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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.
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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]
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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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“This parameter is normal (< 20 ng ⁄ml) in most patients with cutaneous mastocytosis (CM) but is almost invariably > 20 ng ⁄ml in those with SM (a minor SM criterion) (Schwartz et al, 1987, 1995; Schwartz & Irani, 2000; Sperr et al, 2002a; Akin & Metcalfe, 2002).”
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“Serum tryptase levels are known to be elevated in patients with SM and to reflect the burden of neoplastic MCs [41,42,44].”
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“The mean level of S-tryptase was 5´1 ng/ml (range 1´2±13´5 ng/ml), which is within the reported normal value in healthy subjects (Schwartz et al, 1995).”
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“Although tryptase has been used clinically as a biomarker for disorders involving MCs such as systemic anaphylaxis and systemic mastocytosis (Schwartz et al., 1987b, 1989, 1995), its biological and pathobiologic functions are not well understood.”
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“a-Tryptase is the major circulating isoform and may be the main type expressed by basophils (18, 19).”
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“So-called total tryptase levels are elevated in subjects with systemic mastocytosis and reflect the total body burden of mast cells (10).”
BackgroundMethodInfluentialSelf-citationAssociation of Mast Cell-Derived VEGF and Proteases in Dengue Shock Syndrome
Furuta, T., Murao, L. A. E., Lan, N. T. P., Huy, N. T., Huong, V. T. Q., Thúy, T. T., Tham, V. D., Nga, C. T. P., Ha, T. T. N., Ohmoto, Y., et al. (2012) · PLoS neglected tropical diseases · doi:10.1371/journal.pntd.0001505 · Cited by 120
“Mast cell proteases are key protein components of secretory mast cell granules and are essential for innate antimicrobial inflammatory responses [27–29].”
BackgroundBrockow, K., Akin, C., Huber, M., & Metcalfe, D. D. (2003) · Journal of the American Academy of Dermatology · doi:10.1067/mjd.2003.98 · Cited by 120
Self-citationHypersensitivity to Biological Agents—Updated Diagnosis, Management, and Treatment
Galvão, V. R., & Castells, M. (2015) · The Journal of Allergy and Clinical Immunology In Practice · doi:10.1016/j.jaip.2014.12.006 · Cited by 118
Mast Cells as Key Players in Allergy and Inflammation
González‐de‐Olano, D., & Álvarez‐Twöse, I. (2018) · Journal of Investigational Allergology and Clinical Immunology · doi:10.18176/jiaci.0327 · Cited by 122
“Therefore, the high levels of total serum tryptase frequently found in patients with mastocytosis are the result of increased chronic release of α-tryptase as a consequence of an increased total MC burden [130-132].”
BackgroundBuckley, M. G., Walters, C., Wong, W., CAWLEY, M. I. D., Ren, S., Schwartz, L. B., & Walls, A. F. (1997) · Clinical Science · doi:10.1042/cs0930363 · Cited by 122
Self-citationExpression of α-tryptase and β-tryptase by human basophils
Jogie-Brahim, S., Min, H.-K., Fukuoka, Y., Xia, H.-Z., & Schwartz, L. B. (2004) · Journal of Allergy and Clinical Immunology · doi:10.1016/j.jaci.2004.02.032 · Cited by 113
Self-citationLaroche, D., Gomis, P., Gallimidi, E., Malinovsky, J., & Mertès, P. (2014) · Anesthesiology · doi:10.1097/aln.0000000000000276 · Cited by 112
Clinical utility of tryptase levels in systemic mastocytosis and associated hematologic disorders
Schwartz, L. B. (2001) · Leukemia Research · doi:10.1016/s0145-2126(01)00020-0 · Cited by 110
Self-citationCarter, M. C., Metcalfe, D. D., & Komarow, H. D. (2013) · Immunology and Allergy Clinics of North America · doi:10.1016/j.iac.2013.09.001 · Cited by 104
Self-citationUzzaman, A., Marić, I., Noël, P., Kettelhut, B. V., Metcalfe, D. D., & Carter, M. C. (2009) · Pediatric Blood & Cancer · doi:10.1002/pbc.22125 · Cited by 104
“One patient had persistent DCM, and it is known that such patients with extensive cutaneous disease may have elevated tryptase levels [17].”
