Clinica Chimica Acta最新文献

{"title":"The diagnostic accuracy of HE4 in the differential diagnosis of pleural effusions","authors":"Silvia Bérgamo ,&nbsp;Jaume Trapé ,&nbsp;Laura González-García ,&nbsp;Carolina González-Fernández ,&nbsp;Carme Vergara ,&nbsp;Noelia de- la-Torre ,&nbsp;Laia Bosch-Presegué ,&nbsp;Marta Otero-Viñas ,&nbsp;Silvia Catot ,&nbsp;Manuel Crespo-Casal ,&nbsp;Jose Rives-Jimenez ,&nbsp;Anna Arnau ,&nbsp;Roser Costa ,&nbsp;José Ramón Cugat ,&nbsp;Francesc Gonzalez-Sánchez ,&nbsp;Xavier Pla-Salas ,&nbsp;Francesc Sant","doi":"10.1016/j.cca.2024.120027","DOIUrl":"10.1016/j.cca.2024.120027","url":null,"abstract":"<div><h3>Background</h3><div>Pleural effusions are challenging to diagnose, with approximately 20–50% of malignant effusions not diagnosed by cytology. Human epididymal protein 4 (HE4) may be useful in the differential diagnosis of pleural effusions. In serum, this biomarker shows false-positive results in some benign diseases. The aim of this study was to evaluate the diagnostic utility of HE4 in this setting and to identify false positives.</div></div><div><h3>Methods</h3><div>Concentrations of HE4, adenosine deaminase, % polynuclear cells, and C-reactive protein, were determined in 238 pleural fluid samples and the estimated glomerular filtration rate (eGFr) in serum.</div></div><div><h3>Results</h3><div>HE4 values ​​differed significantly (p &lt; 0.01) between malignant [median (IQR)] [1065 (2085)] pmol/L and benign effusions [699 (589)] pmol/L. HE4 concentrations in gynecological and pulmonary tumors were significantly higher than in other tumors.</div><div>For a cut-off point of 3050 pmol/L, 22 % sensitivity and 100 % specificity were obtained.</div><div>In patients with benign disease, significant increases in HE4 were identified only in those with eGFr &lt; 30 mL/min/1.73 m² [1050(596)] pmol/L, and not in those with eGFr &gt; 30 mL/min/1.73 m² [597(532)] pmol/L).</div><div>Two cut-offs were established for maximum specificity, depending on the eGFr: 3050 pmol/L for eGFr &lt; 30 mL/min/1.73 m² and 1992 pmol/L for eGFr &gt; 30 mL/min/1.73 m². A sensitivity of 28.5 % was obtained for patients with eGFr &gt; 30 mL/min/1.73 m² and 36.3 % for patients with eGFr &lt; 30 mL/min/1.73 m². The sensitivity using a specific cut-off point was 29.7 %.</div></div><div><h3>Conclusions</h3><div>The determination of HE4 in pleural fluids demonstrates high specificity and low sensitivity. The use of specific cutoff points that are clinically adjusted improves sensitivity while maintaining maximum specificity.</div></div>","PeriodicalId":10205,"journal":{"name":"Clinica Chimica Acta","volume":"566 ","pages":"Article 120027"},"PeriodicalIF":3.2,"publicationDate":"2024-11-09","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142615961","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":"Comprehensive evaluation of the impact of whole-genome bisulfite sequencing (WGBS) on the fragmentomic characteristics of plasma cell-free DNA","authors":"Shaogang Li ,&nbsp;Yu Lin ,&nbsp;Fengxia Su ,&nbsp;Xintao Hu ,&nbsp;Lingguo Li ,&nbsp;Wei Yan ,&nbsp;Yan Zhang ,&nbsp;Min Zhuo ,&nbsp;Ya Gao ,&nbsp;Xin Jin ,&nbsp;Haiqiang Zhang","doi":"10.1016/j.cca.2024.120033","DOIUrl":"10.1016/j.cca.2024.120033","url":null,"abstract":"<div><h3>Background</h3><div>Cell-free DNA (cfDNA) is non-randomly fragmented in human body fluids. Analyzing such fragmentation patterns of cfDNA holds great promise for liquid biopsy. Whole-genome bisulfite sequencing (WGBS) is widely used for cfDNA methylation profiling. However, its applicability for studying fragmentomic characteristics remains largely unexplored.</div></div><div><h3>Methods</h3><div>We performed paired WGBS and whole-genome sequencing (WGS) on 66 peripheral plasma samples from 58 pregnant women. Then, we systematically compared the fragmentation patterns of cell-free nuclear DNA and mitochondrial DNA (mtDNA) sequenced from these two approaches. Additionally, we evaluated the extent of the size shortening in fetal-derived cfDNA and estimated the fetal DNA fraction in maternal plasma using both sequencing methods.