Journal of Clinical Laboratory Analysis最新文献

{"title":"Evaluating the Role of PD1 and MTNR1B Gene Variants in Breast Cancer Susceptibility: A Case-Control Study in Bangladesh.","authors":"Farhan Jamil, Mohammad Mahfuz Enam Elahi, Al-Shahriar Evan, Sakif Ahamed Khan, Israt Jahan Annee, Furhatun-Noor, Ankita Islam, Rana Tabassum, Md Aminul Haque","doi":"10.1002/jcla.70086","DOIUrl":"https://doi.org/10.1002/jcla.70086","url":null,"abstract":"<p><strong>Objectives: </strong>Breast cancer is one of the most common malignancies in women. The PD1 and MTNR1B gene polymorphisms have been extensively studied for their potential role in cancer susceptibility. This study aimed to investigate associations between breast cancer risk and PD1 (rs36084323) and MTNR1B (rs10830963) polymorphisms.</p><p><strong>Methods: </strong>A case-control study was conducted with 112 breast cancer patients from Dhaka Cancer and General Hospital, Bangladesh, and 124 age- and sex-matched healthy controls. Genotyping of PD1 (rs36084323) and MTNR1B (rs10830963) polymorphisms was performed using the Polymerase Chain Reaction-Restriction Fragment Length Polymorphism (PCR-RFLP) method.</p><p><strong>Results: </strong>The genotype distributions for both SNPs adhered to Hardy-Weinberg equilibrium (HWE). The PD1 GG genotype was more prevalent in controls, indicating a protective effect, whereas the GG genotype of MTNR1B showed no statistically significant association with breast cancer risk. The recessive model of PD1 (GG vs. AG + AA) demonstrated a lower odds ratio (0.2873), while the recessive model of MTNR1B (2.307) suggested a potential risk. Dominant models for both genes (AG + GG vs. AA for PD1 and CG + GG vs. CC for MTNR1B) showed statistically significant associations with breast cancer susceptibility.</p><p><strong>Conclusion: </strong>The PD1 GG genotype exhibited a significant protective effect against breast cancer, while the MTNR1B CG genotype was associated with reduced risk, but GG showed no correlation. Larger studies across diverse populations are recommended to validate these findings.</p>","PeriodicalId":15509,"journal":{"name":"Journal of Clinical Laboratory Analysis","volume":" ","pages":"e70086"},"PeriodicalIF":2.9,"publicationDate":"2025-07-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144742232","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":"Evaluating High Fluorescence Lymphocyte Count as a Predictor of Severe Dengue Infection.","authors":"Anh Vu Hong, Kien Nguyen Trung, Hanh Nguyen Thi Hien, Hung Ta Viet","doi":"10.1002/jcla.70083","DOIUrl":"https://doi.org/10.1002/jcla.70083","url":null,"abstract":"<p><strong>Background: </strong>Dengue infection (DI) is a significant global health concern, with severe cases leading to plasma leakage, organ failure, and shock. Identifying reliable biomarkers for early risk stratification is crucial for improving patient management.</p><p><strong>Methods: </strong>This descriptive cross-sectional study included 268 DI patients at 103 Military Hospital, Vietnam, from July 2022 to October 2023. Patients were classified into Non-Severe DI and Severe DI groups per the 2009 WHO dengue guideline. High Fluorescent Lymphocyte Count (HFLC), a parameter from the Sysmex hematology analyzer, was analyzed. HFLC% represents the proportion of high fluorescent lymphocytes among total WBCs, while HFLC# is these cells' absolute count (G/L). Statistical methods included Mann-Whitney U, Kruskal-Wallis, Chi-square tests, ROC curve analysis, and binary logistic regression.</p><p><strong>Results: </strong>HFLC% and HFLC# were significantly elevated in Severe DI compared to Non-Severe DI (p < 0.001). HFLC% negatively correlated with platelet count and positively with liver enzymes (AST, ALT), suggesting an association with severe complications. ROC analysis showed that HFLC# (AUC = 0.913, p < 0.001, cut-off = 1.00 G/L) had 70.6% sensitivity and 90.8% specificity, while HFLC% (AUC = 0.833, p < 0.001, cut-off = 13.15%) had 70.6% sensitivity and 80.5% specificity for predicting severe DI.</p><p><strong>Conclusion: </strong>Elevated HFLC at admission is strongly associated with severe DI, with HFLC# demonstrating excellent predictive accuracy. These findings suggest that HFLC is a promising biomarker for early identification of high-risk dengue patients. Further large-scale validation is required to confirm its clinical utility.