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

ObjectivesTo investigate the concordance of blood count indices measured locally and at a central laboratory.Design and methodsIn 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.ResultsLocal 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.ConclusionOvernight 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.

► Data are limited on the quality of shipped/stored blood samples in clinical trials. ► We compared the CBC indices between local and central laboratories in Baby Hug study. ► ANC and AMC were significantly higher locally compared to the central measurements. ► Overnight shipping with processing delay causes spurious reductions in ANC and AMC.