</div></div><div><h3>Results</h3><div>Compared to WGS samples, WGBS samples demonstrated a significantly lower genome coverage and higher GC content in cfDNA. They also showed a significant decrease in the size of cell-free nuclear DNA, along with alterations in the end motif pattern that were specifically associated with CpG and “CC” sites. While there was a slight shift in the inferred nucleosome footprint from cfDNA coverages in WGBS samples, the cfDNA coverage patterns in CTCF and TSS regions remained highly consistent between these two sequencing methods. Both methods accurately reflected gene expression levels through their TSS coverages. Additionally, WGBS samples exhibited an increased abundance and longer length of mtDNA in plasma. Furthermore, we observed the size shortening of fetal cfDNA in plasma consistently, with a highly correlated fetal DNA fraction inferred by cfDNA coverage between WGBS and WGS samples (r = 0.996). However, the estimated fetal cfDNA fraction in WGBS samples was approximately 7 % lower than in WGS samples.</div></div><div><h3>Conclusions</h3><div>We confirmed that WGBS can introduce artificial breakages to cfDNA, leading to altered fragmentomic patterns in both nuclear and mitochondrial DNA. However, WGBS cfDNA remains suitable for analyzing certain cfDNA fragmentomic characteristics, such as coverage in genome regulation regions and the essential characteristics of fetal DNA in maternal plasma.</div></div>","PeriodicalId":10205,"journal":{"name":"Clinica Chimica Acta","volume":"566 ","pages":"Article 120033"},"PeriodicalIF":3.2,"publicationDate":"2024-11-09","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142615955","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":"Pre-processing stability of routine clinical chemistry analytes in a clotting tube; investigating the (un)suitability for at-home sample collection","authors":"Maaike Roelofs ,&nbsp;Kalpana Ramkisoensing ,&nbsp;Rixt Even ,&nbsp;Huub H. van Rossum","doi":"10.1016/j.cca.2024.120035","DOIUrl":"10.1016/j.cca.2024.120035","url":null,"abstract":"<div><h3>Background</h3><div>There is a growing interest in self-collection of blood for clinical applications. Next to allowing patients to self-sample blood, adequate sample stability of the analyte is essential to provide an accurate and reliable test result. This is particularly important for self-collected blood, as the transport of the sample to the clinical laboratory will generally require significantly more time than routine blood samples collected by healthcare professionals, and under less controlled circumstances.</div></div><div><h3>Methods</h3><div>Three additional blood collection tubes (coagulation tubes) were collected from nine patients; one was processed immediately, the second and third were processed after 48 h of storage at 20 °C and 37 °C, respectively. The collected serum was stored at −20 °C and samples collected from individual patients were analyzed in the same analytical run for 18 routine chemistry analytes and the tumor markers PSA and CEA. The recoveries obtained after delayed processing were quantified and the quality of the sample for each analyte was determined using the analytical performance specifications based on biological variation.</div></div><div><h3>Results</h3><div>For each analyte, the quality level of samples with delayed processing was determined. For the CEA, PSA, CRP, creatinine, HDL-cholestrol, triglycerides and yGT the recovery was within the desirable bias requirement. Recovery for glucose, all included electrolytes, ALT and AST exceeded the minimum bias criterion.</div></div><div><h3>Conclusions</h3><div>Several analytes including sodium, chloride, potassium, calcium, and liver enzymes were not, while others; CEA, PSA, CRP, creatinine and triglycerides, were found to be sufficiently stable in coagulated blood, when processed with a delay of 48 h.