Clinical Criteria for the Diagnosis of Anaphylaxis in Emergency Department Patients


About this study

The goal is to assess the criterion and predictive validity of the diagnostic criteria for anaphylaxis proposed by the 2nd Symposium on the Definition and Management of Anaphylaxis. Determination of the clinical utility of the diagnostic criteria is essential for the criteria to be widely adopted into clinical practice.  Prospectively, the NIAID/FAAN criteria continued to be highly sensitive (95%) but had lower specificity (71%) than on retrospective assessment. These criteria are likely to be useful for the diagnosis of anaphylaxis in the ED.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria

  • Patients presenting to the ED with chief complaints related to:
    • Allergic reactions 
    • Medication reactions 
    • Insect/bee/wasp stings 
    • Angioedema 
    • Anaphylaxis 
  • Small sample of patients with chief complaints of:
    • Hives 
    • Shortness of breath 
    • Syncope

Exclusion Criteria

  • Patients or caregivers unable to provide a reliable history due to conditions such as altered mental status or dementia

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Ronna Campbell, M.D., Ph.D.

Closed-enrolling by invitation

What is this? (?)
Not open to everyone who meets the eligibility criteria, but only those invited to participate by the study team.

Contact information:

Ronna Campbell M.D., Ph.D.

(507) 255-5385

More information


Publications are currently not available

Mayo Clinic Footer