Clinical biochemistry最新文献

{"title":"Genomic sequencing enhances metabolic newborn screening in Thailand","authors":"Chulaluck Kuptanon ,&nbsp;Pawinee Innark ,&nbsp;Kannikar Punnapum ,&nbsp;Supaporn Nammoonnoy ,&nbsp;Rotjanapan Pankanjanato ,&nbsp;Maliwan Numnuan ,&nbsp;Orapan Sripichai ,&nbsp;Sukanya Wattanapokayakit ,&nbsp;Punna Kunhapan ,&nbsp;Ekke Kunphol","doi":"10.1016/j.clinbiochem.2026.111107","DOIUrl":"10.1016/j.clinbiochem.2026.111107","url":null,"abstract":"<div><h3>Objectives</h3><div>Thailand expanded metabolic newborn screening (NBS) program to include inherited metabolic diseases (IMDs) using tandem mass spectrometry since 2022. Molecular testing has increasingly been used as a second-tier tool to clarify ambiguous results or confirm diagnosis for abnormal metabolic NBS screening. This study aimed to assess the performance of whole genome sequencing (WGS) as a second-tier test for abnormal IMD screening results in Thai neonates.</div></div><div><h3>Design and methods</h3><div>From August 2023 to December 2024, neonates with abnormal IMD screens were recruited for WGS, in addition to the routine biochemical confirmation.</div></div><div><h3>Results</h3><div>Seventy-four newborns and 27 mothers were included in the study. Biochemical testing confirmed 40 IMDs, 12 borderline, and 21 normal cases, while WGS identified 3 additional IMDs and 8 carriers. Among 73 newborns, WGS identified 41 IMD cases and 32 normal (22 carriers), achieving 95% sensitivity, 100% specificity, 100% positive predictive value, and 97% negative predictive value. WGS refined disease subtypes, resolved borderline amino acid abnormalities, and guided individualized management. Limitations included missed large structural variants and lower sensitivity for detecting single heterozygous variants, emphasizing that molecular testing complements rather than replaces biochemical confirmation.</div></div><div><h3>Conclusions</h3><div>WGS as a second-tier test enhances diagnostic precision, clarifies ambiguous NBS results, supports early, targeted intervention, and precision care in Thai newborns.</div></div>","PeriodicalId":10172,"journal":{"name":"Clinical biochemistry","volume":"142 ","pages":"Article 111107"},"PeriodicalIF":2.1,"publicationDate":"2026-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147269573","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":"Laboratory medicine and sustainability: towards a green lab","authors":"Andre Mattman,&nbsp;Janet Simons","doi":"10.1016/j.clinbiochem.2025.111072","DOIUrl":"10.1016/j.clinbiochem.2025.111072","url":null,"abstract":"<div><div>This article introduces the special issue of Clinical Biochemistry that focuses on sustainability in laboratory medicine.</div></div>","PeriodicalId":10172,"journal":{"name":"Clinical biochemistry","volume":"142 ","pages":"Article 111072"},"PeriodicalIF":2.1,"publicationDate":"2026-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145917212","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":"α-Synuclein seed amplification assay methodology and performance in Parkinson’s disease, lewy body dementia, and multiple system atrophy: A meta-analysis","authors":"Cyril Helbling ,&nbsp;Serena Yeung ,&nbsp;Mari L. DeMarco","doi":"10.1016/j.clinbiochem.2026.111093","DOIUrl":"10.1016/j.clinbiochem.2026.111093","url":null,"abstract":"<div><div>Seed amplification assays have shown promise in research for accurate diagnosis of synucleinopathies. In consideration of clinical implementation, gaps in the literature include that performance data are frequently determined using clinically unrelated controls (e.g., healthy controls or phenotypically unrelated conditions [UC]), and a lack of emphasis on methodological variability, including required replicates and positivity thresholds. A review and meta-analysis were performed to assess the methodological parameters and diagnostic performance of seed amplification assays for detecting synucleinopathies and, where necessary, cohorts were adjusted to be more representative of the populations in which the testing would be deployed in clinical practice. A search was conducted for α-synuclein seed amplification assay studies on Parkinson’s disease, dementia with Lewy bodies, and multiple system atrophy, for matrices including cerebrospinal fluid (CSF), skin, and olfactory mucosa (OM). Assay methodological details were extracted, as were diagnostic performance data. For the latter, negative controls were divided into two distinct groups: disease mimics (DM) and UC. A total of 55 studies met the inclusion/exclusion criteria. Methodological