Clinica Chimica Acta最新文献

{"title":"Reliable quantification of fecal elastase-1: A study on sample stability, IDK ELISA and IDK Extract® device.","authors":"Jenny K Kiviaho, Mikko Anttonen, Henrik Alfthan, Outi Itkonen","doi":"10.1016/j.cca.2025.120541","DOIUrl":"10.1016/j.cca.2025.120541","url":null,"abstract":"<p><p>Quantitation of fecal elastase 1 (FE-1) is a non-invasive test for pancreatic function to detect moderate or severe exocrine insufficiency. The enzyme-linked immunosorbent assays (ELISA) are well-established tests for FE-1 detection. Traditional sample preparation by manual weighing and extraction is laborious, but new sample devices allow more effective sample preparation. FE-1 in stool has good stability but systematic studies on FE-1 stability in sampling and extraction devices are lacking. We examined the stability of FE-1 in the IDK Extract® device and intact stool samples at room temperature, 4 °C or -20 °C. Furthermore, we assessed the suitability of the IDK Extract® device for FE-1 testing and compared the performance of IDK FE-1 ELISA to that of the established ScheBo assay. FE-1 is stable in IDK Extract® device and intact stool for at least 29 days at all storage temperatures tested with deviation < 20 % from day zero concentration. When compared to weighing, the IDK Extract® device proved to be a reliable tool for sample preparation. Based on common clinical decision limits of pancreatic exocrine function, the ScheBo and IDK assays showed good agreement. In conclusion, IDK FE-1 assay together with the IDK Extract® device offers an effective and reliable method to determine exocrine pancreatic insufficiency. FE-1 is stable at various temperatures and the IDK and ScheBo assays perform equally. Thus, stool samples from outpatient clinics can be transported to the analytical laboratory cost-effectively at room temperature.</p>","PeriodicalId":10205,"journal":{"name":"Clinica Chimica Acta","volume":" ","pages":"120541"},"PeriodicalIF":2.9,"publicationDate":"2026-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144811882","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Viral detection using Clustered Regularly Interspaced Short Palindromic Repeats/CRISPR-associated protein and Argonaute nucleases.","authors":"Liang Xu, Xuping Wu","doi":"10.1016/j.cca.2025.120526","DOIUrl":"10.1016/j.cca.2025.120526","url":null,"abstract":"<p><p>Viral pandemics pose severe threats to human health and societal stability, exemplified by the COVID-19 outbreak in 2019. Conventional viral detection methods such as Polymerase chain reaction (PCR) typically require trained personnel, expensive equipment, and 2-4 h for processing. Clustered Regularly Interspaced Short Palindromic Repeats (CRISPR)/CRISPR-associated protein (Cas) and Argonaute (Ago) system-based detection methods achieve attomolar sensitivity or single-copy detection limits with single-base specificity within 1 h, without requiring complex or costly instruments. This review firstly introduces the mechanisms and functions of CRISPR/Cas systems (Cas9, Cas12, Cas13) and Ago systems. It also introduces viruses with significant social impact, and continued with reviewing applications of these systems in single and multiplex virus detection. Single viral detection includes recently developed DNA/RNA-activated Cas9 detection (DACD/RACD) using Cas9 trans-cleavage activity, Cas12-based DNA Endonuclease-targeted CRISPR Trans Reporter (DETECTR) with attomolar sensitivity, CRISPR/Cas13a-based Fluorescent Nanoparticle SARS-CoV-2 (CFNS) achieving 1 copy/mL sensitivity with quantum dot reporters, and amplification-free mobile phone detection detecting 31 copies/μL without amplification. Multiplex viral detection includes Microfluidic Device Integrated with CRISPR/Cas12a and Multiplex Recombinase Polymerase Amplification (MiCaR) enabling 30-plex detection through microfluidic chips with spatial discrimination, PfAgo-mediated Nucleic acid Detection (PAND) utilizing Ago-produced guide sequences for 5-plex detection, Specific High-Sensitivity Enzymatic Reporter UnLOCKing v2 (SHERLOCKv2) achieving 4-plex detection with multi-enzyme single-reaction systems, and Multiplexed Evaluation of Nucleic acids (CARMEN) supporting over 100 target assays. Finally, this review discusses challenges in CRISPR/Cas and Ago-based detection methods, including Protospacer Adjacent Motif (PAM) sequence requirements for Cas9/12, prolonged reaction times due to nucleic acid extraction/amplification, and instability of core components like nucleases and crRNAs. Detection specificity and multiplex capabilities could be further improved. Future directions are outlined for improving detection specificity, developing multiplex capabilities and advancing POCT. Developing diagnostic tools using CRISPR/Cas and Ago systems could transform molecular diagnostics, such tools promise to be easily accessible worldwide. They are essential for precise identification and strategic containment of infectious disease transmission.