期刊
BRITISH JOURNAL OF HAEMATOLOGY
卷 108, 期 4, 页码 784-792出版社
BLACKWELL SCIENCE LTD
DOI: 10.1046/j.1365-2141.2000.01932.x
关键词
CD34(+) stem cell enumeration; flow cytometry; standardized protocols; clinical cell analysis
类别
The European Working Group on Clinical Cell Analysis (EWGCCA) has, in preparation for a multicentre peripheral blood stem cell clinical trial, developed a single-platform flow cytometric protocol for the enumeration of CD34(+) stem cells. Using this protocol, stabilized blood and targeted training, the EWGCCA have attempted to standardize CD34(+) stem cell enumeration across 24 clinical sites. Results were directly compared with participants in the UK National External Quality Assessment Scheme (NEQAS) for CD34(+) Stem Cell Quantification that analysed the same specimens using non-standardized methods. Two bead-counting systems, Flow-Count and TruCount, were also evaluated by the EWGCCA participants during trials 2 and 3. Using Flow-Count, the intralaboratory coefficient of variation (CV) was less than or equal to 5% in 39% of the laboratories (trial 1), increasing to 65% by trial 3, Interlaboratory variation was reduced from 23.3% (trial 1) to 10.8% in trial 3, In trial 2, 70% of laboratories achieved an intralaboratory CV less than or equal to 5% using TruCount, increasing to 74% for trial 3; the interlaboratory CV was reduced from 23.4% to 9.5%. Comparative analysis of the EWGCCA and the UK NEQAS cohorts revealed that EWGCCA laboratories, using the standardized approach, had lower interlaboratory variation, Thus, the use of a common standardized protocol and targeted training significantly reduced intra- and interlaboratory CD34(+) cell count variation.
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