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Reduction of intra‐ and interlaboratory variation in CD34 + stem cell enumeration using stable test material, standard protocols and targeted training
Author(s) -
Barnett D.,
Granger V.,
Kraan J.,
Whitby L.,
Reilly J. T.,
Papa S.,
Gratama J. W.
Publication year - 2000
Publication title -
british journal of haematology
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.907
H-Index - 186
eISSN - 1365-2141
pISSN - 0007-1048
DOI - 10.1046/j.1365-2141.2000.01932.x
Subject(s) - coefficient of variation , medicine , cd34 , enumeration , stem cell , clinical trial , protocol (science) , external quality assessment , nuclear medicine , pathology , biology , chemistry , mathematics , chromatography , genetics , alternative medicine , combinatorics
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 ≤ 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 ≤ 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.