{"title":"Next-generation reference interval for total IgE in the United States: A retrospective real-world analysis","authors":"","doi":"10.1016/j.cca.2024.119895","DOIUrl":null,"url":null,"abstract":"<div><h3>Objective</h3><p>To establish a next-generation reference interval (RI) for total IgE (tIgE) and evaluate its usefulness.</p></div><div><h3>Methods</h3><p>A new allergen-specific IgE (sIgE)-based tIgE RI, including a continuous RI in children, was established using the NHANES 2005–2006 project. The usefulness of the RI was evaluated by sensitivity (Sen), specificity (Spec), positive predictive value (PPV), negative predictive value (NPV), κ coefficient and consistency.</p></div><div><h3>Results</h3><p>The new tIgE RI showed better performance in identifying allergic sensitization (Sen 0.53, Spec 0.90, PPV 0.83, NPV 0.68, κ 0.44, consistency 0.72) than allergic diseases (Sen 0.37, Spec 0.75, PPV 0.55, NPV 0.60, κ 0.13, consistency 0.59). The 2014 U.S. tIgE RI was more effective in identifying allergic diseases (consistency 0.63 vs. 0.54, <em>P</em><0.001) but less accurate in identifying allergic sensitization (consistency 0.59 vs. 0.67, <em>P</em><0.001) in children than in adults. The new RI improved the accuracy of identifying allergic sensitization in children to a level similar to that in adults (consistency 0.72 vs 0.73, <em>P</em>=0.37) and maintained its advantage in identifying allergic diseases in children (consistency 0.64 vs 0.55, <em>P</em><0.001).</p></div><div><h3>Conclusions</h3><p>The established next-generation tIgE RI is useful for identifying allergic sensitization, especially in children.</p></div>","PeriodicalId":10205,"journal":{"name":"Clinica Chimica Acta","volume":null,"pages":null},"PeriodicalIF":3.2000,"publicationDate":"2024-07-27","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"Clinica Chimica Acta","FirstCategoryId":"3","ListUrlMain":"https://www.sciencedirect.com/science/article/pii/S000989812402148X","RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q2","JCRName":"MEDICAL LABORATORY TECHNOLOGY","Score":null,"Total":0}
引用次数: 0
Abstract
Objective
To establish a next-generation reference interval (RI) for total IgE (tIgE) and evaluate its usefulness.
Methods
A new allergen-specific IgE (sIgE)-based tIgE RI, including a continuous RI in children, was established using the NHANES 2005–2006 project. The usefulness of the RI was evaluated by sensitivity (Sen), specificity (Spec), positive predictive value (PPV), negative predictive value (NPV), κ coefficient and consistency.
Results
The new tIgE RI showed better performance in identifying allergic sensitization (Sen 0.53, Spec 0.90, PPV 0.83, NPV 0.68, κ 0.44, consistency 0.72) than allergic diseases (Sen 0.37, Spec 0.75, PPV 0.55, NPV 0.60, κ 0.13, consistency 0.59). The 2014 U.S. tIgE RI was more effective in identifying allergic diseases (consistency 0.63 vs. 0.54, P<0.001) but less accurate in identifying allergic sensitization (consistency 0.59 vs. 0.67, P<0.001) in children than in adults. The new RI improved the accuracy of identifying allergic sensitization in children to a level similar to that in adults (consistency 0.72 vs 0.73, P=0.37) and maintained its advantage in identifying allergic diseases in children (consistency 0.64 vs 0.55, P<0.001).
Conclusions
The established next-generation tIgE RI is useful for identifying allergic sensitization, especially in children.
目的建立下一代总 IgE（tIgE）参考区间（RI）并评估其实用性：方法：利用 NHANES 2005-2006 年项目建立了基于过敏原特异性 IgE (sIgE) 的新 tIgE 参考区间，包括儿童的连续参考区间。通过灵敏度（Sen）、特异性（Spec）、阳性预测值（PPV）、阴性预测值（NPV）、κ系数和一致性来评估 RI 的实用性：新的 tIgE RI 在鉴别过敏致敏（Sen 0.53、Spec 0.90、PPV 0.83、NPV 0.68、κ 0.44、一致性 0.72）方面的表现优于过敏性疾病（Sen 0.37、Spec 0.75、PPV 0.55、NPV 0.60、κ 0.13、一致性 0.59）。2014 年美国 tIgE RI 在鉴别过敏性疾病方面更为有效（一致性为 0.63 vs. 0.54，PConclusions：已建立的新一代 tIgE RI 可用于鉴别过敏性疾病，尤其是儿童过敏性疾病。
期刊介绍：
The Official Journal of the International Federation of Clinical Chemistry and Laboratory Medicine (IFCC)
Clinica Chimica Acta is a high-quality journal which publishes original Research Communications in the field of clinical chemistry and laboratory medicine, defined as the diagnostic application of chemistry, biochemistry, immunochemistry, biochemical aspects of hematology, toxicology, and molecular biology to the study of human disease in body fluids and cells.
The objective of the journal is to publish novel information leading to a better understanding of biological mechanisms of human diseases, their prevention, diagnosis, and patient management. Reports of an applied clinical character are also welcome. Papers concerned with normal metabolic processes or with constituents of normal cells or body fluids, such as reports of experimental or clinical studies in animals, are only considered when they are clearly and directly relevant to human disease. Evaluation of commercial products have a low priority for publication, unless they are novel or represent a technological breakthrough. Studies dealing with effects of drugs and natural products and studies dealing with the redox status in various diseases are not within the journal''s scope. Development and evaluation of novel analytical methodologies where applicable to diagnostic clinical chemistry and laboratory medicine, including point-of-care testing, and topics on laboratory management and informatics will also be considered. Studies focused on emerging diagnostic technologies and (big) data analysis procedures including digitalization, mobile Health, and artificial Intelligence applied to Laboratory Medicine are also of interest.
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