BackgroundSelf-citationPardanani, A. (2013) · Blood · doi:10.1182/blood-2013-01-453183 · Cited by 101
“tryptase levels below the WHO-defined threshold of 20 ng/mL (sensitivity 80%, specificity 98%).(21,22) Further, the sensitivity of KITD816V detection in peripheral blood is”
BackgroundSperr, W. R., El‐Samahi, A., Kundi, M., Girschikofsky, M., Winkler, S., Lutz, D., Endler, G., Rumpold, H., Agis, H., Sillaber, C., et al. (2009) · European Journal of Clinical Investigation · doi:10.1111/j.1365-2362.2009.02184.x · Cited by 98
Serum Interleukin-6 Reflects Disease Severity and Osteoporosis in Mastocytosis Patients
Theoharides, T. C., Boucher, W. S., & Spear, K. (2002) · International Archives of Allergy and Immunology · doi:10.1159/000063858 · Cited by 105
“It has been reported that α-tryptase is secreted constitutively and represents the mast cell ‘burden’, while β-tryptase is secreted only during active SM [”
BackgroundKawabata, A., Nishikawa, H., Kuroda, R., Kawai, K., & Hollenberg, M. D. (2000) · British Journal of Pharmacology · doi:10.1038/sj.bjp.0703274 · Cited by 100
“…out that exposure of rats to an intestinal antigenic challenge can result in the release of mast cell proteinases into the circulation (Scudamore et al., 1995) and that elevated levels of a-tryptase can be detected in the blood of individuals with systemic mastocytosis (Schwartz et al., 1995).”
BackgroundTryptase, a novel link between allergic inflammation and fibrosis
Levi‐Schaffer, F., & Piliponsky, A. M. (2003) · Trends in Immunology · doi:10.1016/s1471-4906(03)00058-9 · Cited by 96
Paired acute‐baseline serum tryptase levels in perioperative anaphylaxis: An observational study
Vitte, J., Amadei, L., Gouitaa, M., Mezouar, S., Zieleskiewicz, L., Albanese, J., Bruder, N., Lagier, D., Mertès, P. M., Mège, J., et al. (2019) · Allergy · doi:10.1111/all.13752 · Cited by 94
“The α and β isoforms contribute to tryptase blood concentrations, at baseline as protryptases and with systemic anaphylaxis as pro‐ plus mature tryptases.(11,12) A portion of the α and β monomeric pro‐forms are secreted continuously at baseline from MC at rest.”
BackgroundSelf-citationIL-6 levels predict disease variant and extent of organ involvement in patients with mastocytosis
Brockow, K., Akin, C., Huber, M., & Metcalfe, D. D. (2005) · Clinical Immunology · doi:10.1016/j.clim.2005.01.011 · Cited by 93
Self-citationValent, P., Akin, C., Nedoszytko, B., Bonadonna, P., Hartmann, K., Niedoszytko, M., Brockow, K., Siebenhaar, F., Triggiani, M., Arock, M., et al. (2020) · International Journal of Molecular Sciences · doi:10.3390/ijms21239030 · Cited by 92
Self-citationSystemic mastocytosis presenting as profound cardiovascular collapse during anaesthesia
Vaughan, S. T. A., & Jones, G. N. (1998) · Anaesthesia · doi:10.1046/j.1365-2044.1998.00536.x · Cited by 91
Mast Cell Tryptase Deficiency Attenuates Mouse Abdominal Aortic Aneurysm Formation
Zhang, J., Sun, J., Lindholt, J. S., Sukhova, G. K., Sinnamon, M. J., Stevens, R. L., Adachi, R., Libby, P., Thompson, R. W., & Shi, G. (2011) · Circulation Research · doi:10.1161/circresaha.111.243758 · Cited by 92
Mast cell tryptase in postmortem serum—reference values and confounders
Edston, E., Eriksson, O., & van Hage, M. (2006) · International Journal of Legal Medicine · doi:10.1007/s00414-006-0101-2 · Cited by 92
“From previous studies, it is also known that in food anaphylaxis, for example, tryptase is not or only moderately elevated [4].”
