Clinica Chimica Acta最新文献

{"title":"Practical sustainable laboratory medicine","authors":"Tony Badrick ,&nbsp;Guzin Aykal ,&nbsp;Tuija Mannisto ,&nbsp;John Anetor ,&nbsp;On behalf of the Task Force on the Environmental Impact of Laboratory Medicine","doi":"10.1016/j.cca.2025.120428","DOIUrl":"10.1016/j.cca.2025.120428","url":null,"abstract":"<div><div>Medical laboratories now face the challenge of sustainability. Many publications provide evidence of healthcare’s impact on the environment and, increasingly, specific laboratory-focused examples. However, few documents guide how to plan to reduce the impact on the environment.</div><div>This paper aims to provide some practical steps that a laboratory can use to reduce waste and environmental impact.</div><div>The six steps are Step 1: Awareness – Look Around; Step 2: Form a green team of like-minded green champions – Think Green; Step 3: Develop a laboratory-wide action plan to reduce waste – Small Steps, Big Impacts; Step 4: Incorporate environmental management into the laboratory’s operational and strategic planning – Integrate Sustainable Practices; Step 5: Seek EFLM Green and Sustainable Laboratory Certification or MyGreenLab Certification – Be Proud and Show It; and, Step 6: From Certification to Culture/ Sustaining Sustainability – Make a Difference.</div><div>These laboratory initiatives have broader health care system benefits for countries. The paper also describes Green Chemistry, which refers to the design of chemical products and processes that reduce or eliminate the generation of hazardous substances. The concept applies across the life cycle of chemical products, including their design, manufacture, use and ultimate disposal.</div><div>Adopting this approach provides a laboratory’s Environmental, Social, and Governance framework.</div></div>","PeriodicalId":10205,"journal":{"name":"Clinica Chimica Acta","volume":"576 ","pages":"Article 120428"},"PeriodicalIF":3.2,"publicationDate":"2025-06-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144293444","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":"Determination of testosterone by liquid Chromatography–Tandem mass spectrometry in dried plasma obtained from capillary blood using the HealthID PSD microsampling device","authors":"Amanda Pacheco Bondan ,&nbsp;Ana Paula Grando ,&nbsp;Eduarda Milena Reichert ,&nbsp;Giovana Piva Peteffi ,&nbsp;Giovanna da Silva Grassi ,&nbsp;Maitê de Moraes Machado ,&nbsp;Roberta Zilles Hahn ,&nbsp;Marina Venzon Antunes ,&nbsp;Eduardo Guimarães Camargo ,&nbsp;Mariele Feiffer Charão ,&nbsp;Rafael Linden","doi":"10.1016/j.cca.2025.120421","DOIUrl":"10.1016/j.cca.2025.120421","url":null,"abstract":"<div><div>Monitoring testosterone (T) levels is essential in various clinical contexts, but traditional venous sampling is invasive and limits access. This study describes the development and validation of a liquid chromatography-tandem mass spectrometry (LC-MS/MS) method to quantify T in dried plasma spot (DPS) samples obtained from capillary blood using the HealthID PSD microsampling device. A chloride-based correction of plasma volume in the DPS and a multiplication factor were applied to estimate venous plasma concentrations. The method showed linearity from 1.63 to 104.02 nmol/L, with accuracy ranging from 96.8 % to 105.2 % and precision between 1.90 % and 7.24 %. Matrix effects were adequately corrected by the internal standard, and extraction yield exceeded 89 %. T in DPS samples was stable for up to 10 days at room temperature and 40 °C. Clinical validation involved 104 volunteers, including cisgender men and transgender individuals on hormone therapy. A strong correlation was observed between DPS-derived and venous plasma testosterone levels (<em>r</em> = 0.950), and the percent total error (TE%) of 16.41 % met the desirable performance criterion derived from biological variation data. The method proved robust against hematocrit variation and sample volume differences. This is the first report on T quantification using a capillary plasma separation device, highlighting the potential of the HealthID PSD for simplified, decentralized T monitoring. The approach offers practical advantages in collection, transport, and storage, making it a promising alternative to conventional phlebotomy for clinical applications.