</p>","PeriodicalId":15509,"journal":{"name":"Journal of Clinical Laboratory Analysis","volume":" ","pages":"e70083"},"PeriodicalIF":2.9,"publicationDate":"2025-07-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144731204","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":"Clinical and Serological Correlates of Serum C1Q and Anti-C1Q Antibodies in South Africans With Systemic Lupus Erythematosus.","authors":"Mohammed Tikly, Lillemor Skattum, Mohamed Amin Makda","doi":"10.1002/jcla.70087","DOIUrl":"https://doi.org/10.1002/jcla.70087","url":null,"abstract":"<p><strong>Objective: </strong>To investigate prevalence and clinical correlates of serum C1q and anti-C1q antibody titres in black South Africans with systemic lupus erythematosus (SLE).</p><p><strong>Methods: </strong>Cross-sectional study of 96 SLE patients, 49 with lupus nephritis (LN). Anti-C1q antibodies were tested by ELISA. Serum C1q was measured as a percentage of normal by immunoelectrophoresis. Disease activity was assessed using the SELENA-SLE disease activity index.</p><p><strong>Results: </strong>Most patients were female (90.7%), mean (SD) age and follow-up period diagnosis of 38.1 (13.0) and 4.2 (4.4) years, respectively. Low serum C1q and positive anti-C1q antibody test were detected in 17 (17.7%) and 12 (12.5%) patients, respectively, overall. There was an inverse correlation between serum C1q and anti-C1q antibodies titres (r = -0.22, p = 0.03) and a direct correlation of anti-C1q antibodies titres with SELENA-SLEDAI scores (r = 0.27, p = 0.008). Patients with an active urine sediment (n = 21) had higher anti-C1q antibodies titres (p = 0.007) and low serum C1q (OR = 4.51, p = 0.01), compared to the remainder of patients. Anti-C1q antibody titres were higher in patients with C3/C4 hypocomplementaemia (n = 14) than those with normal C3/C4 (p = 0.02). A positive Coombs test (without evidence of red cell haemolysis) (n = 17) was associated with a positive anti-C1q antibody test (OR = 4.29, p = 0.02), low serum C1q (OR = 3.37, p = 0.04) and C3/C4 hypocomplementaemia (OR = 4.84, p = 0.02).</p><p><strong>Conclusion: </strong>Our findings broadly confirm the clinical utility of the anti-C1q antibody test in SLE. Raised anti-C1q antibody titres were associated with active LN, as evidenced by an active urine sediment. The association of a positive anti-C1q antibody and low serum C1q with a positive Direct Coombs' test merits further study and confirmation.</p>","PeriodicalId":15509,"journal":{"name":"Journal of Clinical Laboratory Analysis","volume":" ","pages":"e70087"},"PeriodicalIF":2.9,"publicationDate":"2025-07-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144731195","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":"CYP2C19 Loss-of-Function Is an Independent Risk Factor of Coronary Artery Disease in Patients With Hypertension.","authors":"Guoliang Wei, Bin Li, Hao Wang, Wenhao Chen, Kehui Chen, Weihong Wang, Shen Wang, Hui Zeng, Yuanliang Liu, Yue Zeng, Hui Rao","doi":"10.1002/jcla.70088","DOIUrl":"https://doi.org/10.1002/jcla.70088","url":null,"abstract":"<p><strong>Objective: </strong>Cytochrome P450 2C19 (CYP2C19) is affected by its gene polymorphisms and is involved in the occurrence and development of diseases. To assess the relationship between CYP2C19 polymorphisms and coronary artery disease (CAD) susceptibility in hypertensive patients.</p><p><strong>Methods: </strong>This study retrospectively analyzed 3404 hypertensive patients who were admitted to Meizhou People's Hospital from November 2019 to August 2023, including 1438 CAD patients and 1966 nonCAD individuals. The CYP2C19 rs4244285 (681G>A, *2) and rs4986893 (636G>A, *3) polymorphisms were genotyped by polymerase chain reaction (PCR)-chip technique. The relationship between CYP2C19 polymorphisms and CAD was analyzed.</p><p><strong>Results: </strong>There were 1567 (46.0%), 1491 (43.8%), and 346 (10.2%) individuals with CYP2C19 extensive metabolizer (EM) (CYP2C19*1/*1), intermediate metabolizer (IM) (CYP2C19*1/*2 and *1/*3), and poor metabolizer (PM) (CYP2C19*2/*2, *2/*3, and *3/*3) phenotype. The CAD patients had higher frequencies of the *2 allele (30.2% vs. 26.0%, p < 0.001), *3 allele (4.9% vs. 3.8%, p = 0.021) and lower frequency of *1 allele (64.8% vs. 70.2%, p < 0.001) than controls. Logistic regression analysis showed that body mass index (BMI) ≥ 24.0 kg/m² (odds ratio (OR): 1.364, 95% confidence interval (CI): 1.184-1.571, p < 0.001), history of alcoholism (OR: 1.761 95% CI: 1.211-2.559, p = 0.003), and CYP2C19 IM + PM phenotypes (IM + PM vs. EM, OR: 1.314, 95% CI: 1.145-1.508, p < 0.001) were independent risk factors for CAD in hypertensive patients.