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Definitions, Criteria and Global Classification of Mast Cell Disorders with Special Reference to Mast Cell Activation Syndromes: A Consensus Proposal
Open accessAbstract
Activation of tissue mast cells (MCs) and their abnormal growth and accumulation in various organs are typically found in primary MC disorders also referred to as mastocytosis. However, increasing numbers of patients are now being informed that their clinical findings are due to MC activation (MCA) that is neither associated with mastocytosis nor with a defined allergic or inflammatory reaction. In other patients with MCA, MCs appear to be clonal cells, but criteria for diagnosing mastocytosis are not met. A working conference was organized in 2010 with the aim to define criteria for diagnosing MCA and related disorders, and to propose a global unifying classification of all MC disorders and pathologic MC reactions. This classification includes three types of ‘MCA syndromes’ (MCASs), namely primary MCAS, secondary MCAS and idiopathic MCAS. MCA is now defined by robust and generally applicable criteria, including (1) typical clinical symptoms, (2) a substantial transient increase in serum total tryptase level or an increase in other MC-derived mediators, such as histamine or prostaglandin D 2, or their urinary metabolites, and (3) a response of clinical symptoms to agents that attenuate the production or activities of MC mediators. These criteria should assist in the identification and diagnosis of patients with MCAS, and in avoiding misdiagnoses or overinterpretation of clinical symptoms in daily practice. Moreover, the MCAS concept should stimulate research in order to identify and exploit new molecular mechanisms and therapeutic targets.
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“Severe, episodic, and recurrent symptoms induced by MC mediators with concurrent involvement of at least two organ systems are required to meet the clinical consensus criterion of MCAS.”
From Selecting the Right Criteria and Proper Classification to Diagnose Mast Cell Activation Syndromes: A Critical Review (2021) · cites this paper as [28]
Checked by a reasoning model — may be wrong.
Experimental — accuracy not yet measuredThe cited source doesn’t support the claim as written.
In the citing paper
“According to the consensus criteria for the diagnosis of MCAS, sAT should be greater than sBT -1.2 þ 2 ng/mL to con fi rm the presence of MCAS.”
From Selecting the Right Criteria and Proper Classification to Diagnose Mast Cell Activation Syndromes: A Critical Review (2021) · cites this paper as [28]
Checked by a reasoning model — may be wrong.
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
“a documented clinically meaningful response to drugs that either target MC-derived mediators (e.g., H1 antihistamines or antileukotrienes) and/or suppress MC activation (e.g., cromoglycate, ketotifen, or omalizumab) [19, 21, 22].”
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 [19]
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
“documented recurrent episodic occurrence of typical systemic symptoms that are produced by MC mediators and involve at least 2 organ systems”
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 [19]
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
“Well-recognized symptoms of systemic MCA include, among others, acute urticaria, flushing, abdominal cramping, diarrhea, hypotensive syncope or near syncope and tachycardia (Table 3) (1-3,26-28,31).”
From Proposed Diagnostic Algorithm for Patients with Suspected Mast Cell Activation Syndrome (2019) · cites this paper as [27]
Experimental — accuracy not yet measured
The source backs part of the claim, not all of it — or backs it for a different population, condition or comparison.
In the citing paper
“severe MCA fulfilling MCAS consensus criteria is almost always associated with the occurrence of acute severe recurrent symptoms affecting more than one organ or tissue, often with severe hypotension and anaphylaxis (26-28).”
From Proposed Diagnostic Algorithm for Patients with Suspected Mast Cell Activation Syndrome (2019) · cites this paper as [27]
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
“The likelihood of MCA increases when two or more of such symptoms are documented, and the likelihood is even higher when the symptoms respond to agents blocking mediator effects, mediator production or mediator secretion.”
From Proposed Diagnostic Algorithm for Patients with Suspected Mast Cell Activation Syndrome (2019) · cites this paper as [27]
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
“Based on the underlying condition, patients with MCAS should then be further classified into i) primary MCAS where KIT-mutated, clonal (CD25+) MC are detected (with or without an underlying diagnosis of mastocytosis), ii) secondary MCAS where an underlying non-neoplastic disease, usually an IgE-dependent allergy or other hypersensitivity reaction is detected, and iii) idiopathic MCAS, where no KIT”
From Proposed Diagnostic Algorithm for Patients with Suspected Mast Cell Activation Syndrome (2019) · cites this paper as [27]
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
“The consensus group has recommended that in cases with mastocytosis (irrespective of the variant) any form of MCA requiring continuous mediator-targeted therapy should be marked by the diagnostic label ‘SY’”
From Proposed Diagnostic Algorithm for Patients with Suspected Mast Cell Activation Syndrome (2019) · cites this paper as [27]
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
“If an IgE-dependent allergy or other underlying reactive disease (e.g., IgE-dependent or other hypersensitivity disorder) is present in the absence of clonal MC, the diagnosis is secondary MCAS (Table 2, Figure 2).”
