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

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

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.

Publication types

  • Clinical Trial
  • Comparative Study
  • Multicenter Study

MeSH terms

  • Anemia, Sickle Cell / blood*
  • Anemia, Sickle Cell / diagnosis
  • Anemia, Sickle Cell / drug therapy
  • Blood Cell Count / methods*
  • Hematology / standards
  • Humans
  • Hydroxyurea / therapeutic use
  • Infant
  • Laboratories / standards*
  • Laboratory Proficiency Testing*
  • Lymphocytes / chemistry
  • Monocytes / chemistry
  • Neutrophils / chemistry
  • Regression Analysis
  • Reproducibility of Results

Substances

  • Hydroxyurea