Identification of factors contributing to variability in a blood-based gene expression test.

ABSTRACT:

Background

Corus CAD is a clinically validated test based on age, sex, and expression levels of 23 genes in whole blood that provides a score (1-40 points) proportional to the likelihood of obstructive coronary disease. Clinical laboratory process variability was examined using whole blood controls across a 24 month period: Intra-batch variability was assessed using sample replicates; inter-batch variability examined as a function of laboratory personnel, equipment, and reagent lots.

Methods/results

To assess intra-batch variability, five batches of 132 whole blood controls were processed; inter-batch variability was estimated using 895 whole blood control samples. ANOVA was used to examine inter-batch variability at 4 process steps: RNA extraction, cDNA synthesis, cDNA addi

SUBMITTER: Elashoff MR 

PROVIDER: S-EPMC3388994 | biostudies-literature | 2012

REPOSITORIES: biostudies-literature