Clinica Chimica Acta最新文献

{"title":"Clot waveform analysis potentially provides predictive information on the sensitivity of activated partial thromboplastin time reagents to lupus anticoagulants.","authors":"Shusaku Oka, Masatoshi Wakui, Yuta Fujimori, Terumichi Nakagawa, Maria Ziparo, Hisao Haniu, Hiromichi Matsushita","doi":"10.1016/j.cca.2025.120628","DOIUrl":"https://doi.org/10.1016/j.cca.2025.120628","url":null,"abstract":"<p><strong>Background: </strong>While previous studies have assessed the clinical values of clot waveform analysis (CWA) for detecting lupus anticoagulants (LA), there are no reports focusing on whether CWA predicts the LA sensitivity of activated partial thromboplastin time (APTT) reagents. The present study aimed to assess the usefulness of CWA in evaluating the LA sensitivity of APTT reagents.</p><p><strong>Methods: </strong>Commercially available pooled normal plasma (PNP) and LA-positive plasma control (LPC) were used. CWA findings were compared among nine APTT reagents.</p><p><strong>Results: </strong>Waveform abnormality appeared in assays with six APTT reagents for LPC but not for PNP. No waveform abnormality was evident in assays with three reagents for LPC or for PNP. In assays using reagents exhibiting waveform abnormality, APTT for LPC was longer and ratios of APTT for LPC/APTT for PNP were higher. Waveform abnormality was associated with indexes for evaluating mixing tests. Quantitative evaluation regarding the reduction of CWA parameters adjusted to compensate the influence of fibrinogen was likely applicable for predicting the LA sensitivity of APTT reagents.</p><p><strong>Conclusion: </strong>The present study suggested the usefulness of CWA for evaluating the LA sensitivity of APTT reagents. The results provide insights into use of APTT reagents for LA screening.</p>","PeriodicalId":10205,"journal":{"name":"Clinica Chimica Acta","volume":" ","pages":"120628"},"PeriodicalIF":2.9,"publicationDate":"2025-09-27","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145190944","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":"ALARRM: A laboratory approach for rapid risk-assessment for myocardial infarction.","authors":"Peter A Kavsak, Sameer Sharif, Craig Ainsworth, Jinhui Ma, Shawn E Mondoux, Dennis T Ko, Andrew Worster","doi":"10.1016/j.cca.2025.120630","DOIUrl":"https://doi.org/10.1016/j.cca.2025.120630","url":null,"abstract":"<p><strong>Background: </strong>Current pathways using high-sensitivity cardiac troponin (hs-cTn) to rule in and rule out myocardial infarction (MI) are assay specific. This requires clinicians and laboratories to use the correct assay-specific cutoffs, deltas, and time between measurements for optimal decision making. To overcome these challenges, we developed a new common laboratory pathway (i.e., ALARRM: a laboratory approach for rapid risk-assessment for MI) to aid in early risk stratification for MI in the emergency department (ED) using the combined validated clinical chemistry score (CCS) and common change criteria (3C) algorithm. The objective of our study was to assess the diagnostic performance (sensitivity and specificity) and effectiveness (combination of rule out/low risk and rule in/high risk) of ALARRM.</p><p><strong>Methods: </strong>The study cohort (n = 855) consisted of patients presenting to the ED with acute coronary syndrome symptoms and had two blood samples collected three hours apart for measurement of Abbott hs-cTnI, Ortho hs-cTnI, Roche hs-cTnT, glucose, and creatinine (for the estimated glomerular filtration rate (eGFR) calculation). We also assessed the European society of cardiology (ESC) single sample assay-specific cutoffs with both ALARRM and ESC criteria being assessed for index MI in the cohort.</p><p><strong>Results: </strong>The sensitivity for MI using ALARRM was 100 % for all three assays, however this was not the case for the ESC single cutoffs where the Ortho hs-cTnI assay missed 4 MIs. The specificities in patients with serial measurements with ALARRM were > 90 %, with the overall effectiveness for ALARRM being 61 % (95 %CI: 58 to 64) for Roche, 80 % (95 %CI: 77 to 82) for Abbott, and 89 % (95 %CI: 86 to 91) for Ortho.