Validation of a rapid fluorescence immunoassay for soluble interleukin-2 receptor α in a pediatric population.

IF 4 3区医学 Q2 IMMUNOLOGY

Expert Review of Clinical Immunology Pub Date : 2026-02-01 Epub Date: 2026-02-27 DOI:10.1080/1744666X.2026.2637765

Samantha M Logan, Tina Henderson, Mehdi Hooshmandi, Luke Y C Chen, Kristi L Smiley, Rebecca Marsh, Lusia Sepiashvili

{"title":"Validation of a rapid fluorescence immunoassay for soluble interleukin-2 receptor α in a pediatric population.","authors":"Samantha M Logan, Tina Henderson, Mehdi Hooshmandi, Luke Y C Chen, Kristi L Smiley, Rebecca Marsh, Lusia Sepiashvili","doi":"10.1080/1744666X.2026.2637765","DOIUrl":null,"url":null,"abstract":"Introduction: The objective of this study was to assess the analytical performance of an automated fluorescence immunoassay (FIA) on the ProteinSimple Ella for rapid measurement of sIL-2 Rα in pediatrics.Research design and methods: Analytical performance evaluation included imprecision, linearity, accuracy, and reference interval establishment. Accuracy was evaluated via method comparison with a chemiluminescent immunoassay (CMIA) through split sampling of EDTA plasma (n = 28). Reference intervals were established per CLSI guidelines (EP28-A3) using plasma from 222 metabolically stable outpatients aged 0 to 19 years.Results: Imprecision at quality control concentrations of 34 and 1943 pg/mL was 5.0% and 6.9%, respectively. The method was linear across the analytical measuring range. A strong linear correlation between FIA and CMIA (slope: 0.99, bias: -10%, R = 0.99) was found. It was determined that the 2400 U/mL clinical cutoff is equivalent to 10,320 pg/mL. sIL-2 r concentrations were inversely correlated with age. Age-specific reference ranges were established: (1) 0 to <6 years: 1377 - 5022, (2) 6 to <14 years: 851 - 3288, and (3) 565-2499 pg/mL.Conclusions: Characterization of the analytical performance of the automated FIA for sIL-2 Rα measurement and establishment of age-specific reference ranges is expected to facilitate future investigations of this biomarker in children and adolescents.","PeriodicalId":12175,"journal":{"name":"Expert Review of Clinical Immunology","volume":" ","pages":"243-248"},"PeriodicalIF":4.0000,"publicationDate":"2026-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"Expert Review of Clinical Immunology","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1080/1744666X.2026.2637765","RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"2026/2/27 0:00:00","PubModel":"Epub","JCR":"Q2","JCRName":"IMMUNOLOGY","Score":null,"Total":0}

引用次数: 0

Abstract

Introduction: The objective of this study was to assess the analytical performance of an automated fluorescence immunoassay (FIA) on the ProteinSimple Ella for rapid measurement of sIL-2 Rα in pediatrics.

Research design and methods: Analytical performance evaluation included imprecision, linearity, accuracy, and reference interval establishment. Accuracy was evaluated via method comparison with a chemiluminescent immunoassay (CMIA) through split sampling of EDTA plasma (n = 28). Reference intervals were established per CLSI guidelines (EP28-A3) using plasma from 222 metabolically stable outpatients aged 0 to 19 years.

Results: Imprecision at quality control concentrations of 34 and 1943 pg/mL was 5.0% and 6.9%, respectively. The method was linear across the analytical measuring range. A strong linear correlation between FIA and CMIA (slope: 0.99, bias: -10%, R = 0.99) was found. It was determined that the 2400 U/mL clinical cutoff is equivalent to 10,320 pg/mL. sIL-2 r concentrations were inversely correlated with age. Age-specific reference ranges were established: (1) 0 to <6 years: 1377 - 5022, (2) 6 to <14 years: 851 - 3288, and (3) 565-2499 pg/mL.

Conclusions: Characterization of the analytical performance of the automated FIA for sIL-2 Rα measurement and establishment of age-specific reference ranges is expected to facilitate future investigations of this biomarker in children and adolescents.

查看原文本刊更多论文

儿童可溶性白细胞介素-2受体α的快速荧光免疫分析验证。

简介：本研究的目的是评估自动荧光免疫分析法（FIA）对快速测定儿科sIL-2 Rα的ProteinSimple Ella的分析性能。研究设计与方法：分析性能评价包括不精密度、线性度、准确度和参考区间的建立。通过EDTA血浆分离取样（n = 28），与化学发光免疫分析法（CMIA）进行方法比较，评估准确性。根据CLSI指南（EP28-A3）建立参考区间，使用222名年龄在0至19岁之间代谢稳定的门诊患者的血浆。结果：在质量控制浓度为34和1943 pg/mL时，不精密度分别为5.0%和6.9%。该方法在整个分析测量范围内呈线性。发现FIA与CMIA之间有很强的线性相关性（斜率：0.99，偏差：-10%，R = 0.99）。2400 U/mL的临床临界值相当于10320 pg/mL。sil - 2r浓度与年龄呈负相关。建立了年龄特异性参考范围：(1)0 ~结论：自动化FIA测定sIL-2 Rα分析性能的表征和年龄特异性参考范围的建立有望促进未来儿童和青少年中这一生物标志物的研究。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

求助全文

约1分钟内获得全文求助全文

来源期刊

Expert Review of Clinical Immunology IMMUNOLOGY-

CiteScore

7.60

自引率

2.30%

发文量

221

审稿时长

6-12 weeks

期刊介绍： Expert Review of Clinical Immunology (ISSN 1744-666X) provides expert analysis and commentary regarding the performance of new therapeutic and diagnostic modalities in clinical immunology. Members of the International Editorial Advisory Panel of Expert Review of Clinical Immunology are the forefront of their area of expertise. This panel works with our dedicated editorial team to identify the most important and topical review themes and the corresponding expert(s) most appropriate to provide commentary and analysis. All articles are subject to rigorous peer-review, and the finished reviews provide an essential contribution to decision-making in clinical immunology. Articles focus on the following key areas: • Therapeutic overviews of specific immunologic disorders highlighting optimal therapy and prospects for new medicines • Performance and benefits of newly approved therapeutic agents • New diagnostic approaches • Screening and patient stratification • Pharmacoeconomic studies • New therapeutic indications for existing therapies • Adverse effects, occurrence and reduction • Prospects for medicines in late-stage trials approaching regulatory approval • Novel treatment strategies • Epidemiological studies • Commentary and comparison of treatment guidelines Topics include infection and immunity, inflammation, host defense mechanisms, congenital and acquired immunodeficiencies, anaphylaxis and allergy, systemic immune diseases, organ-specific inflammatory diseases, transplantation immunology, endocrinology and diabetes, cancer immunology, neuroimmunology and hematological diseases.