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Enumeration of Major Peripheral Blood Leukocyte Populations for Multicenter Clinical Trials Using a Whole Blood Phenotyping Assay
Published on: September 16, 2012
Comparison of hematologic measurements between local and central laboratories: data from the BABY HUG trial
Ram Kalpatthi1, Bruce Thompson, Ming Lu
1Children's Mercy Hospitals and Clinics, Kansas City, MO, USA. rvkalpatthi@cmh.edu
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.
