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Published on: May 31, 2021
Prospective assessment of diagnostic tests for pediatric penicillin allergy: From clinical history to challenge tests
María Dolores Ibáñez1, Pablo Rodríguez Del Río1, Eva Maria Lasa2
1Allergy Department, Niño Jesús University Children's Hospital, Madrid, Spain; The Research Network ARADyAL RD16/0006/0026.
Insights
Penicillin allergy testing in children can be simplified. Drug provocation tests are accurate for diagnosing non-severe penicillin allergies in children, even when other tests are negative.
Area of Science:
- Pediatric Allergy and Immunology
- Clinical Diagnostics
- Pharmacovigilance
Background:
- Current penicillin allergy diagnostic guidelines for children are complex and may not be optimal.
- Existing protocols are often based on adult data, necessitating pediatric-specific research.
Purpose of the Study:
- To evaluate the diagnostic accuracy of various tools for identifying penicillin allergy in pediatric populations.
- To assess the reliability of clinical history, skin tests, and serum specific IgE (sIgE) compared to drug provocation tests (DPTs).
Main Methods:
- A prospective, multicenter study involved 732 children with reported non-severe penicillin adverse events.
- A comprehensive diagnostic protocol included clinical history, skin tests, sIgE, and DPTs for all participants.
- Amoxicillin was the primary drug used for provocation testing.
Main Results:
- Penicillin allergy was confirmed in 4.8% of children, with 83% presenting as nonimmediate reactions.
- Drug provocation tests (DPTs) confirmed allergy in 35 children, with no severe reactions observed.
- Skin tests and sIgE results were negative in 91% of children ultimately diagnosed with penicillin allergy.
Conclusions:
- Conventional allergy predictors showed limited accuracy in this pediatric cohort.
- The study supports the use of straightforward drug provocation testing in experienced centers for diagnosing non-severe penicillin allergy in children.
- This approach offers a more reliable method for pediatric penicillin allergy diagnosis.
Background:
Diagnostic guidelines for penicillin allergy in children recommend cumbersome protocols based partially on data from adults, which may be suboptimal for pediatric use.
Objective:
To assess the accuracy of tools for diagnosis of penicillin allergy in children.
Methods:
A prospective, multicenter study was conducted in children with reported adverse events related to penicillin, excluding severe reactions. All patients underwent a uniform diagnostic protocol that consisted of clinical history, skin tests, serum specific IgE (sIgE), and, regardless of these results, drug provocation tests (DPTs).
Results:
A total of 732 children (mean age, 5.5 years; 51.2% males) completed the allergy workup, including DPTs. Amoxicillin triggered 96.9% of all reactions. None of the patients with an immediate index reaction (IR) developed a reaction on DPT. Penicillin allergy was confirmed in 35 children (4.8%): 6 immediate reactions (17%) and 29 nonimmediate reactions (83%) on the DPT. No severe reactions were recorded. The allergist diagnosis based on the clinical history was not associated with the DPT final outcome. In 30 of 33 allergic patients (91%), the results of all skin tests and sIgE tests were negative. A logistic regression model identified the following to be associated with penicillin allergy: a family history of drug allergy (odds ratio [OR], 3.03; 95% confidence interval [CI], 1.33-6.89; P = .008), an IR lasting more than 3 days vs 24 hours or less (OR, 8.96; 95% CI, 2.01-39.86; P = .004), and an IR treated with corticosteroids (OR, 2.68; 95% CI, 1.30-5.54; P = .007).
Conclusion:
Conventional predictors of allergy to penicillin performed weakly. The authors propose straightforward penicillin provocation testing in controlled, experienced centers for the diagnosis of nonsevere penicillin allergy in children.
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