β-lactams (BLCs) are the most widely used antibiotics and consequently the most common cause of drug allergy in the world. The diagnosis of drug allergy is complex and represents a serious challenge that includes a wide variety of methods. In vitro tests are based on the immunological determination of allergen-specific IgE, but the tests in the market lack the required sensitivity and specificity. In addition, the large sample volume, long incubation times, and single-plex configuration have brought their use into question to complement the clinical information. Here, we report a chemiluminescence immunoassay (CLIA) for multiparametric quantification of specific IgE to penicillin G, penicillin V, amoxicillin, and piperacillin, using histone H1 as a carrier. The developed CLIA allowed the determination of BLC-specific IgE below 0.1 IU/mL, thus allowing identification of allergic patients with better sensitivity, using only 25 μL of a sample (serum). The immunoassay was successfully applied in a cohort of 140 human serum samples, showing good sensitivity (64.6%) as well as specificity (100%), which significantly improve the predictive character of existing BLC-allergy in vitro tests.

中文翻译：

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多参数高灵敏度化学发光免疫分析法定量β-内酰胺特异性免疫球蛋白E

β-内酰胺（BLC）是使用最广泛的抗生素，因此是世界上药物过敏的最常见原因。药物过敏的诊断非常复杂，是一项严峻的挑战，其中包括多种方法。体外测试基于过敏原特异性IgE的免疫学测定，但是市场上的测试缺乏所需的敏感性和特异性。此外，大样本量，较长的孵育时间和单重配置使它们成为补充临床信息的质疑。在这里，我们报告化学发光免疫分析法（CLIA），使用组蛋白H1作为载体，对青霉素G，青霉素V，阿莫西林和哌拉西林的特异性IgE进行多参数定量。开发的CLIA可以测定低于0.1 IU / mL的BLC特异性IgE，因此，仅使用25μL的样品（血清）即可鉴定出敏感性更高的过敏患者。该免疫测定已成功应用于140份人类血清样本中，显示出良好的敏感性（64.6％）和特异性（100％），可显着改善现有BLC过敏体外试验的预测特征。