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. 2025 Nov;80(11):3217-3221.
doi: 10.1111/all.70069. Epub 2025 Sep 24.

Baseline Serum Tryptase: Sex- and Age-Specific Reference Intervals in the Pediatric and Adult Population

Yannick Chantran  1   2   3 , Hélène Novakowski  4   5 , Amandine Vial-Dupuy  6 , Christine Bouz  7 , Pol André Apoil  8 , Simone Choi  1   3 , Eric Fromentin  9 , Julien Goret  10 , Patricia Mathieu  11 , Moïse Michel  12 , Ariane Nemni  13 , Edouard Sève  14 , Céline Roda  1 , Fanny Rancière  1 , Joana Vitte  15 , Isabelle Momas  1 , Caroline Klingebiel  5 ; GTBA of the SFA
Affiliations

Baseline Serum Tryptase: Sex- and Age-Specific Reference Intervals in the Pediatric and Adult Population

Yannick Chantran et al. Allergy. 2025 Nov.
No abstract available

Keywords: age; biomarker; elderly; hereditary alpha‐tryptasemia; mast cell disorders; pediatrics; reference intervals; sex; tryptase.

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Conflict of interest statement

Y. Chantran serves on the scientific advisory board for Thermo Fisher Scientific, received honoraria from Thermo Fisher Scientific, and research grants from Blueprint Medicines and Thermo Fisher Scientific. M. Michel received honoraria from Thermo Fisher Scientific. J. Vitte reports speaker and consultancy fees in the past 5 years from Astra Zeneca, HpVac, L'Oréal, Novartis, Sanofi, Thermo Fisher Scientific, Zambon, and travel support from Stallergènes‐Greer, outside the submitted work. C. Klingebiel received honoraria from Thermo Fisher Scientific. J.G. reports speaker and travel support in the past 5 years from ALK, Stallergenes‐Greer, Thermo Fisher Scientific, and Menarini, outside the submitted work. Éric Fromentin—ALK‐Abelló, Menarini, Stallergenes Greer, Thermo Fisher, and Viatris. The other authors declare that they have no relevant conflicts of interest.

Figures

FIGURE 1
FIGURE 1
Distribution of bST values in the training cohort and determined age‐ and sex‐specific reference intervals for bST values. (A) Distribution of bST values in the training cohort (n = 21,216). Of note, 0.46% (n = 97) participants of the training cohort presented with bST values > 100 μg/L, are not displayed in the histogram, but were included in the statistical analysis. The red line represents the modelization of the distribution by the UGM95 model. (B–D) Reference intervals are depicted for a theoretical 1:1 male: Female population (B, gray), for females (C, orange), and males (D, purple). The plain bold midline represents the predicted median bST values in the reference population. The lower and upper dotted lines represent the predicted 2.5th and 97.5th percentiles of bST values in the reference population. BST, basal serum tryptase levels; UGM95, Unimodal Gaussian Model on the lowest 95th percentiles.
FIGURE 2
FIGURE 2
Proposed algorithm for the diagnostic work‐up and follow‐up of patients according to their age‐ and sex‐specific bST percentiles and the presence or absence of clinical suspicion of clonal mast cell disorder. 1Relevant clinical events might include: Cutaneous lesions evocative of mastocytosis (e.g., Urticaria Pigmentosa/maculopapular cutaneous mastocytosis); mast cell activation syndrome; severe hymenoptera venom anaphylaxis; severe idiopathic anaphylaxis; anaphylaxis with REMA score ≥ 2; early, severe, and unexplained osteopenia/osteoporosis. 2Bone marrow investigations might comprise the following: search for mast cell cluster on bone marrow biopsy; search for mast cell abnormal morphology on bone marrow biopsy or bone marrow smear; search for mast cell aberrant expression of CD2, CD25, or CD30 on bone marrow biopsy or bone marrow aspirate; search for KIT D816V or other KIT activating mutations on bone marrow aspirate. Of note, positive PB KIT D816V should trigger bone marrow investigations unless already performed. 3For instance, individuals with α‐duplications usually display bST < 30 μg/L, while some rare individuals with remarkably high α‐tryptase copy number can present with bST > 100 μg/L. 4Other explanations for mildly elevated bST might include: Overweight/obesity, chronic tobacco smoke exposure, other cardiovascular risk factors/metabolic syndrome, chronic urticaria, chronic kidney disease. Other explanations for highly elevated bST might include: Active chronic urticaria, advanced chronic kidney disease, myeloid hematological malignancy apart from clonal mast cell disorder. 5We propose that an elevation of follow‐up bST levels above +30% of baseline bST (i.e., at diagnosis) should be regarded as a significant bST increase over time. BM, bone marrow; bST, basal serum tryptase levels; cMCD, clonal mast cell disorder; PB KIT D816V, search for the KIT D816V mutation in the peripheral blood by a recommended method; REMA, Spanish Network on Mastocytosis; SM, systemic mastocytosis.
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References

    1. Valent P., Hoermann G., Bonadonna P., et al., “The Normal Range of Baseline Tryptase Should be 1 to 15 Ng/mL and Covers Healthy Individuals With HαT,” Journal of Allergy and Clinical Immunology: In Practice 11, no. 10 (2023): 3010–3020, 10.1016/j.jaip.2023.08.008. - DOI - PMC - PubMed
    1. Chovanec J., Tunc I., Hughes J., et al., “Genetically Determining Individualized Clinical Reference Ranges for the Biomarker Tryptase Can Limit Unnecessary Procedures and Unmask Myeloid Neoplasms,” Blood Advances 7, no. 9 (2022): 1796–1810, 10.1182/bloodadvances.2022007936. - DOI - PMC - PubMed
    1. Slot M. C., Claessen L. H. J., Bons J. A. P., Menheere P. P. C. A., Nieuwhof C. M. G., and de Boer D., “Tryptase Reference Ranges Are Age‐Dependent in a Large Population‐Based Cohort,” Allergy 77, no. 9 (2022): 2833–2834, 10.1111/all.15369. - DOI - PMC - PubMed
    1. Puel M., Rossignol J., Devin C., et al., “Redefining Tryptase Norms in the Pediatric Population Reveals Sex‐Based Differences: Clinical Implications,” Allergy 80, no. 1 (2024): 335–338, 10.1111/all.16365. - DOI - PMC - PubMed
    1. Francois F., Mauff B. L., Waeckel L., et al., “Basal Serum Tryptase: A Critical Reconsideration of Reference Values,” Allergy 78 (2023): 3003–3006, 10.1111/all.15790. - DOI - PubMed

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