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Influence of total serum IgE levels on the in vitro detection of beta-lactams-specific IgE antibodies.

机译:总血清IgE水平对体外检测β-内酰胺类特异性IgE抗体的影响。

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BACKGROUND: Allergic reactions to beta-lactams are a frequent cause of adverse drug reactions; the diagnosis is based on history, clinical examination, skin testing (prick and intradermal) and demonstration of serum-specific IgE antibodies (Abs). OBJECTIVE: We compared the diagnostic performance of the Phadia CAP system for the detection of IgE to beta-lactams carried out using the new test with cut-off limits of 0.10 kUA/L and the old test with cut-off limits of 0.35 kUA/L for positive results; subsequently, we analysed the effect of total serum IgE values and of atopic phenotype on the diagnostic performance of the tests. METHODS: The study comprised a total of 34 patients with a history of immediate adverse reactions to beta-lactams, which were confirmed by positive skin testing, and 115 control subjects with tolerance to beta-lactams over the last year. The Phadia CAP System was used for the determination of serum total and specific IgE Abs towards penicilloyl G (c1), penicilloyl V (c2), ampicilloyl (c5) and amoxicilloyl (c6). The overall diagnostic performance was assessed as a diagnostic odds ratio (DOR). RESULTS: The new test showed a higher sensitivity (85% vs. 44%) than the old test and a lower specificity (54% vs. 80%) but the overall diagnostic performance was poor (DOR 6.78 vs. 3.16, P = 0.333) in both tests. The total IgE value influences the DOR of both tests; DOR was better for values under 200 kU/L [DOR = 66; 95% confidence interval (CI): 11.3-384.1] or 500 kU/L (DOR = 45.7; 95% CI: 5.3-394.4) for the new and old tests, respectively. CONCLUSIONS: The reduction in the positive cut off value has not significantly improved the overall diagnostic performance of the beta-lactams-specific IgE assay. Because of the influence of serum total IgE on the detection of beta-lactam-specific IgE Abs, the combination of both tests is mandatory in the in vitro diagnostic approach of beta-lactam allergy.
机译:背景:对β-内酰胺类的过敏反应是药物不良反应的常见原因。诊断基于病史,临床检查,皮肤测试(点刺和皮内)和血清特异性IgE抗体(Abs)的证实。目的:我们将Phadia CAP系统对IgE的诊断性能与β-内酰胺的诊断性能进行了比较,使用新的检测限为0.10 kUA / L和旧的检测限为0.35 kUA / L L为阳性结果;随后,我们分析了血清总IgE值和特应性表型对测试诊断性能的影响。方法:该研究包括总共34名对β-内酰胺类有立即不良反应史的患者,这些患者已通过积极的皮肤试验得到证实;在过去的一年中,有115名对β-内酰胺类药物具有耐受性的对照受试者。 Phadia CAP系统用于测定针对青霉素G(c1),青霉素V(c2),氨苄基(c5)和阿莫昔洛利(c6)的血清总IgE抗体和特异性IgE Abs。总体诊断性能以诊断优势比(DOR)进行评估。结果:新测试显示出比旧测试更高的灵敏度(85%比44%)和更低的特异性(54%比80%),但总体诊断性能较差(DOR 6.78 vs. 3.16,P = 0.333 )。 IgE的总值会影响两个测试的DOR。对于200 kU / L以下的值,DOR更好[DOR = 66;对于新测试和旧测试,分别为95%置信区间(CI):11.3-384.1]或500 kU / L(DOR = 45.7; 95%CI:5.3-394.4)。结论:降低阳性截止值并不能显着改善β-内酰胺类特异性IgE检测的总体诊断性能。由于血清总IgE对β-内酰胺特异性IgE Abs的检测有影响,因此在β-内酰胺过敏的体外诊断方法中,两种测试的组合是必需的。

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