Clinica Chimica Acta最新文献

{"title":"Tailored pharmacotherapy monitoring in Parkinson’s disease and Schizophrenia using a rapid and sensitive α-Synuclein assay","authors":"Neelam Upadhyay ,&nbsp;Manjari Tripathi ,&nbsp;Rakesh Kumar Chaddha ,&nbsp;Rashmi Ramachandran ,&nbsp;Arunmozhimaran Elavarasi ,&nbsp;Gururao Hariprasad ,&nbsp;Ravikrishnan Elangovan","doi":"10.1016/j.cca.2025.120349","DOIUrl":"10.1016/j.cca.2025.120349","url":null,"abstract":"<div><h3>Background</h3><div>While Parkinson’s disease is a low dopamine neurodegenerative disorder, Schizophrenia is considered a high dopamine psychiatric disorder. Pharmacological interventions that are directed to normalize dopamine concentrations in the mid-brain for an extended duration lead to unintended consequences. Parkinson’s disease patients experience psychosis, and Schizophrenia patients develop extra-pyramidal symptoms due to dopamine levels overshooting their physiological range. An objective monitoring technique is therefore required for better therapeutic efficacy in these two neurological diseases.</div></div><div><h3>Methods</h3><div>A rapid and sensitive assay for α-Synuclein based on magnetic enrichment and enzymatic fluorescent signal generation was developed. This assay has been benchmarked with conventional ELISA and validated in 53 CSF and 36 serum samples.</div></div><div><h3>Results</h3><div>Developed assay from an experimental perspective has a sensitivity of less than 10 pg/mL; requires a turnaround time of 45 mins; and uses 2 µL of CSF/serum fluid samples to quantify alpha synuclein. From a utility perspective, the assay showed (a) a two-fold linearity across clinical phenotypes of Parkinson’s disease, neurological controls, and schizophrenia patients; (b) variation between the naïve and treated patients; (c) correlation with severity of the disease. From a diagnostic perspective, the serum-based assay had a 100 % specificity and a minimum of 67 % sensitivity in differentiating naïve patients from treated patients; the CSF/serum-based assays had a minimum of 91 % specificity and a minimum of 85 % sensitivity in differentiating patients from neurological controls.</div></div><div><h3>Conclusions</h3><div>The developed assay can be used to quantify alpha-synuclein in serum and CSF samples, thereby setting a translational platform for diagnosis, prognosis, and monitoring pharmacotherapy patients with Parkinson’s disease and Schizophrenia.</div></div>","PeriodicalId":10205,"journal":{"name":"Clinica Chimica Acta","volume":"574 ","pages":"Article 120349"},"PeriodicalIF":3.2,"publicationDate":"2025-05-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143922114","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":"Rapid prediction of cervical cancer and high-grade precursor lesions: An integrated approach using low-field 1H NMR and chemometric analysis","authors":"Luana Quadros de Souza Leão ,&nbsp;Jelmir Craveiro de Andrade ,&nbsp;Giovanna Melo Marques ,&nbsp;Cristiane Cunha Guimarães ,&nbsp;Rosyana de Fátima Vieira de Albuquerque ,&nbsp;Alessandra Silva e Silva ,&nbsp;Kamila Pereira de Araujo ,&nbsp;Mikele Praia de Oliveira ,&nbsp;Anderson Ferreira Gonçalves ,&nbsp;Higino Felipe Figueiredo ,&nbsp;Daniel Lourenço Lira ,&nbsp;Marina Amaral Alves ,&nbsp;Carlos Adam Conte-Junior ,&nbsp;Priscila Ferreira de Aquino","doi":"10.1016/j.cca.2025.120346","DOIUrl":"10.1016/j.cca.2025.120346","url":null,"abstract":"<div><div>Cervical cancer (CC) is a significant cause of morbidity and mortality in women, often preceded by high-grade cervical intraepithelial lesions (HSIL). Although conventional cytology (Pap smear) is widely used for screening, its sensitivity limitations and high false-positive rate reinforce the need for complementary methods. This study investigated the feasibility of low-field ¹H NMR spectroscopy combined with chemometric modeling to differentiate healthy individuals (CON) from patients with HSIL and CC. Principal Component Analysis (PCA) was applied to explore metabolic patterns and identify relevant spectral variables in group differentiation. PCA1 highlighted the separation between CC and the other groups, while PCA2 and PCA3 evidenced intermediate metabolic characteristics in