</div></div>","PeriodicalId":10205,"journal":{"name":"Clinica Chimica Acta","volume":"576 ","pages":"Article 120421"},"PeriodicalIF":3.2,"publicationDate":"2025-06-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144263492","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":"Genetic landscape of primary ovarian insufficiency in Bangladeshi women through whole exome sequencing","authors":"Hasna Hena Pervin ,&nbsp;Rabeya Akter Mim ,&nbsp;Athoi Ganguly ,&nbsp;Rezaul Karim Kazal ,&nbsp;Rohit Gutgutia ,&nbsp;Tamannyat Binte Eshaque ,&nbsp;Farjana Binta Omar ,&nbsp;Md.Atikur Rahaman ,&nbsp;Md.Nahid Hasan ,&nbsp;Amirul Islam ,&nbsp;Nasna Nassir ,&nbsp;Mohammad Shahnoor Hossain ,&nbsp;Hosneara Akter ,&nbsp;Mohammed Uddin","doi":"10.1016/j.cca.2025.120423","DOIUrl":"10.1016/j.cca.2025.120423","url":null,"abstract":"<div><h3>Background</h3><div>Primary Ovarian Insufficiency (POI), a significant cause of female infertility, involves premature ovarian dysfunction before the age of 40 and is influenced by genetic predispositions, autoimmune disorders, environmental factors, and metabolic changes. In this study, we employed Whole Exome Sequencing (WES) to explore genetic variations linked to POI in Bangladeshi women.</div></div><div><h3>Materials and methods</h3><div>This study encompassed 30 Bangladeshi women aged 16 to 40 diagnosed with POI. The diagnosis was based on clinical criteria, including elevated Follicle-Stimulating Hormone levels and a history of at least four months of oligomenorrhea or amenorrhea. WES was performed on POI cases and used population specific internal cohort to filter out and identify genes impacting ovarian function. Subsequently, Sanger Sequencing was used to validate pathogenic or likely pathogenic variants.</div></div><div><h3>Results</h3><div>We detected seven pathogenic variants in 23% of all POI cases (7/30) across six genes: Thyroglobulin (<em>TG</em>)<em>,</em> Thyroid-Stimulating Hormone Receptor (<em>TSHR</em>)<em>,</em> tubulin beta 8 class viii (<em>TUBB8</em>)<em>,</em> PR/SET domain 9 (<em>PRDM9</em>)<em>,</em> required for meiotic nuclear division 1 homolog (<em>RMND1</em>)<em>,</em> and homologous recombination factor with OB-fold (<em>HROB</em>). Two novel likely pathogenic variants were identified, including a heterozygous frameshift variant in <em>TG</em> (p.H209Pfs11) and a heterozygous missense variant in <em>TSHR</em> (p.T1904C). Additionally, variants of uncertain significance were found in 63% (19/30) of the cases, with seven being novel. Incidental findings of pathogenic variants were observed in several genes, with Hemoglobin subunit Beta (<em>HBB</em>) being the most common.</div></div><div><h3>Conclusions</h3><div>This study highlights the utility of whole exome sequencing in identifying genetic risk factors for POI, suggesting that incorporating genetic screening into routine clinical practice could improve diagnostic and therapeutic strategies, particularly in regions lacking genomic data on this condition.</div></div>","PeriodicalId":10205,"journal":{"name":"Clinica Chimica Acta","volume":"576 ","pages":"Article 120423"},"PeriodicalIF":3.2,"publicationDate":"2025-06-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144263493","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 integrated framework for universal coagulation test reference intervals: Cross-platform validation of eleven indirect algorithms and age-specific hierarchical optimization","authors":"Yunfeng Wu ,&nbsp;Tingting Huang ,&nbsp;Huixian Huang,&nbsp;Fan Yu,&nbsp;Jiao Liu,&nbsp;Xi Tang,&nbsp;Lei Chen,&nbsp;Yiwen Zhou,&nbsp;Haihong He","doi":"10.1016/j.cca.2025.120422","DOIUrl":"10.1016/j.cca.2025.120422","url":null,"abstract":"<div><h3>Background</h3><div>The conventional direct method for establishing coagulation reference intervals (RIs) faces challenges, including difficulties in recruiting healthy populations, non-Gaussian distributions, and complex age-related effects. Indirect methods utilizing real-world data (RWD) are limited by a lack of consensus on algorithm selection and insufficient cross-platform validation.</div></div><div><h3>Objective</h3><div>To develop a multi-algorithm collaborative framework for systematically evaluating the performance of 11 outlier detection algorithms, thereby optimizing coagulation RIs for the Chinese population and validating their cross-platform applicability.