Methods and kits for used as an internal or external control in rare cell
analysis are disclosed. A plurality of fluorescently distinct sets of
cells is used to define a range to assess the isolation of rare target
cells from a sample. Thus, a known number of cells, expressing the
surface and intracellular antigens present in the targeted rare cells,
are stabilized and modified in such a way that they can be discriminated
from the targeted rare cells. In addition, these cells are separated into
at least two sets based upon the number. These sets are detectably
distinct from each other and provide an upper and lower indication of the
detection ability of the rare cell assay.