Testing Algorithm

Note: This test is only available to clients who have MayoAccess or MayoLink.

The client is responsible for the interpretation and billing of the professional component; Mayo Clinic will bill the technical component only.

The testing process begins with a screening panel. The screening panel will be charged based on the number of markers tested (FIRST for first marker, ADD1 for each additional marker). Additional testing may be performed at an additional charge for each marker tested (ADD1, as applicable) if needed to fully characterize a disease state or clarify any abnormalities from the screening panel.

The tissue panel is initially performed to evaluate for monotypic B cells by kappa and lambda immunoglobulin light chain expression, CD5, CD10, CD19, CD20, and CD23.  Increased numbers of blasts and plasma cells are identified by CD45 expression along with side scatter gating.  The tissue panel also includes CD3, CD5, and CD7 antibodies to evaluate T cells. Additionally, viability is assessed on all tissue specimens using 7-AAD (7-Amino-Actinomycin D) exclusion.

This initial testing, together with the provided clinical history and morphologic review, is used to determine what, if any, additional testing is needed for disease diagnosis or classification. If additional testing is required, it will be added per algorithm to fully characterize a disease state with a charge per unique antibody tested.

Cases requiring testing for granular lymphocytic leukemia (killer-cell immunoglobulin-like receptor panel) will have an interpretation added which will be performed by a Mayo Clinic pathologist at an additional charge.

If no abnormalities are detected by the initial panel, no further flow cytometric assessment will be performed unless otherwise indicated by specific features of the clinical presentation or prior laboratory results.