Clinica Chimica Acta最新文献

{"title":"The impact of thyroid dysfunction on COVID-19 severity and mortality: A systematic review and Meta-Analysis","authors":"İpek Dağdeviren ,&nbsp;Meliha Melin Uygur ,&nbsp;Elif Çiğdem Keleş","doi":"10.1016/j.cca.2026.120851","DOIUrl":"10.1016/j.cca.2026.120851","url":null,"abstract":"<div><div>Thyroid function abnormalities have been increasingly reported in patients with coronavirus disease 2019 (COVID-19), yet the clinical significance of these alterations remains uncertain. Because early identification of individuals at risk for severe illness is essential, this study systematically evaluated the association between thyroid dysfunction and COVID-19 severity. A comprehensive search of major databases identified 4260 records, of which 13 observational studies met the eligibility criteria, yielding a total of 2829 patients from diverse geographical regions. Mild, moderate, and non-ICU patients were categorized as the non-severe group, while the severe-to-critical group included patients classified as severe or critical, those requiring ICU admission, or hospitalized in dedicated COVID-19 wards according to the criteria used in the original studies.</div><div>The pooled analysis demonstrated that total and free triiodothyronine (TT3 and FT3) levels were consistently lower in patients with more severe disease, and thyroid dysfunction was associated with 4.8-fold higher odds of severe-to-critical COVID-19. Although thyroid-stimulating hormone (TSH) levels were reduced in patients with COVID-19 compared with non-infected individuals, TSH alone did not predict disease severity. Higher TT3 and FT3 concentrations were consistently associated with a milder clinical course.</div><div>These findings suggest that thyroid function tests may provide useful prognostic information in patients with COVID-19. The observed hormonal patterns may reflect alterations along the hypothalamic–pituitary–thyroid axis; however, this interpretation remains hypothetical and requires confirmation through studies incorporating direct pituitary hormone assessment.</div><div>Low TT3 and FT3 levels appear to be associated with worse clinical outcomes in COVID-19 patients, suggesting their potential utility as prognostic indicators. However, further prospective studies are needed before recommending routine monitoring for clinical management.</div></div>","PeriodicalId":10205,"journal":{"name":"Clinica Chimica Acta","volume":"584 ","pages":"Article 120851"},"PeriodicalIF":2.9,"publicationDate":"2026-03-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"146060507","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":"Saliva Speaks: A Critical Analysis of Salivary Biomarkers as an Early Oral Cancer Diagnostic Tool","authors":"Bidisha Kongor,&nbsp;Ritam Chatterjee","doi":"10.1016/j.cca.2026.120853","DOIUrl":"10.1016/j.cca.2026.120853","url":null,"abstract":"<div><div>Saliva is an easily accessible bio-fluid which consists of various diagnostic components that can reflect any tumor-related changes, offering a promising non-invasive approach for more accurate and early detection of oral cancer. The primary aim of this review is to provide an integrative evaluation of salivary biomarkers for oral cancer by combining qualitative synthesis with a semi-quantitative analysis of various diagnostic parameters. The work highlights biomarker trends by understanding their diagnostic potential across molecular categories through the visual representation of these quantitative data in bar graphs and heatmaps. Comprehensive literature evaluation was performed by using search engines like Pubmed, Science Direct, Google Scholar etc. on the topic of using salivary biomarkers as an oral cancer detection tool. Relevant data on study design, demographic information, sample type, analytical method, biomarker significance etc. were qualitatively summarized. Quantitative parameters including sensitivity, specificity, accuracy and <em>p</em>-values were either extracted or calculated from selected studies and visualized through bar graphs and heatmaps to facilitate comparative