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Cited by 70Drug-Induced Adverse ReactionsFood Allergy and Anaphylaxis ResearchContact Dermatitis and Allergies

Penicillin allergy evaluation: a prospective, multicenter, open-label evaluation of a comprehensive penicillin skin test kit.

Solensky, Roland, Jacobs, Joshua, Lester, Mitchell, Lieberman, Phillip, McCafferty, Frank, Nilsson, Thomas, Park, Miguel, Schwarz, Gavin +10 more·2019·The Journal of Allergy and Clinical Immunology In Practice
DOI 10.1016/j.jaip.2019.02.040
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Abstract

Background Ten percent of the population claims an allergy to penicillin, but 90% of these individuals are not allergic. Patients labeled as penicillin-allergic have higher medical costs, longer hospital stays, are more likely to be treated with broad-spectrum antibiotics, and develop drug-resistant bacterial infections. Most penicillin skin test reagents are not approved by the Food and drug Administration or readily available to evaluate patients labeled penicillin-allergic.Objective To determine the negative predictive value (NPV) of the Penicillin Skin Test Kit containing the major allergenic determinant (penicilloyl polylysine), a minor determinant mixture (penicillin G, penicilloate, penilloate), and amoxicillin, produced according to Food and Drug Administration standards.Methods This was a prospective, multicenter, open-label investigation of penicillin skin testing using the Penicillin Skin Test Kit. Skin test-negative subjects were challenged with 250 mg amoxicillin, whereas skin test-positive patients were not challenged. The primary end point was NPV of the Penicillin Skin Test Kit, defined as the percentage of subjects with negative skin test results who did not experience an IgE-dependent reaction within 72 hours of amoxicillin challenge.Results In total, 455 patients with a history of penicillin allergy underwent skin testing and 63 (13.8%) had 1 or more positive test results; 65% of the positive test results were to the minor determinant mixture and/or amoxicillin alone. In the per protocol group of 373 skin test-negative subjects, 8 developed potential IgE-dependent reactions following oral amoxicillin challenge, translating to an NPV of 97.9% (95% CI, 95.8-99.1; P < .0001). All but 1 of the reactions was mild or moderate, and most subjects who required treatment received only antihistamines.Conclusions The Penicillin Skin Test Kit, containing all relevant penicillin allergenic determinants, demonstrated very high NPV. Removal of a penicillin allergy label in a large majority of currently mislabeled patients has substantial personal and public health implications.

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Crossref · 10.1016/j.jaip.2019.02.040

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  • A revised version of the penicillin skin test kit has been evaluated among 455 patients with previous allergy history and has a negative predictive value of 98%.

    “This penicillin skin test kit has been evaluated among 455 patients (677) with previous allergy history and has a negative predictive value of 98%.”

    From Sexually Transmitted Infections Treatment Guidelines, 2021 (2021) · cites this paper as [677]

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Authors
Solensky, R., Jacobs, J., Lester, M., Lieberman, P., McCafferty, F., Nilsson, T., Park, M., Schwarz, G., Soong, W., Wagelie-Steffen, A., Wedner, H. J., Weiss, M., Windom, H., Tonascia, J., Yates, K. P., Mendelson, L. M., Wolfe, J., & Adkinson, N. F.
Affiliations
  • Oregon State University (US)
  • University of Tennessee Health Science Center (US)
  • Allergy Clinic of Tulsa (US)
  • Mayo Clinic (US)
  • University of Arizona (US)
  • Washington University in St. Louis (US)
  • University of Washington (US)
  • University of South Florida (US)
  • Johns Hopkins University (US)
  • University of Connecticut (US)
  • Santa Clara Valley Medical Center (US)
Corresponding author
Solensky, Roland
ORCID
Venue
The Journal of Allergy and Clinical Immunology In Practice
Publisher
Elsevier BV
Published
2019-07
Volume
7
Issue
6
Pages
1876-1885.e3
ISSN
2213-2198 (ISSN-L)
DOI
10.1016/j.jaip.2019.02.040
OpenAlex
W2921369182
Cited by
70
References
50
Citations by year
2026: 4 · 2025: 6 · 2024: 7 · 2023: 8 · 2022: 14 · 2021: 11 · 2020: 10 · 2019: 10
FWCI
7.01
Type
journal article
Language
en
Open access
closed
Licence
Locations
  • The Journal of Allergy and Clinical Immunology In Practice (publishedVersion)
  • PubMed (publishedVersion)
Funders
  • Sanofi Genzyme
  • Sanofi
  • North Carolina GlaxoSmithKline Foundation
  • Pfizer
  • AbbVie
  • AstraZeneca
  • Shire
  • Regeneron Pharmaceuticals
  • Novartis
  • Genentech
Topics
  • Health Sciences › Medicine › Pharmacology › Drug-Induced Adverse Reactions
  • Health Sciences › Medicine › Immunology and Allergy › Food Allergy and Anaphylaxis Research
  • Health Sciences › Medicine › Dermatology › Contact Dermatitis and Allergies
Keywords
penicillin allergy, penicillin skin testing, negative predictive value, drug allergy labeling
MeSH terms
Adolescent, Adult, Aged, Aged, 80 and over, Anti-Bacterial Agents, Drug Hypersensitivity, Female, Humans, Male, Middle Aged, Penicillins, Predictive Value of Tests, Skin Tests, Young Adult

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