Journal
INTERNATIONAL JOURNAL OF MOLECULAR SCIENCES
Volume 23, Issue 13, Pages -Publisher
MDPI
DOI: 10.3390/ijms23136992
Keywords
allergy diagnosis; drug allergy; IgE; immunologic tests
Funding
- Institute of Health 'Carlos III' (ISCIII) of the Ministry of Economy and Competitiveness (MINECO)
- European Regional Development Fund [PI15/01206, PI17/01237, PI18/00095, RETICS ARADYAL RD16/0006/0001]
- Andalusian Regional Ministry of Health [PE-0172-2018, PI-0127-2020]
- ISCIII thorough AES 2019 within the ERANET-EuroNanoMed-III framework [AC19/00082]
- European Social Fund (ESF): Andalucia se mueve con Europa
- Rio Hortega contract [CM20/00210]
- ISCIII of MINECO [JR18/00054, JR21/00024]
- ESF
- Andalusian Regional Ministry Health [RC-0004-2021]
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This study analyzed the utility of ImmunoCAP (R) for detecting sIgE to penicillin G (PG) and amoxicillin (AX) in patients with confirmed penicillin allergy. The results showed limitations of ImmunoCAP (R) in evaluating individuals with type I hypersensitivity reactions to penicillins.
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 (R) (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 (R) 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 (R) 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 (R) is a diagnostic tool with relevant limitations in the evaluation of subjects with type I hypersensitivity reactions to penicillins.
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