Annals of Clinical Biochemistry最新文献

{"title":"Establishment of a candidate reference method and verification of reference intervals for serum copper in pregnant and non-pregnant women.","authors":"Mengyu Xu, YunGang Pu, Tianyue Zhang, Zhenni Liu, Qian Zhang, Weiyan Zhou, Yuhang Deng, Chao Zhang, Hao Zheng, Haijian Zhao, Jiangtao Zhang, Tianjiao Zhang, Jing Wang, Jie Zeng, Chuanbao Zhang","doi":"10.1177/00045632261426839","DOIUrl":"10.1177/00045632261426839","url":null,"abstract":"<p><p>BackgroundSerum copper is an essential trace element, and accurate quantification is important for assessing copper status in pregnancy and supporting early clinical interventions. However, current serum copper assays face several challenges, including potential inaccuracy, poor comparability between methods, and difficulties in transferring reference intervals (RIs) between populations. This study aimed to establish a simple inductively coupled plasma mass spectrometry (ICP-MS)-based candidate reference method for serum copper to strengthen the reference measurement system, and to verify whether recently proposed multicenter RIs for serum copper can be transferred to a Chinese population.MethodsCobalt was used as the internal standard. After digestion with Optima-grade ultrapure nitric acid, samples were diluted 100-fold with ultrapure water. The ⁶³Cu/⁵⁹Co ratio was measured in helium collision mode, with the gas flow rate set to 5 mL/min. Analytical performance was validated, and serum copper RIs in pregnant and non-pregnant women were subsequently verified.ResultsA candidate reference method was established. The method demonstrated excellent linearity, with a correlation coefficient (R) exceeding 0.99998 over the range 0-13.75 μg/g. The total precision ranged from 0.30% to 0.40%. The spike recovery was 100.06% (99.95-100.14%). Trueness was confirmed by measurements of NIST SRM 1598a, which fell within the certified value and its stated uncertainty. The RI for healthy non-pregnant women was transferable to healthy Chinese women, whereas the pregnancy-specific RI for serum copper was not fully transferable and requires further adjustment for Chinese women.ConclusionA highly sensitive and specific candidate reference method for serum copper was established, strengthening the reference measurement system and contributing to the standardization and harmonization of serum copper assays. Pregnancy-specific RIs for serum copper in Chinese women should be established.</p>","PeriodicalId":8005,"journal":{"name":"Annals of Clinical Biochemistry","volume":" ","pages":"382-393"},"PeriodicalIF":1.1,"publicationDate":"2026-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"146148816","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"First report of daratumumab interference in urine immunofixation electrophoresis confirmed by the HYDRASHIFT 2/4 Daratumumab assay.","authors":"Hyun-Woo Lee, Sooho Yu, Se-Eun Koo, Ghee Young Kwon, Kihyun Kim, Hyung-Doo Park","doi":"10.1177/00045632261479641","DOIUrl":"https://doi.org/10.1177/00045632261479641","url":null,"abstract":"<p><p>A case of analytical interference in urine immunofixation electrophoresis (IFE) caused by daratumumab is presented. Daratumumab, an IgG1-kappa monoclonal antibody, is well-known to produce a false IgG-kappa band in serum IFE, but urinary interference has not been reported because intact IgG is generally not filtered through the glomerulus. A 67-year-old man presented with nephrotic syndrome and was found to have markedly elevated serum creatinine (3.10 mg/dL), free kappa light chains (453.42 mg/dL) and kappa/lambda ratio (23.23). Baseline serum and urine electrophoresis and IFE showed no monoclonal protein (M-protein), while bone marrow examination confirmed light chain deposition disease with kappa restriction. Following two cycles of daratumumab-based chemotherapy, new IgG-kappa bands appeared in both serum and urine IFE despite improving free light chain levels and unremarkable protein electrophoretic patterns. Suspecting therapeutic antibody interference, the HYDRASHIFT 2/4 Daratumumab assay (HYDRASHIFT assay) was applied to both serum and concentrated urine samples. The IgG-kappa bands in both serum and urine IFE disappeared and exhibited a cathodal shift, confirming that they represented daratumumab rather than endogenous M-protein. This case demonstrates that daratumumab may become detectable in urine in the setting of severely impaired glomerular permeability and highlights that the HYDRASHIFT assay can be effectively applied to urine to resolve analytical interference. Awareness of this phenomenon is important for the accurate interpretation of urine IFE results in patients receiving daratumumab.