Testing Algorithm

This assay uses 2 panels for identifying cell populations of interest and for characterizing their phenotypic features. In the myelodysplastic syndrome panel, blasts are identified by CD45/side scatter gating strategy and by CD34 expression; promyelocytes are identified by bright CD13, CD33, and CD117 expression without CD34; granulocytes and precursors are defined by their variable expression of CD13 and CD16 according to their maturational stages. Abnormal patterns of myeloid maturation are determined according to the presence or absence of the following features: distinct blast increases over 5%; heterogeneous blast distribution on CD13/HLA-DR plot; expression of CD2, CD7, and/or CD56 on blasts; and disrupted granulocytic maturation on CD13/CD16 plot.(1,2)

Additionally, a triage panel is performed to ensure that monotypic B-cells, increased plasma cells, and phenotypically aberrant populations of CD3-positive T-cells and CD16-positive/CD3-negative natural killer (NK) cells, if present, are identified. This is necessary especially for cases where the reason for referral is broad, where clonal myeloid neoplasms may not be the only diagnostic consideration, or where there is incomplete clinical history and morphologic data.

These panels are used in combination with any available provided clinical history and morphologic findings to determine if any additional testing may be needed for complete disease characterization. If such additional testing is required, it will be added according to laboratory algorithms at an additional charge per unique antibody tested.