interpretation of diagnostic performance. Multiple salivary biomarkers were identified across genomic, transcriptomic, proteomic, metabolomic, and metagenomic levels, each showing significant involvement in molecular alterations and metabolic pathway dysregulation linked to oral malignancies. This review offers a novel semi-quantitative approach that bridges comprehensive literature summarization with diagnostic data interpretation. By integrating quantitative indices into bar graphs and heatmaps, it enables rapid visual comparison of salivary biomarker performance by revealing high-performing candidates of early oral cancer detection. Thus, saliva-based diagnostics hold great potential as a non-invasive, cost-effective reliable alternative to the conventional oral cancer detection methods.</div></div>","PeriodicalId":10205,"journal":{"name":"Clinica Chimica Acta","volume":"584 ","pages":"Article 120853"},"PeriodicalIF":2.9,"publicationDate":"2026-03-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"146050761","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":"Comparison of manual with artificial intelligence-aided interpretation of ANA HEp-2 IIF assay patterns in a clinical diagnostics lab","authors":"Jonas Schmidt ,&nbsp;Sarina Weiß ,&nbsp;Frithjof Blessing ,&nbsp;Josef Blessing ,&nbsp;Peter Schierack ,&nbsp;Stefan Rödiger ,&nbsp;Rico Hiemann ,&nbsp;Dirk Roggenbuck","doi":"10.1016/j.cca.2026.120881","DOIUrl":"10.1016/j.cca.2026.120881","url":null,"abstract":"<div><h3>Objectives</h3><div>Detection of antinuclear antibody (ANA) via indirect immunofluorescence (IIF) on HEp-2 cells is a screening test for the serological diagnosis of systemic autoimmune rheumatic diseases. Automated interpretation of ANA classification by novel artificial intelligence (AI)-aided pattern recognition was compared with expert reading under routine conditions.</div></div><div><h3>Methods</h3><div>Consecutive serum samples of 2671 individuals referred to a routine laboratory were analysed for ANA titers and patterns using the automated interpretation system akironNeo. AI-based ANA detection was compared with independent classification by two experienced immunologists according to the international consensus on ANA patterns (ICAP) competence level.</div></div><div><h3>Results</h3><div>Overall, a good agreement (κ &gt; 0.60) between the different evaluators both for positive/negative classification of ANA fluorescence images as well as for the pattern classification of positive samples with a titer ≥ 1:320 was observed. Positive/negative differentiation at different cut-offs revealed κ values from 0.584 to 0.760 whereas corresponding pattern recognition for interphase, metaphase and cytoplasmic patterns demonstrated κ values from 0.560 to 0.736 for samples scored as positive by all three evaluators.</div></div><div><h3>Conclusions</h3><div>The AI-based software showed a similar performance compared to human observers. AI-aided ANA image analysis can facilitate the diagnostic workflow of ANA IIF assays and reduce subjectivity during image classification.</div></div>","PeriodicalId":10205,"journal":{"name":"Clinica Chimica Acta","volume":"584 ","pages":"Article 120881"},"PeriodicalIF":2.9,"publicationDate":"2026-03-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"146104394","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 microRNA biomarkers in ovarian cancer detection: systematic review and meta-analysis","authors":"Qidan Huang ,&nbsp;Jieping Chen ,&nbsp;Jingsong Huang","doi":"10.1016/j.cca.2025.120771","DOIUrl":"10.1016/j.cca.2025.120771","url":null,"abstract":"<div><h3>Background</h3><div>Ovarian cancer (OC) is the deadliest gynecologic malignancy, mainly due to late-stage diagnosis and the limited accuracy of biomarkers such as Carbohydrate Antigen 125 and Human Epididymis Protein 4. Exosomal microRNAs are promising non-invasive biomarkers for early OC detection. This study assessed the diagnostic accuracy of these methods through a systematic review and meta-analysis.