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Clinical Trial
. 2013 Feb;46(3):278-81.
doi: 10.1016/j.clinbiochem.2012.10.032. Epub 2012 Oct 31.

Comparison of hematologic measurements between local and central laboratories: data from the BABY HUG trial

Collaborators, Affiliations
Clinical Trial

Comparison of hematologic measurements between local and central laboratories: data from the BABY HUG trial

Ram Kalpatthi et al. Clin Biochem. 2013 Feb.

Abstract

Objectives: To investigate the concordance of blood count indices measured locally and at a central laboratory.

Design and methods: In a multi-center clinical trial of hydroxyurea therapy in infants with sickle cell anemia (BABY HUG), the concordance between blood count indices measured locally and at a central laboratory was investigated.

Results: Local laboratory measurements of neutrophil and monocyte counts were significantly higher (44% and 37%, respectively) compared to the central measurements (p<0.0001), and mean corpuscular volume (MCV) was higher centrally.

Conclusion: Overnight shipping with processing delay causes spurious reductions in absolute neutrophil count (ANC) and absolute monocyte count (AMC) that may result in incorrect monitoring decisions in multicenter clinical trials.

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Figures

Figure 1
Figure 1
Bland-Altman plots of hematological measurements. Y-axis is the difference between local and central measurements; x-axis is the average of the local and central measurements.

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