</p><p><strong>Conclusions: </strong>CYP2C19 loss-of-function, BMI ≥ 24.0 kg/m², and history of alcoholism were independent risk factors for CAD in hypertensive patients. Hypertensive patients who carried CYP2C19 loss-of-function need to be aware of the risk of developing CAD, and it provides further evidence for the relationship between CYP2C19 and CAD.</p>","PeriodicalId":15509,"journal":{"name":"Journal of Clinical Laboratory Analysis","volume":" ","pages":"e70088"},"PeriodicalIF":2.6,"publicationDate":"2025-07-25","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144717998","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":"Serum Circ-DLGAP4 and miR-9 as Potential Biomarkers in Pancreatic Cancer.","authors":"Marwa A Ali, Olfat G Shaker, Eman M Ezzat, Mohamed Saad Zaghloul Ahmed, Shimaa Mohammed Elasmer, Marwa Mamdouh Ahmed Abdelhafeez, Mohamed Zaidan, Raghda Yahia Abu El-Ela, Marwa N AbdelHafez, Eman Fares, Ahmad A Al Abdulqader, Aeshah A Awaji, Mariam K Alamoudi, Omayma O Abdelaleem","doi":"10.1002/jcla.70076","DOIUrl":"https://doi.org/10.1002/jcla.70076","url":null,"abstract":"<p><strong>Background: </strong>Pancreatic cancer remains one of the malignancies characterized by the most insidious onset and dire prognosis. Preliminary diagnostic biomarkers are essential for timely identification and improved prognosis. CircularRNA-DLGAP4 (Circ-DLGAP4) and microRNA-9 (miR-9) are intriguing, easily accessible genetic indicators for numerous diseases.</p><p><strong>Aim: </strong>To quantify serum expression levels of Circ-DLGAP4 and miR-9 in pancreatic cancer patients and juxtapose these values with those of control persons to assess their potential as diagnostic biomarkers. It also aims to correlate their expression levels with the clinicopathological features of the disease.</p><p><strong>Method: </strong>Quantitative analysis of serum samples collected from 40 pancreatic cancer patients and 40 control subjects with RT-PCR.</p><p><strong>Results: </strong>There were statistically significant elevations in blood levels of Circ-DLGAP4 and miR-9 in pancreatic cancer patients compared to healthy persons, with median (range) values of 8.2 (0.39-17.32), p-value < 0.001, and 9.5 (4.06-14.7), respectively. The blood level of Circ-DLGAP4 exhibited a significant positive correlation with the serum concentration of miR-9 (r = 0.89, p = 0.001).</p><p><strong>Conclusions: </strong>Circ-DLGAP4 and miR-9 serve as diagnostic biomarkers for pancreatic cancer.</p>","PeriodicalId":15509,"journal":{"name":"Journal of Clinical Laboratory Analysis","volume":" ","pages":"e70076"},"PeriodicalIF":2.6,"publicationDate":"2025-07-25","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144707651","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":"Sex-Specific Associations of Serum Alkaline Phosphatase With Metabolic Syndrome and Its Components: Over 15 Years of Follow-Up Among Iranian Adults.","authors":"Parto Hadaegh, Amir Abdi, Mitra Hasheminia, Farzad Hadaegh, Fereidoun Azizi, Maryam Tohidi","doi":"10.1002/jcla.70075","DOIUrl":"https://doi.org/10.1002/jcla.70075","url":null,"abstract":"<p><strong>Background: </strong>To investigate the association of serum alkaline phosphatase (ALP) with incident metabolic syndrome (MetS) and its components, as well as the influence of sex on this relationship among Iranian adults.</p><p><strong>Methods: </strong>The multivariable Cox proportional hazards regression models were applied to assess the associations between ALP both as continuous and categorical variables with incident MetS and its components.</p><p><strong>Results: </strong>Among 831 subjects (467 women) with a mean age of 44.51 years, during a median follow-up of 15.6 years, 597 MetS cases (336 women) occurred. Interaction was found between ALP quartiles and sex (p-value = 0.006). Among women, increasing levels of ALP across the second to fourth quartiles were associated with hazard ratios (HRs) of 1.269, 1.491, and 2.092 for MetS, respectively (p for trend < 0.001). Among men, no association was found between ALP and incident MetS. Among women, the second and fourth quartiles of ALP were associated with incident high triglycerides (TG), with HRs of 1.793 and 1.815, respectively. Moreover, a 1-SD increase in ALP conferred a 17.9% higher risk of low high-density lipoprotein cholesterol (HDL-C). Among men, a 1-SD increase in ALP was associated with an HR of 1.222 for incident high waist circumference (WC) (All p-values < 0.05).</p><p><strong>Conclusion: </strong>Sex significantly influenced the impact of serum ALP on the incidence of MetS and its components. In women, ALP was a strong harbinger for incident MetS and its dyslipidemia components. However, among men, the increasing value of ALP was associated with incident central obesity but not MetS.