开发临床可部署的肺癌诊断外泌体平台。我们检查了样本与答案的整合，对队列分析的验证，以及可重复测量的监管考虑的概念含义。这种方法促进了实际应用，如筛查、治疗监测和早期复发检测。

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引用次数: 0

Point-of-care testing in ischemic stroke 缺血性卒中的即时护理试验。

IF 2.9 3区医学 Q2 MEDICAL LABORATORY TECHNOLOGY

Clinica Chimica Acta

Pub Date : 2026-01-16 DOI: 10.1016/j.cca.2026.120845

Ziqi Han , Yunping Wu , Ruikang Sun , Wen Zhao , He Liang , Lu Wang , Yalin Xi , Yi Liu

Ischemic stroke (IS) is a major cause of death and long-term disability worldwide, placing a significant burden on patients, families, and healthcare systems. Given the increasing incidence and the trend toward younger patients worldwide, early diagnosis and precision control are essential. Imaging techniques such as computed tomography (CT) and magnetic resonance imaging (MRI) are standard; however, their large footprint and need for specialist interpretation preclude on-site use.

Point-of-care testing (POCT) has emerged as a rapid, user-friendly, and cost-effective alternative for near-patient detection. However, despite advancements, the clinical application of POCT remains limited due to technological, regulatory, and economic barriers. The implementation of rapid POCT for diagnosis and monitoring holds substantial potential to improve stroke care pathways and patient outcomes. Previous research has inadequately explored the intersection of POCT and IS, lacking foresight and practical applicability. This article aims to synthesize recent progress in POCT applications for IS diagnosis, therapeutic monitoring, and precision medication, highlighting its potential to enhance patient prognosis and optimize healthcare systems.

缺血性中风（IS）是世界范围内死亡和长期残疾的主要原因，给患者、家庭和卫生保健系统带来了沉重的负担。鉴于世界范围内发病率的增加和患者年轻化的趋势，早期诊断和精确控制至关重要。成像技术，如计算机断层扫描（CT）和磁共振成像（MRI）是标准的；然而，它们占地面积大，需要专家解释，因此无法在现场使用。即时检测（POCT）已成为一种快速、用户友好且具有成本效益的近患者检测方法。然而，尽管取得了进展，但由于技术、监管和经济障碍，POCT的临床应用仍然有限。快速POCT诊断和监测的实施在改善卒中治疗途径和患者预后方面具有巨大潜力。以往的研究对POCT与IS的交集探索不足，缺乏前瞻性和实用性。本文旨在综合POCT在IS诊断、治疗监测和精准用药方面的最新进展，强调POCT在改善患者预后和优化医疗保健系统方面的潜力。

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引用次数: 0

Retraction notice to "A novel sensor to estimate the prevalence of hypochlorous (HOCl) toxicity in individuals with type 2 diabetes and dyslipidemia" [Clin. Chim. Acta 458 (2016) 144-153]. “一种用于估计2型糖尿病和血脂异常患者中次氯酸（HOCl）毒性流行程度的新型传感器”的撤回通知[临床。詹。学报458(2016)144-153]。

IF 2.9 3区医学 Q2 MEDICAL LABORATORY TECHNOLOGY

Clinica Chimica Acta

Pub Date : 2026-01-15 Epub Date: 2025-09-25 DOI: 10.1016/j.cca.2025.120588

Kakali Ghoshal, Sangita Das, Krishnendu Aich, Shyamaprosad Goswami, Subhankar Chowdhury, Maitree Bhattacharyya

引用次数: 0

Corrigendum to "Rapid molecular diagnostic method for Gardnerella vaginalis based on CRISPR-Cas12a and recombinase-aided amplification (RAA)" [Clin. Chim. Acta 579 (2025) 120625]. “基于CRISPR-Cas12a和重组酶辅助扩增（RAA）的阴道加德纳菌快速分子诊断方法”的勘误表[临床]。詹。学报579(2025)120625]。

IF 2.9 3区医学 Q2 MEDICAL LABORATORY TECHNOLOGY

Clinica Chimica Acta

Pub Date : 2026-01-15 Epub Date: 2025-10-17 DOI: 10.1016/j.cca.2025.120645

Tong Jiang, Chuang Zhang, Daqing Wang, Zijing Guo, Yong Guo, Hua Liu, Zhuo Wang

引用次数: 0

Phenotype-genotype correlation in a cohort of 15 patients with hereditary ichthyosis 15例遗传性鱼鳞病患者的表型-基因型相关性研究。

IF 2.9 3区医学 Q2 MEDICAL LABORATORY TECHNOLOGY

Clinica Chimica Acta

Pub Date : 2026-01-15 DOI: 10.1016/j.cca.2026.120844

Yu-jie Ma , Jing Li , Yang Liu , Tian-ying Wei , Jia-en Liu , Jing Zhang , Hua-ying Hu , Kai Yang

Background

Hereditary ichthyosis is a heterogeneous group of skin disorders classified within the Mendelian disorders of cornification (MEDOC). Its primary clinical manifestations include hyperkeratosis, dryness, and scaling as a result of desquamation. Due to symptomatic overlap with other keratinization disorders, accurate differential diagnosis is essential. Furthermore, genetic diagnosis of hereditary ichthyosis provides critical information for genetic counseling and informed reproductive decision-making for affected families.

