Mast cell activation syndrome: Proposed diagnostic criteria
Open accessAbstract
The term mast cell activation syndrome (MCAS) is finding increasing use as a diagnosis for subjects who present with signs and symptoms involving the dermis, gastrointestinal track, and cardiovascular system frequently accompanied by neurologic complaints. Such patients often have undergone multiple extensive medical evaluations by different physicians in varied disciplines without a definitive medical diagnosis until the diagnosis of MCAS is applied. However, MCAS as a distinct clinical entity has not been generally accepted, nor do there exist definitive criteria for diagnosis. Based on current understanding of this disease "syndrome" and on what we do know about mast cell activation and resulting pathology, we will explore and propose criteria for its diagnosis. The proposed criteria will be discussed in the context of other disorders involving mast cells or with similar presentations and as a basis for further scientific study and validation.
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If an IgE-dependent allergy or other underlying reactive disease is present without clonal MC, the diagnosis is secondary MCAS.
“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 [26]
In “Proposed Criteria for the diagnosis of idiopathic mast cell activation syndrome,” the paper calls this a secondary mast cell activation disorder when clonal markers are absent and an allergic or other concurrent disease is established. It proposes an MCAS diagnosis only after secondary diseases associated with mast cell activation have been eliminated, contrary to the cited sentence’s diagnosis of “secondary MCAS.” (LLM, conf=0.84)
Checked by a reasoning model — may be wrong.
Experimental — accuracy not yet measuredPatients with clonal KIT-mutated CD25+ MC but only one or two minor SM criteria and no major SM criterion, as well as those with cutaneous mastocytosis or SM, are classified as primary clonal MCAS.
“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 [26]
The section on primary mast cell activation identifies patients with one or two minor mastocytosis criteria as having MMAS. But the proposed diagnostic criteria section explicitly says patients with urticaria pigmentosa, a form of cutaneous mastocytosis, are excluded from an MCAS diagnosis; it assigns patients with clonal markers to systemic mastocytosis or MMAS according to WHO criteria. The copy does not classify all these patients together as primary (clonal) MCAS. Page numbers are unavailable in the indexed passages. (LLM, conf=0.86)
Checked by a reasoning model — may be wrong.
Experimental — accuracy not yet measuredThe most specific and reliable indicator of systemic mast cell activation is a transient, event-related, substantial rise in serum tryptase above the patient's own baseline.
“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 [17]
In the proposed diagnostic criteria section (page unavailable), the paper says tryptase rises transiently during mast cell activation and recommends comparing levels measured during symptoms with the patient’s baseline. It does not establish that a substantial rise in tryptase is the most specific and reliable indicator compared with other mast-cell mediators, which it also recommends measuring. (LLM, conf=0.86)
Experimental — accuracy not yet measuredDuring and soon after a severe anaphylactic event, serum tryptase rises substantially above the individual's baseline.
“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 [17]
The Proposed Criteria section says serum tryptase should be measured within four hours of symptom onset, compared with the patient’s baseline, and rises transiently during mast-cell activation. It identifies anaphylaxis as a mast-cell activation disorder, but does not establish that the rise during a severe anaphylactic event is necessarily substantial. (LLM, conf=0.83)
Experimental — accuracy not yet measuredTryptase has repeatedly been described as the most specific and reliable biomarker of severe systemic mast cell activation in daily practice.
“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 [17]
The proposed diagnostic criteria section (page unavailable) identifies serum tryptase as a test for documenting mast cell activation during symptomatic episodes. It also lists other mediator tests and does not establish that tryptase is the most specific or reliable biomarker for severe systemic activation in daily practice. (LLM, conf=0.84)
Experimental — accuracy not yet measured
Although prior literature and specialized-center experience made tryptase the biomarker of choice for defining anaphylaxis and MCAS, no diagnostic threshold existed.
“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 [17]
In “Proposed Criteria for the diagnosis of idiopathic mast cell activation syndrome” (page unavailable), the paper identifies serum tryptase as a test for mast-cell activation, calls for comparison with baseline, and says objective diagnostic guidelines lacked consensus. It does not call tryptase the biomarker of choice over other mediators, and it gives a conditional >15 ng/ml criterion rather than saying no diagnostic threshold of any kind existed. (LLM, conf=0.84)
Experimental — accuracy not yet measuredSevere MCA fulfilling MCAS consensus criteria is almost always associated with acute severe recurrent symptoms affecting more than one organ or tissue, often with severe hypotension and anaphylaxis.