</p>","PeriodicalId":8005,"journal":{"name":"Annals of Clinical Biochemistry","volume":" ","pages":"45632261479641"},"PeriodicalIF":1.1,"publicationDate":"2026-08-21","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148787536","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Cryoglobulinaemia is more frequently associated with IgM paraproteins than previously reported, interfering with their quantification, and resulting in potential treatment delays.","authors":"Aaron Niblock, Philip Logue, Kerrie Sweeney","doi":"10.1177/00045632261479628","DOIUrl":"https://doi.org/10.1177/00045632261479628","url":null,"abstract":"","PeriodicalId":8005,"journal":{"name":"Annals of Clinical Biochemistry","volume":" ","pages":"45632261479628"},"PeriodicalIF":1.1,"publicationDate":"2026-08-20","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148787570","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Pseudo-hypouricemia in four patients with lymphoma and one patient with breast cancer: Interference analysis and elimination.","authors":"Guanqiao Shen, Qi Zhang, Shunchang Li","doi":"10.1177/00045632261478795","DOIUrl":"https://doi.org/10.1177/00045632261478795","url":null,"abstract":"<p><p>ObjectiveTo investigate the interfering factors and correction methods in the determination of serum uric acid (UA) using the uricase method in patients with elevated immunoglobulin M (IgM).Materials and MethodsIn clinical practice, the UA levels of five patients with elevated IgM were measured using the Beckman AU5800 analyzer with its reagents or Zhongyuan reagents. The reaction curves were analyzed. Three methods dilution with normal saline, dilution with saturated saline, and polyethylene glycol 6000 (PEG 6000) precipitation were applied to eliminate interference. For comparison, UA was also measured using the Abbott Ci8200 analyzer with its reagents.ResultsThe serum IgM levels for cases 1 to 5 were 12.39, 27.0, 12.09, 7.33, and 11.05 g/L, respectively. The initial UA results obtained with the Beckman AU5800 and its reagents were 48.4, 101.3, 96.6, 0.6, and 66.6 μmol/L. All five cases exhibited abnormal biochemical reaction curves. After treatment with normal saline, samples 1 and 5 yielded negative values, while after saturated saline treatment, sample 5 still showed a negative value and sample 1 showed an extremely low value, indicating incomplete correction of the interference. In contrast, the PEG precipitation method markedly improved the UA results, and the obtained values were comparable to those from the Abbott system.ConclusionThe PEG precipitation method provides superior correction compared to dilution with normal or saturated saline and yields results that are closer to the patient's true value.</p>","PeriodicalId":8005,"journal":{"name":"Annals of Clinical Biochemistry","volume":" ","pages":"45632261478795"},"PeriodicalIF":1.1,"publicationDate":"2026-08-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148787544","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Preparation and evaluation of in-house multi-analyte quality control materials for ANA, Anti-dsDNA, and autoantibody profile assays.","authors":"Lin Xu, Hongxiang Xie","doi":"10.1177/00045632261481996","DOIUrl":"10.1177/00045632261481996","url":null,"abstract":"<p><p>BackgroundThis study explored the preparation and evaluation of in-house quality control (QC) materials for antinuclear antibody (ANA) and anti-double-stranded DNA antibody (anti-dsDNA) testing by indirect immunofluorescence test (IIFT), and ANA profile testing by line immunoassay (LIA), with the aim of providing a reference for other in-house QC materials.MethodsPatient sera were pooled to prepare a QC serum positive for all targets, while sera from healthy individuals were pooled to prepare a negative control. QC materials were heat-inactivated, centrifuged, aliquoted, and stored at -20°C. Stability was assessed at 37°C and during long-term storage at -20°C. Inter-vial variation was evaluated using 20 vials, and intra-vial variation was assessed by 20 replicates of one vial.ResultsDuring the 8-day 37°C stability test, ANA and anti-dsDNA titers remained within ±1 serial dilution of the baseline value, and all ANA profile antibodies remained within the predefined ±20% acceptance criterion. During long-term storage, ANA and anti-dsDNA titers also remained within ±1 serial dilution, and the CVs of all ANA profile antibodies were below 20%. Both inter-vial and intra-vial variation met predefined criteria, and all negative controls remained negative.ConclusionsThe in-house QC materials showed good stability and reproducibility, with simple preparation and potential suitability for routine use in primary healthcare laboratories.