</div></div>","PeriodicalId":10205,"journal":{"name":"Clinica Chimica Acta","volume":"567 ","pages":"Article 120035"},"PeriodicalIF":3.2,"publicationDate":"2024-11-09","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142615979","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":"An overview about biomarkers in breast cancer: Insights into the diagnostic and prognostic significance","authors":"Vanessa Emanuelle Pereira Santos ,&nbsp;Pedro Luiz de França Neto ,&nbsp;Beatriz Eda de Oliveira Isídio,&nbsp;Pedro Henrique Bezerra Fontes,&nbsp;Ingrid Andrêssa de Moura,&nbsp;Bruna Isabel Santos Cruz,&nbsp;Mylenna Máyra Gois de Sousa,&nbsp;Daffany Luana dos Santos,&nbsp;Bianca de França São Marcos,&nbsp;Samara Sousa de Pinho,&nbsp;Beatriz Mendonça Alves Bandeira,&nbsp;Stephanie Loureiro Leão,&nbsp;Thainá de Almeida Lima,&nbsp;Maria da Conceição Viana Invenção,&nbsp;Lígia Rosa Sales Leal,&nbsp;Benigno Cristofer Flores Espinoza,&nbsp;Larissa Silva de Macêdo,&nbsp;Matheus do Nascimento Carvalho,&nbsp;Anna Jéssica Duarte Silva,&nbsp;Antonio Carlos de Freitas","doi":"10.1016/j.cca.2024.120030","DOIUrl":"10.1016/j.cca.2024.120030","url":null,"abstract":"<div><div>Breast cancer (BC) is one of the most significant neoplasms globally due to its high incidence and mortality, particularly among females. As a highly heterogeneous pathology, biomarkers are essential for characterizing specific tumors. Currently, several biological processes are well-described in the context of this neoplasm, such as alterations in BRCA1/2, HER, and pathways involving estrogen and progesterone hormone receptors. These studies have enabled the use of these findings as more precise methods for diagnosis, prognosis, and treatment. However, beyond patients who do not exhibit these classic markers, some individuals within the same risk group respond differently to treatment. Therefore, the search for biological markers that can improve diagnosis, aid in stratification, or serve as therapeutic targets is continuous and urgent. Genetic signatures have led to molecular tests currently used in clinical practice, though certain limitations persist. Understanding genetic and epigenetic mechanisms facilitates the identification of potential biomarkers. Biomarker targets must undergo experimental and clinical trials on samples of significant size before reaching clinical utility. In this review, we compile the classical markers and describe the potential use of other markers associated with the biological processes of this neoplasm.</div></div>","PeriodicalId":10205,"journal":{"name":"Clinica Chimica Acta","volume":"567 ","pages":"Article 120030"},"PeriodicalIF":3.2,"publicationDate":"2024-11-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142615973","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":"MultiThal-classifier, a machine learning-based multi-class model for thalassemia diagnosis and classification","authors":"WenQiang Wang,&nbsp;RenQing Ye,&nbsp;BaoJia Tang,&nbsp;YuYing Qi","doi":"10.1016/j.cca.2024.120025","DOIUrl":"10.1016/j.cca.2024.120025","url":null,"abstract":"<div><h3>Background</h3><div>The differential diagnosis between iron deficiency anemia (IDA) and thalassemia trait (TT) remains a significant clinical challenge. This study aimed to develop a machine learning-based multi-class model to differentiate among Microcytic-TT(TT with low mean corpuscular volume), Normocytic-TT (TT with normal mean corpuscular volume), IDA, and healthy individuals.</div></div><div><h3>Methods</h3><div>A comprehensive dataset comprising 1,819 individuals was analyzed using six distinct machine learning algorithms. The eXtreme Gradient Boosting (XGBoost) algorithm was ultimately selected to construct the MultiThal-Classifier (M−THAL) model. SMOTENC (Synthetic Minority Over-sampling Technique for Nominal and Continuous features) was employed to address data imbalance. Model performance was evaluated using various metrics, and SHAP values were applied to interpret the model’s predictions.Additionally, external validation was conducted to assess the model’s robustness and generalizability.