“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 [26]
The proposed diagnostic criteria section (page unavailable) requires manifestations in at least two organ systems and mediator elevation during symptomatic episodes. It does not establish that symptoms are almost always severe or often involve severe hypotension and anaphylaxis; it explicitly says not all patients with MCAS need have anaphylaxis. (LLM, conf=0.88)
Experimental — accuracy not yet measuredWell-recognized symptoms of systemic MCA include acute urticaria, flushing, abdominal cramping, diarrhea, hypotensive syncope or near syncope, and tachycardia.
“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 [26]
The proposed diagnostic criteria identify urticaria, flushing and diarrhea as manifestations of mast cell activation. The section on primary mast cell activation also describes cramping, lightheadedness, loss of consciousness and severe hypotension in a group of patients with clonal mast cells. The copy does not identify tachycardia as a symptom, so it does not support the full list. (LLM, conf=0.87)
Experimental — accuracy not yet measuredIf no evidence for primary or secondary MCAS is found, the patient is classified as having idiopathic MCAS.
“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 [26]
The section on proposed criteria for idiopathic MCAS supports ruling out primary and secondary causes before making the diagnosis. It also requires three additional diagnostic criteria; the cited sentence makes exclusion alone sound sufficient for classification. (LLM, conf=0.82)
Experimental — accuracy not yet measuredTwo principal proposals for diagnostic criteria for MCAS have emerged.
“Two principal proposals for diagnostic criteria have emerged.”
From Diagnosis of mast cell activation syndrome: a global "consensus-2" (2021) · cites this paper as [7]
The Proposed Criteria section (page unavailable) sets out this paper’s proposed criteria for MCAS. The Abstract likewise says the authors will propose criteria, but neither passage establishes that two principal proposals had emerged. (LLM, conf=0.84)
Experimental — accuracy not yet measuredResponse to mediator-blocking drugs is a criterion of MCAS.
“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 [26]
The likelihood of MCA increases when two or more recognized symptoms are documented, and increases further when symptoms respond to agents blocking mediator effects, production, or secretion.
“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 [26]
Nine publications offering new or modified schemes for diagnosing the full range of MCAS were found, and each fell into one of two principal schools of thought.
“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 [7]
Mast cell activation syndromes are characterized by recurrent episodes of systemic symptoms linked to the release of mast cell-derived mediators.
“Mast cell activation syndromes (MCASs) are characterized by recurrent episodes of systemic symptoms associated with the release of mast cell (MC)-derived mediators (Fig 1).1,2”
From Mast cell activation syndrome: Current understanding and research needs (2024) · cites this paper as [1]
A formula of acute event-related tryptase increase of 20% from baseline plus 2 ng/ml has been proposed as a clinically significant confirmation of mast cell activation.
“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 [122]
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- Authors
- Akin, C., Valent, P., & Metcalfe, D. D.
- Affiliations
- University of Michigan (US)
- Ludwig Boltzmann Institute for Hematology and Oncology (AT)
- National Institutes of Health (US)
- Corresponding author
- Metcalfe, Dean D.
- Venue
- Journal of Allergy and Clinical Immunology
- Publisher
- Elsevier BV
- Published
- 2010-12
- Volume
- 126
- Issue
- 6
- Pages
- 1099-1104.e4
- ISSN
- 0091-6749 (ISSN-L)
- PMC
- PMC3753019
- OpenAlex
- W2003100495
- Cited by
- 327
- References
- 32
- Citations by year
- 2026: 11 · 2025: 21 · 2024: 20 · 2023: 26 · 2022: 19 · 2021: 26 · 2020: 19 · 2019: 32 · 2018: 21 · 2017: 16 · 2016: 13 · 2015: 18 · 2014: 22 · 2013: 28 · 2012: 16
- FWCI
- 8.52
- Type
- journal article
- Language
- en
- Open access
- green
- europepmc.org
- Locations
- Journal of Allergy and Clinical Immunology (publishedVersion)
- PubMed (publishedVersion)
- Europe PMC (PubMed Central) (acceptedVersion)
- PubMed Central (acceptedVersion)
- Funders
- National Institutes of Health
- U.S. Public Health Service (P21173-B13)
- National Institute of Allergy and Infectious Diseases (Z01AI000249, ZIAAI000249)
- 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 › Physiology › Asthma and respiratory diseases
- Keywords
- mast cell activation syndrome, diagnostic criteria, mast cell activation, mast cell disease, dermal symptoms, gastrointestinal symptoms, cardiovascular symptoms, neurological symptoms, unexplained symptoms
- MeSH terms
- Abnormalities, Multiple, Diagnosis, Differential, Humans, Mast Cells, Syndrome, Prostaglandin D2, Cell Degranulation, Cytokines, Practice Guidelines as Topic, Leukotriene C4
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