</p>","PeriodicalId":8005,"journal":{"name":"Annals of Clinical Biochemistry","volume":" ","pages":"45632261481996"},"PeriodicalIF":1.1,"publicationDate":"2026-08-14","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148762985","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Immune checkpoint inhibitors in the real world: A service evaluation of immune-related adverse event incidence and blood test requesting at Portsmouth Hospitals University Trust.","authors":"Louise E Duvall, Laura Wainwright, Laura Bryant, George Sandy, Vanessa Owusu-Yeboah, Adam Hurlstone","doi":"10.1177/00045632261475616","DOIUrl":"https://doi.org/10.1177/00045632261475616","url":null,"abstract":"<p><p>BackgroundImmune checkpoint inhibitors (ICI) have revolutionised oncology care but can cause immune-related adverse events (irAE) requiring hospitalisation or lifelong treatment. Diagnosing irAE is complex, and laboratory testing is vital; however, ordering appropriate tests at appropriate intervals is challenging because of the abundance of conflicting guidelines. The burden of irAE within the NHS is not well defined, and there may be significant variation in irAE across local areas. This study seeks to inform vital local service planning.Methods1028 ICI patients were identified (2018-2023). Medical records and laboratory data were extracted and anonymised before being analysed using SQL and R to investigate the burden of irAE on hospitals and blood test request patterns by primary tumour origin.ResultsThe overall incidence of irAE was 36.8%, and the most common irAEs were skin rashes, hypothyroidism, colitis, and hepatitis. Increased prescribing of ICI across more tumour types has led to an increase in hospital inpatient days. Monitoring was inconsistent: while standard laboratory tests such as complete blood counts, liver function panel, and urea and electrolytes were frequently requested, guideline-recommended baseline tests, including AST, glucose, and thyroid testing, were significantly underutilised, with inconsistent repeat intervals.ConclusionRising ICI use at PHUT has increased irAE related hospital admissions. Blood test requests between 2018 and 2023 were found to be inconsistent across primary tumour origins, and standardised blood test profiles may help streamline the diagnosis of irAEs, leading to earlier diagnosis and interventions.</p>","PeriodicalId":8005,"journal":{"name":"Annals of Clinical Biochemistry","volume":" ","pages":"45632261475616"},"PeriodicalIF":1.1,"publicationDate":"2026-08-09","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148700606","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"CORRIGENDUM to \"Standardising lipid testing and reporting in the United Kingdom; a joint statement by HEART UK and The Association for Laboratory Medicine\".","authors":"","doi":"10.1177/00045632261471456","DOIUrl":"https://doi.org/10.1177/00045632261471456","url":null,"abstract":"","PeriodicalId":8005,"journal":{"name":"Annals of Clinical Biochemistry","volume":" ","pages":"45632261471456"},"PeriodicalIF":1.1,"publicationDate":"2026-08-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148676854","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Is improved folate status in Northern Ireland a result of improved analytical performance or the implementation of folic acid fortification of flour legislation?","authors":"Gillian Law, Kathryn Ryan, Derek McKillop","doi":"10.1177/00045632261474775","DOIUrl":"https://doi.org/10.1177/00045632261474775","url":null,"abstract":"","PeriodicalId":8005,"journal":{"name":"Annals of Clinical Biochemistry","volume":" ","pages":"45632261474775"},"PeriodicalIF":1.1,"publicationDate":"2026-07-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148618097","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Untargeted LC-MS/MS profiling identifies ST18 as a novel serum marker for T2DM-associated depression.","authors":"Jiya Singh, Sabyasachi Bandyopadhyay, Atanu Sen, Ravi Kant, Anindya Das, Sarama Saha","doi":"10.1177/00045632261475614","DOIUrl":"10.1177/00045632261475614","url":null,"abstract":"<p><p>Depression