</p>","PeriodicalId":15509,"journal":{"name":"Journal of Clinical Laboratory Analysis","volume":" ","pages":"e70075"},"PeriodicalIF":2.6,"publicationDate":"2025-07-23","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144690468","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":"Laboratory Practices for the Detection and Characterization of Cryoglobulins and Cryofibrinogen.","authors":"Teresa Troiano, Anna Marinaccio, Pamela Patierno, Alessandra Di Geronimo, Lucia Demarinis, Francesca Di Serio","doi":"10.1002/jcla.70074","DOIUrl":"https://doi.org/10.1002/jcla.70074","url":null,"abstract":"<p><strong>Background: </strong>Cryoglobulins (CGs) and Cryofibrinogen (CF) are proteins that precipitate at low temperatures. Complex laboratory procedures are necessary to identify them.</p><p><strong>Methods: </strong>Between December 2022 and December 2023, 1171 patient samples for analysis of CGs and CF were received in the laboratory from different clinical departments with suggestive clinical symptoms and signs of cryoproteinemia and were analyzed using pre-analytical, analytical, and post-analytical procedures.</p><p><strong>Results: </strong>Cryoproteins were detected in 281 samples (47%); CGs⁺ were found in association with CF⁺ in 74 samples (12.52%); CF⁺ was detected with CGs^- in 119 patients (20.13%); and CGs⁺ were found with CF^- in 88 patients (14.9%).</p><p><strong>Conclusions: </strong>CGs testing has long been common in laboratories, and the analytical and pre-analytical procedures are well known, in contrast to CF testing, which has only emerged in recent years. Therefore, appropriate procedures are needed for testing both cryoproteins to optimize economic and human resources and reduce laboratory diagnostic times. At last, confirming a clinical suspicion of cryoproteinemia in a short time could improve patient outcomes, allowing suitable therapies to be implemented for vasculitis and related thromboembolic phenomena.</p>","PeriodicalId":15509,"journal":{"name":"Journal of Clinical Laboratory Analysis","volume":" ","pages":"e70074"},"PeriodicalIF":2.6,"publicationDate":"2025-07-19","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144667746","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":"Performance Evaluation of a New HRD Assay (HRDsig) in Ovarian Carcinomas in Australia.","authors":"Pranav Dorwal, Liyan Song, Priscillia Siswara, Amit Kumar, Julie Robin, Noel Djitro, Anna Fong Na Goh, Ravikiran Vedururu, Bin Yuan, Ashleigh Levine, Suzanne Svobodova, Beena Kumar","doi":"10.1002/jcla.70085","DOIUrl":"https://doi.org/10.1002/jcla.70085","url":null,"abstract":"<p><strong>Background: </strong>Homologous recombination repair (HRR) is the preferred pathway for repairing double-strand DNA breaks, using proteins like BRCA1 and BRCA2, among others, while the PARP-mediated repair pathway is primarily used for single-strand breaks. When a tumour becomes HRR-deficient (HRD), then those tumour cells become reliant on PARP-mediated repair. Poly ADP-ribose polymerase inhibitors, olaparib and niraparib, have been approved in Australia for advanced (FIGO III-IV), high-grade serous or other high-grade ovarian, fallopian tube or primary peritoneal carcinoma with homologous recombination deficiency (HRD).</p><p><strong>Methods: </strong>HRDsig (Roche Inc) is a new HRD biomarker that is part of the AVENIO Tumor Tissue CGP Kit V2. We have studied the performance of HRDsig against two NATA (National Association of Testing Authorities, Australia) accredited HRD assays in the cases of high-grade ovarian carcinomas. We have evaluated the performance of HRDsig using a total 40 HRD results against the two accredited HRD assays, as well as against commercial controls and inter-laboratory comparison samples.</p><p><strong>Results: </strong>HRDsig has demonstrated a high concordance rate for HRD by comparing it with two different locally accredited HRD assays in cases of ovarian cancers.</p><p><strong>Conclusion: </strong>These findings provide real-world evidence of the performance of a new HRD assay (HRDsig) in ovarian carcinomas.