The serum tryptase test: an emerging robust biomarker in clinical hematology
Open accessAbstract
During the past few years, a number of molecular markers have been developed in clinical hematology, most of them related to specific gene defects. However, there is also an unmet need to develop novel serologic parameters to improve diagnostics and prognostication in daily practice. Among these, the serum tryptase appears to be a most reliable biomarker of myeloid neoplasms. Elevated tryptase levels are found in subgroups of patients with mastocytosis, myelodysplastic syndrome, myeloproliferative neoplasm, acute myeloid leukemia, chronic myeloid leukemia and chronic eosinophilic leukemia. In these patients, the tryptase level is of diagnostic and/or prognostic significance. In mastocytosis, an elevated tryptase level is a minor criterion of systemic disease and in BCR-ABL1(+) chronic myeloid leukemia, elevated tryptase at diagnosis correlates with treatment responses and overall survival. In patients with elevated tryptase, the enzyme also serves as follow-up parameter and can be employed to measure treatment-responses. In the current article, we review and update the perspectives of tryptase and provide recommendations for use of this conventional biomarker in daily practice.
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More than 30% of patients with myeloid neoplasms, including mastocytosis, have raised basal tryptase.
“over 30% of all patients with myeloid neoplasms, including mastocytosis, have elevated basal tryptase levels.”
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 [27]
The section “Elevated basal serum tryptase levels are frequently detected in patient with myeloid neoplasms” (page not provided) reports elevated levels in more than 90% of patients with systemic mastocytosis, about 30–40% with AML, and about 30–35% with CML. It says the incidence is lower in MPN and MDS and gives no rate for all myeloid neoplasms combined, so it does not establish the claimed overall figure of over 30%. (LLM, conf=0.86)
Experimental — accuracy not yet measuredSerum tryptase baseline concentrations differ according to the underlying disease and the person's genetic makeup.
“the baseline level of tryptase varies depending on the underlying disease and the genetic background.”
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 [27]
In “Cellular origin, historical overview and development of the test” (page unavailable), the paper reports that basal tryptase is usually elevated in systemic mastocytosis but normal in most cases of cutaneous mastocytosis, supporting variation by underlying disease. The searched passages do not establish that a person’s genetic background independently determines baseline tryptase; the mention of elevated levels in familial mast-cell activation syndromes does not make that broader point. (LLM, conf=0.82)
Experimental — accuracy not yet measuredUsing the 11.4 ng/mL threshold, raised basal tryptase is frequent in otherwise healthy people (about 5-10% of the general population), in various reactive states, and in hematologic disorders, especially myeloid malignancies (about 20-30%).
“when taking the 11.4 threshold as denominator, an increased basal tryptase level is found frequently in otherwise healthy individuals (roughly 5–10% of the general population), in diverse reactive states, and in hematologic disorders, especially in myeloid malignancies (roughly 20–30%; Table 2) [25–31].”
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 [27]
In “Total serum tryptase levels in healthy individuals” (page unavailable), the paper recognizes 11.4 ng/mL as a cutoff used by many centers and says many healthy people have levels between 10 and 15 ng/mL, but it does not give a 5–10% prevalence above 11.4 ng/mL. In “Elevated basal serum tryptase levels are frequently detected in patient with myeloid neoplasms” (page unavailable), it reports elevations in several myeloid disorders, but gives disease-specific figures measured against >15 ng/mL rather than an overall 20–30% figure at 11.4 ng/mL. It mentions some nonmalignant causes of increases, while saying infections and other inflammatory processes generally leave levels stable. (LLM, conf=0.85)
Experimental — accuracy not yet measuredThese conditions include tryptase gene replications such as hereditary alpha tryptasemia, chronic infections such as helminth infections, renal insufficiency especially in hemodialysis patients, and myeloid neoplasms including myelodysplastic syndromes, systemic mastocytosis, acute myeloid leukemia, chronic myeloid leukemia, and chronic eosinophilic leukemia.