BackgroundValent, P., Hartmann, K., Bonadonna, P., Gülen, T., Brockow, K., Alvarez-Twose, I., Hermine, O., Niedoszytko, M., Carter, M. C., Hoermann, G., et al. (2022) · The Journal of Allergy and Clinical Immunology: In Practice · doi:10.1016/j.jaip.2022.05.007 · Cited by 90
Self-citationSoter, N. A. (2000) · Hematology/Oncology Clinics of North America · doi:10.1016/s0889-8588(05)70295-1 · Cited by 90
Genetic deficiency of human mast cell a‐tryptase
Soto, D., Malmsten, C., Blount, J. L., Muilenburg, D. J., & Caughey, G. H. (2002) · Clinical & Experimental Allergy · doi:10.1046/j.1365-2222.2002.01416.x · Cited by 89
Huang, C. B., Li, L., Krilis, S. A., Chanasyk, K., Tang, Y., Li, Z., Hunt, J. E., & Stevens, R. L. (1999) · Journal of Biological Chemistry · doi:10.1074/jbc.274.28.19670 · Cited by 87
Tryptase Levels Are Not Increased during Vancomycin-induced Anaphylactoid Reactions
Renz, C. L., Laroche, D., Thurn, J. D., Finn, H. A., Lynch, J. P., Thisted, R. A., & Moss, J. (1998) · Anesthesiology · doi:10.1097/00000542-199809000-00010 · Cited by 87
Regulation and Function of Mast Cell Proteases in Inflammation
Huang, C. B., Šali, A., & Stevens, R. L. (1998) · Journal of Clinical Immunology · doi:10.1023/a:1020574820797 · Cited by 87
SERUM TRYPTASE AND THE LABORATORY DIAGNOSIS OF SYSTEMIC MASTOCYTOSIS
Schwartz, L. B., & Irani, A.-M. A. (2000) · Hematology/Oncology Clinics of North America · doi:10.1016/s0889-8588(05)70300-2 · Cited by 87
Self-citationThe Crystal Structure of Human α1-Tryptase Reveals a Blocked Substrate-binding Region
Marquardt, U., Zettl, F., Huber, R., Bode, W., & Sommerhoff, C. P. (2002) · Journal of Molecular Biology · doi:10.1016/s0022-2836(02)00625-3 · Cited by 85
Mayer, D. E., Krauskopf, A., Hemmer, W., Moritz, K., Jarisch, R., & Reiter, C. G. (2011) · Forensic Science International · doi:10.1016/j.forsciint.2011.05.020 · Cited by 84
Wiechers, T., Rabenhorst, A., Schick, T., Preußner, L., Förster, A., Valent, P., Horny, H., Sotlar, K., & Hartmann, K. (2015) · Journal of Allergy and Clinical Immunology · doi:10.1016/j.jaci.2015.05.034 · Cited by 84
Clinical assessment of drug-induced disease
Gruchalla, R. S. (2000) · The Lancet · doi:10.1016/s0140-6736(00)02885-3 · Cited by 84
The serum tryptase test: an emerging robust biomarker in clinical hematology
Valent, P., Sperr, W. R., Sotlar, K., Reiter, A., Akin, C., Gotlib, J., Horny, H.-P., & Arock, M. (2014) · Expert Review of Hematology · doi:10.1586/17474086.2014.955008 · Cited by 83
“The initial evaluation of tryptase as a diagnostic marker in hematology focused on mast cell disorders [41].”
InfluentialMayerhofer, M., Gleixner, K. V., Hoelbl‐Kovacic, A., Florian, S., Hoermann, G., Aichberger, K. J., Bilban, M., Esterbauer, H., Krauth, M., Sperr, W. R., et al. (2008) · The Journal of Immunology · doi:10.4049/jimmunol.180.8.5466 · Cited by 85
Anaphylactoid shock – a common cause of death in heroin addicts?
Edston, E., van Hage, M., & Edston, E. (1997) · Allergy · doi:10.1111/j.1398-9995.1997.tb01256.x · Cited by 81
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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