</div></div><div><h3>Methods</h3><div>PubMed, EMBASE, and Web of Science were searched for studies indexed to 29 June 2025 using predefined MeSH and free-text terms. Studies were screened in Rayyan under a PICO framework. Reviewers extracted data on study design, exosomal miRNAs, sample type, detection method, and diagnostic performance. Quality was assessed using a modified QUADAS-2 tool. Meta-analysis in STATA (“MIDAS” package) calculated pooled sensitivity, specificity, and area under the summary ROC (SROC) curve. Heterogeneity was evaluated using the I² statistic, and publication bias was assessed with Deeks' funnel-plot test.</div></div><div><h3>Results</h3><div>Twenty-seven studies met inclusion criteria; diagnostic data from 16 cohorts were pooled. Sensitivity and specificity were 0.82 (95 % CI: 0.76–0.86) and 0.81 (95 % CI: 0.75–0.86), with an SROC area of 0.88. No publication bias was detected.</div></div><div><h3>Conclusion</h3><div>Exosomal miRNAs show strong diagnostic accuracy for non-invasive OC detection. Standardized methods and prospective validation are required for clinical application.</div></div>","PeriodicalId":10205,"journal":{"name":"Clinica Chimica Acta","volume":"584 ","pages":"Article 120771"},"PeriodicalIF":2.9,"publicationDate":"2026-03-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145707590","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/Cas9 and reproductive failure: applications, ethical challenges, and future perspectives in human germline genome editing","authors":"Wasim Shah ,&nbsp;Mujahid Hussain ,&nbsp;Ayesha Serwat ,&nbsp;Muhammad Bilal ,&nbsp;Yousaf Raza ,&nbsp;Abu Mansoor ,&nbsp;Ahmad Faraz","doi":"10.1016/j.cca.2026.120875","DOIUrl":"10.1016/j.cca.2026.120875","url":null,"abstract":"<div><div>Reproductive failure affects millions of couples worldwide and frequently arises from genetic defects that impair gametogenesis, fertilization, or early embryonic development. Clustered regularly interspaced short palindromic repeats (CRISPR)/CRISPR-associated protein 9 (Cas9) genome-editing technology has emerged as a powerful experimental platform for dissecting infertility-associated genes and, in principle, correcting pathogenic variants in germline cells or preimplantation embryos. This review critically examines current applications of CRISPR/Cas9 in reproductive biology, including disease modeling in animal systems, editing of spermatogonial stem cells (SSCs), manipulation of oocytes and zygotes, and proof-of-concept studies in human embryos.</div><div>Particular emphasis is placed on the major technical barriers that currently preclude clinical translation, including off-target mutagenesis, embryo mosaicism, and the low efficiency of homology-directed repair relative to non-homologous end joining. Limitations related to delivery strategies, DNA damage responses, chromosomal rearrangements, and the genetic heterogeneity of infertility are also evaluated. Comparative discussion highlights how germline editing differs fundamentally from somatic CRISPR therapies that have already reached clinical application in hematologic disorders.</div><div>The review further analyzes ethical and regulatory challenges associated with heritable genome modification, including long-term safety, consent across generations, international governance disparities, and the continued reliance on assisted reproductive technologies combined with preimplantation genetic testing as safer clinical alternatives. Collectively, current evidence indicates that CRISPR/Cas9 remains primarily a research tool for elucidating reproductive biology rather than an imminent therapeutic option for human infertility. Continued technological refinement, rigorous preclinical validation, and globally harmonized oversight will be essential before germline applications can be ethically or clinically justified.