BACKGROUND The measurement of specific IgE to allergenic extracts and molecules in patients with allergic rhinitis (AR) is crucial for a precise diagnosis and further immunotherapy. Companies providing in vitro diagnostic methods in allergology continuously strive for the optimization and modernization of such methods. A new generation of automated allergy tests based on chemiluminescence detection and paramagnetic microparticles is now available, with possible advantages in sample volume, cost-effectiveness, and avoidance of sample-related interference. OBJECTIVES To test whether sIgE antibody levels obtained with a new singleplex chemiluminescent method have a good agreement with the corresponding results obtained with a "gold standard" test. METHODS We tested sera from 368 AR patients. Specific IgE sera levels (kU/L) to a comprehensive panel of 15 allergen extracts and 6 molecules were tested with ImmunoCAP® (Thermo Fisher Scientific Inc., Phadia AB, Uppsala, Sweden) and NOVEOS™ (HYCOR® Biomedical, Garden Grove, CA, USA). We evaluated the qualitative and quantitative performance of the new NOVEOS system in matching the outcome of ImmunoCAP to each of the examined allergens. RESULTS In relation to ImmunoCAP, the overall diagnostic sensitivity and specificity of sIgE tests with NOVEOS were 90.8% (95%CI=88.6-92.7) and 96.2% (95%CI=93.9-97.8), respectively. These values were higher when only molecules were considered (sensitivity=98.7% [95%CI= 96.4-99.7%]; specificity=94.2% [95%CI= 88.4-97.6%]) and lower when only extracts were considered (sensitivity=87.6% [95%CI= 84.7-90.2%]; specificity=97% [95%CI= 94.4-98.6%]). Spearman correlation between the data set of both methods for a ≥0.1 kU/l cutoff was 0.84 (p<0.001). CONCLUSIONS The new singleplex NOVEOS system presented good results for qualitative and quantitative comparisons when testing specific serum IgE antibodies against a range of 21 allergens. This novel immunoassay system using only 4 microliters of sample per test appears to be robust and reliable, and can, therefore, be used as an aid in allergy diagnosis.

中文翻译：

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在一组意大利过敏性鼻炎患者中进行新的化学发光单重 IgE 检测的验证研究

背景对过敏性鼻炎（AR）患者的过敏原提取物和分子进行特异性IgE的测量对于精确诊断和进一步的免疫治疗至关重要。提供过敏学体外诊断方法的公司不断努力实现此类方法的优化和现代化。现在可以使用基于化学发光检测和顺磁性微粒的新一代自动化过敏测试，在样品量、成本效益和避免样品相关干扰方面可能具有优势。目的测试新的单重化学发光方法获得的sIgE抗体水平是否与“金标准”测试获得的相应结果具有良好的一致性。方法 我们测试了 368 名 AR 患者的血清。使用 ImmunoCAP®（Thermo Fisher Scientific Inc.，Phadia AB，瑞典乌普萨拉）和 NOVEOS™（HYCOR® Biomedical，Garden Grove，加利福尼亚州，美国）。我们评估了新的 NOVEOS 系统在将 ImmunoCAP 的结果与每种检查的过敏原匹配方面的定性和定量性能。结果 与 ImmunoCAP 相关，使用 NOVEOS 进行 sIgE 检测的总体诊断敏感性和特异性分别为 90.8% (95%CI=88.6-92.7) 和 96.2% (95%CI=93.9-97.8)。当仅考虑分子时，这些值较高（敏感性=98.7% [95%CI= 96.4-99.7%]；特异性=94.2% [95%CI= 88.4-97.6%]）而仅考虑提取物时这些值较低（敏感性= 87.6% [95%CI= 84.7-90.2%]；特异性=97% [95%CI= 94.4-98.6%]）。对于 ≥0.1 kU/l 的截止值，两种方法的数据集之间的 Spearman 相关性为 0.84（p<0.001）。结论 在针对 21 种过敏原测试特定血清 IgE 抗体时，新的单重 NOVEOS 系统在定性和定量比较方面表现出良好的结果。这种新型免疫分析系统每次测试仅使用 4 微升样本，看起来稳健可靠，因此可用作过敏诊断的辅助工具。