Routine KIT p.D816V screening identifies clonal mast cell disease in patients with Hymenoptera allergy regularly missed using baseline tryptase levels alone
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Background Clonal mast cell disorders and elevated basal serum tryptase (BST) levels with unknown cause(s) are associated with severe Hymenoptera venom-triggered anaphylaxis (HVA). However, some individuals with clonal disease have a normal BST level (<11.4 ng/mL).Objective Our aim was to evaluate whether screening for KIT p.D816V in the blood is a useful clinical tool to risk-stratify patients with venom allergy.Methods We prospectively recruited 374 patients with Hymenoptera allergy and no overt signs of mastocytosis who were referred to our center during the years 2018 and 2019. KIT p.D816V was determined in their peripheral blood by quantitative PCR, and tryptase genotyping was performed by droplet digital PCR.Results In all, 351 patients (93.9%) had normal levels of BST, and KIT p.D816V was detected in 8% of patients (28 of 351), predominantly in patients with the most severe Mueller grade IV anaphylaxis (18.2% [24 of 132] vs 1.8% in patients with lower grades [4 of 88 with grade III and 0 of 131 with other grades]; P < .001). In grade IV patients with a normal BST level, KIT p.D816V was associated with more severe symptoms, including a significantly higher frequency of loss of consciousness (58.3% [14 of 24] vs 34.3% [37 of 108]; P = .03) and absence of skin symptoms (41.7% [10 of 24] vs 15.7% [17 of 108]; P = .004). Among patients with a normal BST level, KIT p.D816V (OR = 10.25 [95% CI = 3.75-36.14]; P < .0001) was the major risk factor associated with severe HVA. Hereditary α-tryptasemia (HαT) due to increased germline copies of TPSAB1 encoding α-tryptase was the most common cause (65.2% [15 of 23]) of elevated BST level in patients with HVA, and together with KIT p.D816V, it accounted for 90% of BST level elevations (20 of 23) in patients with HVA.Conclusion These results indicate that routine KIT p.D816V screening identifies clonal disease in high-risk patients with HVA who are regularly missed when BST level is used alone.
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Patients with systemic mastocytosis and anaphylaxis seem to have a lower baseline serum tryptase in contrast to patients with systemic mastocytosis without anaphylaxis.
“One should be cautious that patients with SM and anaphylaxis seem to have a lower bST in contrast to patients with SM without anaphylaxis [61,62,63,64,65].”
From Diagnostic Significance of Tryptase for Suspected Mast Cell Disorders (2023) · cites this paper as [64]
In Results and Discussion (page not provided), the paper reports that one patient with normal baseline serum tryptase and four with elevated levels had severe venom anaphylaxis and met criteria for indolent systemic mastocytosis. This supports the caution that anaphylaxis can occur in systemic mastocytosis despite normal tryptase, but the paper does not compare tryptase levels with patients who have systemic mastocytosis without anaphylaxis. (LLM, conf=0.82)
Experimental — accuracy not yet measuredHαT is enriched in patients with SM, Hymenoptera-allergic patients with severe anaphylaxis, and patients with idiopathic anaphylaxis.
“HαT is enriched in patients with SM,42,43 in Hymenoptera-allergic patients with severe anaphylaxis,44,45 and in patients with idiopathic anaphylaxis.42,43,45,46”
From Mast cell activation syndrome: Current understanding and research needs (2024) · cites this paper as [44]
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Siebenhaar, F., Nojarov, N., & Pyatilova, P. (2026) · Allergo Journal · doi:10.1007/s15007-025-6622-0
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Hereditary Alpha-Tryptasemia (HαT) as a Risk Modifier for Severe Anaphylaxis
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Self-citationDiagnostics and monitoring in Hymenoptera venom allergy: current and future perspectives
Wilińska, W., Starosz, A., & Grubczak, K. (2026) · Frontiers in Allergy · doi:10.3389/falgy.2026.1757776
Teufelberger, A. R., Čerpes, U., Dan, A.-R., Bokanovic, D., Fink‐Puches, R., Mahnke, N. A., Vera, C., Wang, S.-Y. C., Pyatilova, P., Fedai, K., et al. (2026) · Journal of Investigative Dermatology · doi:10.1016/j.jid.2026.04.022
Karaaslan, Ç., Palomares, Ó., Kilic, B., Mayorga, C., Hoffmann, H., Eberlein, B., Knol, E. F., Fernández‐Santamaría, R., Vitte, J., Izquierdo, E., et al. (2026) · Clinical and Translational Allergy · doi:10.1002/clt2.70210
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Self-citationHereditary α-tryptasemia is associated with response to omalizumab in severe allergic asthma
Rijavec, M., Svetina, M., Škrgat, S., Zidarn, M., Lyons, J. J., Šelb, J., Barber, C., Vorobeva, E., Haitchi, H. M., Graham, N. J., et al. (2026) · Annals of Allergy Asthma & Immunology · doi:10.1016/j.anai.2026.10.014
Self-citation
- Authors
- Šelb, J., Rijavec, M., Eržen, R., Zidarn, M., Kopač, P., Škerget, M., Bajrović, N., Luzar, A. D., Park, Y. H., Liu, Y., Šerbec, V. Č., Zver, S., Košnik, M., Lyons, J. J., & Korošec, P.
- Affiliations
- University of Ljubljana (SI)
- University Clinic of Pulmonary and Allergic Diseases Golnik (SI)
- National Institutes of Health (US)
- Blood Transfusion Centre of Slovenia (SI)
- Corresponding author
- Korošec, Peter
- ORCID
- Venue
- Journal of Allergy and Clinical Immunology
- Publisher
- Elsevier BV
- Published
- 2021-08
- Volume
- 148
- Issue
- 2
- Pages
- 621-626.e7
- ISSN
- 0091-6749 (ISSN-L)
- PMC
- PMC10964493
- OpenAlex
- W3136573001
- Cited by
- 65
- References
- 23
- Citations by year
- 2026: 10 · 2025: 15 · 2024: 18 · 2023: 9 · 2022: 8 · 2021: 5
- FWCI
- 3.73
- Type
- journal article
- Language
- en
- Open access
- bronze
- doi.org
- Locations
- Journal of Allergy and Clinical Immunology (publishedVersion)
- PubMed (publishedVersion)
- PubMed Central (acceptedVersion)
- Funders
- National Institutes of Health
- National Institute of Allergy and Infectious Diseases
- Javna Agencija za Raziskovalno Dejavnost RS (P3-0360)
- Topics
- Life Sciences › Immunology and Microbiology › Immunology › Mast cells and histamine
- Health Sciences › Medicine › Immunology and Allergy › Food Allergy and Anaphylaxis Research
- Health Sciences › Medicine › Pharmacology › Drug-Induced Adverse Reactions
- Keywords
- hymenoptera venom allergy, serum tryptase, hereditary alpha-tryptasemia, TPSAB1, risk stratification, anaphylaxis severity, loss of consciousness, mastocytosis, KIT mutations
- MeSH terms
- Adult, Aged, Aged, 80 and over, Anaphylaxis, Arthropod Venoms, Female, Genetic Testing, Humans, Male, Mast Cells, Middle Aged, Proto-Oncogene Proteins c-kit, Amino Acid Substitution, Mutation, Missense, Mastocytosis, Systemic, Tryptases
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