</p>","PeriodicalId":15509,"journal":{"name":"Journal of Clinical Laboratory Analysis","volume":" ","pages":"e70085"},"PeriodicalIF":2.6,"publicationDate":"2025-07-19","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144667747","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":"The Application of Six Sigma to Assess the Analytical Performance of Plasma Proteins and Design a Risk-Based Statistical Quality Control Strategy: A Multicenter Study.","authors":"Ming Hu, Jiaping Wang, Huan Yang, Sugang Zang, Tingting Gao, Jian Zeng, Fumeng Yang","doi":"10.1002/jcla.70080","DOIUrl":"https://doi.org/10.1002/jcla.70080","url":null,"abstract":"<p><strong>Background: </strong>This study applied the six sigma model to evaluate plasma protein testing performance in six laboratories, with customized quality control programs and targeted improvements introduced where necessary.</p><p><strong>Methods: </strong>Internal quality control (IQC) and external quality assessment (EQA) data for plasma proteins were gathered from six laboratories. Sigma values for each analyte were determined based on the coefficient of variation (CV), bias, and total allowable error (TEa). Using six sigma performance verification charts, we calibrated analyte performance and, guided by Westgard sigma rules, batch length, and quality goal index (QGI), developed laboratory-specific quality control schemes and improvement plans.</p><p><strong>Results: </strong>Despite standardized platforms and reagents, sigma values showed significant inter-laboratory variation, with some differences also observed within labs at varying analyte concentrations. For projects with sigma < 6, tailored quality control measures were implemented, leading to marked performance improvements.</p><p><strong>Conclusion: </strong>The six sigma model provides an objective framework for evaluating plasma protein test performance and enhancing quality. It enables quantitative assessment of laboratory management and supports the development and implementation of customized, risk-based statistical quality control (SQC) strategies and improvement measures across multiple laboratory systems.</p>","PeriodicalId":15509,"journal":{"name":"Journal of Clinical Laboratory Analysis","volume":" ","pages":"e70080"},"PeriodicalIF":2.6,"publicationDate":"2025-07-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144659362","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":"Determination of Biotin Interference in Pediatric Obesity Related ELISA Research Kits Biotin Interference in Manual ELISA Kits.","authors":"Ezgi Kürkçü Kahraman, Orkide Donma, Mustafa Metin Donma, Ahsen Yılmaz, Savaş Güzel","doi":"10.1002/jcla.70079","DOIUrl":"https://doi.org/10.1002/jcla.70079","url":null,"abstract":"<p><strong>Background: </strong>Although high-dose biotin interference in automated immunoassays is now considered, there are very few studies showing biotin interference in manually operated research kits, especially with enzyme-linked immunosorbent assay (ELISA). The aims of our study were to determine the effects of biotin interference on various parameters, including leptin, leptin receptor (LEPR), ghrelin, acylated ghrelin, deacylated ghrelin, ghrelin receptor (GHSR), kisspeptin (KISS1), kisspeptin receptor (KISS1R), preptin, peroxisome proliferator activated receptor gamma (PPARγ), nod-like receptor pyrin domain-containing 3 (NLRP3) and interleukin-18 (IL-18), which contribute to energy homeostasis in healthy and obese children.</p><p><strong>Methods: </strong>Serum pools were prepared from healthy and obese individuals, and biotin concentrations in samples containing different amounts of biotin were measured via sandwich and competitive ELISA methods. In addition, possible biotin interactions were investigated by determining the concentrations of all the study parameters in serum pools containing different amounts of biotin.</p><p><strong>Results: </strong>We found that the biotin-competitive, ghrelin-competitive, KISS1-competitive, GHSR, leptin and LEPR ELISA kits were less affected by biotin interference and the results of these assay kits were more reliable. Unexpectedly, high levels were also measured in the biotin sandwich ELISA kit, indicating that biotin interference can also occur in manually operated assay kits.</p><p><strong>Conclusions: </strong>Biotin exhibited an interference effect even in well-functioning, qualified kits, and this negative effect was less common in competitive kits. Biotin interference was closely associated with the quality of the research kit, the parameters studied, and the presence of high biotin concentrations in the blood.</p>","PeriodicalId":15509,"journal":{"name":"Journal of Clinical Laboratory Analysis","volume":" ","pages":"e70079"},"PeriodicalIF":2.6,"publicationDate":"2025-07-14","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144626429","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}