Comparison of ELISA with automated ECLIA for IL-6 determination in COVID-19 patients: An Italian real-life experience

IF 1.7 Q3 MEDICAL LABORATORY TECHNOLOGY

Practical Laboratory Medicine Pub Date : 2024-03-01 DOI:10.1016/j.plabm.2024.e00392

Francesca Romano , Luisa Lanzilao , Edda Russo , Maria Infantino , Francesca Nencini , Giovanni Cappelli , Stefano Dugheri , Mariangela Manfredi , Alessandra Fanelli , Amedeo Amedei , Nicola Mucci

{"title":"Comparison of ELISA with automated ECLIA for IL-6 determination in COVID-19 patients: An Italian real-life experience","authors":"Francesca Romano , Luisa Lanzilao , Edda Russo , Maria Infantino , Francesca Nencini , Giovanni Cappelli , Stefano Dugheri , Mariangela Manfredi , Alessandra Fanelli , Amedeo Amedei , Nicola Mucci","doi":"10.1016/j.plabm.2024.e00392","DOIUrl":null,"url":null,"abstract":"<div><h3>Objectives</h3><p>Coronavirus disease 2019 (COVID-19) has a wide spectrum of clinical severity. A cytokine storm is associated with COVID-19 severity. Of these, IL-6 is significantly associated with higher mortality and is also a marker for predicting disease prognosis. IL-6 may act as a target for therapeutics and, a blockade of IL-6 function by Tocilizumab has been described as a treatment of the inflammatory process COVID-19-related. This study aims to describe our experience comparing two different methods, in detail Human IL-6 Instant ELISA and the Elecsys IL-6 based on ECLIA, for the IL-6 assessment.</p></div><div><h3>Design and methods</h3><p>IL-6 levels from serum samples of 104 COVID-19 patients, admitted to the AOU Careggi (Hospital in Florence -Italy), were assessed by using the two above-mentioned methods, and the results were analysed through Passing-Bablok regression fit and Bland-Altman plot.</p></div><div><h3>Results</h3><p>The regression exhibited a linear relation between the methods with a regression equation (y = - 0.13 + 0.63 x; 95 % C.I. intercept = − 0.13 to 4.55; 95 % C.I. slope = 1.03 to 1.26 with R<sup>2</sup> = 0.89, p > 0.05), showing a positive slope. The agreement of the two methods reported a bias of −25.0 pg/mL. Thus, the two methods correlate but do not agree in terms of numeric results.</p></div><div><h3>Conclusions</h3><p>The two assays showed good comparability. However, because of the extremely wide linear range of the ECLIA, its throughput and its capacity for immune profiling, it represents an interesting emerging technology in the immunology field.</p></div>","PeriodicalId":20421,"journal":{"name":"Practical Laboratory Medicine","volume":"39 ","pages":"Article e00392"},"PeriodicalIF":1.7000,"publicationDate":"2024-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.sciencedirect.com/science/article/pii/S2352551724000386/pdfft?md5=64418fd3a8a63ef0df4c826f7a545a12&pid=1-s2.0-S2352551724000386-main.pdf","citationCount":"0","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"Practical Laboratory Medicine","FirstCategoryId":"1085","ListUrlMain":"https://www.sciencedirect.com/science/article/pii/S2352551724000386","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q3","JCRName":"MEDICAL LABORATORY TECHNOLOGY","Score":null,"Total":0}

引用次数: 0

Abstract

Objectives

Coronavirus disease 2019 (COVID-19) has a wide spectrum of clinical severity. A cytokine storm is associated with COVID-19 severity. Of these, IL-6 is significantly associated with higher mortality and is also a marker for predicting disease prognosis. IL-6 may act as a target for therapeutics and, a blockade of IL-6 function by Tocilizumab has been described as a treatment of the inflammatory process COVID-19-related. This study aims to describe our experience comparing two different methods, in detail Human IL-6 Instant ELISA and the Elecsys IL-6 based on ECLIA, for the IL-6 assessment.

Design and methods

IL-6 levels from serum samples of 104 COVID-19 patients, admitted to the AOU Careggi (Hospital in Florence -Italy), were assessed by using the two above-mentioned methods, and the results were analysed through Passing-Bablok regression fit and Bland-Altman plot.

Results

The regression exhibited a linear relation between the methods with a regression equation (y = - 0.13 + 0.63 x; 95 % C.I. intercept = − 0.13 to 4.55; 95 % C.I. slope = 1.03 to 1.26 with R² = 0.89, p > 0.05), showing a positive slope. The agreement of the two methods reported a bias of −25.0 pg/mL. Thus, the two methods correlate but do not agree in terms of numeric results.

Conclusions

The two assays showed good comparability. However, because of the extremely wide linear range of the ECLIA, its throughput and its capacity for immune profiling, it represents an interesting emerging technology in the immunology field.

查看原文本刊更多论文

比较 ELISA 和自动 ECLIA 对 COVID-19 患者 IL-6 的测定：意大利的实际经验

目标2019年冠状病毒病（COVID-19）的临床严重程度范围很广。细胞因子风暴与 COVID-19 的严重程度相关。其中，IL-6 与较高的死亡率密切相关，也是预测疾病预后的标志物。IL-6可作为治疗药物的靶点，Tocilizumab阻断IL-6的功能已被描述为治疗COVID-19相关炎症过程的一种方法。本研究旨在介绍我们比较两种不同方法评估 IL-6 的经验，分别是人类 IL-6 瞬时 ELISA 和基于 ECLIA 的 Elecsys IL-6。设计和方法使用上述两种方法评估 104 名 COVID-19 患者的血清样本中的 IL-6 水平，并通过 Passing-Bablok 回归拟合和 Bland-Altman 图分析结果。结果回归结果显示，两种方法之间呈线性关系，回归方程为（y = - 0.13 + 0.63 x; 95 % C.I. 截距 = - 0.13 至 4.55; 95 % C.I. 斜率 = 1.03 至 1.26，R2 = 0.89，p > 0.05），斜率为正。两种方法的一致性报告偏差为-25.0 pg/mL。因此，这两种方法具有相关性，但在数值结果上并不一致。不过，由于 ECLIA 的线性范围极宽、通量大且可用于免疫分析，因此它是免疫学领域一项令人感兴趣的新兴技术。

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

Practical Laboratory Medicine Health Professions-Radiological and Ultrasound Technology

CiteScore

3.50

自引率

0.00%

发文量

审稿时长

7 weeks

期刊介绍： Practical Laboratory Medicine is a high-quality, peer-reviewed, international open-access journal publishing original research, new methods and critical evaluations, case reports and short papers in the fields of clinical chemistry and laboratory medicine. The objective of the journal is to provide practical information of immediate relevance to workers in clinical laboratories. The primary scope of the journal covers clinical chemistry, hematology, molecular biology and genetics relevant to laboratory medicine, microbiology, immunology, therapeutic drug monitoring and toxicology, laboratory management and informatics. We welcome papers which describe critical evaluations of biomarkers and their role in the diagnosis and treatment of clinically significant disease, validation of commercial and in-house IVD methods, method comparisons, interference reports, the development of new reagents and reference materials, reference range studies and regulatory compliance reports. Manuscripts describing the development of new methods applicable to laboratory medicine (including point-of-care testing) are particularly encouraged, even if preliminary or small scale.