parameters varied including the concentration, sequence and source of the assay substrate, as well as required assay replicates and determination of the positivity threshold. Median sensitivities and specificities relative to DM groups for CSF were 0.92 (95% confidence interval: 0.88–0.96) and 0.90 (0.89–0.96), for skin were 0.94 (0.79–1.0) and 0.86 (0.83–1.0), and for OM were 0.69 (0.33–1.0) and 0.94 (0.83–1.0), respectively. Although diagnostic performance was slightly reduced when adjusting for clinically relevant populations, it remained encouragingly high. Towards broader clinical implementation, valuable research directions include further streamlining of analytical workflows, and characterizing diagnostic performance by stage of disease and co-pathologies.</div></div>","PeriodicalId":10172,"journal":{"name":"Clinical biochemistry","volume":"142 ","pages":"Article 111093"},"PeriodicalIF":2.1,"publicationDate":"2026-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"146099612","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":"Indirect reference intervals for thyroid function tests: refineR, RefLim and effects of pathological test results","authors":"Finn Erik Aas ,&nbsp;Alexander Bauer Westbye ,&nbsp;Magnus A.R. Husøy ,&nbsp;Oskar E. Kelp ,&nbsp;Svetlana N. Zykova ,&nbsp;Per M. Thorsby","doi":"10.1016/j.clinbiochem.2026.111101","DOIUrl":"10.1016/j.clinbiochem.2026.111101","url":null,"abstract":"<div><h3>Background</h3><div>Biochemical tests with reference intervals (RIs) are extensively used in medicine. RIs should reflect the population tested, and indirect methods for RI construction are increasingly used. Thyroid function tests (TFTs) are used to diagnose and monitor thyroid disorders, that are especially common among women. We report investigations into factors that influence indirect TFT RIs using real world data.</div></div><div><h3>Methods</h3><div>Indirect RIs were calculated (refineR and RefLim) for two laboratories with very different proportions of pathological results for thyroid stimulating hormone (TSH), free thyroxine (FT4) and free triiodothyronine (FT3), all measured on Abbott Alinity i. For one laboratory total thyroxine (TT4) and total triiodothyronine (TT3) were also investigated. Effects of pathological results on indirect RIs were investigated and indirect RIs were compared to direct RIs from Abbott and from a reference population (HUNT4).</div></div><div><h3>Results</h3><div>Some TFT RIs differed markedly between the two laboratories, but removal of suspected pathological results reduced the discrepancy. Choice of algorithm for indirect RIs influenced the RIs, and indirect RIs were wider than the direct RIs from HUNT4. Most of our calculated RIs − from indirect (real world data) or direct (HUNT4) methods − were markedly narrower than Abbott-provided RIs, particularly for FT4 and FT3.</div></div><div><h3>Conclusions</h3><div>Indirect RIs for TFT are easily calculated but are affected by several factors that laboratories should be aware of. Manufacturer-provided RIs can differ markedly from in-house RIs.</div></div>","PeriodicalId":10172,"journal":{"name":"Clinical biochemistry","volume":"142 ","pages":"Article 111101"},"PeriodicalIF":2.1,"publicationDate":"2026-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"146212242","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":"AMH levels and diagnosis in PCOS phenotype D","authors":"Xiaofang Xuan ,&nbsp;Minxia Zhang ,&nbsp;Yaqi Fang ,&nbsp;Liyun Su ,&nbsp;Ke Xu","doi":"10.1016/j.clinbiochem.2026.111080","DOIUrl":"10.1016/j.clinbiochem.2026.111080","url":null,"abstract":"<div><h3>Objectives</h3><div>To evaluate the diagnostic performance of serum anti-Müllerian hormone (AMH) for polycystic ovary syndrome (PCOS) phenotype D, to define overall and age-specific AMH cut-off values, and to explore the associations between AMH and other reproductive hormones.</div></div><div><h3>Design &amp; Methods</h3><div>In this cross-sectional study, serum AMH levels were measured in 169 women with PCOS phenotype D and 224 age-matched healthy controls using a magnetic microparticle acridinium ester chemiluminescence immunoassay. Follicle-stimulating hormone (FSH), luteinizing hormone (LH), and testosterone were assessed with immunoluminescence assays. Correlations between AMH and other hormones were analyzed, and receiver operating characteristic (ROC) curves were used to evaluate diagnostic performance and derive cut-off values, including age-stratified thresholds.