re CD34 Quantitation

From: D. Robert Sutherland (rob.sutherland@utoronto.ca)
Date: Wed May 05 1999 - 02:57:08 EST


Hi Doug,

Both Procount and StemKit are designed for the clinical evaluation of
CD34+
cells in peripheral blood and apheresis samples. They are both
fluorescent bead-based single
platform methods that allow the direct determination of CD34+  cells
from a flow
cytometer, without the need for a hematology analyser. Procount uses a
vital nuclear
dye in FL1, CD34PE in FL2 and CD45PerCp in FL3. Cells are defined as dye
positive,
CD34+/CD45dim. The nucleic acid dye is not a viability dye. It is used
to delineate nucleated cells from unlysed red cells and other debris
present after lyse-no-wash sample processing.   Since the lysing agent
contains a fixative, Procount is incompatible with viability dyes such
as 7-AAD. The Procount Kit requires three channels of a cytometer to
measure the absolute CD34+ cell number precluding the use (on three
channel instruments at least) of other antibody conjugates in a more
sophisticated qualitative analysis of CD34+ cell subsets. A useful
feature for the clinical laboratory is that Procount comes with
automated setup and analysis software.
The Stem-Kit from Coulter Immunotech is based on the single platform
version of the
ISHAGE Protocol using CD45FITC and CD34PE (see J Hematotherapy 3:
213-226,
1996 and Cytometry [Communications in Clinical Cytometry]) 34: 61-7,
1998). Fixative-free ammonium chloride based lyse-no-wash sample
processing is utilised and as such is entirely compatible with viability
dyes.  While Procount (that was designed to measure CD34  cells in fresh
peripheral blood and apheresis products) and Stem-Kit can be expected to
give very similar results on fresh blood and apheresis samples in good
condition, approximately 10% of apheresis
samples  contain platelet aggregates and/or other debris that can be
problematic for
the automated Procount software.  BD have issued a 'circular' indicating
that such
samples must be analysed manually by 'experienced laboratory personnel'.
A potential problem with both assays  is the need for extremely accurate
pipetting (reverse pipetting is recommended). The Procount method
requires pipetting of the sample into a Trucount tube pre-loaded with
lyophilized beads, whereas the Stemkit requires pipetting of both beads
and sample. Note however that for many apheresis samples, accurate
dilution will also be required for both protocols.

The basic ISHAGE method was originally developed to be capable of
enumerating CD34+  cells on a wide variety of samples currently used in
both the research and clinical laboratories, including cord blood,
fetal, normal and abnormal marrow, ex vivo manipulated (purged) samples
and when properly set-up, can do so with great accuracy and sensitivity.
Isotype controls are not required and the method can be performed on all
modern cytometers tested to date including Coulter XL and Elite, BD
FACScan, Calibur and Vantage instruments. Incorporation of counting
beads and the viability dye 7-AAD allows the determination of absolute
viable CD34+  cells with this methodology.
This capability has great utility on samples that may have been
'held-overnight' prior to analysis,or otherwise 'mishandled', or have
been shipped in less than pristine condition to the flow laboratory (eg
cord blood samples shipped to the local 'bank').  Dual platform absolute
counting (flow cytometry plus automated hematology analyser) using
so-called simple methods like the Milan protocol or its derivatives  can
generate highly inaccurate data on such samples due to the loss of
neutrophils, increased platelet and other debris, and dead cells that
can masquerade as CD34+  cells. Similarly, dual platform methods can
generate inaccurate data on cord blood samples due to the presence of
significant numbers of nucleated red cells that alter the denominator in
the calculation of '%CD34+ cells'.
More sophisticated analysis is possible starting from the basic ISHAGE
protocol, and we routinely
perform three and four colour subset analysis/sorting on CD34+  cells in
a variety of
clinical and research settings.  Thus, for example, the utility of new
growth factor/chemotherapy combinations that mobilise candidate stem
cells within the total CD34+  cell compartment can be assessed.
Alternatively, if needed, one can also simultaneously perform CD34 cell
enumeration alongside residual T cell quantitation in the allogeneic
setting. Many of these methods are detailed in an upcoming article
(Enumeration of CD34 Hematopoietic Stem and Progenitor Cells by Gratama
et al) to be published in Current Protocols in Cytometry.
With specific reference to 'which kit to use in the clinical
laboratory', except for the above caveats re platelet aggregates and
debris in a monority of samples, either kit should do an adequate job on
enumerating CD34+ cells in fresh blood and apheresis samples.


We hope this is helpful.


Rob Sutherland
Rakash Nayar
The Toronto Hospital
Mike Keeney
Ian Chin-Yee
London Health Sciences Center
Ontario.



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