</div></div>","PeriodicalId":10205,"journal":{"name":"Clinica Chimica Acta","volume":"584 ","pages":"Article 120875"},"PeriodicalIF":2.9,"publicationDate":"2026-03-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"146075483","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 genetic mutation distribution and metabolic characteristics in patients with primary carnitine deficiency from the Ganzhou area, China","authors":"Xiangwen Tu ,&nbsp;Feng Zhang ,&nbsp;Junkun Chen ,&nbsp;Chunlian Xie","doi":"10.1016/j.cca.2026.120873","DOIUrl":"10.1016/j.cca.2026.120873","url":null,"abstract":"<div><h3>Objective</h3><div>To investigate genetic and metabolic profiles in primary carnitine deficiency (PCD) patients from Ganzhou.</div></div><div><h3>Methods</h3><div>Newborns screened in Ganzhou were included. Free carnitine (C0) and acylcarnitines were quantified using tandem mass spectrometry (MS/MS). Positive cases underwent <em>SLC22A5</em> gene analysis using next-generation and sanger sequencing. Clinical data, genetic results, and amino acid/acylcarnitine levels were collected for confirmed PCD patients. Regional PCD variant frequencies were analyzed. Metabolic profiles of normal infants and PCD patients were compared to identify disease features. Homozygous and compound heterozygous PCD groups were analyzed.</div></div><div><h3>Results</h3><div>Screening 392,389 newborns identified 43 PCD cases (1:9125). Five maternal PCD cases were also identified. Of 48 PCD patients, 10 were homozygous and 38 heterozygous. Nineteen <em>SLC22A5</em> mutations were found; the most common were c.51C &gt; G (32.30%), c.1400C &gt; G (26.00%), and c.428C &gt; T (10.40%). In newborn PCD patients, C0 and multiple acylcarnitines including acetylcarnitine (C2), propionylcarnitine (C3), butyrylcarnitine (C4), isovalerylcarnitine (C5), hexanoylcarnitine (C6), octanoylcarnitine (C8), decanoylcarnitine (C10), dodecanoylcarnitine (C12), tetradecanoylcarnitine (C14), hexadecanoylcarnitine (C16), and octadecanoylcarnitine (C18) were significantly lower compared to controls (<em>P</em> &lt; 0.05). Additionally, levels of glycine (GLY), ornithine (ORN), phenylalanine (PHE), tyrosine (TYR), and proline (PRO) were reduced(all <em>P</em> &lt; 0.05), whereas arginine (ARG) was found to be elevated in PCD patients (<em>P</em> = 0.002). Furthermore, homozygous PCD patients exhibited lower C0 levels than heterozygous PCD patients (<em>P</em> = 0.049).</div></div><div><h3>Conclusion</h3><div>PCD incidence is high in Ganzhou Area. The most common mutations are c.51C &gt; G, followed by c.1400C &gt; G and c.428C &gt; T. Multiple acylcarnitine reductions are a hallmark of PCD. Homozygous mutations correlate with lower C0 levels compared to heterozygous ones.</div></div>","PeriodicalId":10205,"journal":{"name":"Clinica Chimica Acta","volume":"584 ","pages":"Article 120873"},"PeriodicalIF":2.9,"publicationDate":"2026-03-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"146096993","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":"Circulating biomarkers in leukemia","authors":"Aiyun Dong ,&nbsp;Mehdi Jahedi Zargar ,&nbsp;Amirhossein Mirzazadeh ,&nbsp;Mohammad Navid Khaksari ,&nbsp;Mobina Nazari ,&nbsp;Niloofar Pilehvari ,&nbsp;Hamed Soleimani Samarkhazan","doi":"10.1016/j.cca.2026.120865","DOIUrl":"10.1016/j.cca.2026.120865","url":null,"abstract":"<div><div>Liquid biopsy is a minimally invasive approach that analyzes circulating biomarkers, including cell-free DNA (cfDNA), circulating tumor DNA (ctDNA), microRNAs (miRNAs), and extracellular vesicles (EVs), to provide real-time information about the genetic and epigenetic state of hematologic malignancies. Compared with bone-marrow biopsy, blood-based assays enable serial sampling and can better capture temporal changes and spatial heterogeneity. Advances in high-throughput sequencing and digital PCR have improved detection sensitivity for minimal residual disease (MRD), clonal evolution, and resistance mutations. Integration of circulating biomarkers into clinical care may support personalized treatment decisions and earlier relapse detection, but barriers remain: assay standardization, biological variability, and interpretation of low-frequency variants. Interpretation of existing clinical studies suggests that ctDNA kinetics (for example, early on-treatment clearance vs persistent detection) frequently correlate with progression-free and overall survival (OS) in lymphoid and myeloid malignancies, supporting ctDNA as a candidate early surrogate of treatment benefit; however, sensitivity differs by disease biology (marrow-predominant AML vs nodal lymphomas) and therefore ctDNA should be used in combination with marrow-based MRD and leukocyte sequencing until prospective standardization is established. This review summarizes current technologies, clinical applications, and translational opportunities for circulating biomarkers in leukemia and discusses outstanding challenges for clinical implementation.