From Proposed Diagnostic Algorithm for Patients with Suspected Mast Cell Activation Syndrome (2019) · cites this paper as [27]
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
“Serum tryptase levels serve as the most speci fi c marker and gold standard for measuring the MC burden (sBT) as well as MCA and thus MCAS (sAT over sBT).”
From Selecting the Right Criteria and Proper Classification to Diagnose Mast Cell Activation Syndromes: A Critical Review (2021) · cites this paper as [28]
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
“Another required criterion of MCAS is a documented therapeutic response to speci fi c drugs that target MC-derived mediators or mediator effects and/or suppress MCA”
From Selecting the Right Criteria and Proper Classification to Diagnose Mast Cell Activation Syndromes: A Critical Review (2021) · cites this paper as [28]
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
“The 2012 proposal for mast cell activation syndrome (MCAS) by Valent et al. (30) recommends that an increase in BST levels of more than “20% + 2” (measured within 4 h from symptom onset) should be considered highly suggestive of MCAS.”
From Defining “Normal” basal serum tryptase levels: a context-dependent approach to improve diagnostics in systemic mastocytosis (2025) · cites this paper as [30]
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
“as an increasing number of patients are being given a misdiagnosis of MCAS based on nonspeci fi c criteria”
From Selecting the Right Criteria and Proper Classification to Diagnose Mast Cell Activation Syndromes: A Critical Review (2021) · cites this paper as [28]
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
“and thus fail to respond to MCAS therapies.”
From Selecting the Right Criteria and Proper Classification to Diagnose Mast Cell Activation Syndromes: A Critical Review (2021) · cites this paper as [28]
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
“The de fi nition of MCAS after the Vienna consensus is based on three diagnostic criteria that have to be ful fi lled before the diagnosis of MCAS can be established: (1) typical (MCA-related) clinical symptoms; (2) an event-related increase in serum tryptase above the individual ' s baseline tryptase (sBT), according to the formula: sBT þ 20% of sBT ( ¼ 120% of sBT ¼ sBT -1.2) plus 2 ng/mL; and (”
From Selecting the Right Criteria and Proper Classification to Diagnose Mast Cell Activation Syndromes: A Critical Review (2021) · cites this paper as [28]
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
“Thus, an increasing number of patients who believe that they are, or have been informed that they are, experiencing MCAS are being referred to specialized centers.”
From Selecting the Right Criteria and Proper Classification to Diagnose Mast Cell Activation Syndromes: A Critical Review (2021) · cites this paper as [28]
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
“In many instances, these patients have an unrelated disease”
From Selecting the Right Criteria and Proper Classification to Diagnose Mast Cell Activation Syndromes: A Critical Review (2021) · cites this paper as [28]
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
“do not ful fi ll the classical stringent Vienna consensus criteria of MCAS”
From Selecting the Right Criteria and Proper Classification to Diagnose Mast Cell Activation Syndromes: A Critical Review (2021) · cites this paper as [28]
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
“The most frequently reported symptoms of MCAS encompass cardiovascular, cutaneous, gastrointestinal, respiratory, and naso-ocular symptoms.”
From Selecting the Right Criteria and Proper Classification to Diagnose Mast Cell Activation Syndromes: A Critical Review (2021) · cites this paper as [28]
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
“Some of these patients may easily be given the incorrect diagnosis of having MCAS when applying less stringent criteria, but not the validated Vienna consensus criteria. 28,30”
From Selecting the Right Criteria and Proper Classification to Diagnose Mast Cell Activation Syndromes: A Critical Review (2021) · cites this paper as [28]
Experimental — accuracy not yet measuredThe cited source says what the claim attributes to it.
In the citing paper
“However, the sensitivity of the tryptase algorithm decreases with decreasing clinical severity and with delayed blood draws after resolution of clinical symptoms.”
From Proposed Diagnostic Algorithm for Patients with Suspected Mast Cell Activation Syndrome (2019) · cites this paper as [27]
The cited source says what the claim attributes to it.
In the citing paper
“Indeed, the response to such drugs is helpful in practice and is therefore a criterion of MCAS (26-28).”