“These include tryptase gene replications such as hereditary alpha tryptasemia; chronic infections, such as helminth infections; renal insufficiency – especially hemodialysis patients; and myeloid neoplasms, including myelodysplastic syndromes, SM, acute myeloid leukemia, chronic myeloid leukemia (CML), and chronic eosinophilic leukemia [25–33].”
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 [27]
The sections on healthy individuals and myeloid neoplasms report elevated tryptase with chronic active helminth infection, renal failure, and each listed neoplasm. The References section names a study of raised baseline tryptase in hemodialysis patients. Our copy does not identify tryptase gene replication or hereditary alpha tryptasemia as a cause. (LLM, conf=0.88)
Experimental — accuracy not yet measuredSeveral genetic, inflammatory, and neoplastic conditions are linked to raised basal serum tryptase.
“Thus, a number of genetic, inflammatory, and neoplastic conditions are associated with an increased basal serum tryptase level.”
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 [27]
The sections on myeloid neoplasms and tryptase screening (pages not provided) link elevated basal tryptase to several neoplasms and say it may occur in familial mast-cell activation syndromes. The section on healthy individuals says levels may rise slightly during chronic active helminth infection, but remain stable during viral or bacterial infections and other inflammatory processes. The claim is therefore supported for the neoplastic and familial examples but overgeneralizes the inflammatory association. (LLM, conf=0.84)
Experimental — accuracy not yet measured
Elevated basal tryptase is found in mastocytosis, hereditary alpha-tryptasemia where anaphylaxis risk may be increased, and myeloid non-MC-lineage neoplasms.
“an elevated basal tryptase level is not only found in patients with mastocytosis or hereditary alpha-tryptasemia (where the risk for anaphylaxis may be increased) but also in patients with myeloid non-MC-lineage neoplasms (Supplemental Table S1) (68-71).”
From Proposed Diagnostic Algorithm for Patients with Suspected Mast Cell Activation Syndrome (2019) · cites this paper as [71]
The sections on elevated basal serum tryptase and cellular origin report elevated levels in systemic mastocytosis and several other myeloid neoplasms, including AML and CML (page not provided). The paper also mentions familial mast-cell activation syndromes, but the passages do not identify hereditary alpha-tryptasemia or link that condition to increased anaphylaxis risk. Its discussion of anaphylaxis concerns a rise in tryptase during a reaction, not that risk claim. (LLM, conf=0.87)
Experimental — accuracy not yet measuredAn elevated basal serum tryptase level by itself is neither an indication for MCA or MCAS nor an a priori risk factor for MCA or MCAS.
“an elevated basal serum tryptase level per se is neither an indication for MCA or MCAS nor is it an ‘a priori’ risk factor for the occurrence of MCA or MCAS.”
From Proposed Diagnostic Algorithm for Patients with Suspected Mast Cell Activation Syndrome (2019) · cites this paper as [71]
The section on the test’s development (page not supplied) identifies a rise above baseline during anaphylaxis—not an elevated basal level—as a diagnostic parameter of mast-cell activation. The screening section also describes elevated basal levels in other conditions. These passages support the distinction between basal elevation and evidence of activation, but do not address whether basal elevation is an a priori risk factor for MCA or MCAS. (LLM, conf=0.79)
Experimental — accuracy not yet measuredPatients with primary MCAS and insect venom allergy require special attention.
“The population requiring special attention consists of patients suffering from primary MCAS and insect venom allergy.”
From Proposed Diagnostic Algorithm for Patients with Suspected Mast Cell Activation Syndrome (2019) · cites this paper as [71]
The ‘Cellular origin, historical overview and development of the test’ section says that measuring baseline tryptase during a symptom-free interval is especially important for patients with MCAS. The ‘Value of tryptase testing in patients with mastocytosis’ section highlights known Hymenoptera venom allergy when interpreting elevated tryptase. Neither passage identifies patients with *primary* MCAS and insect venom allergy together as the population requiring special attention. (LLM, conf=0.82)
Experimental — accuracy not yet measuredInduction of long-term tolerance to insect venom allergen is reduced in primary MCAS, and severe or fatal reactions after discontinuation of immunotherapy have been described.
“The induction of long-term tolerance to an insect venom allergen is reduced in primary MCAS and severe or even fatal reactions after discontinuation of immunotherapy have been described (71,72).”