HSIL, reinforcing its role as a transition stage. Three classification scenarios were evaluated using Data-Driven Soft Independent Modeling of Class Analogy (DD-SIMCA): (1) CON as target class, HSIL/CC as outclass classes; (2) HSIL as target class, CON as outclass class; and (3) CC as target class, CON as outclass class. Calibration was optimal (100 % SEN, SPE, ACC, MCC), and prediction showed higher efficacy in detecting CC (SPE = 100 %, MCC = 70 %), indicating that the model was more efficient in screening cervical cancer cases. Furthermore, low-field ¹H NMR has demonstrated potential as a metabolomic screening tool. It is a promising alternative due to its greater accessibility, lower operational cost, and non-invasive nature, complementing traditional methods of early detection of tumors and cervical lesions.</div></div>","PeriodicalId":10205,"journal":{"name":"Clinica Chimica Acta","volume":"574 ","pages":"Article 120346"},"PeriodicalIF":3.2,"publicationDate":"2025-05-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143912222","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":"Uncovering NINJ1 in SLE: Biomarker potential for renal and hematologic manifestations","authors":"Muyuan Li ,&nbsp;Ke Liu ,&nbsp;Meidong Liu ,&nbsp;Huali Zhang ,&nbsp;Yiying Yang","doi":"10.1016/j.cca.2025.120347","DOIUrl":"10.1016/j.cca.2025.120347","url":null,"abstract":"<div><h3>Objective</h3><div>Systemic lupus erythematosus (SLE) is a complex autoimmune disease, with an unclear etiology. This study investigated the clinical relevance of serum NINJ1 levels in SLE and evaluated its potential as a biomarker.</div></div><div><h3>Methods</h3><div>Serum NINJ1 levels were measured in 99 newly diagnosed SLE patients and 43 healthy controls. Associations with clinical features, inflammatory markers, and autoantibodies were analyzed. ROC curve analysis was performed for diagnostic evaluation.</div></div><div><h3>Results</h3><div>Serum NINJ1 levels were significantly higher in SLE patients (p &lt; 0.0001) and further elevated in those with lupus nephritis (LN) and thrombocytopenia. Positive correlations with proteinuria, CRP, and NLR were found. ROC analysis showed good diagnostic performance (AUC = 0.83).</div></div><div><h3>Conclusion</h3><div>Serum NINJ1 is a promising biomarker for SLE, particularly for identifying LN and thrombocytopenia, and may aid in disease stratification and monitoring.</div></div>","PeriodicalId":10205,"journal":{"name":"Clinica Chimica Acta","volume":"574 ","pages":"Article 120347"},"PeriodicalIF":3.2,"publicationDate":"2025-05-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143912146","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":"Artificial intelligence (AI) in point-of-care testing","authors":"Tahir S. Pillay ,&nbsp;Adil I. Khan ,&nbsp;Sedef Yenice","doi":"10.1016/j.cca.2025.120341","DOIUrl":"10.1016/j.cca.2025.120341","url":null,"abstract":"<div><div>The integration of artificial intelligence (AI) into point-of-care testing (POCT) represents a transformative leap in modern healthcare, addressing critical challenges in diagnostic accuracy, workflow efficiency, and equitable access. While POCT has revolutionized decentralized care through rapid results, its potential is hindered by variability in accuracy, integration hurdles, and resource constraints. AI technologies—encompassing machine learning, deep learning, and natural language processing—offer robust solutions: convolutional neural networks improve malaria detection in sub-Saharan Africa to 95 % sensitivity, while predictive analytics reduce device downtime by 20 % in resource-limited settings. AI-driven decision support systems curtail antibiotic misuse by 40 % through real-time data synthesis, and portable AI devices enable anaemia screening in rural India with 94 % accuracy, slashing diagnostic delays from weeks to hours. Despite these advancements, challenges persist, including data privacy risks, algorithmic opacity, and infrastructural gaps in low- and middle-income countries. Explainable AI frameworks and blockchain encryption are critical to building clinician trust and ensuring regulatory compliance. Future directions emphasize the convergence of AI with Internet of Things (IoT) and