</div></div>","PeriodicalId":10205,"journal":{"name":"Clinica Chimica Acta","volume":"584 ","pages":"Article 120865"},"PeriodicalIF":2.9,"publicationDate":"2026-03-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"146046149","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":"Identification of diabetic kidney disease biomarkers via iTRAQ plasma proteomics analysis","authors":"Juan Yuan ,&nbsp;Man Zhan ,&nbsp;Xinglai Zhang ,&nbsp;Xixiao Lin ,&nbsp;Wei Lu ,&nbsp;Xi Yan ,&nbsp;Zhiyuan Liang ,&nbsp;Yuan Sun ,&nbsp;Minshan Su ,&nbsp;Liming Shen ,&nbsp;Haiying Li","doi":"10.1016/j.cca.2026.120866","DOIUrl":"10.1016/j.cca.2026.120866","url":null,"abstract":"<div><div>Diabetic kidney disease (DKD) is a major diabetic complication that often progresses to end-stage renal disease and causes high mortality. Early diagnosis is essential for effective prevention and treatment. To explore the underlying mechanisms of DKD and identify plasma biomarkers for early diagnosis. In this study, healthy adults and individuals with diabetes mellitus (classified into normal albuminuria (NA), microalbuminuria (MI), and macroalbuminuria (MA) groups) were recruited. Plasma samples were collected from all participants, and 12 subjects per group were then randomly selected as a discovery cohort for proteomic analysis. Proteomics identified 95 differentially expressed proteins (DEPs) among the groups. These DEPs associated pathways evolved in a stage-specific manner in which inflammation dominated the early NA/Ctrl stage, complement and coagulation cascades became the main drivers during MI/NA, and MA/MI exhibited newly emerged disturbances in oxidative detoxification, lysosomal function, and nitrogen metabolism alongside sustained complement and coagulation changes. Among them, the complement and coagulation cascades were closely related to DKD progression. Through hub protein analysis, five proteins (FGG, ITIH4, A2M, C3, and APOE) that showed consistent trends across disease stages were identified as potential diagnostic biomarkers for DKD. Our research provides new insights into the mechanisms and early diagnosis of DKD.</div></div>","PeriodicalId":10205,"journal":{"name":"Clinica Chimica Acta","volume":"584 ","pages":"Article 120866"},"PeriodicalIF":2.9,"publicationDate":"2026-03-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"146046171","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":"Simultaneous quantification of acetylsalicylic acid, clopidogrel, ticagrelor and their major metabolites in human plasma by liquid chromatography–tandem mass spectrometry","authors":"Wenqiang Wang ,&nbsp;Lijiao Zhang ,&nbsp;Ciren Baima ,&nbsp;Shenghao Gao ,&nbsp;Xiaoyu Sun ,&nbsp;Xiaoguang Xu ,&nbsp;Yunfeng Cao","doi":"10.1016/j.cca.2025.120816","DOIUrl":"10.1016/j.cca.2025.120816","url":null,"abstract":"<div><div>In recent years, there has been a critical need for therapeutic drug monitoring (TDM) of antiplatelet agents. To address this, we developed a sensitive, rapid, and reliable liquid chromatography–tandem mass spectrometry (LC-MS/MS) method as a unified assay for the simultaneous quantification of aspirin (ASA), salicylic acid (SA), clopidogrel (CLP), its carboxylic acid metabolite (CLPM), ticagrelor (TGL), and its active metabolite AR-C124910XX for the first time. Plasma samples were pretreated by protein precipitation and separated on an ACQUITY UPLC BEH C18 column (2.1 × 50 mm, 1.7 μm) with a total run time of 4 min. Mass spectrometry was performed in polarity-switching mode, and quantification was achieved using multiple