</p><p><strong>Conclusion: </strong>The ALARRM pathway represents a highly efficacious and common approach using hs-cTn for early risk stratification for MI.</p>","PeriodicalId":10205,"journal":{"name":"Clinica Chimica Acta","volume":" ","pages":"120630"},"PeriodicalIF":2.9,"publicationDate":"2025-09-27","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145190881","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":"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].","authors":"Kakali Ghoshal, Sangita Das, Krishnendu Aich, Shyamaprosad Goswami, Subhankar Chowdhury, Maitree Bhattacharyya","doi":"10.1016/j.cca.2025.120588","DOIUrl":"10.1016/j.cca.2025.120588","url":null,"abstract":"","PeriodicalId":10205,"journal":{"name":"Clinica Chimica Acta","volume":" ","pages":"120588"},"PeriodicalIF":2.9,"publicationDate":"2025-09-25","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145174051","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":"New sex hormone-binding globulin and estimated free testosterone reference intervals for children and adolescents: The effects of age, sex, BMI and oral contraceptives.","authors":"Pierre Dürgen, Philip Johann Wölfle, Uta Ceglarek, Jürgen Kratzsch, Wieland Kiess, Mandy Vogel","doi":"10.1016/j.cca.2025.120621","DOIUrl":"https://doi.org/10.1016/j.cca.2025.120621","url":null,"abstract":"<p><strong>Context: </strong>Sex-hormone-binding-globulin (SHBG) affects the bioavailability of androgens and estrogens. SHBG is used to calculate free testosterone levels, assess and monitor the hypothalamic-pituitary-gonadal axis, and identify sex-hormone-related diseases in children and adults. However, current pediatric reference intervals for SHBG from large cohort studies are scarce.</p><p><strong>Objective: </strong>We aimed to establish continuous age- and sex-adjusted percentiles for SHBG in children and adolescents and identify influencing factors to support clinical decision-making.</p><p><strong>Design and setting: </strong>We conducted a large, prospective, population-based, open-cohort study in Leipzig, Germany.</p><p><strong>Participants: </strong>SHBG serum levels came from 9702 blood samples (44.97 % female) from 3109 participants aged 0.43 to 18.98 years in the LIFE Child Study.</p><p><strong>Main outcome measures: </strong>We computed associations between SHBG (analyzed with an electrochemiluminescence assay) and potential predictors (BMI, puberty, and liver proteins).</p><p><strong>Results: </strong>SHBG levels declined throughout childhood, starting from approximately 145 nmol/l. The decline steepened at the beginning of puberty until it plateaued at around 15 (in females) or 16 years (in males) with a median of 59.1 nmol/l and 32.0 nmol/l, respectively. SHBG serum levels showed a strong sex-dependent association with age, especially during puberty. In normal-weight and children with obesity, SHBG-SDS values decreased with increasing BMI-SDS (β_NW = -0.38, p < 0.001; β_OB = -0.42, p < 0.001). The effect was even stronger in participants with overweight (β_OW = -1.15, p < 0.001).</p><p><strong>Conclusions: </strong>We present SHBG percentiles for children and adolescents to support diagnoses of sex-hormone-related diseases. Confounders, such as BMI, Tanner stages, and contraceptive use should also be considered when interpreting SHBG measurements. Trial registration number - NCT02550236.</p>","PeriodicalId":10205,"journal":{"name":"Clinica Chimica Acta","volume":" ","pages":"120621"},"PeriodicalIF":2.9,"publicationDate":"2025-09-25","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145181713","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":"Progress in biomarkers and diagnostic approaches for myocardial infarction.","authors":"Ying Qi, Ming Cai, Yangfei Kang, Jianhua Liu","doi":"10.1016/j.cca.2025.120629","DOIUrl":"10.1016/j.cca.2025.120629","url":null,"abstract":"<p><p>Myocardial infarction (MI) remains one of the leading cardiovascular diseases that pose a serious threat to human health, characterized by sudden onset