blockchain for predictive diagnostics, as demonstrated by AI-IoT systems forecasting dengue outbreaks 14 days in advance. Personalized medicine, powered by genomic and wearable data integration, further underscores AI potential to tailor therapies, reducing cardiovascular events by 25 %. Realizing this vision demands interdisciplinary collaboration, ethical governance, and equitable implementation to bridge global health disparities. By harmonizing innovation with accessibility, AI-enhanced POCT emerges as a cornerstone of proactive, patient-centered healthcare, poised to democratize diagnostics and drive sustainable health equity worldwide.</div></div>","PeriodicalId":10205,"journal":{"name":"Clinica Chimica Acta","volume":"574 ","pages":"Article 120341"},"PeriodicalIF":3.2,"publicationDate":"2025-05-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143932032","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":"Cardiac troponin","authors":"Yumeng Gao ,&nbsp;Danchen Wang ,&nbsp;Danni Mu ,&nbsp;Yichen Ma ,&nbsp;Yuemeng Li ,&nbsp;Ling Qiu ,&nbsp;Songlin Yu ,&nbsp;Xinqi Cheng","doi":"10.1016/j.cca.2025.120344","DOIUrl":"10.1016/j.cca.2025.120344","url":null,"abstract":"<div><div>Cardiac troponin (cTn) testing plays a crucial role in the diagnosis of cardiovascular diseases, particularly acute coronary syndrome (ACS), which includes acute myocardial infarction (AMI). However, conventional immunoassays may be subject to interference from autoantibodies, cross-reactivity, and biotin-related effects, compromising diagnostic accuracy. A thorough investigation of these interference mechanisms is necessary to improve assay methodologies, ensuring greater reliability and precision. In recent years, significant advancements in mass spectrometry (MS) technology have sparked increased interest in its application for cTn testing. For instance, liquid chromatography-tandem mass spectrometry (LC-MS/MS) employs multiple reaction monitoring (MRM) to accurately quantify cardiac troponin I (cTnI)-specific tryptic peptides along with their fragment ions. This technique effectively reduces immunoassay interference while improving analytical specificity. Compared to traditional immunoassays, MS-based approaches alleviate matrix effects and analytical interferences while achieving superior specificity. Nonetheless, clinical adoption remains constrained by technical complexity; thus clinicians can obtain more reliable diagnostic insights. This review summarizes the current landscape of cTn detection technologies by examining the prevalence of false-positive results across various methods. It further explores both the practical applications and challenges associated with MS-based techniques in cTn testing. Ultimately, this review aims to improve cTn testing reliability, enhance cardiovascular disease diagnosis, and guide personalized treatment strategies.</div></div>","PeriodicalId":10205,"journal":{"name":"Clinica Chimica Acta","volume":"574 ","pages":"Article 120344"},"PeriodicalIF":3.2,"publicationDate":"2025-05-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143922112","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":"Rapid and reliable detection of G6PD mutations using recombinase polymerase amplification coupled with lateral flow strip","authors":"Beatriz Aira C. Jacob ,&nbsp;Warangkhana Songsungthong ,&nbsp;Ubolsree Leartsakulpanich ,&nbsp;Usa Boonyuen","doi":"10.1016/j.cca.2025.120345","DOIUrl":"10.1016/j.cca.2025.120345","url":null,"abstract":"<div><div>Glucose-6-phosphate dehydrogenase (G6PD) deficiency is the most common enzymopathy, affecting approximately 500 million people worldwide. It results from inherited mutations in the <em>G6PD</em> gene, causing increased susceptibility to drug-induced hemolytic anemia and severe neonatal jaundice. While phenotypic tests are commonly used, genetic testing is increasingly recognized for its value in the accurate diagnosis of G6PD deficiency, especially in heterozygous females and newborns.