reaction monitoring (MRM) with stable isotope-labeled internal standards (SA-d6, CLPM-d4, TGL-d7) for normalization. Method validation demonstrated excellent linearity over the range of 0.5–2000 ng/mL (R² ≥ 0.9938), with extraction recoveries of 98.2 %–107 % and negligible matrix effects. Stability testing indicated that all analytes were generally stable under clinically relevant conditions; however, ASA underwent rapid esterase-mediated hydrolysis at room temperature, forming SA as the major degradation product, whereas it remained relatively stable at 2–8 °C and was stable for at least 15 days at −80 °C. The method was successfully applied to plasma samples from 61 cardiovascular patients, confirming its utility for evaluating medication adherence as well as inter- and intra-individual variability in drug exposure. In conclusion, the developed LC-MS/MS method provides high sensitivity, high throughput, and robust performance, offering a powerful analytical tool to support individualized antiplatelet therapy.</div></div>","PeriodicalId":10205,"journal":{"name":"Clinica Chimica Acta","volume":"584 ","pages":"Article 120816"},"PeriodicalIF":2.9,"publicationDate":"2026-03-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145892119","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":"Bioequivalence of C-reactive protein in fingerprick blood and serum measured using the point-of-care LumiraDx test for tuberculosis diagnosis in exposed contacts","authors":"Arthur M. Chiwaya ,&nbsp;Shima M. Abdulgader ,&nbsp;Patricia Manjate ,&nbsp;James Sserubiri ,&nbsp;Bayanda Mdoda ,&nbsp;Loide N.N. Shipingana ,&nbsp;Dinis Nguenha ,&nbsp;Derrick Semugenze ,&nbsp;Marc Bañuls ,&nbsp;Vinzeigh N. Leukes ,&nbsp;Adam Penn-Nicholson ,&nbsp;Achilles Katamba ,&nbsp;Moses Joloba ,&nbsp;Willy Ssengooba ,&nbsp;Alberto L. García-Basteiro ,&nbsp;Frank Cobelens ,&nbsp;Grant Theron","doi":"10.1016/j.cca.2026.120876","DOIUrl":"10.1016/j.cca.2026.120876","url":null,"abstract":"<div><h3>Background</h3><div>C-reactive protein (CRP) is recommended to screen people living with HIV (PLWH) for tuberculosis (TB). LumiraDx is a portable platform that uses fingerprick blood. How CRP compares in fingerprick blood and serum is unknown.</div></div><div><h3>Methods</h3><div>CRP was measured in 1034 consecutively recruited contacts of people with TB using fresh fingerprick blood (LumiraDx at point-of-care) and stored (−80 °C) serum [LumiraDx and cobas C-Reactive Protein (Latex) High Sensitive (CRPHS) in laboratories]. Agreement was assessed using Lin's concordance correlation coefficient (CCC), Passing-Bablok (PB) regression, and Bland-Altman (BA) plots. Sensitivity and specificity for TB were evaluated in 156 contacts with microbiological reference standard information, namely culture, Xpert MTB/RIF Ultra, or both.</div></div><div><h3>Results</h3><div>Strong agreement [CCC = 0.85, PB slope −0.27 (95% confidence interval −0.82, 0.2), BA mean difference 1 (−1,3)] was observed between LumiraDx on fingerprick blood and serum. Similar agreement occurred for serum CRPHS vs. LumiraDx on serum [0.79; 1.1 (−1.1, 2.3); 11 (9, 14)] or fingerprick blood [0.75; 1.3 (−0.6, 2.5); 10 (8, 13)]. Areas under the receiver operating characteristic curves (AUROCs) were 0.747 (0.595, 0.899) for fingerprick LumiraDx, 0.761 (0.628, 0.893) for serum LumiraDx and 0.775 (0.636, 0.914) for serum CRPHS. At &gt;5 mg/L, all tests showed identical sensitivity [77% (70, 83)]. Specificities were 60% (53, 68), 64% (57, 72) and 50% (43, 58), respectively. Serum storage duration did not affect performance.</div></div><div><h3>Conclusions</h3><div>LumiraDx CRP readouts on fingerprick blood and serum correlate closely. Stored serum can be used for LumiraDx CRP measurement. High sensitivity methods increase the proportion of people who screen false-positive.</div></div>","PeriodicalId":10205,"journal":{"name":"Clinica Chimica Acta","volume":"584 ","pages":"Article 120876"},"PeriodicalIF":2.9,"publicationDate":"2026-03-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"146104397","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}