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The alpha form of human tryptase is the predominant type present in blood at baseline in normal subjects and is elevated in those with systemic mastocytosis.
Open accessAbstract
Tryptase, a protease produced by all mast cells, was evaluated as a clinical marker of systemic mastocytosis. Two sandwich immunoassays were evaluated, one which used the mAb G5 for capture, the other which used B12 for capture. The B12 capture assay measured both recombinant alpha- and beta-tryptase, whereas the G5 capture assay measured primarily recombinant beta-tryptase. G5 binds with low affinity to both recombinant alpha-tryptase and tryptase in blood from normal and nonacute mastocytosis subjects, and binds with high affinity to recombinant beta-tryptase, tryptase in serum during anaphylaxis, and tryptase stored in mast cell secretory granules. B12 recognizes all of these forms of tryptase with high affinity. As reported previously, during systemic anaphylaxis in patients without known mastocytosis, the ratio of B12- to G5-measured tryptase was always < 5 and approached unity (Schwartz L.B., T.R. Bradford, C. Rouse, A.-M. Irani, G. Rasp, J.K. Van der Zwan and P.-W.G. Van der Linden, J. Clin. Immunol. 14:190-204). In this report, most mastocytosis patients with systemic disease have B12-measured tryptase levels that are elevated (> 20 ng/ml) and are at least 10-fold greater than the corresponding G5-measured tryptase level. Most of those subjects with B12-measured tryptase levels of < 20 ng/ml had only cutaneous manifestations. The B12 assay for alpha-tryptase and beta-tryptase, particularly when performed in conjunction with the G5 assay for beta-tryptase, provides a more precise measure of mast cell involvement than currently available assessments, a promising potential screening test for systemic mastocytosis and may provide an improved means to follow disease progression and response to therapy.
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“the most specific and reliable marker of systemic MC activation is an acute and substantial event-related (transient) increase in the serum tryptase level over the individual’s baseline value.”
From Why the 20% + 2 Tryptase Formula Is a Diagnostic Gold Standard for Severe Systemic Mast Cell Activation and Mast Cell Activation Syndrome (2019) · cites this paper as [12]
Experimental — accuracy not yet measuredThe source backs part of the claim, not all of it — or backs it for a different population, condition or comparison.
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“although it was clear that tryptase is the biomarker of choice to define anaphylaxis and thus MCAS based on previous literature data and experience in specialized centers [12–18], a diagnostic threshold was missing.”
From Why the 20% + 2 Tryptase Formula Is a Diagnostic Gold Standard for Severe Systemic Mast Cell Activation and Mast Cell Activation Syndrome (2019) · cites this paper as [12]
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“tryptase has been repeatedly described as the most specific and reliable biomarker of severe systemic MC activation in daily practice [12–18].”
From Why the 20% + 2 Tryptase Formula Is a Diagnostic Gold Standard for Severe Systemic Mast Cell Activation and Mast Cell Activation Syndrome (2019) · cites this paper as [12]
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“during and shortly after a severe anaphylactic event where MC release large amounts of tryptase, the serum tryptase level increases substantially over the individual’s baseline (Fig. 1) [12–17].”
From Why the 20% + 2 Tryptase Formula Is a Diagnostic Gold Standard for Severe Systemic Mast Cell Activation and Mast Cell Activation Syndrome (2019) · cites this paper as [12]
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“On the other hand, b-tryptase is believed to be the predominant form during systemic anaphylaxis [16].”
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“Furthermore, there is no evidence of increased circulating alpha tryptase levels in CIU, an indicator of total body mast cell number [ 35 ], nor evidence of the increased presence of stem cell factor in the serum of CIU subjects [36].”
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“These data confirmed previous studies that have shown that a substantial increase in tryptase is a reliable parameter to document MC activation during anaphylactic episodes in patients with SM [23 • , 24, 26].”
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“In selected cases, the tryptase ELISA B12 immunoassay for α-tryptase and β-tryptase performed in conjunction with a biotin-G5 immunoassay for β-tryptase, provides a precise measure of mast cell involvement [61].”
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“Tryptase is a well-established and important disease-related marker that should be determined in patients with suspected mastocytosis [21,22].”
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“Mast cell leukaemia, however is often associated with significant elevations in tryptase [14].”
Diffuse Cutaneous Mastocytosis with Bullous Lesions and Pulmonary Involvement: A Rare Case
Dhar, S., Maji, B., Sk, R., & Dhar, S. (2015) · Indian Journal of Dermatology · doi:10.4103/0019-5154.152522 · Cited by 5
Urticaria pigmentosa and systemic mastocytosis
Keow, J. Y., Chin-Yee, B. H., Hsia, C. C., & Robertson, K. (2023) · Clinical Case Reports · doi:10.1002/ccr3.8302 · Cited by 5
“19,20 Persistent elevations above 20 ng/mL are suggestive for systemic mastocytosis and may prompt further investigations, such as bone scintigraphy and a bone marrow biopsy, as was done with this patient.”