</div></div><div><h3>Methods</h3><div>We retrospectively analysed 630,946 coagulation test records from Shenzhen Hospital of Southern Medical University. Outlier removal was performed using eleven algorithms. Algorithm stability and sex/age effects were quantified via reference change value (RCV) and variance component models. Validation was conducted across Mindray CX-9000 and Stago STA R Max platforms.</div></div><div><h3>Results</h3><div>Among the 11 algorithms, Z-Score and Tukey demonstrated optimal performance for 8 coagulation parameters, yielding RIs with minimal deviation from manufacturer standards. Sex-based analysis revealed minimal differences (Standard deviation ratio (SDR) &lt; 0.40, Standardized effect size (Cohen’s d) &lt;0.50), eliminating the need for sex stratification. Age stratification was required for D-Dimer (≥60 years subgroup: SDR = 0.62, Cohen’s d = 0.54). Cross-platform consistency confirmed algorithm generalizability.</div></div><div><h3>Conclusions</h3><div>This RCV-driven multi-algorithm framework establishes the Z-Score and Tukey methods as optimal for coagulation RIs derivation, advocates age-specific D-Dimer RIs, and deems sex stratification unnecessary. This scalable approach enhances standardization in coagulation testing.</div></div>","PeriodicalId":10205,"journal":{"name":"Clinica Chimica Acta","volume":"576 ","pages":"Article 120422"},"PeriodicalIF":3.2,"publicationDate":"2025-06-09","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144254102","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Comparison of four indirect methods for establishing sex- and age-specific reference intervals for IgG: based on real world data","authors":"Wensong Liu ,&nbsp;Zhixian Xie ,&nbsp;Meng Wang ,&nbsp;Zhixuan Guo ,&nbsp;Qian Zhang ,&nbsp;Lijuan Wang ,&nbsp;Jiaqi Zhang ,&nbsp;Xiaoshuang Zhu ,&nbsp;Chuanbao Li ,&nbsp;Shunli Zhang","doi":"10.1016/j.cca.2025.120420","DOIUrl":"10.1016/j.cca.2025.120420","url":null,"abstract":"<div><h3>Objective</h3><div>To compare four indirect methods for establishing sex- and age-specific reference intervals (RI) for adult serum immunoglobulin G (IgG) based on real world data.</div></div><div><h3>Methods</h3><div>All serum IgG measurement results from 2020 to 2021 in Beijing Hospital were collated. Following data screening, four indirect methods were applied to calculate the RI of the total population, different sexes, ages and seasons (months). The results were then compared with the manufacturer’s RI and National Industry Standard in China to verify the reliability of the RI obtained in this study. The minimal allowable bias of the CV of the RI and the permissible difference (pD) elaborated by the German Society for Clinical Chemistry and Laboratory Medicine (DGKL) were used as the criterion.</div></div><div><h3>Results</h3><div>A total of 13,162 data points were obtained. There were significant differences between men and women within the RI calculated by four methods. With increasing age, the upper limit of RI (URL) increased and the lower limit reference (LRL )decreased. However, there was no obvious trend in different seasons. The LRL of the four methods were within the pD based on manufacturer’s RI, while the URL of the Hoffmann and RefineR methods conformed to the pD based on the National Industry Standard’s RI, and neither the RI of the National Industry Standard nor the manufacturer's were within the minimal allowable bias of the CV of the RI with our study.</div></div><div><h3>Conclusions</h3><div>The serum IgG RI were established by four indirect method. The significant differences were found between males and females, younger and older. Clinical laboratories should establish their own RI in order to better diagnose and treat disease.