</div><div>This study aimed to develop and evaluate a rapid, field-deployable genetic test for the detection of four common <em>G6PD</em> variants in Thailand: <em>G6PD</em> Gaohe (c.95A &gt; G), <em>G6PD</em> Mahidol (c.487G &gt; A), <em>G6PD</em> Viangchan (c.871G &gt; A), and <em>G6PD</em> Canton (c.1376G &gt; T). The assays utilize recombinase polymerase amplification with allele-specific primers incorporating locked nucleic acids to enhance specificity, followed by lateral flow strip detection for visual readout.</div><div>The assays deliver results within 45 min at 37 ˚C. Singleplex detection demonstrated 100 % diagnostic sensitivity (Confidence interval (CI): 95.01–100.0 %) and specificity (CI: 95.49–100.0 %). Duplex assays (Gaohe + Canton and Mahidol + Viangchan) also demonstrated 100 % diagnostic sensitivity (CI: 94.87–100.0 %) and specificity (CI: 91.19–100.0 %). Limits of detection (LOD) for singleplex assays were 0.25, 1.00, 0.50, and 0.50 ng/µL, for Gaohe, Mahidol, Viangchan, and Canton, respectively. Duplex assays showed LODs of 0.10 ng/μL for Mahidol + Viangchan and 10.00  ng/μL for Gaohe + Canton. Band intensity differences ranged from 5.25 to 19.61 pixels between mutant, wild-type, and nontarget alleles, enabling clear allele discrimination.</div><div>This innovative diagnostic tool offers a rapid, reliable, and accessible solution for point-of-care genetic testing, with the potential to improve clinical management and healthcare outcomes in regions with a high burden of G6PD deficiency.</div></div>","PeriodicalId":10205,"journal":{"name":"Clinica Chimica Acta","volume":"574 ","pages":"Article 120345"},"PeriodicalIF":3.2,"publicationDate":"2025-05-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143912145","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 “CRISPR-Cas12a-based detection and differentiation of Mycobacterium spp” [Clinica Chimica Acta 567 (2025) 120101]","authors":"Peeraphan Compiro,&nbsp;Nantinee Chomta,&nbsp;Juthamas Nimnual,&nbsp;Samitanan Sunantawanit,&nbsp;Sunchai Payungporn,&nbsp;Suwatchareeporn Rotcheewaphan,&nbsp;Pornchai Kaewsapsak","doi":"10.1016/j.cca.2025.120333","DOIUrl":"10.1016/j.cca.2025.120333","url":null,"abstract":"","PeriodicalId":10205,"journal":{"name":"Clinica Chimica Acta","volume":"574 ","pages":"Article 120333"},"PeriodicalIF":3.2,"publicationDate":"2025-05-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143966600","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":"Roles of HDL function and sphingosine-1-phosphate in vasospastic angina","authors":"Kei Sasaki ,&nbsp;Hirotaka Ezaki ,&nbsp;Yasuhiro Endo ,&nbsp;Daisuke Kudo ,&nbsp;Yumiko Suenaga ,&nbsp;Makoto Ayaori ,&nbsp;Masami Sakurada ,&nbsp;Katsunori Ikewaki","doi":"10.1016/j.cca.2025.120338","DOIUrl":"10.1016/j.cca.2025.120338","url":null,"abstract":"<div><h3>Background</h3><div>High-density lipoprotein cholesterol (HDL-C) levels are often reduced in patients with vasospastic angina (VSA), but the relevance of HDL functionality to VSA pathogenesis remains unclear. Cholesterol uptake capacity (CUC), a novel cell-free assay reflecting HDL-mediated cholesterol efflux, offers a practical measure of HDL functionality. In parallel, sphingosine-1-phosphate (S1P), an HDL-associated bioactive sphingolipid with vasoprotective properties, may also contribute to VSA. This study aimed to evaluate CUC and vasodilatory HDL components, including S1P, in patients with VSA.</div></div><div><h3>Methods and Results</h3><div>Seventy-seven patients, comprising 53 patients who underwent an acetylcholine (Ach) provocation test (32 VSA at diagnosis and 21 non-VSA) and an additional 24 VSA outpatients were included. Patients with VSA had higher triglyceride levels compared with non-VSA patients, but HDL-C levels were not different. Further analysis revealed that CUC was lower in VSA patients at diagnosis compared with non-VSA patients. Serum levels of sphingosine-1-phosphate (S1P), a sphingolipid associated with HDL, were elevated in the VSA group (1.74 ± 0.76 vs. 1.31 ± 0.49 µM; p &lt; 0.01). In the VSA outpatient and Non-VSA groups, S1P levels in crude analysis were significantly associated with VSA (OR = 3.14, 95 % CI: 1.25–7.88, p = 0.01). This association remained significant across all adjusted models (Models 1–4).</div></div><div><h3>Conclusions</h3><div>The present study found that CUC was a novel indicator of vasospasm-related HDL dysfunctionality and that S1P is a promising biomarker for treated patients with VSA. The cholesterol efflux pathway and sphingolipid metabolism could contribute to the etiology of vasospasm.