Allergy Research Group, Instituto de Investigación Biomédica de Málaga-IBIMA, 29009 Malaga, Spain.
Allergy Unit, Hospital Regional Universitario de Málaga, 29009 Malaga, Spain.
Int J Mol Sci. 2022 Jun 23;23(13):6992. doi: 10.3390/ijms23136992.
Diagnosis of type I hypersensitivity reactions (IgE-mediated reactions) to penicillins is based on clinical history, skin tests (STs), and drug provocation tests (DPTs). Among in vitro complementary tests, the fluoro-enzyme immunoassay (FEIA) ImmunoCAP (Thermo-Fisher, Waltham, MA, USA) is the most widely used commercial method for detecting drug-specific IgE (sIgE). In this study, we aimed to analyze the utility of ImmunoCAP for detecting sIgE to penicillin G (PG) and amoxicillin (AX) in patients with confirmed penicillin allergy. The study includes 139 and 250 patients evaluated in Spain and Italy, respectively. All had experienced type I hypersensitivity reactions to penicillins confirmed by positive STs. Additionally, selective or cross-reactive reactions were confirmed by DPTs in a subgroup of patients for further analysis. Positive ImmunoCAP results were 39.6% for PG and/or AX in Spanish subjects and 52.4% in Italian subjects. When only PG or AX sIgE where analyzed, the percentages were 15.1% and 30.4%, respectively, in Spanish patients; and 38.9% and 46% in Italian ones. The analysis of positive STs showed a statistically significant higher percentage of positive STs to PG determinants in Italian patients. False-positive results to PG (16%) were detected in selective AX patients with confirmed PG tolerance. Low and variable sensitivity values observed in a well-defined population with confirmed allergy diagnosis, as well as false-positive results to PG, suggest that ImmunoCAP is a diagnostic tool with relevant limitations in the evaluation of subjects with type I hypersensitivity reactions to penicillins.
诊断 I 型超敏反应（IgE 介导的反应）对青霉素类药物过敏基于临床病史、皮肤试验（ST）和药物激发试验（DPT）。在体外补充试验中，荧光酶免疫测定（FEIA）ImmunoCAP（美国 Thermo-Fisher，Waltham，MA）是检测药物特异性 IgE（sIgE）最广泛使用的商业方法。在这项研究中，我们旨在分析 ImmunoCAP 在检测确认对青霉素过敏的患者的青霉素 G（PG）和阿莫西林（AX）sIgE 的实用性。该研究包括分别在西班牙和意大利评估的 139 名和 250 名患者。所有患者均经历过 I 型超敏反应，由阳性 ST 证实对青霉素类药物过敏。此外，在患者亚组中通过 DPT 进一步确认了选择性或交叉反应性反应。西班牙患者中 PG 和/或 AX 的阳性 ImmunoCAP 结果为 39.6%，意大利患者中为 52.4%。当仅分析 PG 或 AX sIgE 时，西班牙患者的百分比分别为 15.1%和 30.4%，意大利患者的百分比分别为 38.9%和 46%。阳性 ST 分析显示，意大利患者对 PG 决定因素的阳性 ST 具有统计学意义更高的百分比。在确认 PG 耐受的选择性 AX 患者中检测到对 PG 的假阳性结果（16%）。在明确诊断为过敏的人群中，观察到敏感性值低且可变，以及对 PG 的假阳性结果，表明 ImmunoCAP 是一种具有相关限制的诊断工具，用于评估对青霉素 I 型超敏反应的患者。