</div></div><div><h3>Results</h3><div>After performing 1000 bootstrap resamples of the test set, the average performance metrics of M−THAL and the 95 % confidence interval(CI) were as follows, sensitivity 90.27 % (95 % CI: 84.88–95.26), specificity 97.87 % (95% CI: 97.10–98.55), PPV 93.42 % (95 % CI: 89.34–96.48), NPV 97.82% (95 % CI: 97.00–98.53), F1-score 91.50 % (95% CI: 87.29–95.34), Youden’s index 88.15 % (95 % CI: 82.33–93.70), accuracy 97.06 % (95% CI: 96.06–97.99), and AUC 94.07 % (95 % CI: 91.17–96.84).Feature importance analysis identified mean corpuscular volume(MCV), mean corpuscular hemoglobin(MCH), red cell distribution width − standard deviation(RDW-SD), and hemoglobin (HGB) were identified as the most important features. External validation confirmed the model’s robustness and generalizability.</div></div><div><h3>Conclusion</h3><div>The M−THAL effectively distinguishes Normocytic-TT, Microcytic-TT, IDA, and healthy individuals using hematological parameters, offers a rapid and cost-effective screening tool that can be readily implemented in diverse healthcare settings.</div></div>","PeriodicalId":10205,"journal":{"name":"Clinica Chimica Acta","volume":"567 ","pages":"Article 120025"},"PeriodicalIF":3.2,"publicationDate":"2024-11-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142615976","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":"Systematic review and meta-analysis of biological variation data of urine albumin, albumin to creatinine ratio and other markers in urine","authors":"Berna Aslan ,&nbsp;Anna Carobene ,&nbsp;Niels Jonker ,&nbsp;Kornelia Galior ,&nbsp;Beatriz Boned ,&nbsp;Fernando Marqués-García ,&nbsp;Carmen Ricós ,&nbsp;William Bartlett ,&nbsp;Abdurrahman Coskun ,&nbsp;Jorge Diaz-Garzon ,&nbsp;Pilar Fernández-Calle ,&nbsp;Elisabet Gonzalez-Lao ,&nbsp;Margarida Simon ,&nbsp;Sverre Sandberg ,&nbsp;Aasne K. Aarsand ,&nbsp;on behalf of the European Federation of Clinical Chemistry, Laboratory Medicine Task Group for the Biological Variation Database","doi":"10.1016/j.cca.2024.120032","DOIUrl":"10.1016/j.cca.2024.120032","url":null,"abstract":"<div><h3>Introduction</h3><div>Significant variations in Biological Variation (BV) estimates have been reported for urine markers. This study aimed to systematically review and critically appraise BV studies for albumin, creatinine, albumin-to-creatinine ratio (ACR), and other urine markers to perform a <em>meta</em>-analysis of eligible studies.</div></div><div><h3>Methods</h3><div>Publications were identified through a systematic search and evaluated using the Biological Variation Data Critical Appraisal Checklist (BIVAC). BIVAC-compliant studies (grades A-C; A being fully compliant) conducted in healthy individuals were included in the <em>meta</em>-analysis, providing within-subject (CV_I) and between-subject (CV_G) BV estimates with 95% confidence intervals for various sample collection types.</div></div><div><h3>Results</h3><div>Out of 37 studies evaluated, 16 were included (one grade A, three B, twelve C). No eligible publications were identified for <em>meta</em>-analysis of albumin and ACR. Limited data were available for first-morning urine specimens. A CV_I between 15% and 30% was found for most measurands in 24-hour urine samples, while CV_I estimates for random urine appeared higher.</div></div><div><h3>Conclusion</h3><div>Published BV studies on urine markers utilized different sample collections and reporting units. Most were considered unfit for use or ineligible for <em>meta</em>-analysis. Given the critical role of urine albumin and ACR in chronic kidney disease risk assessment, there is a need for more BIVAC-compliant studies.</div></div>","PeriodicalId":10205,"journal":{"name":"Clinica Chimica Acta","volume":"566 ","pages":"Article 120032"},"PeriodicalIF":3.2,"publicationDate":"2024-11-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142615960","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":"Fatty acid binding protein as a new age biomarker","authors":"Harshita Shand ,&nbsp;Soumendu Patra ,&nbsp;Suvankar Ghorai","doi":"10.1016/j.cca.2024.120029","DOIUrl":"10.1016/j.cca.2024.120029","url":null,"abstract":"<div><div>Small lipid-binding proteins known as fatty acid-binding proteins (FABPs) are extensively expressed in cells having elevated levels of fatty acid (FA) metabolism. There are ten known FABPs in mammals that exhibit expression patterns specific to tissues and tertiary structures that are substantially preserved. FABPs were first investigated as FA transport proteins inside cells. Subsequent