Figure 3

Histogram of PCR positive controls (RNaseP) run prior to and during the clinical validation study. An RNaseP TaqMan assay, with gDNA as the template, was distributed across twelve wells of a 384-well qPCR plate and used as the qPCR positive control. A pre-specified acceptance criterion of 1%CV was applied. During the clinical validation study, only twenty eight samples (2%) failed this 1% CV specification, demonstrating a highly controlled process.