</p>","PeriodicalId":10205,"journal":{"name":"Clinica Chimica Acta","volume":" ","pages":"120526"},"PeriodicalIF":2.9,"publicationDate":"2026-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144788397","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Exosomal RNA biomarkers in pancreatic ductal adenocarcinoma: Systematic review and meta-analysis.","authors":"Amir Tiyuri, Haniyeh Hatami, Zahra Mobarezi, Mina Zareardalan, Ghazal Salari, Aida Zandi Abbas Abadi, Marziyeh Mirzazad, Anahita Ebrahimi Mojaveri, Davod Jafari","doi":"10.1016/j.cca.2025.120532","DOIUrl":"10.1016/j.cca.2025.120532","url":null,"abstract":"<p><p>Pancreatic cancer is a highly lethal malignancy, ranking tenth in incidence among all cancers and standing as the fourth leading cause of cancer-related mortality worldwide. This systematic review and meta-analysis evaluated the diagnostic performance of exosomal biomarkers for detecting pancreatic ductal adenocarcinoma (PDAC). A total of 1,666 records were identified through comprehensive searches in Scopus, Web of Science, and PubMed. After removing duplicates and screening titles, abstracts, and full texts, 15 studies comprising 1,961 individuals (971 PDAC patients and 990 controls) were included. The quality of studies was assessed using the QUADAS-2 tool, revealing potential biases mainly in patient selection and index test domains. Three biomarker categories were analyzed: exosomal microRNAs (exomiRs), cancer antigen 19-9 (CA 19-9), and glypican-1 (GPC1). ExomiRs demonstrated the highest pooled sensitivity (0.86; 95 % CI: 0.80-0.90) and lowest negative likelihood ratio (0.16; 95 % CI: 0.11-0.24), while CA 19-9 showed the highest specificity (0.91; 95 % CI: 0.84-0.95) and positive likelihood ratio (8.5; 95 % CI: 4.4-16.4). ExomiRs also had the highest diagnostic odds ratio (DOR = 35.4; 95 % CI: 18.7-67.0) and area under the SROC curve (AUC = 0.92; 95 % CI: 0.89-0.94), indicating superior diagnostic performance compared to CA 19-9 and GPC1 (AUC = 0.88 and 0.78, respectively). GPC1 consistently showed lower diagnostic metrics across all analyses. Deeks' funnel plot suggested no publication bias for CA 19-9 and GPC1, but indicated potential bias for exomiRs (P = 0.01). Overall, exomiRs appear to be promising non-invasive biomarkers for the early detection of PDAC, outperforming traditional and other exosome-based markers in diagnostic accuracy.</p>","PeriodicalId":10205,"journal":{"name":"Clinica Chimica Acta","volume":" ","pages":"120532"},"PeriodicalIF":2.9,"publicationDate":"2026-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144803725","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Unmasking hidden shapes: unusual red cell morphologies in urine sediment.","authors":"Oscar D Pons-Belda, Santiago Mariño-Lopez, Paloma Livianos-Arias-Camison, Emilia Moreno-Noguero, Cassandra E Puig-Hooper","doi":"10.1016/j.cca.2025.120670","DOIUrl":"https://doi.org/10.1016/j.cca.2025.120670","url":null,"abstract":"<p><p>Schistocytes are fragmented red blood cells (RBCs) classically restricted to peripheral blood smears, where they serve as a hallmark of microangiopathic haemolytic anemia (MAHA) and thrombotic microangiopathy (TMA). Their presence in urine has been rarely documented. We report a 30-year-old postpartum woman who developed severe anemia, thrombocytopenia, acute kidney injury, and biochemical evidence of intravascular haemolysis following massive transfusion after caesarean delivery. Urinalysis revealed haematuria and proteinuria, and manual phase-contrast microscopy demonstrated atypical RBC morphology. Parallel blood smear examination corroborated systemic schistocytosis. ADAMTS13 activity of 35 % with absent anti-ADAMTS13 antibodies excluded thrombotic thrombocytopenic purpura (TTP), and the clinical course favoured a diagnosis of atypical haemolytic uremic syndrome (aHUS). Initiation of complement blockade with eculizumab led to rapid haematological and renal recovery. This case provides the first report linking the detection of schistocytes in voided urine to aHUS, a mechanistically plausible phenomenon in renal microangiopathy with disruption of the glomerular filtration barrier (GFB). Beyond its novelty, it underscores the enduring diagnostic value of urine sediment microscopy in revealing clinically meaningful features of TMA.