research has shown that they are involved in signalling within their expression cells and in metabolism of lipid, directly and through the control of expression of gene. Additionally, there is evidence that they might be released and influence circulatory function. It has been observed that some tissues and organs linked to inflammatory, metabolic illnesses and also infectious disease have markedly elevated expression levels of FABPs. Thus, in addition to previously identified markers, FABPs represent a promising new biomarker that require additional investigation to optimise illness detection and prognosis techniques.</div></div>","PeriodicalId":10205,"journal":{"name":"Clinica Chimica Acta","volume":"565 ","pages":"Article 120029"},"PeriodicalIF":3.2,"publicationDate":"2024-11-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142615972","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":"Highly specific multiplex DNA methylation detection for liquid biopsy of colorectal cancer","authors":"Dewen Zhu ,&nbsp;Jinlei Li ,&nbsp;Wenwen Zhang ,&nbsp;Yishuai Wang ,&nbsp;Huidong Wang ,&nbsp;Ruoyan Fei ,&nbsp;Qian Ye ,&nbsp;Danli Peng ,&nbsp;Ju Luan ,&nbsp;Chang Xu ,&nbsp;Xiaoli Wu ,&nbsp;Dan Huang ,&nbsp;Chunming Ding ,&nbsp;Shengnan Jin","doi":"10.1016/j.cca.2024.120026","DOIUrl":"10.1016/j.cca.2024.120026","url":null,"abstract":"<div><h3>Background</h3><div>Circulating tumor DNA (ctDNA) has emerged as a useful biomarker for cancer detection and prognosis. In this study, we developed a strategy for developing a highly specific multiplex qPCR assay to detect methylated ctDNA in the blood of colorectal cancer (CRC) patients and investigated the potential use for the detection and prognosis of CRC.</div></div><div><h3>Methods</h3><div>Bisulfite conversion and amplicon sequencing were used to confirm potential CRC-specific DNA methylation markers. The selected DNA methylation candidates were validated by qMSP. The six best-performing markers were used to develop a new single-tube multiplex quantitative methylation-specific PCR assay (mqMSP). The mqMSP assay was applied to analyze plasma samples from 114 CRC patients, 47 patients with advanced adenoma, 45 patients with benign polyps, and 57 healthy controls. The clinical performance of the assay and associations with clinical outcomes were assessed.</div></div><div><h3>Results</h3><div>Six DNA methylation biomarkers were confirmed to be specifically hypermethylated in CRC tumor tissues. The newly developed mqMSP assay detected CRC with extremely high specificity (specificity of 98.2 %, with sensitivity of 67.5 %). The detection rate of ctDNA was significantly correlated with tumor size and clinical stage, with ctDNA methylation levels in the blood markedly increased with larger tumor size, poor differentiation, and advanced stage. Moreover, high preoperative methylated ctDNA level was associated with worse recurrence-free survival and overall survival.</div></div><div><h3>Conclusion</h3><div>We provided a strategy for identification of multiple highly-specific DNA methylation markers for designing multiplex DNA methylation assays for liquid biopsies of CRC. The newly developed assay has potential for CRC early detection, and prognosis.</div></div>","PeriodicalId":10205,"journal":{"name":"Clinica Chimica Acta","volume":"565 ","pages":"Article 120026"},"PeriodicalIF":3.2,"publicationDate":"2024-11-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142567558","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":"A systematic review of total IgE reference intervals − A 2024 update","authors":"Erik Wilhelm Vinnes ,&nbsp;Eirik Åsen Røys ,&nbsp;Renate Renstrøm ,&nbsp;Ida Sofie Karlsen Sletten ,&nbsp;Sutirtha Chakraborty","doi":"10.1016/j.cca.2024.120024","DOIUrl":"10.1016/j.cca.2024.120024","url":null,"abstract":"<div><h3>Background</h3><div>Total IgE (tIgE) is a frequently requested analyte in patients presenting with symptoms of atopy. Although tIgE has limited clinical utility in the diagnosis of atopic diseases, it is still important that appropriate reference intervals are provided to the intepreting clinician. Concerns have recently been raised whether laboratories may be using outdated tIgE reference intervals. The aim of this study was therefore to perform the first systematic literature review of tIgE reference intervals to aid laboratories in choosing appropriate sources.