BackgroundMastocytose systémique du nourrisson : à propos d’un cas avec atteinte respiratoire et digestive
Chemli, J., Krid, S., Tfefha, A., Abroug, S., & Harbi, A. (2003) · Archives de Pédiatrie · doi:10.1016/s0929-693x(03)00458-5 · Cited by 5
Diagnosis and Treatment of Anaphylaxis in Patients with Mastocytosis
Valent, P., Akin, C., & Arock, M. (2014) · Current Treatment Options in Allergy · doi:10.1007/s40521-014-0021-1 · Cited by 5
“The basal serum tryptase level is usually elevated (920 ng/mL) [3–6, 16–18].”
BackgroundThe roles of mast cells in allergic inflammation and mast cell-related disorders
Kim, H.-K. (2017) · Allergy Asthma & Respiratory Disease · doi:10.4168/aard.2017.5.5.248 · Cited by 5
Álvarez‐Twöse, I., & Carter, M. C. (2019) · Springer eBooks · doi:10.1007/978-3-030-27820-5_6 · Cited by 5
Lawson, C., Walker, C., Awford, J., Biffen, M., Mallinder, P. R., & Jackson, A. M. (2002) · Protein Expression and Purification · doi:10.1016/s1046-5928(02)00007-4 · Cited by 5
Utility of biomarkers in the postmortem diagnosis of fatal Anaphylaxis: A scoping review
Karthikeyan, B., James, R. I., Daniel, J., Senthil Kumar, R., Varughese, B. T., Manoj, D., Arakkal, A. L., & Johnson, L. R. (2025) · Legal Medicine · doi:10.1016/j.legalmed.2025.102610 · Cited by 5
Utility of tryptase genotyping in the screening, diagnosis, and management of systemic mastocytosis
McMurray, J. C., Schornack, B. J., Villar, J., George, T. I., & Boggs, N. A. (2025) · Frontiers in Allergy · doi:10.3389/falgy.2025.1599358 · Cited by 4
Gotlib, J. R., Horny, H., & Valent, P. (2017) · Elsevier eBooks · doi:10.1016/b978-0-323-35762-3.00072-x · Cited by 4
Mast Cell Activation Disorders
(2014) · The Journal of Allergy and Clinical Immunology In Practice · doi:10.1016/j.jaip.2014.03.008 · Cited by 5
Awan, S. F., Schwartz, L. B., Marić, I., Metcalfe, D. D., & Carter, M. C. (2022) · Annals of Allergy Asthma & Immunology · doi:10.1016/j.anai.2022.04.030 · Cited by 4
Self-citationRymut, S. M., Henderson, L. M., Poon, V., Staton, T. L., Cai, F., Sukumaran, S., Rhee, H. H., Owen, R., Ramanujan, S., & Yoshida, K. J. (2023) · Clinical and Translational Science · doi:10.1111/cts.13483 · Cited by 4
The mast cells - Cytokines axis in Autism Spectrum Disorder
Kovacheva, E., Gevezova, M., Maes, M. H. J., & Sarafian, V. S. (2024) · Neuropharmacology · doi:10.1016/j.neuropharm.2024.109890 · Cited by 5
Expression of a-tryptase and b-tryptase by human basophils
Jogie‐Brahim, S., Min, H., Fukuoka, Y., & Schwartz, L. B. (2004) · Cited by 4
Self-citationExploration biologique de l'hypersensibilité immédiate
Roumier, A.-S., & Marin, V. (2002) · Revue Française des Laboratoires · doi:10.1016/s0338-9898(02)80183-4 · Cited by 4
Tryptase inhibitors: a novel class of anti-inflammatory drugs
Numerof, R. P., Simpson, P. J., & Tanaka, R. D. (1997) · Expert Opinion on Investigational Drugs · doi:10.1517/13543784.6.7.811 · Cited by 4
Diagnose der gewaltsamen Erstickung
Gutjahr, E., & Madea, B. (2020) · Rechtsmedizin · doi:10.1007/s00194-020-00380-6 · Cited by 4
Human and Mouse Mast Cell Tryptases
Stevens, R. L. (2000) · Elsevier eBooks · doi:10.1016/b978-012473335-0/50018-0 · Cited by 4
Horny, H. (2010) · Encyclopedia of Life Sciences · doi:10.1002/9780470015902.a0002175.pub2 · Cited by 4
Classification and Response Criteria in Mast Cell Disorders: Time to Revise?
