Quality assurance of CD34+ cell estimation in leucapheresis products

In order to examine the feasibility of an external quality assurance (QA) scheme for CD34+ cell enumeration and to identify causes of the differences between laboratories for CD34 counts, we carried out a pilot QA exercise in two parts. There were eight participating laboratories in the initial study and each performed CD34 counts using their in-house method. A series of 12 samples of cryopreserved peripheral blood progenitor cells (PBPC) were analysed by each of the eight laboratories. A very wide range of values for all the samples was found for the different in-house methods. For the second part of the study, 12 laboratories analysed a different set of 12 PBPC samples and each used the same anti-CD34 antibody (HPCA-2 PE), anti-CD45 antibodies to identify leucocytes, and counted a minimum of 50,000 events. These measures have reduced the interlaboratory variation in results but this variation is still too high to allow us to realistically compare values between centres. Overall, most centres performed comparably, but there was one centre in part one of the study which gave results that were significantly different from the other centres.