and high mortality. Timely and accurate detection of myocardial injury is critical for early diagnosis, therapeutic decision-making, and improving patient outcomes. Traditional biomarkers, such as myoglobin, creatine kinase-MB, and cardiac troponins, as well as emerging biomarkers, including high-sensitivity cardiac troponins, microRNAs, and heart-type fatty acid-binding protein, have demonstrated significant clinical utility in the diagnosis of MI. In addition, advances in biosensor technologies have further expanded the diagnostic toolbox. This review summarizes recent progress in biomarker- and sensor-based approaches for the laboratory diagnosis of MI, aiming to provide insights for clinical practice and patient management.</p>","PeriodicalId":10205,"journal":{"name":"Clinica Chimica Acta","volume":" ","pages":"120629"},"PeriodicalIF":2.9,"publicationDate":"2025-09-24","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145174032","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":"Analysis of urine cell-free DNA copy number and fragment size from healthy individuals.","authors":"Jufen Wang, Zilong Wu, Bingyu Wu, Xinghao Lin, Wenhe Wu, Jun Li","doi":"10.1016/j.cca.2025.120627","DOIUrl":"10.1016/j.cca.2025.120627","url":null,"abstract":"<p><strong>Objective: </strong>This study characterizes urine cell-free DNA (cfDNA) copy number and fragment size in healthy individuals and explores their associations with routine clinical parameters.</p><p><strong>Methods: </strong>Sixty healthy subjects were enrolled, providing paired blood and urine samples. Six primer pairs targeting nuclear (GAPDH-61/168/241) and mitochondrial DNA (ND1-57/167/240) were designed for absolute qPCR. Optimal urine collection, pre-treatment, and cfDNA detection protocols were evaluated. Correlations between cfDNA characteristics (fragment size and copy number) and clinical parameters (complete blood count, urinalysis, hepatic/renal function biomarkers) were analyzed.</p><p><strong>Results: </strong>Non-extracted urine retained a higher proportion of fragments < 100 bp and > 2000 bp than extracted samples. The optimal pre-treatment involved immediate EDTA addition, centrifugation at 4°C, and storage at -80°C. Urine cfDNA comprised short, medium, and long fragments. Cell-free mitochondrial DNA (cf-mtDNA) showed the highest copy numbers in short fragments, decreasing with length, whereas cell-free nuclear DNA (cf-nDNA) peaked in medium fragments. ND1-57 Cq values correlated negatively with neutrophil percentage (P < 0.01) and positively with lymphocyte percentage (P < 0.05). Lymphocyte percentage was moderately correlated with ND1 short fragment (ND1-S, P < 0.01) and weakly with the ND1-S to ND1 medium fragment (ND1-M) ratio (P < 0.05). Absolute lymphocyte count correlated weakly with ND1-S (P < 0.01) and ND1-M (P < 0.05). Neutrophil percentage correlated weakly with ND1-S (P < 0.01) and ND1-S to ND1 long fragment (ND1-L) ratio (P < 0.05).</p><p><strong>Conclusion: </strong>Urine cfDNA displays three distinct fragment sizes, with cf-mtDNA predominantly found in short fragments and showing stronger associations with physiological parameters than cf-nDNA.</p>","PeriodicalId":10205,"journal":{"name":"Clinica Chimica Acta","volume":" ","pages":"120627"},"PeriodicalIF":2.9,"publicationDate":"2025-09-23","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145148140","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 molecular diagnostic method for Gardnerella vaginalis based on CRISPR-Cas12a and recombinase-aided amplification (RAA)","authors":"Tong Jiang,&nbsp;Chuang Zhang,&nbsp;Daqing Wang,&nbsp;Zijing Guo,&nbsp;Yong Guo,&nbsp;Hua Liu,&nbsp;Zhuo Wang","doi":"10.1016/j.cca.2025.120625","DOIUrl":"10.1016/j.cca.2025.120625","url":null,"abstract":"<div><div>Imbalance of the vaginal microbiota, particularly the overgrowth of <em>Gardnerella vaginalis</em>, is the primary cause of bacterial vaginosis (BV), which poses a significant threat to women's reproductive health. Therefore, early and rapid diagnosis of BV is crucial. Current laboratory diagnostic methods for BV mainly rely on