{"title":"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","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":"{\"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}","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}
Comparison of ELISA with automated ECLIA for IL-6 determination in COVID-19 patients: An Italian real-life experience
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.
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.
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