</div></div><div><h3>Results</h3><div>Serum AMH, testosterone, and the LH/FSH ratio were significantly higher in the PCOS phenotype D group than in controls (p &lt; 0.0001). AMH was positively correlated with testosterone (r = 0.233, p = 0.002) but not with the LH/FSH ratio. AMH discriminated phenotype D from controls with an area under the ROC curve of 0.779 (95 % CI 0.734–0.825); the optimal overall cut-off was 43.16 pmol/L (sensitivity 71.93 %, specificity 70.67 %). Age-stratified analyses showed robust diagnostic performance across reproductive ages, with cut-off values declining progressively (e.g., 54.16 pmol/L for ≤ 25 years; 35.59 pmol/L for 31–35 years).</div></div><div><h3>Conclusions</h3><div>Serum AMH is a valuable biomarker for diagnosing PCOS phenotype D. The use of age-specific AMH cut-off values may improve diagnostic accuracy and facilitate earlier recognition of this frequently underdiagnosed PCOS subtype.</div></div>","PeriodicalId":10172,"journal":{"name":"Clinical biochemistry","volume":"142 ","pages":"Article 111080"},"PeriodicalIF":2.1,"publicationDate":"2026-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145941396","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":"Choosing Wisely Canada recommendations for point of care testing utilization in the acute care setting: Expert-based Delphi consensus from the Canadian Society of Clinical Chemists","authors":"Sukhbir Kaur ,&nbsp;Saranya Arnoldo ,&nbsp;Jennifer Taher ,&nbsp;Dana Bailey ,&nbsp;Lori Beach ,&nbsp;Daniel R. Beriault ,&nbsp;Ihssan Bouhtiauy ,&nbsp;Miranda Brun ,&nbsp;Manal Elnenaei ,&nbsp;Yun Huang ,&nbsp;Adil I. Khan ,&nbsp;David Kinniburgh ,&nbsp;Lyne Massicotte ,&nbsp;Atoosa Rezvanpour ,&nbsp;Karina Rodriguez-Capote ,&nbsp;Vinita Thakur ,&nbsp;Paul Yip ,&nbsp;Allison A. Venner","doi":"10.1016/j.clinbiochem.2026.111100","DOIUrl":"10.1016/j.clinbiochem.2026.111100","url":null,"abstract":"<div><h3>Introduction</h3><div>Point of care testing (POCT) offers a broader selection of clinical testing outside of a central laboratory due to its many benefits, such as accessibility and rapid turn-around-time. However, it does have disadvantages and challenges, so proper utilization of POCT is vital to its success. A common area for POCT use is in the acute care setting, and improving the use and quality of POCT in this setting remains clinically important. The Canadian Society of Clinical Chemists (CSCC) POCT Special Interest Group (SIG) and Utilization Management SIG aimed to develop Choosing Wisely Canada recommendations for POCT in the acute care setting.</div></div><div><h3>Methods</h3><div>A working group consisting of 17 experts from the CSCC POCT and Utilization Management SIGs formed to develop recommendations to be evaluated through a two-round modified Delphi consensus survey. Survey consensus was reached if &gt; 80% of the experts rated recommendations with a score of 4 or 5.</div></div><div><h3>Results</h3><div>A final draft of 12 recommendations were developed, with accompanying rationale and references. Choosing Wisely Canada completed their review, including review by their stakeholder national societies, which led to a finalized seven recommendations.</div></div><div><h3>Conclusions</h3><div>A collaborative adoption of the evidence-based, seven Choosing Wisely Canada POCT recommendations in acute care settings will help support improved patient care through strong diagnostic integrity, augmented safeguards to patients, and optimization of related healthcare resources. A strong quality management system framework embedded within the implementation of these recommendations will augment the value of POCT within a sustained patient-centered acute care healthcare setting.</div></div>","PeriodicalId":10172,"journal":{"name":"Clinical biochemistry","volume":"142 ","pages":"Article 111100"},"PeriodicalIF":2.1,"publicationDate":"2026-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"146199843","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":"Acquired bisalbuminemia: A case report","authors":"R. Addesso ,&nbsp;S. Sarpa ,&nbsp;M. Ferrandino ,&nbsp;C. Giorgione ,&nbsp;A. Marrone ,&nbsp;M. Savoia ,&nbsp;G. Castaldo","doi":"10.1016/j.clinbiochem.2026.111085","DOIUrl":"10.1016/j.clinbiochem.2026.111085","url":null,"abstract":"<div><h3>Background</h3><div>Bisalbuminemia is a rare condition characterized by the presence of two distinct albumin peaks with different mobilities on serum protein electrophoresis (SPE). It may be inherited or acquired. In several cases it can result from interactions with different metabolites.