Amsel's clinical criteria, bacterial culture, and PCR techniques. However, these methods have notable limitations: Amsel's criteria are subject to operator subjectivity, culture methods are time-consuming and require specialized expertise, while PCR necessitates expensive instrumentation. These constraints hinder their widespread clinical application. To address this issue, developing a highly accurate and low-cost molecular diagnostic method holds significant clinical value for BV detection. In recent years, recombinase-aided amplification (RAA) and CRISPR-Cas12a gene-editing technologies have achieved groundbreaking progress in nucleic acid detection. This study innovatively integrates RAA isothermal amplification with CRISPR-Cas12a detection to successfully establish a rapid nucleic acid detection platform for <em>Gardnerella vaginalis</em>. Experimental results demonstrate that this platform achieves a detection sensitivity of 10 copies/mL for <em>Gardnerella vaginalis</em> genomic DNA, with no cross-reactivity against other common reproductive tract pathogens. In validation tests using 44 clinical vaginal swab samples, the platform showed a 100.00 % positive agreement rate compared to qPCR. These findings confirm that the CRISPR-Cas12a-based detection platform exhibits excellent specificity, sensitivity, and reliability, serving as an effective tool for monitoring <em>Gardnerella vaginalis</em> colonization levels. This approach provides a novel molecular diagnostic solution for early BV screening and prevention.</div></div>","PeriodicalId":10205,"journal":{"name":"Clinica Chimica Acta","volume":"579 ","pages":"Article 120625"},"PeriodicalIF":2.9,"publicationDate":"2025-09-22","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145136633","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":"Personalized biomarkers in male infertility","authors":"Ali Parvin ,&nbsp;Mohammad Mehdi Shadravan ,&nbsp;Sonia Sadeghpour ,&nbsp;Mortaza Taheri-Anganeh ,&nbsp;Hojat Ghasemnejad-Berenji","doi":"10.1016/j.cca.2025.120623","DOIUrl":"10.1016/j.cca.2025.120623","url":null,"abstract":"<div><div>Male-related factors account for 30% of infertility cases and contribute an additional 20% when combined with female infertility factors. Consequently, it is crucial to diagnose, predict, and develop innovative strategies to tackle male infertility. The evaluation of male infertility extends beyond medical history and physical examination, with a primary focus on semen analysis (SA) and endocrine assessment. SA assesses various macroscopic semen parameters such as volume, pH, color, and viscosity. Because of the significant variability in these parameters, a range of complementary biomarkers has been introduced over time. The limited effectiveness of traditional biomarkers in identifying the underlying causes of male infertility has driven the search for more accessible, cost-effective, and predictive markers of reproductive outcomes. The emerging field of omics, which includes genomic, proteomic, and metabolomic biomarkers, offers a promising pathway for targeted diagnostics in male infertility. This review aims to highlight the significance of biomarkers in male infertility. Given the limitations of conventional diagnostic techniques, biomarkers provide valuable insights into the underlying causes of male infertility and potential pathways for personalized treatment. The review discusses the definition, prevalence, and etiology of male infertility, followed by an examination of various types of biomarkers, including proteomic, genomic, epigenetic, and metabolomic markers.