Methods

In this study, we performed a comprehensive genetic analysis on 15 probands with clinically confirmed or suspected ichthyosis. Using whole-exome sequencing (WES) and chromosomal microarray analysis (CMA), we identified potential pathogenic variants, which were subsequently verified in family members using Sanger sequencing or Quantitative fluorescent PCR (QF-PCR). The functional impact of detected missense variants was assessed by analyzing the conservation of the affected amino acid residues using the MEGA7 software.

Results

Our analysis revealed disease-associated variants in several genes, including FLG, STS, TGM1, and ABCA12. Notably, we identified four previously unreported variants: c.82 T > A (p.L28M) and c.9774C > A (p.H3258Q) in the FLG gene, and c.974C > T (p.S325F) and c.614 A > C (p.N205T) in the ABCA12 gene.

Conclusion

This study establishes a clear molecular diagnosis for the enrolled ichthyosis patients. The findings expand the known variant spectrum of hereditary ichthyosis, providing a solid basis for genetic counseling and valuable insights for future reproductive planning in these families.

背景：遗传性鱼鳞病是一种异质性皮肤病，属于孟德尔角化病（MEDOC）。其主要临床表现包括角化过度、干燥和脱屑引起的脱屑。由于与其他角化疾病的症状重叠，准确的鉴别诊断是必不可少的。此外，遗传性鱼鳞病的遗传诊断为受影响家庭的遗传咨询和知情生殖决策提供了重要信息。方法：本研究对15例临床确诊或疑似鱼鳞病的先证者进行了全面的遗传分析。利用全外显子组测序（WES）和染色体微阵列分析（CMA），我们确定了潜在的致病变异，随后使用Sanger测序或定量荧光PCR （QF-PCR）在家族成员中进行了验证。利用MEGA7软件分析受影响氨基酸残基的保守性，评估检测到的错义变异对功能的影响。结果：我们的分析揭示了几种基因的疾病相关变异，包括FLG、STS、TGM1和ABCA12。值得注意的是,我们确定了四个以前未报告的变体:c.82 T > (p.L28M)和c.9774C > FLG基因(p.H3258Q),和c.974C > T (p.S325F)和c.614 一 > C (p.N205T) ABCA12基因。结论：本研究为纳入的鱼鳞病患者建立了明确的分子诊断。研究结果扩大了已知的遗传性鱼鳞病变异谱，为遗传咨询提供了坚实的基础，并为这些家庭未来的生殖计划提供了有价值的见解。

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引用次数: 0

Corrigendum to "Soluble thrombomodulin in preeclampsia: A systematic review and meta-analysis". [Clin. Chimica Acta 549 (2024) 120323]. “可溶性血栓调节素在子痫前期：一项系统综述和荟萃分析”的更正。(中国。化学学报549(2024):120323。

IF 2.9 3区医学 Q2 MEDICAL LABORATORY TECHNOLOGY

Clinica Chimica Acta

Pub Date : 2026-01-15 Epub Date: 2025-09-12 DOI: 10.1016/j.cca.2025.120589

Jesiel Francisco de Jesus Fernandes Martins Lima, Thaíse Emilia Moreira da Silva, Ana Cristina Dos Santos Lopes, Victor Antonio Ferreira Freire, Melina Barros-Pinheiro, Patrícia Nessralla Alpoim

引用次数: 0

Corrigendum to "The predictive value of serum mRNA-RGS10 for the severity and prognosis of acute pancreatitis" [Clin. Chim. Acta 578 (2026) 120531]. “血清mRNA-RGS10对急性胰腺炎严重程度和预后的预测价值”的勘误表[临床。詹。学报578(2026):120531。

IF 2.9 3区医学 Q2 MEDICAL LABORATORY TECHNOLOGY

Clinica Chimica Acta

Pub Date : 2026-01-15 Epub Date: 2025-09-27 DOI: 10.1016/j.cca.2025.120622

Jie Li, Hanhui Li, Xiaoping Tan, Jun Zhang, Shengqi Du, Yueyue Lu, Qing Zhang

引用次数: 0

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