</p>","PeriodicalId":10205,"journal":{"name":"Clinica Chimica Acta","volume":"579 ","pages":"120670"},"PeriodicalIF":2.9,"publicationDate":"2025-10-19","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145343955","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Establishing reference intervals for venous whole blood micronutrients in the healthy older Chinese population via dried blood spot technology.","authors":"Zehao Wang, Huilian Duan, Xiaocui Cheng, Cheng Cheng, Wen Li, Fei Ma, Ruikun He, Zhongxia Li, Mengtong Yang, Di Wang, Zhenghua Huang, Yongjie Chen, Guowei Huang","doi":"10.1016/j.cca.2025.120674","DOIUrl":"10.1016/j.cca.2025.120674","url":null,"abstract":"<p><strong>Background: </strong>The reference intervals (RIs) for venous whole blood micronutrients are instrumental in evaluating nutritional status within populations. However, research on establishing micronutrient RIs using the simple and efficient dried blood spot (DBS) technique remains scarce. Consequently, this study aims to establish RIs for venous whole blood micronutrients among healthy Chinese older individuals via DBS.</p><p><strong>Methods: </strong>Participants were recruited from the general community of Baodi District, Tianjin, northern China. Healthy populations were identified based on the recommendations of the Clinical and Laboratory Standards Institute guidelines, physical signs (body mass index and waist circumference), and blood biochemical parameters (serum lipid status and hemoglobin). The micronutrient levels were measured via the DBS technique. For normally distributed data, the RI was calculated as the mean ± 2SD. For non-normally distributed data, the RI is calculated as the 2.5th to 97.5th percentiles.</p><p><strong>Results: </strong>This study established RIs for 8 vitamins (vitamins A, D, E, B₁, B₂, B₃, B₆, B₉) and 5 minerals (Mg, Cu, Fe, Zn, Se) in healthy older adults. For males, the RIs are as follows: VA (157.76-828.81 ng/mL); VD (8.89-58.32 ng/mL); VE (1.84-13.78 μg/mL); VB₁ (0.19-5.36 ng/mL); VB₂ (0.53-13.84 ng/mL); VB₃ (4.43-13.70 μg/mL); VB₆ (1.09-26.00 ng/mL); VB₉ (1.02-9.48 ng/mL); Mg (27.54-52.99 mg/L); Cu (0.57-1.64 mg/L); Fe (287.00-708.60 mg/L); Zn (4.10-20.85 mg/L); Se (70.57-167.63 μg/L). For females: VA (142.62-755.78 ng/mL); VD (10.10-66.20 ng/mL); VE (1.87-13.43 ng/mL); VB₁ (0.15-4.20 ng/mL); VB₂ (0.61-12.81 ng/mL); VB₃ (4.51-15.53 ng/mL); VB₆ (1.82-24.05 ng/mL); VB₉ (0.60-9.62 ng/mL); Mg (25.73-51.94 mg/L); Cu (0.58-1.41 mg/L); Fe (236.75-599.81 mg/L); Zn (3.93-22.22 mg/L); Se (70.57-167.63 μg/L).</p><p><strong>Conclusions: </strong>This study presents venous whole blood micronutrient parameters that can facilitate nutrition-related epidemiological research and inform personalized intervention strategies, thereby enhancing the quality of healthcare for elderly individuals in China.</p>","PeriodicalId":10205,"journal":{"name":"Clinica Chimica Acta","volume":" ","pages":"120674"},"PeriodicalIF":2.9,"publicationDate":"2025-10-19","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145343934","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Unmasking complex polymerization interferences in multiple myeloma diagnostics: A case study.","authors":"Dan Han, Emily A Wolters, Folagbayi K Arowolo, Syed P Salam, Gia M Irudhayanathan, Damodara R Mendu","doi":"10.1016/j.cca.2025.120675","DOIUrl":"https://doi.org/10.1016/j.cca.2025.120675","url":null,"abstract":"<p><p>Monoclonal gammopathies, defined by the clonal overexpression of immunoglobulins, are typically diagnosed using serum protein electrophoresis (SPEP), immunofixation electrophoresis (IFE), and serum free light chain (FLC) assays. However, atypical immunoglobulin structures can introduce diagnostic challenges. We describe a case of IgG-lambda multiple myeloma presenting with a double M-spike on SPEP: one in the anodal gamma region and another in the cathodal gamma region, mimicking biclonal gammopathy. IFE showed biclonal-like lambda bands, and serum lambda FLC levels were markedly elevated by turbidimetric analysis. These discrepancies were resolved following treatment with dithiothreitol (DTT), which disrupted disulfide-linked lambda FLC polymers, confirming that polymerization was the source of the assay interferences. This case study highlights the critical role of DTT treatment in FLC lambda multiple myeloma that by breaking FLC lambda polymers into monomers, the overestimation by turbidimetric method of FLC lambda level can be dramatically improved.