From Proposed Diagnostic Algorithm for Patients with Suspected Mast Cell Activation Syndrome (2019) · cites this paper as [27]
The cited source says what the claim attributes to it.
In the citing paper
“a minimal increase of the acute serum tryptase level to greater than plus 20% of baseline plus 2 ng/mL absolute tryptase strongly supports the diagnosis of MCAS (27).”
From Proposed Diagnostic Algorithm for Patients with Suspected Mast Cell Activation Syndrome (2019) · cites this paper as [27]
The cited source says what the claim attributes to it.
In the citing paper
“Some mediators, like tryptase, are more specific than others for MC and thereby considered as the most precise parameters for the demonstration and documentation of MCA (27,28,37-40).”
From Proposed Diagnostic Algorithm for Patients with Suspected Mast Cell Activation Syndrome (2019) · cites this paper as [27]
The cited source says what the claim attributes to it.
In the citing paper
“Therefore, in a routine evaluation, a rapid substantial increase in serum tryptase levels above the individual’s baseline is considered specific for MC involvement and MCA, and thus can be employed as a MCAS criterion.”
From Proposed Diagnostic Algorithm for Patients with Suspected Mast Cell Activation Syndrome (2019) · cites this paper as [27]
The cited source says what the claim attributes to it.
In the citing paper
“Whenever a major increase in the PGD2 metabolite level is found and the symptoms respond to cyclooxygenase inhibitors, the diagnosis of MCAS may also be considered (27) although the cell source may be ambiguous, particularly if both tryptase and histamine or histamine metabolite levels are normal.”
From Proposed Diagnostic Algorithm for Patients with Suspected Mast Cell Activation Syndrome (2019) · cites this paper as [27]
The cited source says what the claim attributes to it.
In the citing paper
“Diagnostic MCAS criteria include typical clinical symptoms, often with hypotension, an event-related, substantial increase in serum tryptase levels and response of clinical symptoms to MC-stabilizing drugs or drugs counteracting the effects of MC-derived mediators.”
From Proposed Diagnostic Algorithm for Patients with Suspected Mast Cell Activation Syndrome (2019) · cites this paper as [27]
The cited source says what the claim attributes to it.
In the citing paper
“If no evidence for primary or secondary MCAS is found, the patient is classified as having idiopathic MCAS (Table 2, Figure 1) (26-28).”
From Proposed Diagnostic Algorithm for Patients with Suspected Mast Cell Activation Syndrome (2019) · cites this paper as [27]
Experimental — accuracy not yet measuredThe cited source says what the claim attributes to it.
In the citing paper
“These patients as well as those with cutaneous mastocytosis (CM) or SM are both classified as primary (clonal) MCAS (Table 2).”
From Proposed Diagnostic Algorithm for Patients with Suspected Mast Cell Activation Syndrome (2019) · cites this paper as [27]
The cited source says what the claim attributes to it.
In the citing paper
“Finally, there are MCAS patients in whom no KIT -mutated MCs, no allergy, and no overt in fl ammatory disorders or triggers of a hypersensitivity reaction are detected. These patients have idiopathic MCAS. 28,30”
From Selecting the Right Criteria and Proper Classification to Diagnose Mast Cell Activation Syndromes: A Critical Review (2021) · cites this paper as [28]
The cited source says what the claim attributes to it.
In the citing paper
“We found nine such publications [7][8][9][19][20][21][22][23][24], reviewed them, and found each to fall into one of two principal schools of thought as defined by their original papers [8,9].”
From Diagnosis of mast cell activation syndrome: a global "consensus-2" (2021) · cites this paper as [9]
The cited source says what the claim attributes to it.
In the citing paper
“This consensus group concluded that MCAS is a heterogeneous disorder”
From Selecting the Right Criteria and Proper Classification to Diagnose Mast Cell Activation Syndromes: A Critical Review (2021) · cites this paper as [28]
The cited source says what the claim attributes to it.
In the citing paper
“The acute serum tryptase (sAT) level, when signi fi cantly elevated from the individual ' s baseline, is a speci fi c marker for MCA and thus MCAS, although sensitivity varies with the severity of the reaction and timing of collection.”
From Selecting the Right Criteria and Proper Classification to Diagnose Mast Cell Activation Syndromes: A Critical Review (2021) · cites this paper as [28]
The cited source says what the claim attributes to it.
In the citing paper
“The Vienna consensus requires clinical symptoms of MCAS to be associated with an acute, event-related increase in the levels of a validated marker of systemic MCA.”
