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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]
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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“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]
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.
In the citing paper
“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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Self-citationExpression of the Chemokine Receptor CCR3 on Human Mast Cells
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BackgroundSelf-citationRecent Advances in Mastocytosis Research
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“In this regard it is noteworthy to state that the basal tryptase level usually results from a constant release of the enzyme from MC in various tissues [42,43].”
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Self-citationMorphologic and Immunophenotypic Properties of Neoplastic Cells in a Case of Mast Cell Sarcoma
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Self-citationTryptase a Novel Biochemical Marker of Acute Myeloid Leukemia
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“Tryptase levels were measured by immunoassay, using G5 and G4 monoclonal anti-tryptase antibodies to capture mature (mainly β) and total tryptase (combination of α, and β protryptases and mature [primarily β] tryptases) respectively, as described [12].”
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“Under such conditions, total tryptase levels range from 1 to 15 ng/mL in healthy subjects, whereas patients with systemic mastocytosis typically have levels >20 ng/mL.(4) Total tryptase levels are also elevated in some patients with various refractory anemias and myelodysplastic or myeloproliferative diseases, particu…”
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Hereditary alpha-tryptasemia: a commonly inherited modifier of anaphylaxis
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“19,20 Insights into the molecular genetic roots of MC disease began emerging in 1993 with identification of the D816V-activating mutation of the kit transmembrane receptor tyrosine kinase, the extracellular portion of which is immunologically recognized as CD117.”
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“Between 1990 and 2000, important disease-related variables and indicators of CM and SM were developed and were in part validated [35–41].”
BackgroundSerum tryptase levels in acute coronary syndromes
Kervinen, H., Kaartinen, M., Mäkynen, H., Palosuo, T., Mänttäri, M., & Kovanen, P. T. (2005) · International Journal of Cardiology · doi:10.1016/j.ijcard.2004.10.023 · Cited by 37
The heterogeneity of mast cell tryptase from human lung and skin
Peng, Q., McEuen, A. R., Benyon, R. C., & Walls, A. F. (2003) · European Journal of Biochemistry · doi:10.1046/j.1432-1033.2003.03385.x · Cited by 37
Elevated Serum Tryptase in Non-Anaphylaxis Cases: A Concise Review
Lee, A. Y. S. (2020) · International Archives of Allergy and Immunology · doi:10.1159/000506199 · Cited by 36
Matito, A., Morgado, J. M., Álvarez‐Twöse, I., Sánchez‐Muñoz, L., Pedreira, C. E., Jara‐Acevedo, M., Teodósio, C., Sánchez-López, P., Fernández-Núñez, E., Moreno-Borque, R., et al. (2013) · PLoS ONE · doi:10.1371/journal.pone.0076116 · Cited by 37
“associated with the formation of enzymatically inactive tetramers [14,15], and it is constitutively released from MC into the plasma [16].”
BackgroundMast cell tryptase – Marker and maker of cardiovascular diseases
Mohajeri, M., Kovanen, P. T., Bianconi, V., Pirro, M., Cicero, A. F. G., & Sahebkar, A. (2019) · Pharmacology & Therapeutics · doi:10.1016/j.pharmthera.2019.03.008 · Cited by 36
Nedoszytko, B., Niedoszytko, M., Lange, M., van Doormaal, J., Gleń, J., Zabłotna, M., Renke, J., Vales, A., Buljubasic, F., Jassem, E., et al. (2009) · Allergy · doi:10.1111/j.1398-9995.2008.01827.x · Cited by 35
“Serum tryptase levels were higher in patients with SM compared with patients with CM, confirming the previous literature (5, 6, 32, 33).”
ResultA case of smouldering mastocytosis with peripheral blood eosinophilia and lymphadenopathy
Hauswirth, A. W., Sperr, W. R., Ghannadan, M., Schernthaner, G.-H., Jordan, J.-H., Fritsche‐Polanz, R., Simonitsch‐Klupp, I., Födinger, M., Lechner, K., & Valent, P. (2002) · Leukemia Research · doi:10.1016/s0145-2126(01)00172-2 · Cited by 35
“Other criteria of SM (SM-criteria) include histologic aspects of MC (major criteria), cytomorphological aspects, an increased serum tryptase level (>20 ng/ml), and expression of CD2 and/or CD25 on bone marrow (bm) MC [12–18].”