</p>","PeriodicalId":10205,"journal":{"name":"Clinica Chimica Acta","volume":" ","pages":"120675"},"PeriodicalIF":2.9,"publicationDate":"2025-10-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145336549","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Unveiling manganese metabolism-related biomarkers in Alzheimer's disease: Insights into diagnosis and therapeutic targets.","authors":"Qianqian Mou, Li Zhao, Huiling Niu, Hongyan Li, Haiqing Jin, Wenjing Wang, Wenjing Tian, Nana Feng, Bing Wu","doi":"10.1016/j.cca.2025.120676","DOIUrl":"https://doi.org/10.1016/j.cca.2025.120676","url":null,"abstract":"<p><strong>Background: </strong>Alzheimer's disease (AD), a neurodegenerative disorder with multifactorial etiologies, has been closely associated with disturbances in manganese metabolism. However, its specific biomarkers remain insufficiently characterized. This study aimed to identify manganese metabolism-related biomarkers implicated in AD.</p><p><strong>Methods: </strong>Differentially expressed genes (DEGs) in AD were extracted from the GSE63060 dataset. A total of 1399 manganese metabolism-related genes were curated from the literature. Weighted gene co-expression network analysis was applied to isolate AD-related module genes. The intersection of these three datasets produced manganese metabolism-related DEGs (MMR-DEGs). Candidate biomarkers were subsequently screened through machine learning approaches and validated by expression analyses. Bioinformatics investigations, including nomogram modeling, immune infiltration analysis, gene set enrichment analysis (GSEA), gene-gene interaction (GGI) network construction, molecular regulatory network mapping, and drug prediction, were conducted to delineate potential functions. Finally, quantitative reverse transcription-PCR (qRT-PCR) was performed to verify mRNA expression levels of the biomarkers.</p><p><strong>Results: </strong>Nine MMR-DEGs were identified, among which four genes (OPTN, HSP90AA1, NDUFS4, and HSPE1) demonstrated favorable predictive performance as biomarkers for AD. Immune infiltration analysis indicated a consistent negative correlation between these biomarkers and M0 macrophages. GSEA revealed predominant enrichment in translation-associated pathways. Within the molecular regulatory network, 24 transcription factors and 72 microRNAs were predicted to target these biomarkers. Additionally, 107 candidate drugs were identified as potential therapeutic agents, and 16 genes exhibited functional interactions with these biomarkers in the GGI network. Moreover, qRT-PCR confirmed that the expression of OPTN, HSP90AA1, and NDUFS4 was significantly down-regulated in AD samples, in agreement with computational predictions.</p><p><strong>Conclusions: </strong>OPTN, HSP90AA1, NDUFS4, and HSPE1 were identified as manganese metabolism-related potential biomarkers in AD. These findings may advance understanding of AD pathophysiology and may provide potential molecular targets for diagnosis and therapeutic intervention.</p>","PeriodicalId":10205,"journal":{"name":"Clinica Chimica Acta","volume":" ","pages":"120676"},"PeriodicalIF":2.9,"publicationDate":"2025-10-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145336606","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Corrigendum to \"Rapid molecular diagnostic method for Gardnerella vaginalis based on CRISPR-Cas12a and recombinase-aided amplification (RAA)\" [Clin. Chim. Acta 579 (2025) 120625].","authors":"Tong Jiang, Chuang Zhang, Daqing Wang, Zijing Guo, Yong Guo, Hua Liu, Zhuo Wang","doi":"10.1016/j.cca.2025.120645","DOIUrl":"https://doi.org/10.1016/j.cca.2025.120645","url":null,"abstract":"","PeriodicalId":10205,"journal":{"name":"Clinica Chimica Acta","volume":" ","pages":"120645"},"PeriodicalIF":2.9,"publicationDate":"2025-10-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145318249","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Multi-omics data improves one-year mortality prediction in acute heart failure","authors":"Xingxing Li ,&nbsp;Ye Jia ,&nbsp;Feng Wang ,&nbsp;Bingzhang Jie ,&nbsp;Pengjuan Sha ,&nbsp;Liwei Chen ,&nbsp;Yan Zhao ,&nbsp;Haifeng Liang ,&nbsp;Xiaohong Li ,&nbsp;Yu Du ,&nbsp;Bin Hong ,&nbsp;Ling Han","doi":"10.1016/j.cca.2025.120669","DOIUrl":"10.1016/j.cca.2025.120669","url":null,"abstract":"<div><h3>Background</h3><div>Acute heart failure (AHF) is a complex high-mortality condition, with risks escalating as age increases. Due to the complexity and heterogeneity of AHF, the development of effective prognostic indicators remains challenging. This study aims to assess the prognostic ability of plasma metabolites, gut microbiota, together with clinical indicators, in predicting mortality risk in AHF patients.