</div></div><div><h3>Methods</h3><div>A 36-year-old woman, with a history of intrahepatic cholestasis of pregnancy and a subsequent episode of severe cholestatic jaundice, underwent biochemical and haematological tests. SPE profile at capillary electrophoresis (CE) revealed an abnormal peak in the alpha1 region, suggestive of acquired bisalbuminemia. To investigate the nature of the ‘atypical’ SPE profile, we performed PEG treatment on the patient’s serum.</div></div><div><h3>Results</h3><div>The experiments performed after PEG treatment confirmed that the iatrogenic bisalbuminemia was due to the albumin-bile acids complex. Furthermore, neither standard nor high-resolution (HR) agarose gel electrophoresis (AGE) revealed bisalbuminemia, detected by CE. The patient’s treatment with odevixibat reduced bile acid and other cholestasis parameters, led to the disappearance of bisalbuminemia.</div></div><div><h3>Conclusion</h3><div>In this case we demonstrated that acquired bisalbuminemia is related to the formation of albumin–bile acids complex. We observed that bisalbuminemia was absent on AGE, both in classical and HR electrophoresis, leading us to conclude that the interference due to albumin–bile acids complex was detected only in CE technique. A critical laboratory approach is essential to distinguish analytical interferences from clinically relevant abnormalities, allowing clinicians to make informed diagnostic and therapeutic decisions.</div></div>","PeriodicalId":10172,"journal":{"name":"Clinical biochemistry","volume":"142 ","pages":"Article 111085"},"PeriodicalIF":2.1,"publicationDate":"2026-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"146024092","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":"The CDKN2A/B rs10811661 polymorphism is associated with metabolic syndrome, insulin resistance, and lipid levels in individuals with obesity and impaired fasting glucose","authors":"Daniel de Luis,&nbsp;Olatz Izaola,&nbsp;David Primo","doi":"10.1016/j.clinbiochem.2026.111089","DOIUrl":"10.1016/j.clinbiochem.2026.111089","url":null,"abstract":"<div><h3>Background &amp; aims</h3><div>A significant association has been confirmed between the rs10811661 polymorphism in the <em>CDKN2</em> gene, and increased susceptibility to type 2 diabetes. The present study aimed to investigate the association of the <em>rs10811661</em> polymorphism with metabolic syndrome (MS) in individuals with obesity and impaired fasting glucose (IFG).</div></div><div><h3>Methods</h3><div>This research was conducted on 110 individuals diagnosed with obesity and IFG. Data collection included anthropometric measurements, arterial blood pressure, biochemical profiles, and the assessment of the prevalence of MS among participants. In addition, the study examined the genotypic distribution of the <em>CDKN2</em> gene polymorphism (<em>rs10811661)</em></div></div><div><h3>Results</h3><div>There were 73 women (66.4%) and 37 men (33.6%) with an average body mass index of 40.1 ± 1.9 kg/m² (range: 35.7–42.4). When comparing the two genotype groups under a recessive model framework (CC + CT versus TT), several differences emerged. Specifically, individuals carrying both T alleles exhibited higher systolic blood pressure levels, waist circumference, fasting glucose, triglycerides, low-density lipoprotein cholesterol, hemoglobin A1c, insulin, and HOMA-IR. Logistic regression analysis showed an increased risk of MS in TT subjects (OR = 2.99, 95% CI = 1.08–18.11; p = 0.03) after adjusting.</div></div><div><h3>Conclusions</h3><div>The CDKN2A/B <em>rs10811661</em> TT genotype is associated with a higher prevalence of MS and adverse metabolic traits in individuals with obesity and IFG.</div></div>","PeriodicalId":10172,"journal":{"name":"Clinical biochemistry","volume":"142 ","pages":"Article 111089"},"PeriodicalIF":2.1,"publicationDate":"2026-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"146050758","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":"Serum zinc, copper, and the Zn/Cu ratio across the glycemic spectrum: evidence from an automated clinical chemistry platform","authors":"Ufuk Sarıkaya ,&nbsp;Şahabettin Selek ,&nbsp;Alime Sarıkaya","doi":"10.1016/j.clinbiochem.2026.111097","DOIUrl":"10.1016/j.clinbiochem.2026.111097","url":null,"abstract":"<div><h3>Objectives</h3><div>The zinc-to-copper ratio (Zn/Cu) integrates the opposing redox and metabolic roles of zinc and copper and may offer additional value for stratifying glycemic risk in clinical practice. This study evaluated serum zinc, copper, and the Zn/Cu ratio across the glycemic spectrum using a routine automated chemistry analyzer.