Valent, P., & Horny, H. (2011) · International Archives of Allergy and Immunology · doi:10.1159/000320381 · Cited by 3
Horny, H., Sotlar, K., & Valent, P. (2011) · Elsevier eBooks · doi:10.1016/b978-0-7216-0040-6.00048-4 · Cited by 3
Cutaneous Tumors and Tumor Syndromes
Paller, A. S., & Mancini, A. J. (2011) · Elsevier eBooks · doi:10.1016/b978-1-4377-0412-9.00009-5 · Cited by 3
Sabbah, A., Drouet, M., & Guittot, M. (1998) · Immuno-analyse & Biologie Spécialisée · doi:10.1016/s0923-2532(98)80027-6 · Cited by 3
Irani, A.-M. A., & Schwartz, L. B. (2009) · CRC Press eBooks · doi:10.3109/9781420077995-10 · Cited by 3
Self-citationRuëff, F., Mastnik, S., & Oppel, E. M. (2017) · Allergo Journal · doi:10.1007/s15007-017-1354-4 · Cited by 2
Raccomandazioni sull'uso della triptasi nella diagnosi dell'anafilassi e della mastocitosi
Platzgummer, S., Caponi, L., Sargentini, V., Visentini, D., Brusca, I., Bizzaro, N., Pesce, G., Bagnasco, M., Deleonardi, G., Caruso, B., et al. (2019) · La Rivista Italiana della Medicina di Laboratorio - Italian Journal of Laboratory Medicine · doi:10.23736/s1825-859x.19.00022-7 · Cited by 2
Forensic Investigation in Anaphylactic Deaths
Trani, N., Reggiani, L., Gualandri, G., Barbolini, G., & Trani, M. (2011) · InTech eBooks · doi:10.5772/23491 · Cited by 2
Apnea as a manifestation of mast cell activation in an infant with mastocytosis
Arnaout, R., Schwartz, L. B., & IRANI, A. (1997) · Journal of Allergy and Clinical Immunology · doi:10.1016/s0091-6749(97)70285-9 · Cited by 2
Self-citationVEGF Is Involved in the Increase of Dermal Microvascular Permeability Induced by Tryptase
Bai, Q., Li, X., Wang, X., Xu, Y., Wang, L., Zhang, Q., & Yin, L. (2012) · ISRN Dermatology · doi:10.5402/2012/941465 · Cited by 2
cDNA cloning and substrate specificity of equine tryptase, a possible mediator in equine heaves
DACRE, K., McAleese, S. M., Knight, P. A., McGorum, B. C., & Pemberton, A. D. (2006) · Clinical & Experimental Allergy · doi:10.1111/j.1365-2222.2006.02571.x · Cited by 2
Metadata
- Authors
- Schwartz, L. B., Sakai, K., Bradford, T. R., Ren, S., Zweiman, B., Worobec, A. S., & Metcalfe, D. D.
- Affiliations
- Virginia Commonwealth University (US)
- National Institutes of Health (US)
- Venue
- Journal of Clinical Investigation
- Published
- 1995-12-01
- Volume
- 96
- Issue
- 6
- Pages
- 2702-2710
- ISSN
- 0021-9738 (ISSN-L)
- PMC
- PMC185977
- OpenAlex
- W2107108810
- Cited by
- 371
- References
- 26
- Citations by year
- 2026: 2 · 2025: 4 · 2024: 7 · 2023: 4 · 2022: 3 · 2021: 8 · 2020: 8 · 2019: 13 · 2018: 8 · 2017: 10 · 2016: 8 · 2015: 9 · 2014: 16 · 2013: 11 · 2012: 10
- FWCI
- 4.15
- Type
- journal article
- Language
- en
- Open access
- bronze
- doi.org
- Locations
- Journal of Clinical Investigation (publishedVersion)
- PubMed Central (publishedVersion)
- PubMed (publishedVersion)
- Funders
- National Institutes of Health (5r01ai014332-21)
- National Institute of Allergy and Infectious Diseases (AI-14332, AI20487, AI-27517, R01AI027517)
- 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 › Hematology › Platelet Disorders and Treatments
- Keywords
- tryptase, beta-tryptase, systemic mastocytosis, mast cells, serum tryptase, anaphylaxis, sandwich immunoassay, diagnostic biomarkers, cutaneous mastocytosis, disease progression monitoring
- MeSH terms
- Acute Disease, Anaphylaxis, Animals, Antibodies, Monoclonal, Electrophoresis, Polyacrylamide Gel, Humans, Isoenzymes, Kinetics, Mast Cells, Mastocytosis, Recombinant Proteins, Reference Values, Serine Endopeptidases, Blotting, Western, Biomarkers, Mice, Tryptases, Chymases
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