</div></div>","PeriodicalId":10205,"journal":{"name":"Clinica Chimica Acta","volume":"576 ","pages":"Article 120420"},"PeriodicalIF":3.2,"publicationDate":"2025-06-08","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144265397","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":"Beta-2 microglobulin in lymphoma","authors":"Gaurav Gupta ,&nbsp;Muhammad Afzal ,&nbsp;Ahsas Goyal ,&nbsp;G. PadmaPriya ,&nbsp;Manish Srivastava ,&nbsp;Kattela Chennakesavulu ,&nbsp;Biswaranjan Mohanty ,&nbsp;A. Rekha ,&nbsp;Avijit Mazumder ,&nbsp;Kavita Goyal ,&nbsp;Haider Ali ,&nbsp;Moyad Shahwan","doi":"10.1016/j.cca.2025.120418","DOIUrl":"10.1016/j.cca.2025.120418","url":null,"abstract":"<div><div>Lymphomas are heterogeneous hematologic malignancies characterised by the abnormal proliferation of lymphocytes. β₂-Microglobulin (β₂M) functions both as a structural subunit of primary histocompatibility complex class I (MHC I) and as a circulating biomarker with established diagnostic and prognostic significance. Serum β₂M &gt; 2.5 mg/L is elevated in 60 % of mantle cell lymphoma and in &gt; 50 % of advanced-stage diffuse large B-cell lymphoma, correlating with higher tumor burden, International Prognostic Index scores, and inferior survival; cerebrospinal fluid β₂M enhances central nervous system lymphoma diagnosis with 97 % sensitivity and specificity. Mechanistically, β₂M stabilizes MHC I to enable CD8⁺ T-cell antigen presentation and, when shed, activates JAK/STAT and NF-κB pathways that drive tumor proliferation and immune evasion. Preclinical strategies targeting these β₂M-driven signals such as anti-β₂M antibodies combined with proteasome inhibitors demonstrate enhanced cytotoxicity in resistant models. Advanced three-dimensional scaffold culture platforms preserve β₂M-tumour-immune interactions, allowing for the investigation of matrix stiffness effects on signalling. Emerging mechanotherapy approaches leverage extracellular matrix rigidity to modulate β₂M-related pathways and sensitize lymphoma cells to therapy. The remaining challenges include assay standardization, cohort variability, and lack of prospective validation of β₂M-based indices. Future efforts should focus on harmonising β₂M measurement methods and integrating mechanistic insights into refined risk stratification and therapeutic strategies.</div></div>","PeriodicalId":10205,"journal":{"name":"Clinica Chimica Acta","volume":"576 ","pages":"Article 120418"},"PeriodicalIF":3.2,"publicationDate":"2025-06-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144241404","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":"Long cardiac troponin T forms in a healthy reference population","authors":"Tuulia Tuominen ,&nbsp;Tuija Vasankari ,&nbsp;Helea Junes ,&nbsp;Selma Salonen ,&nbsp;Konsta Teppo ,&nbsp;Anna Linko-Parvinen ,&nbsp;Hanna-Mari Pallari ,&nbsp;K.E. Juhani Airaksinen ,&nbsp;Saara Wittfooth","doi":"10.1016/j.cca.2025.120419","DOIUrl":"10.1016/j.cca.2025.120419","url":null,"abstract":"<div><h3>Background</h3><div>Cardiac troponin T (cTnT) is an established biomarker in the diagnosis of myocardial infarction (MI). Recent studies show better discrimination between MI and other conditions when measuring only intact or minimally fragmented cTnT forms (long cTnT), compared to current cTnT assays that measure both intact and highly fragmented cTnT forms (total cTnT). This study investigated the long cTnT concentrations in a healthy population.</div></div><div><h3>Methods</h3><div>Lithium-heparin plasma samples were collected from 314 healthy volunteers aged 21–85 years (59 % female). The samples were analyzed for total cTnT with Roche Elecsys high sensitivity cTnT assay and with a novel upconversion luminescence-based long cTnT assay.</div></div><div><h3>Results</h3><div>The median (25th-75th percentile) long cTnT concentration of the reference population was 2.0 (1.3–3.0) ng/l. The 99th percentile URL for the long cTnT assay was 7.3 (95 % confidence interval, 5.6–8.4) ng/l. Of the healthy population 98 % had long cTnT levels above the detection limit of the assay (0.4 ng/l). The imprecision (coefficient of variation) of the long cTnT assay at the 99th percentile URL was 5.1 %. While total cTnT was heavily associated with age, especially in the older population, long cTnT remained low regardless of age. Common comorbidities and medications were also associated with the total cTnT concentration but not with the long cTnT concentration.</div></div><div><h3>Conclusions</h3><div>The long cTnT assay fulfills the requirements for a high sensitivity cTnT assay. Healthy individuals have low long cTnT concentrations regardless of age and common comorbidities.