RT Journal Article T1 Detection of Serum-Specific IgE by Fluoro-Enzyme Immunoassay for Diagnosing Type I Hypersensitivity Reactions to Penicillins. A1 Ariza, Adriana A1 Mayorga, Cristobalina A1 Bogas, Gador A1 Gaeta, Francesco A1 Salas, Maria A1 Valluzzi, Rocco L A1 Labella, Marina A1 Perez-Sanchez, Natalia A1 Caruso, Cristiano A1 Molina, Ana A1 Fernandez, Tahia D A1 Torres, Maria Jose A1 Romano, Antonino K1 IgE K1 Allergy diagnosis K1 Drug allergy K1 Immunologic tests AB 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. PB MDPI YR 2022 FD 2022-06-23 LK http://hdl.handle.net/10668/21169 UL http://hdl.handle.net/10668/21169 LA en NO Ariza A, Mayorga C, Bogas G, Gaeta F, Salas M, Valluzzi RL, et al. Detection of Serum-Specific IgE by Fluoro-Enzyme Immunoassay for Diagnosing Type I Hypersensitivity Reactions to Penicillins. Int J Mol Sci. 2022 Jun 23;23(13):6992 NO This research was funded by the Institute of Health ‘Carlos III’ (ISCIII) of the Ministry of Economy and Competitiveness (MINECO) (grants cofunded by the European Regional Development Fund: PI15/01206, PI17/01237, PI18/00095, RETICS ARADYAL RD16/0006/0001), the Andalusian Regional Ministry of Health (grants PE-0172-2018, PI-0127-2020), and the DrNanoDall project by ISCIII through AES 2019 within the ERANET-EuroNanoMed-III framework (AC19/00082). AA holds a Senior Postdoctoral Contract (RH-0099-2020) with the Andalusian Regional Ministry of Health (cofunded by the European Social Fund (ESF): “Andalucía se mueve con Europa”). ML holds a “Rio Hortega” contract (CM20/00210), GB and N.P.-S. hold “Juan Rodés” contracts (JR18/00054 and JR21/00024, respectively) with ISCIII of MINECO (cofunded by ESF), and CM holds a ‘Nicolas Monardes’ research contract with the Andalusian Regional Ministry of Health (RC-0004-2021). DS RISalud RD Apr 11, 2025