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Detection of Serum-Specific IgE by Fluoro-Enzyme Immunoassay for Diagnosing Type I Hypersensitivity Reactions to Penicillins Ariza Veguillas, Adriana Mayorga Mayorga, Cristobalina Bogas Herrera, Gádor Gaeta, Francesco Salas, María Valluzzi, Rocco Luigi Labella, Marina Pérez-Sánchez, Natalia Isabel Caruso, Cristiano Molina, Ana Fernández-Duarte, Tahía Diana Torres-Jaén, María Josefa Romano, Antonino Alergia-Diagnóstico 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 2022-06-29T11:24:43Z 2022-06-29T11:24:43Z 2022-06-23 journal article Ariza A, Mayorga C, Bogas G, Gaeta F, Salas M, Valluzzi RL, Labella M, Pérez-Sánchez N, Caruso C, Molina A, Fernández TD, Torres MJ, Romano A. Detection of Serum-Specific IgE by Fluoro-Enzyme Immunoassay for Diagnosing Type I Hypersensitivity Reactions to Penicillins. International Journal of Molecular Sciences. 2022; 23(13):6992. https://doi.org/10.3390/ijms23136992 https://hdl.handle.net/10630/24521 https://doi.org/10.3390/ijms23136992 eng http://creativecommons.org/licenses/by/4.0/ open access Atribución 4.0 Internacional IOAP-MPDI