BackgroundMast cell activation syndrome: Importance of consensus criteria and call for research
Valent, P., Akin, C., Bonadonna, P., Hartmann, K., Broesby-Olsen, S., Brockow, K., Butterfield, J. H., Reiter, A., Gotlib, J., Castells, M., et al. (2018) · Journal of Allergy and Clinical Immunology · doi:10.1016/j.jaci.2018.06.004 · Cited by 34
Self-citationSkin manifestations of hormone-secreting tumors
Jabbour, S. A. (2010) · Dermatologic Therapy · doi:10.1111/j.1529-8019.2010.01369.x · Cited by 33
“Serum tryptase levels above 20 ng/mL are suggestive of systemic mastocytosis, whereas patients with only cutaneous mastocytosis tend to have levels below 14 ng/mL (31).”
BackgroundD’Ambrosio, C., Akin, C., Wu, Y., Magnússon, M. K., & Metcalfe, D. D. (2003) · Journal of Allergy and Clinical Immunology · doi:10.1016/j.jaci.2003.07.008 · Cited by 34
Self-citationMast Cell Activation Disorders
Giannetti, A., Filice, E., Caffarelli, C., Ricci, G., & Pession, A. (2021) · Medicina · doi:10.3390/medicina57020124 · Cited by 36
Mastocytosis: Review of Clinical and Experimental Aspects
Hartmann, K., Bruns, S. B., & Henz, B. M. (2001) · Journal of Investigative Dermatology Symposium Proceedings · doi:10.1046/j.0022-202x.2001.00029.x · Cited by 33
Comparative oncology: The paradigmatic example of canine and human mast cell neoplasms
Willmann, M., Hadzijusufovic, E., Hermine, O., Dacasto, M., Marconato, L., Bauer, K., Peter, B., Gamperl, S., Eisenwort, G., Jensen‐Jarolim, E., et al. (2018) · Veterinary and Comparative Oncology · doi:10.1111/vco.12440 · Cited by 40
“In particular, tryptase is a serine protease that is produced and stored almost exclusively in MCs and is secreted from resting MCs into plasma in a constitutive manner.(81,82) As a result, the basal serum tryptase level reflects the total body burden of MCs in healthy individuals (normal physiologic baseline: 1-15 ng…”
BackgroundLongitudinal Study of Pediatric Urticaria Pigmentosa
Heinze, A., Kuemmet, T. J., Chiu, Y. E., & Galbraith, S. S. (2017) · Pediatric Dermatology · doi:10.1111/pde.13066 · Cited by 35
Jabbour, S. A., Davidovici, B. B., & Wolf, R. (2006) · Clinics in Dermatology · doi:10.1016/j.clindermatol.2006.04.005 · Cited by 33
Cutaneous mastocytosis: A dermatological perspective
Raimondo, C. D., DUCA, E. D., Silvaggio, D., Prete, M. D., Lombardo, P., Mazzeo, M., Spallone, G., Campione, E., Botti, E., & Bianchi, L. (2020) · Australasian Journal of Dermatology · doi:10.1111/ajd.13443 · Cited by 30
“The a-protryptase is also used for the follow-up of patients with systemic mastocytosis.(36) High levels of alkaline phosphatase in patients with indolent mastocytosis can predict systemic involvement”
MethodAkin, C., Scott, L. M., & Metcalfe, D. D. (2001) · Leukemia Research · doi:10.1016/s0145-2126(01)00023-6 · Cited by 30
Self-citationNegative venom skin test results and mastocytosis
Kränke, B., Sturm, G. J., & Aberer, W. (2004) · Journal of Allergy and Clinical Immunology · doi:10.1016/j.jaci.2003.10.013 · Cited by 30
Platzgummer, S., Bizzaro, N., Bilò, M. B., Pravettoni, V., Cecchi, L., Sargentini, V., Caponi, L., Visentini, D., Brusca, I., Pesce, G., et al. (2020) · European Annals of Allergy and Clinical Immunology · doi:10.23822/eurannaci.1764-1489.133 · Cited by 32
Bystander Cells and Prognosis in Hodgkin Lymphoma
Molin, D. L. (2004) · Upsala Journal of Medical Sciences · doi:10.3109/2000-1967-084 · Cited by 29
Rohr, K. B., Selwood, T., Marquardt, U., Huber, R., Schechter, N. M., Bode, W., & Than, M. E. (2005) · Journal of Molecular Biology · doi:10.1016/j.jmb.2005.12.037 · Cited by 29