From Selecting the Right Criteria and Proper Classification to Diagnose Mast Cell Activation Syndromes: A Critical Review (2021) · cites this paper as [28]
The cited source says what the claim attributes to it.
In the citing paper
“and that its diagnosis should be rendered only when speci fi c diagnostic criteria for MCAS are met.”
From Selecting the Right Criteria and Proper Classification to Diagnose Mast Cell Activation Syndromes: A Critical Review (2021) · cites this paper as [28]
The cited source says what the claim attributes to it.
In the citing paper
“Primary MCAS includes conditions characterized by MCAS criteria and a population of clonal MCs exhibiting an activating mutation in KIT , usually KIT D816V, and/or aberrant expression of CD25. 28”
From Selecting the Right Criteria and Proper Classification to Diagnose Mast Cell Activation Syndromes: A Critical Review (2021) · cites this paper as [28]
The cited source says what the claim attributes to it.
In the citing paper
“Based on the Vienna consensus, MCAS can be divided into primary (clonal) MCAS, secondary (nonclonal) MCAS, and idiopathic MCAS (Figure 2). 28,30”
From Selecting the Right Criteria and Proper Classification to Diagnose Mast Cell Activation Syndromes: A Critical Review (2021) · cites this paper as [28]
In the citing paper
“Lifetime risk of anaphylaxis in mastocytosis is significantly increased in adults (approximately 49%). 120,121”
From Sinus Tachycardia: a Multidisciplinary Expert Focused Review (2022) · cites this paper as [121]
In the citing paper
“A formula of acute event related tryptase increase of 20% from baseline level +2 ng/ml has been proposed as a clinically significant confirmation of mast cell activation121,122.”
From Sinus Tachycardia: a Multidisciplinary Expert Focused Review (2022) · cites this paper as [121]
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Metadata
- Authors
- Valent, P., Akin, C., Arock, M., Brockow, K., Butterfield, J. H., Carter, M. C., Castells, M., Escribano, L., Hartmann, K., Lieberman, P., Nedoszytko, B., Orfao, A., Schwartz, L. B., Sotlar, K., Sperr, W. R., Triggiani, M., Valenta, R., Horny, H.-P., & Metcalfe, D. D.
- Affiliations
- Medical University of Vienna (AT)
- Brigham and Women's Hospital (US)
- École Normale Supérieure Paris-Saclay (FR)
- Technical University of Munich (DE)
- Mayo Clinic (US)
- National Institutes of Health (US)
- University of Cologne (DE)
- University of Tennessee System (US)
- Virginia Commonwealth University (US)
- Pathologisches Institut (DE)
- Federico II University Hospital (IT)
- ORCID
- Venue
- International Archives of Allergy and Immunology
- Publisher
- S. Karger AG
- Published
- 2011-10-27
- Volume
- 157
- Issue
- 3
- Pages
- 215-225
- ISSN
- 1018-2438 (ISSN-L)
- 1423-0097
- PMC
- PMC3224511
- OpenAlex
- W2139695498
- Cited by
- 654
- References
- 61
- Citations by year
- 2026: 34 · 2025: 35 · 2024: 44 · 2023: 63 · 2022: 49 · 2021: 61 · 2020: 51 · 2019: 54 · 2018: 40 · 2017: 42 · 2016: 34 · 2015: 52 · 2014: 45 · 2013: 33 · 2012: 15
- FWCI
- 13.33
- Type
- journal article
- Language
- en
- Open access
- bronze
- doi.org
- Locations
- International Archives of Allergy and Immunology (publishedVersion)
- Europe PMC (PubMed Central) (publishedVersion)
- PubMed Central (publishedVersion)
- PubMed (publishedVersion)
- edoc (University of Basel) (submittedVersion)
- Open access LMU (Ludwid Maxmilian's Universitat Munchen) (submittedVersion)
- mediaTUM (Technical University of Munich) (submittedVersion)
- Funders
- National Institutes of Health
- Topics
- Life Sciences › Immunology and Microbiology › Immunology › Mast cells and histamine
- Health Sciences › Medicine › Pulmonary and Respiratory Medicine › Asthma and respiratory diseases
- Health Sciences › Medicine › Gastroenterology › Gastrointestinal motility and disorders
- Keywords
- mast cell activation syndrome, mast cell disease, mastocytosis, mast cell activation, diagnostic criteria, classification, tryptase, histamine, prostaglandin D2, mast cell mediators
- MeSH terms
- Attitude to Health, Diagnosis, Differential, Humans, Mast Cells, Mastocytosis, Biomarkers, Tryptases
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