</div><div>Design and Methods:</div><div>In this cross-sectional study, 217 adults were categorized into control (n = 78), impaired fasting glucose (n = 60), insulin resistance (n = 48), and type 2 diabetes mellitus (T2DM; n = 31) groups based on fasting plasma glucose, hemoglobin A1c (HbA1c), and homeostatic model assessment of insulin resistance (HOMA-IR), using American Diabetes Association thresholds. Serum zinc and copper were measured on an ARCHITECT c16000 analyzer with validated colorimetric assays, and the Zn/Cu ratio was calculated. Group comparisons used ANOVA; correlations with glycemic indices were assessed using Pearson’s r and multivariable linear regression adjusted for age and sex. Discrimination of T2DM was evaluated via receiver operator characteristic analysis.</div></div><div><h3>Results</h3><div>Serum copper increased and the Zn/Cu ratio decreased progressively from control to T2DM (p = 0.0148 and p = 0.0135, respectively), while zinc levels did not differ significantly between groups. Zn/Cu showed negative correlations with fasting glucose, insulin, HbA1c, and HOMA-IR, and was independently associated with lower HOMA-IR in regression models (β =  − 6.81; 95% CI: −11.16 to − 2.46). Zn/Cu discriminated T2DM with an area under the curve of 0.675.</div></div><div><h3>Conclusions</h3><div>The Zn/Cu ratio, derived from routine clinical chemistry assays, reflects glycemic dysregulation and insulin resistance. It may serve as a low-cost, pragmatic adjunct to standard markers such as fasting glucose and HbA1c in clinical laboratories.</div></div>","PeriodicalId":10172,"journal":{"name":"Clinical biochemistry","volume":"142 ","pages":"Article 111097"},"PeriodicalIF":2.1,"publicationDate":"2026-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"146156184","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":"Fibrinogen-like protein 1 as a novel biomarker of rheumatoid arthritis and diagnostic basis for disease activity: a diagnostic test study","authors":"Xuan Wang ,&nbsp;Guoqing Wang ,&nbsp;Jiayu Su ,&nbsp;Yan Lu ,&nbsp;Lu Lu ,&nbsp;Lin Zhu ,&nbsp;Boqian Chen ,&nbsp;Wanjian Gu ,&nbsp;Shijia Liu","doi":"10.1016/j.clinbiochem.2026.111084","DOIUrl":"10.1016/j.clinbiochem.2026.111084","url":null,"abstract":"<div><h3>Background</h3><div>Early, accurate diagnosis of Rheumatoid Arthritis (RA) is essential for timely intervention, yet a simple and precise method for assessing disease activity remains a challenge. Biomarkers offer a promising solution for disease prediction and monitoring. Consequently, the discovery of novel biomarkers for RA diagnosis and disease activity evaluation is imperative.</div></div><div><h3>Objective</h3><div>This study seeks to elucidate the diagnostic utility of fibrinogen-like protein 1 (FGL1, also referred to as HFREP1) in rheumatoid arthritis.</div></div><div><h3>Methods</h3><div>A total of 237 RA patients and 236 non-RA control subjects were enrolled in this clinical trial. Serum levels of rheumatoid factor (RF), anti-cyclic citrullinated peptide (CCP) antibodies, erythrocyte sedimentation rate (ESR), and C-reactive protein (CRP) were measured and compared against HFREP1 concentrations quantified via enzyme-linked immunosorbent assay (ELISA).</div></div><div><h3>Results</h3><div>Consistent with the established diagnostic gold standard, HFREP1 demonstrated higher sensitivity and negative predictive value compared to CRP and ESR. The area under the receiver operating characteristic curve (AUC) for HFREP1 was comparable to those of CRP and ESR. The combination of HFREP1, CCP antibody, and ESR yielded an AUC of 0.987, which indicates that HFREP1 does not enhance the diagnostic accuracy of the combination of CCP antibody and ESR. The mean serum concentration of HFREP1 was 71.87 ng/mL in patients with remission or low disease activity, compared to 175.47 ng/mL in those with moderate to high disease activity.</div></div><div><h3>Conclusion</h3><div>HFREP1 demonstrates diagnostic potential for RA and the capability to assess disease activity. It has greater sensitivity than CRP and ESR and can better evaluate disease activity than RF and CCP. These findings support the potential use of HFREP1 as a diagnostic marker for the diagnosis and assessment of RA.</div><div>This trial is registered with the Chinese Clinical Trial Registry (Registration No.: ChiCTR2400082686; Date: 2024/04/03).</div></div>","PeriodicalId":10172,"journal":{"name":"Clinical biochemistry","volume":"142 ","pages":"Article 111084"},"PeriodicalIF":2.1,"publicationDate":"2026-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"146009006","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}