</div></div>","PeriodicalId":10205,"journal":{"name":"Clinica Chimica Acta","volume":"579 ","pages":"Article 120623"},"PeriodicalIF":2.9,"publicationDate":"2025-09-22","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145119234","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":"CRISPR for detection of drug resistance genes.","authors":"Perihan Sena Demirayak, Sevda Akay Sazaklioglu","doi":"10.1016/j.cca.2025.120626","DOIUrl":"10.1016/j.cca.2025.120626","url":null,"abstract":"<p><p>Resistance to antibiotics, anticancer, antiviral, and antiparasitic drugs has become one of the greatest threats to modern medicine, seriously straining global health systems. Antimicrobial resistance threatens the integrity of the health system by reducing the effectiveness of treatment protocols such as chemotherapy, organ transplantation, and major surgical interventions. In this case, not only the development of new drugs but also the rapid, sensitive, and specific detection of resistant microorganisms and genetic markers is of vital importance. Therefore, the need for more innovative diagnostic approaches suitable for field applications is increasing. CRISPR (Clustered Regularly Interspaced Short Palindromic Repeats)-based molecular diagnostic systems developed in recent years stand out as strong candidates that can fill the gap in this area. Thanks to their ability to recognize and target specific DNA or RNA sequences with high specificity, CRISPR systems enable rapid and sensitive detection of drug resistance genes. Various CRISPR effector proteins, such as Cas9, Cas12, and Cas13, have the potential to revolutionize diagnostic technologies due to their ability to both target-specifically cut and generate signals. This review will focus on the application of CRISPR technology for detecting drug resistance genes. In addition, the sensitivity, specificity, application areas, and technical challenges of the systems will be discussed through literature examples of current applications. The review aims to synthesize scientific developments in this field by examining how CRISPR-based diagnostic approaches can play a role in the global fight against drug resistance and to provide a guiding resource for future research.</p>","PeriodicalId":10205,"journal":{"name":"Clinica Chimica Acta","volume":" ","pages":"120626"},"PeriodicalIF":2.9,"publicationDate":"2025-09-22","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145136679","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":"Molecular diagnostics for infectious disease","authors":"Fatemeh Ghaffarian Sayeli ,&nbsp;Mahtab Pirmoradian ,&nbsp;Shayan Zanjaniha ,&nbsp;Haniyeh Moradi ,&nbsp;Yasaman Khorrami ,&nbsp;Mohammad Saedi ,&nbsp;Zahra Bayati ,&nbsp;Paria Zahedi ,&nbsp;Davod Jafari","doi":"10.1016/j.cca.2025.120619","DOIUrl":"10.1016/j.cca.2025.120619","url":null,"abstract":"<div><div>Molecular diagnostic methods have been used in clinical and environmental settings for over three decades. Conventional approaches, which often involve long processing times and limited sensitivity, are gradually being replaced by molecular tests that offer improved analytical performance. Nucleic acid testing (NAT), particularly PCR-based methods and their variants such as quantitative PCR (qPCR) and reverse transcription PCR (RT-PCR), have demonstrated higher sensitivity and specificity than conventional assays. Recent developments in next-generation sequencing (NGS), including metagenomic and whole-genome sequencing, have also enhanced the identification of complex pathogens and resistance mechanisms. Point-of-care testing (POCT) is another advancement, supported by newly developed isothermal amplification (IA) techniques such as loop-mediated isothermal amplification (LAMP) and recombinase polymerase amplification (RPA), which allow rapid detection in decentralized settings. In addition, newer approaches such as droplet digital PCR (ddPCR) and CRISPR-based diagnostics are very promising due to their potential to provide accurate nucleic acid detection in low amounts of target. Aptamer-based sensors are also under extensive research and development for their application in diagnosis of infection. This review outlines both traditional and recent advanced molecular diagnostic tools, with a focus on their application to infectious disease detection.</div></div>","PeriodicalId":10205,"journal":{"name":"Clinica Chimica Acta","volume":"579 ","pages":"Article 120619"},"PeriodicalIF":2.9,"publicationDate":"2025-09-21","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145130250","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}