Evaluation of specificity, sensitivity, linearity, and precision
Analytical specificity was evaluated by testing genomic DNA isolated
from the positive and negative control bacterial strains. Analytical
sensitivity was determined using LoB and LoD assays with samples in 22
replicates. Probit analysis was performed to measure LoD for each
bacterium. The mean value of the copy number and the standard deviation
(SD) were calculated. LoB was calculated as meanblank +
1.645(SDblank). LoD was calculated as
meanblank + 3(SDblank)(Armbruster and
Pry, 2008). The linearity was determined by a 2-fold serial dilution of
the DNA template, and each dilution was measured in 8 replicates.
Precision was evaluated by testing five different concentrations of
genomic DNA in 8 replicates.