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Purpose: Cefaclor, a second-generation oral cephalosporin, is known to cause IgE-mediated hypersensitivity. Assays of serumspecificIgE (sIgE) to cefaclor are commercially available via the ImmunoCAP system (Thermo Fisher Scientific). While serumlevels of sIgE >0.35 kU/L are considered indicative of an allergy, some patients with cefaclor allergy show low serum IgE levels. This study aimed to evaluate the proper cut-off levels of sIgE in the diagnosis of immediate hypersensitivity to cefaclor. Materials and Methods: A total of 269 patients with drug allergy history, who underwent assays of sIgE to cefaclor at Ajou Universityhospital and Dong-A University Hospital, were reviewed retrospectively. Among them, 193 patients exhibited cefaclor-inducedimmediate hypersensitivity with certain or probable causality of an adverse drug reaction according to the WHO-UMC (theWorld Health Organization–the Uppsala Monitoring Centre) algorithm, and 76 controls showed delayed hypersensitivity reactionsto non-antibiotics. Results: In total, 126 of the 193 patients (65.3%) experienced anaphylaxis; they had higher serum sIgE levels than patients withimmediate hypersensitivity who did not experience anaphylaxis (6.36±12.39 kU/L vs. 4.28±13.61 kU/L, p<0.001). The best cut-offvalue for cefaclor-induced immediate hypersensitivity was 0.11 kU/L, with sensitivity of 80.2% and specificity of 81.6%. A cut-offvalue of 0.44 kU/L showed the best sensitivity (75.4%) and specificity (65.7%) for differentiating anaphylaxis from immediate hypersensitivityreactions. Conclusion: Patients with cefaclor anaphylaxis exhibit high serum IgE levels. A cut-off value of 0.11 kU/L of sIgE to cefaclor isproper for identifying patients with cefaclor allergy, and 0.44 kU/L may be useful to detect anaphylaxis.

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