From Proposed Diagnostic Algorithm for Patients with Suspected Mast Cell Activation Syndrome (2019) · cites this paper as [71]
The 'Value of tryptase testing in patients with mastocytosis' section (page unavailable) discusses hymenoptera venom allergy as a context for screening for systemic mastocytosis, not as an immunotherapy outcome. Searches for long-term venom tolerance and reactions after discontinuing immunotherapy found no passage in our copy addressing either claim. (LLM, conf=0.74)
Experimental — accuracy not yet measuredPatients with primary MCAS and insect venom allergy are likely protected only while receiving continuous venom immunotherapy.
“Based on available data, it seems likely that patients with primary MCAS and insect venom allergy are only protected while under continuous venom immunotherapy which is therefore a recommended approach.”
From Proposed Diagnostic Algorithm for Patients with Suspected Mast Cell Activation Syndrome (2019) · cites this paper as [71]
The ‘Value of tryptase testing in patients with mastocytosis’ section discusses elevated tryptase in patients with hymenoptera venom allergy, but not whether immunotherapy protects them. Searches for venom immunotherapy and continuous treatment found no passage addressing the claimed need for ongoing therapy in primary MCAS. (LLM, conf=0.72)
Experimental — accuracy not yet measured
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Self-citationFalse-elevated serum tryptase assay result caused by heterophilic antibodies
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Anaphylaxis: A 2023 practice parameter update
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“Rather, an elevated basal tryptase level is found not only in patients with mastocytosis or hereditary alpha-tryptasemia (where the risk for anaphylaxis may be increased), but also in patients with myeloid noneMC-lineage neoplasms (see Table E1).(68-71) In addition, elevated basal tryptase levels are detectable in pat…”
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- Authors
- Valent, P., Sperr, W. R., Sotlar, K., Reiter, A., Akin, C., Gotlib, J., Horny, H.-P., & Arock, M.
- Affiliations
- Ludwig Boltzmann Institute for Hematology and Oncology (AT)
- Pathologisches Institut (DE)
- Heidelberg University (DE)
- Brigham and Women's Hospital (US)
- Stanford Cancer Institute (US)
- École Normale Supérieure Paris-Saclay (FR)
- Corresponding author
- Valent, Peter
- Venue
- Expert Review of Hematology
- Publisher
- Informa UK Limited
- Published
- 2014-08-28
- Volume
- 7
- Issue
- 5
- Pages
- 683-690
- ISSN
- 1747-4086 (ISSN-L)
- 1747-4094
- PMC
- PMC4603354
- OpenAlex
- W2140307679
- Cited by
- 83
- References
- 80
- Citations by year
- 2026: 5 · 2025: 6 · 2024: 11 · 2023: 6 · 2022: 8 · 2021: 14 · 2020: 6 · 2019: 11 · 2018: 5 · 2017: 4 · 2016: 2 · 2015: 4 · 2014: 1
- FWCI
- 0.36
- Type
- journal article
- Language
- en
- Open access
- green
- www.ncbi.nlm.nih.gov
- Locations
- Expert Review of Hematology (publishedVersion)
- PubMed (publishedVersion)
- PubMed Central (acceptedVersion)
- Topics
- Life Sciences › Immunology and Microbiology › Immunology › Mast cells and histamine
- Health Sciences › Medicine › Hematology › Acute Myeloid Leukemia Research
- Health Sciences › Medicine › Hematology › Chronic Myeloid Leukemia Treatments
- Keywords
- serum tryptase, biomarkers, myeloid neoplasms, mastocytosis, myelodysplastic syndrome, myeloproliferative neoplasms, acute myeloid leukemia, chronic myeloid leukemia, chronic eosinophilic leukemia, BCR-ABL1, prognostic factors, treatment response monitoring, systemic mastocytosis
- MeSH terms
- Humans, Leukemia, Myeloid, Mast Cells, Mastocytosis, Prognosis, Biomarkers, Fusion Proteins, bcr-abl, Receptors, Platelet-Derived Growth Factor, Tryptases
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