</div></div><div><h3>Methods</h3><div>A search was performed in MEDLINE, Embase and the Cochrane Library from time of inception to July 2024. Eligible studies had to provide an estimate of paediatric and/or adult tIgE reference intervals using current generation immunoassays. The methodology followed PRISMA guidelines, and the study protocol was registered in the PROSPERO database (CRD42023396441).</div></div><div><h3>Results</h3><div>A total of 1667 records were screened of which 20 studies remained after full text review. The studies included 23 910 individuals and covered 18 countries. Upper reference limits varied significantly, with participant selection (inclusion or exclusion of in vitro confirmed specific IgE sensitised individuals) and statistical methods identified as the most important factors influencing the upper reference limit.</div></div><div><h3>Conclusion</h3><div>This review emphasises the need for laboratories to carefully evaluate the participant selection criteria and employed statistical methods whilst determining which tIgE reference intervals are the most appropriate to report to clinicians. Further efforts must also be made to harmonise and improve the reporting of tIgE reference interval studies.</div></div>","PeriodicalId":10205,"journal":{"name":"Clinica Chimica Acta","volume":"566 ","pages":"Article 120024"},"PeriodicalIF":3.2,"publicationDate":"2024-11-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142567551","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Establishment of a high-sensitivity time-resolved fluorescence immunoassay with PLA2R-IgG1 antibody and its clinical application in idiopathic membranous nephropathy prognosis","authors":"Shang Gao ,&nbsp;Yafen Yu ,&nbsp;Shangbin Kao ,&nbsp;Tianyu Zheng ,&nbsp;Yuan Qin ,&nbsp;Xiumei Zhou ,&nbsp;Biao Huang ,&nbsp;Heng Li","doi":"10.1016/j.cca.2024.120019","DOIUrl":"10.1016/j.cca.2024.120019","url":null,"abstract":"<div><h3>Introduction</h3><div>The objective of this study was to develop a highly sensitive time-resolved fluorescence immunoassay (TRFIA) method to detect phospholipase A2 receptor (PLA2R)-IgG1 antibodies and evaluate its clinical relevance in predicting the prognosis of individuals with idiopathic membranous nephropathy (IMN).</div></div><div><h3>Materials and methods</h3><div>A three-step indirect TRFIA method was established using a PLA2R antigen-coated microtiter plate to capture PLA2R-IgG antibodies, followed by detection using mouse anti-human IgG1 and Eu³⁺-labeled goat anti-mouse IgG antibodies. This method was applied to the initial serum of 56 patients with PLA2R-IMN to investigate the clinical value of PLA2R-IgG1 antibody levels in predicting IMN prognosis.</div></div><div><h3>Results</h3><div>The detection range of PLA2R-IgG1-TRFIA was 0.85–300<!--> <!-->RU/mL, with intra-assay precision of 3.54–5.93 % and inter-assay precision of 4.39–9.36 %. Recoveries were 101.77–108.04 %. A PLA2R-IgG1 level above 2.21<!--> <!-->RU/mL indicated PLA2R-IMN. At initial diagnosis, the median PLA2R-IgG level was 51.24<!--> <!-->RU/mL in the remission group and 93.27<!--> <!-->RU/mL in the non-remission group. The median PLA2R-IgG1 level was 603.32<!--> <!-->RU/mL in the non-remission group, which was 4.29 times higher than that in the remission group (140.67<!--> <!-->RU/mL). PLA2R-IgG1 levels (P = 0.001) more effectively distinguished between remission and non-remission groups compared with PLA2R-IgG levels (P = 0.094).</div></div><div><h3>Conclusions</h3><div>The first quantitative TRFIA for PLA2R-IgG1 was established, showing greater clinical value in predicting IMN prognosis, compared to that for PLA2R-IgG levels.</div></div>","PeriodicalId":10205,"journal":{"name":"Clinica Chimica Acta","volume":"565 ","pages":"Article 120019"},"PeriodicalIF":3.2,"publicationDate":"2024-11-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142567557","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}