</div></div><div><h3>Methods</h3><div>Plasma trimethylamine N-oxide (TMAO) levels were quantified alongside routine clinical parameters. Non-targeted metabolomic profiling was performed, and gut microbiota composition was determined through 16S rRNA gene sequencing. The predictive power of potential biomarkers for 1-year mortality was identified and evaluated using Cox regression analysis and receiver operating characteristic (ROC) curves.</div></div><div><h3>Results</h3><div>The prognostic value of N-terminal pro-B-type natriuretic peptide (NT-proBNP) alone was shown to have an area under the curve (AUC) of approximately 0.7, while the predictive utility of TMAO was limited. The addition of age and BUN to NT-proBNP enhances prognostic accuracy in AHF. Metabolomic analyses disclosed a subset of 9 metabolites emerged as novel prognostic biomarkers independent of age, BUN, and NT-proBNP. Microbiomic analyses revealed that three differential genera were associated with prognosis in AHF patients. Furthermore, a compact prognostic biomarker panel including NT-proBNP, age, BUN, homoarginine, MHPG sulfate, <em>N</em>-acetylmethionine, methionine methyl ester, leucyl-alanine, proline-hydroxyproline, and <em>Faecalibacterium</em> was developed, achieving an AUC of 0.902 and Brier score of 0.120.</div></div><div><h3>Conclusions</h3><div>Multi-omics analyses unveiled novel prognostic metabolites and gut microbes associated with 1-year mortality in AHF. Integrating these biomarkers with clinical parameters provided a potential model for improving the prognosis of AHF.</div></div>","PeriodicalId":10205,"journal":{"name":"Clinica Chimica Acta","volume":"579 ","pages":"Article 120669"},"PeriodicalIF":2.9,"publicationDate":"2025-10-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145318286","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Nationwide external quality assessment of serum glycated albumin measurement in China during 2024-2025: current situation, challenges and prospects.","authors":"Hao Zheng, Weiyan Zhou, Jie Zeng, Chao Zhang, Haijian Zhao, Jiangtao Zhang, Jing Wang, Chuanbao Zhang, Tianjiao Zhang","doi":"10.1016/j.cca.2025.120673","DOIUrl":"https://doi.org/10.1016/j.cca.2025.120673","url":null,"abstract":"<p><strong>Background: </strong>Glycated albumin (GA) serves an important alternative biomarker of glycemia, playing a key role in diabetes diagnosis. Given that the harmonization status of GA assays in China remains unclear, implementing external quality assessment (EQA) program is essential to evaluate their analytical performance. This will provide reliable information to support patient diagnosis and treatment.</p><p><strong>Methods: </strong>The National Center of Clinical Laboratories (NCCL, Beijing, China) organized a biannual EQA scheme for GA. EQA samples were distributed to the participants, who were required to measure five samples per cycle and submit their results along with detailed information on reagents, methodologies, and instruments used. Following each cycle, NCCL edited comprehensive reports summarizing individual laboratory performance and scores, including an overview of all participants' results.</p><p><strong>Results: </strong>In 2024 and 2025, 93.3 % and 95.7 % of participants achieved satisfactory annual performance, respectively. GA measurements demonstrated high precision within manufacturers, with median intra-manufacturer robust coefficient of variation (CV) below 3.1 %. However, notable disparities emerged across manufacturers: the median inter-manufacturer robust CV was 6.5 %, the median relative deviation from target values reached up to 9.3 %, and maximum deviation was as high as 40 %. Analysis based on laboratory performance showed a steady improvement trend from 2024 to 2025.</p><p><strong>Conclusions: </strong>The nationwide GA EQA program scheme has substantially improved analytical performance and cultivated a robust quality assurance culture across participating laboratories. Persistent challenges to further elevating detection quality through EQA include sample commutability, procedure for target value assignment, and replicate samples. Moving forward, fostering collaborative engagement among all stakeholders are essential to overcome these limitations and establish a harmonized framework for GA detection.</p>","PeriodicalId":10205,"journal":{"name":"Clinica Chimica Acta","volume":" ","pages":"120673"},"PeriodicalIF":2.9,"publicationDate":"2025-10-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145328506","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}