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Defining baseline variability of serum tryptase levels improves accuracy in identifying anaphylaxis

  1. Author:
    Mateja,Allyson
    Wang, Qinlu
    Chovanec, Jack
    Kim, Jiwon
    Wilson, Kenneth J
    Schwartz, Lawrence B
    Glover, Sarah C
    Carter, Melody C
    Metcalfe, Dean D
    Brittain, Erica
    Lyons, Jonathan J

  2. Author Address

    Clinical Monitoring Research Program Directorate, Frederick National Laboratory for Cancer Research., Bioinformatics and Computational Biosciences Branch, Office of Cyber Infrastructure and Computational Biology, NIAID, NIH, Bethesda, MD., Laboratory of Allergic Diseases, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD., Division of Digestive Diseases, Department of Medicine, University of Mississippi Medical Center, Jackson, MS., Department of Internal Medicine, Division of Rheumatology, Allergy and Immunology, Virginia Commonwealth University, Richmond, VA., Division of Digestive Diseases, Department of Medicine, University of Mississippi Medical Center, Jackson, MS; Division of Gastroenterology, Department of Medicine, University of Florida, Gainesville, FL., Biostatistics Research Branch, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD., Laboratory of Allergic Diseases, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD. Electronic address: jonathan.lyons@nih.gov.,
    1. Year: 2021
    2. Date: Aug 20
    3. Epub Date: 2021 08 20
  2. Journal: The Journal of allergy and clinical immunology
  4. Type of Article: Article
  1. Abstract:

    Acute increases of =20%+2 ng/mL (20+2 rule) over basal serum tryptase (BST) is the recommended threshold supporting a clinical diagnosis of anaphylaxis. Prospective studies have demonstrated high sensitivity for this algorithm following parenteral exposures, but specificity has not been evaluated. To define a serum tryptase change that distinguishes baseline variability from anaphylaxis based upon intraindividual variation in BST. Ninety-three subjects with atopy (N=62) or HaT (N=31) and =2 BST measurements were identified. Sequential BST variability measurements was modeled and threshold ratios that optimized sensitivity and/or specificity determined. Models were tested in 22 individuals with physician-diagnosed anaphylaxis, and validated in independent cohorts of individuals with HaT (N=33), ISM (N=52), and ISM+HaT (N=12). Mature tryptase levels were measured in HaT (N=19) and ISM (N=20). An online application was developed for clinical use. Due to BST variability, 9.7% (9/93) of primary cohort patients, and 18% (6/33) of HaT, 30% (16/53) of ISM, and 25% (3/12) of ISM+HaT patients from validation cohorts met the 20+2 rule despite absent immediate hypersensitivity symptoms; mature tryptase was non-contributory among individuals with HaT or ISM at baseline. A ratio of acute tryptase/BST exceeding 1.685 provided the 'optimized' diagnostic rule for jointly maximizing sensitivity and specificity. Statistically significant improvement in specificity relative to the 20+2 rule was observed among individuals with elevated BST caused by HaT and ISM. Using a ratio of 1.685 (acute tryptase/BST) improves specificity of measured changes among individuals with HaT and ISM while maintaining high sensitivity for confirmation of anaphylaxis. Copyright © 2021. Published by Elsevier Inc.

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External Sources

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  2. DOI: 10.1016/j.jaci.2021.08.007
  3. PMID: 34425177
  4. PII : S0091-6749(21)01295-1

Library Notes

  1. Fiscal Year: FY2020-2021
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