is a prevalent but underdiagnosed comorbidity in type 2 diabetes mellitus (T2DM), intensifying disease burden and complicating metabolic management. Reliable biomarkers for early detection remain limited. This study aimed to identify serum protein signatures associated with depression in individuals with T2DM using an untargeted proteomic approach. Methods Serum samples from healthy controls, T2DM patients, and T2DM patients with comorbid depression (n = 6 per group) were analyzed using LC-MS/MS-based untargeted proteomics (total n = 18). Differential protein abundance was assessed using MetaboAnalyst 6.0. Protein-protein interaction networks and pathway enrichment analyses were conducted using the STRING database. Candidate markers were further validated by ELISA in an independent cohort of healthy controls (n = 30), T2DM (n = 30), and T2DM with depression (n = 30). Diagnostic performance was evaluated using receiver operating characteristic (ROC) curves. Results LC-MS/MS identified 242 serum proteins, of which 12 were significantly dysregulated among the groups. Nine proteins showed unique alterations in the T2DM-depression group. STRING analysis highlighted ST18 as a central regulatory protein. ELISA validation confirmed significant elevation of LRG1, APOC2, and ST18 in T2DM with depression compared to controls and T2DM without depression. Among these, ST18 demonstrated the highest diagnostic accuracy, yielding the greatest area under the ROC curve. Conclusion Untargeted proteomic profiling revealed distinct serum protein alterations in T2DM patients with comorbid depression. ST18 emerged as a robust and specific biomarker, suggesting its potential involvement in the molecular interplay between metabolic dysregulation and depressive pathology. Larger, longitudinal studies are required to validate its predictive utility and clarify its role in T2DM-associated depression.</p>","PeriodicalId":8005,"journal":{"name":"Annals of Clinical Biochemistry","volume":" ","pages":"45632261475614"},"PeriodicalIF":1.1,"publicationDate":"2026-07-23","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148576550","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Bayesian secondary reanalysis of published aggregate data on circulating tumor DNA for molecular residual disease detection across cancer types.","authors":"Shugo Yajima, Soichiro Yoshida, Wei Chen, Hiroshi Fukushima, Hajime Tanaka, Hiroyuki Sato, Akihiro Hirakawa, Hitoshi Masuda, Yasuhisa Fujii","doi":"10.1177/00045632261475618","DOIUrl":"10.1177/00045632261475618","url":null,"abstract":"<p><p>BackgroundCirculating tumor DNA (ctDNA)-based molecular residual disease (MRD) testing may help estimate recurrence risk after treatment. We performed a Bayesian secondary reanalysis of published aggregate data to estimate prognostic and diagnostic performance.MethodsData were extracted from Zheng et al. (80 studies, 11 cancer types). Log hazard ratios for recurrence were analyzed using Bayesian normal-normal hierarchical models. Sensitivity and specificity were analyzed using separate logit-scale random-effects models. Posterior probabilities were estimated from posterior samples.ResultsThe prognostic analysis included 109 study arms (approximately 9,980 patients). The pooled hazard ratio for recurrence associated with ctDNA positivity was 7.5 (95% credible interval [CrI], 6.4-8.8). Among cancer-type subgroups reported separately, all 95% CrIs excluded 1.0. In 70 diagnostic studies, pooled sensitivity was 57.6% (95% CrI, 53.2-61.9) and specificity was 90.5% (95% CrI, 88.5-92.3). Longitudinal monitoring had higher sensitivity than landmark testing (73.6% vs 50.0%; posterior probability >99.9%), with similar specificity (89.9% vs 90.8%). mPCR-NGS had specificity of 93.2% (95% CrI, 90.2-95.6); in separate exploratory comparisons, P(mPCR-NGS > ddPCR) and P(mPCR-NGS > hybridization capture NGS) were both 96.0%.ConclusionsThis Bayesian secondary reanalysis supports the association between ctDNA-MRD positivity and recurrence risk. Longitudinal monitoring may improve sensitivity, while assay technology comparisons should be interpreted cautiously because they were based on aggregate, non-head-to-head data.</p>","PeriodicalId":8005,"journal":{"name":"Annals of Clinical Biochemistry","volume":" ","pages":"45632261475618"},"PeriodicalIF":1.1,"publicationDate":"2026-07-23","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148576453","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}