</div></div>","PeriodicalId":10205,"journal":{"name":"Clinica Chimica Acta","volume":"576 ","pages":"Article 120419"},"PeriodicalIF":3.2,"publicationDate":"2025-06-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144241406","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":"Non-coding RNAs in celiac disease","authors":"Asma Vafadar ,&nbsp;Elham Shirazi-Tehrani ,&nbsp;Parisa Vosough ,&nbsp;Shayan Khalili Alashti ,&nbsp;Hossein Kargar Jahromi ,&nbsp;Kamran Bagheri Lankarani ,&nbsp;Amir Savardashtaki ,&nbsp;Sajad Ehtiati","doi":"10.1016/j.cca.2025.120417","DOIUrl":"10.1016/j.cca.2025.120417","url":null,"abstract":"<div><div>Celiac disease (CeD) is a prevalent gluten-induced autoimmune condition that affects approximately 1%-2% of the global population. Recent research has emphasized the pivotal role of non-coding RNAs (ncRNAs) in regulating inflammatory responses and modulating autoimmune processes. This diverse group contains microRNAs (miRNAs), long non-coding RNAs (lncRNAs), and circular RNAs (circRNAs),<!--> <!-->and serves as critical regulators in various physiological and disease-related pathways.<!--> <!-->A group of validated non-coding RNAs have emerged as promising biomarkers for<!--> <!-->the diagnosis and treatment of<!--> <!-->CeD.<!--> <!-->This review aims to elucidate the pathogenesis of CeD and investigate the potential of miRNAs, lncRNAs, and circRNAs as diagnostic biomarkers for this condition. By doing so, we hope to offer valuable insights into the underlying mechanisms of CeD and demonstrate the utility of ncRNAs as diagnostic and therapeutic tools in managing this autoimmune disorder.</div></div>","PeriodicalId":10205,"journal":{"name":"Clinica Chimica Acta","volume":"576 ","pages":"Article 120417"},"PeriodicalIF":3.2,"publicationDate":"2025-06-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144241405","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":"Methodological limitations in the diagnostic validation of P-C4BP-Rf for ovarian clear cell carcinoma versus endometrioma: addressing sample size constraints and selective bias","authors":"Meibo Chen,&nbsp;Shanshan Yuan","doi":"10.1016/j.cca.2025.120416","DOIUrl":"10.1016/j.cca.2025.120416","url":null,"abstract":"","PeriodicalId":10205,"journal":{"name":"Clinica Chimica Acta","volume":"576 ","pages":"Article 120416"},"PeriodicalIF":3.2,"publicationDate":"2025-06-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144221079","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":"Establishment of a microsphere-based flow cytometric assay for quantitative detection of total immunoglobulin E","authors":"Qi Jiang ,&nbsp;Yuanmin Sun ,&nbsp;Xiaoming Cui ,&nbsp;Yixian Li ,&nbsp;Xiaohui Yang ,&nbsp;Xue Li ,&nbsp;Huiqiang Li ,&nbsp;Yang Yu","doi":"10.1016/j.cca.2025.120415","DOIUrl":"10.1016/j.cca.2025.120415","url":null,"abstract":"<div><h3>Background</h3><div>In the diagnosis of allergic diseases, in vitro serum IgE level tests were conventionally used. In recent years, microsphere-based flow cytometric assays for IgE have gained more attention. The present study aimed to establish a microsphere-based flow cytometric assay for quantitative detection of tIgE.</div></div><div><h3>Methods</h3><div>The assay was established after selection of microsphere, antibody pair, detection mode, and optimization of coating ratio. In order to quantitate tIgE, the calibration curve was established. The detection performance of this new tIgE flow cytometric assay was also confirmed. In addition, the correlations between this assay with the ImmunoCAP assay or the immunoturbidimetry assay were evaluated.</div></div><div><h3>Results</h3><div>This new tIgE flow cytometric assay has low CVs of repeatability (7.62 % and 6.98 %) and intermediate precision (7.50 % and 8.41 %). The detection range was 2 ∼ 6000 IU/mL. The range of linearity was from 2 ∼ 3363 IU/L (<em>r</em> = 0.9932). The correlation coefficient (r) for the correlation analysis between the results of the newly developed tIgE flow cytometric assay and ImmunoCAP assay or immunoturbidimetry assay was 0.9345 and 0.9348, respectively.</div></div><div><h3>Conclusion</h3><div>A tIgE flow cytometric assay was successfully established. It could be used in clinical laboratories and quantitate lots of allergen-sIgE detected by flow cytometric assay.</div></div>","PeriodicalId":10205,"journal":{"name":"Clinica Chimica Acta","volume":"576 ","pages":"Article 120415"},"PeriodicalIF":3.2,"publicationDate":"2025-06-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144241486","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}