Söderström L, Kober A, Ahlstedt S, de Groot H, Lange C-E, Paganelli R, Roovers M H W M, Sastre J
Pharmacia Diagnostics AB, SE-751 82 Uppsala, Sweden.
Allergy. 2003 Sep;58(9):921-8. doi: 10.1034/j.1398-9995.2003.00227.x.
The evaluation and interpretation of the results from blood tests measuring specific immunoglobulin E (IgE) antibody concentration is currently made using the dichotomized result from the test despite a quantitative result is obtained. It has been shown that different levels of IgE antibodies, assessed by blood test and skin prick test, may have a relation to presence of symptoms, implying that there is more information in a quantitative result than in the dichotomous--positive or negative.
To investigate the clinical utility of quantification of IgE antibodies in the diagnosis of allergic patients and whether such procedure has any advantage to the presently dichotomously used sensitivity and specificity at a fixed cut-off.
Data from a previously published study (R. Paganelli, I.J. Ansoteugi, J. Sastre, C.-E. Lange, M.H.W.M. Roovers, H. de Groot, N.B. Lindholm, P.W. Ewan, Allergy, 1998; 53) analysing diagnosis of allergic patients in four different clinics were re-evaluated. In the original study consecutive patients with suspected IgE-mediated allergy had been examined and evaluated according to the clinical routine at each clinic, using case history, physical examination, skin tests and laboratory tests, except the test to be evaluated, and given a "doctors' allergen-specific diagnosis" as positive or negative. In the present study the relation between "doctors' allergen-specific diagnosis", expressed as pos/neg, and the quantitative levels of specific IgE antibody concentration was analysed using a logistic regression model. This presentation of results was also compared with the more common characteristics of sensitivity and specificity, and also with Receiver-operator characteristics (ROC) curves.
The used logistic model described the relationship between allergen-specific diagnosis in each study and the levels of IgE antibodies. The shape of the curve illustrated the physicians' disposition for a positive diagnose in the study, in relation to the specific IgE antibody level. Differences in the shape of the curve was found both between allergens within clinics and between clinics for the same allergen. No association could be demonstrated between prevalence and shape of the curve.
Conventional sensitivity/specificity figures or ROC concepts only use the qualitative statement of whether IgE is present or not. A risk assessment using the quantitative level of IgE antibody to an allergen increases the utility of the information in clinical context compared with a qualitative statement of whether IgE is present or not. The quantification demonstrated the link between specific IgE antibodies and allergic reactions. The use of objective, well performing quantitative tests should help improve diagnostic accuracy and might provide a way for the patient to understand and manage his or her daily situation and risk for reactions.
目前,在评估和解读测量特异性免疫球蛋白E(IgE)抗体浓度的血液检测结果时,尽管获得的是定量结果,但仍采用检测的二分法结果。研究表明,通过血液检测和皮肤点刺试验评估的不同水平的IgE抗体可能与症状的出现有关,这意味着定量结果比二分法结果(阳性或阴性)包含更多信息。
研究IgE抗体定量在过敏性患者诊断中的临床应用,以及该方法相对于目前在固定临界值下使用的二分法敏感性和特异性是否具有优势。
对之前发表的一项研究(R. Paganelli、I.J. Ansoteugi、J. Sastre、C.-E. Lange、M.H.W.M. Roovers、H. de Groot、N.B. Lindholm、P.W. Ewan,《过敏》,1998年;53卷)的数据进行了重新评估,该研究分析了四个不同诊所中过敏性患者的诊断情况。在原研究中,对连续的疑似IgE介导过敏的患者按照每个诊所的临床常规进行了检查和评估,采用病史、体格检查、皮肤试验和实验室检测(不包括待评估的检测),并给出“医生的过敏原特异性诊断”为阳性或阴性。在本研究中,使用逻辑回归模型分析了以阳性/阴性表示的“医生的过敏原特异性诊断”与特异性IgE抗体浓度定量水平之间的关系。还将这种结果呈现方式与更常见的敏感性和特异性特征以及受试者工作特征(ROC)曲线进行了比较。
所使用的逻辑模型描述了每项研究中过敏原特异性诊断与IgE抗体水平之间的关系。曲线形状说明了研究中医生对阳性诊断的倾向与特异性IgE抗体水平的关系。在诊所内的过敏原之间以及同一过敏原在不同诊所之间,曲线形状均存在差异。曲线的患病率与形状之间未显示出关联。
传统的敏感性/特异性数值或ROC概念仅使用IgE是否存在的定性表述。与IgE是否存在的定性表述相比,使用针对过敏原的IgE抗体定量水平进行风险评估可提高临床背景下信息的实用性。定量分析显示了特异性IgE抗体与过敏反应之间的联系。使用客观、性能良好的定量检测应有助于提高诊断准确性,并可能为患者提供一种了解和管理其日常情况及反应风险的方法。