Recent advances in laboratory assays for nonhemolytic transfusion reactions
Hirayama, F. (2009) · Transfusion · doi:10.1111/j.1537-2995.2009.02388.x · Cited by 30
“The tryptase test is also useful because tryptase is the most abundant secretory granule–derived serine proteinase contained in mast cells, and elevated levels of tryptase in serum, plasma, and other biologic fluids are consistent with mast cell activation in systemic anaphylaxis and other immediate hypersensitivity a…”
BackgroundJordan, J.-H., Schernthaner, G.-H., Fritsche‐Polanz, R., Sperr, W. R., Födinger, M., Chott, A., Geissler, K. H., Lechner, K., Horny, H., & Valent, P. (2002) · Leukemia & lymphoma/Leukemia and lymphoma · doi:10.1080/10428190290012065 · Cited by 29
“Serum total tryptase (a-protryptase+b-tryptase, referred to as tryptase in this article) levels were determined by a commercial fluoroenzymeimmunoassay (FIA; from Pharmacia, Uppsala, Sweden) as described [31,32].”
BackgroundMethodTryptase, ein Marker für die Aktivierung und Lokalisation von Mastzellen
Ludolph-Hauser, D., Ruëff, F., Sommerhoff, C. P., & Przybilla, B. (1999) · Der Hautarzt · doi:10.1007/s001050050958 · Cited by 28
Divekar, R., & Butterfield, J. (2015) · Allergy · doi:10.1111/all.12668 · Cited by 27
“As currently defined, the WHO criteria to diagnose SM include tryptase elevation above 20 ng/ml, approximately twice the upper limit of normal (1, 2, 36); however, none of the other noninvasive biomarkers of mast cell function whose levels or activities have been reported to be increased in this disorder are currently…”
BackgroundEbo, D. G., De Puysseleyr, L. P., Van Gasse, A. L., Elst, J., Poorten, M.-L. V. D., Faber, M. A., Mertens, C., Van Houdt, M., Hagendorens, M. M., Sermeus, L., et al. (2021) · The Journal of Allergy and Clinical Immunology In Practice · doi:10.1016/j.jaip.2021.03.050 · Cited by 26
Identifying patients at risk of anaphylaxis
du Toit, G., Smith, P., Muraro, A., Fox, A. T., Roberts, G., Ring, J., & Worm, M. (2024) · The World Allergy Organization Journal · doi:10.1016/j.waojou.2024.100904 · Cited by 23
No long-lasting or intermittent mast cell activation in acute coronary syndromes
van Haelst, P. L., Timmer, J. R., Crijns, H. J. G. M., Kauffman, H. F., Gans, R. O. B., & van Doormaal, J. J. (2001) · International Journal of Cardiology · doi:10.1016/s0167-5273(00)00475-7 · Cited by 26
Cooper, P. J., Schwartz, L. B., Irani, A.-M. A., Awadzi, K., Guderian, R. H., & Nutman, T. B. (2002) · The Journal of Infectious Diseases · doi:10.1086/344318 · Cited by 26
“In contrast, oland possibly ^-tryptase precursors are spontaneously secreted by mast cells [16,17] and perhaps basophils.”
BackgroundSelf-citation(2023) · The Journal of Allergy and Clinical Immunology: In Practice · doi:10.1016/j.jaip.2023.07.001 · Cited by 25
“31,39 It is generally accepted that the lower limit of detection in this assay is about 1 ng/mL (some individuals have even lower or undetectable tryptase levels that is not relevant clinically).”
Self-citationImproving diagnostic accuracy of anaphylaxis in the acute care setting.
Björnsson, H. M., & Graffeo, C. S. (2010) · Europe PMC (PubMed Central) · Cited by 25
Paolino, G., Corsetti, P., Moliterni, E., Corsetti, S., Didona, D., Albanesi, M., Mattozzi, C., Lido, P., & Calvieri, S. (2019) · Giornale Italiano di Dermatologia e Venereologia · doi:10.23736/s0392-0488.17.05818-7 · Cited by 27
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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