</div><div>Study registration: This clinical study was registered with the University Hospital Medical Information Network Clinical Trials Registry (UMIN000020942).</div></div>","PeriodicalId":10205,"journal":{"name":"Clinica Chimica Acta","volume":"574 ","pages":"Article 120338"},"PeriodicalIF":3.2,"publicationDate":"2025-05-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143901955","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":"Soluble thrombomodulin in preeclampsia: Systematic review and meta-analysis","authors":"Jesiel Francisco de Jesus Fernandes Martins Lima ,&nbsp;Thaíse Emilia Moreira da Silva ,&nbsp;Ana Cristina dos Santos Lopes ,&nbsp;Victor Antonio Ferreira Freire ,&nbsp;Melina Barros-Pinheiro ,&nbsp;Patrícia Nessralla Alpoim","doi":"10.1016/j.cca.2025.120323","DOIUrl":"10.1016/j.cca.2025.120323","url":null,"abstract":"<div><div>Preeclampsia (PE) is a severe pregnancy complication associated with endothelial dysfunction. Soluble thrombomodulin (sTM) is a biomarker of endothelial injury, but its role in PE remains unclear. Although previous studies suggest elevated sTM levels in PE, inconsistencies in study designs and diagnostic criteria have led to conflicting findings. Our study addresses this gap through a systematic review and <em>meta</em>-analysis using standardized effect sizes and predefined severity groups to clarify the association between sTM and PE. This review followed the Cochrane Handbook and PRISMA guidelines and was registered in PROSPERO (CRD42023456919). A comprehensive search was conducted in MEDLINE/PubMed, EMBASE, and Web of Science for observational studies evaluating sTM levels in PE and normotensive controls. Eligible studies included case-control and cohort designs measuring sTM in plasma or serum. Two reviewers independently conducted data extraction and risk of bias assessment (Newcastle-Ottawa Scale). A random-effects <em>meta</em>-analysis estimated the Standardized Mean Difference (SMD) and 95 % confidence intervals (CI). Of 285 screened studies, 26 met inclusion criteria, and 20 were included in the <em>meta</em>-analysis. sTM levels were significantly higher in PE (SMD = 0.91, 95 % CI 0.3 to 1.53; I² = 94 %) with greater elevation in severe PE (SMD: 0.86, 95 % CI 0.55 to 1.16; I² = 50 %) than mild PE (SMD: 0.57, 95 % CI 0.08 to 1.06; I² = 82 %). High heterogeneity was observed, likely due to variations in inclusion criteria, measurement techniques, and diagnostic definitions. These findings support the potential of sTM as a biomarker for assessing PE severity. However, its clinical use remains limited by methodological heterogeneity and lack of standardized cutoff values. Further prospective studies are needed to validate its diagnostic and prognostic value and to enable its integration into clinical practice.</div></div>","PeriodicalId":10205,"journal":{"name":"Clinica Chimica Acta","volume":"574 ","pages":"Article 120323"},"PeriodicalIF":3.2,"publicationDate":"2025-05-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143922090","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":"Divergences between IFCC recommendations for internal quality control and ISO standards","authors":"Marco Pradella","doi":"10.1016/j.cca.2025.120334","DOIUrl":"10.1016/j.cca.2025.120334","url":null,"abstract":"<div><div>The Task Force on Global Lab Quality of the International Federation of Clinical Chemistry and Laboratory Medicine published its Recommendations on the topic of IQC, stating that they are derived from the ISO 15189:20222 standard. TF-GLQ deviates in several places from ISO 15189. Some references to CLSI documents are incorrect. Laboratories and Accreditation Bodies, however, may not deviate for the requirements of ISO 15189 from the original text of the ISO standard and the guides that remain compliant with it.</div></div>","PeriodicalId":10205,"journal":{"name":"Clinica Chimica Acta","volume":"574 ","pages":"Article 120334"},"PeriodicalIF":3.2,"publicationDate":"2025-05-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143903910","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}