Table 7.
Diagnostic Criteria for Systemic Mastocytosis
| Major criterion | a. Multifocal, dense infiltrates of mast cells (≥15 mast cells in aggregates) detected in intramedullary biopsy sections and/or extramedullary organ(s). |
| Minor criteria | a. In intramedullary biopsy sections or other extramedullary ones >25% of the mast cells in the infiltrate are spindle shaped or have atypical morphology, or of all mast cells in bone marrow aspirate smears >25% are immature or atypical |
| b. Gain of function point mutation of KIT at codon 816 (usually KIT D816V) in bone marrow, blood, or other extracutaneous organ | |
| c. Aberrant immunophenotype of mast cells of CD2 and/or CD25 in bone marrow, blood, or other extracutaneous organ (in addition to normal mast cell markers) | |
| d. Persistently elevated baseline serum total tryptase (>20 ng/ml). |