Assay Sensitivity

The sensitivity of the assay was determined as the minimum quantifiable plasmid copy number（PCN）[2].The minimum quantifiable PCN was calculated as the sample PCN divided by the sample dilution factor at which the minimum plasmid DNA area value at the linear range（mimimum quantifiable pDNA peak area value）was detected for this sample.The quantitation limit of peak area for plasmid DNA is 0.1 to 1.0（see Materials and Methods）.The results shown in the Table 5 are based on five replicate experiments with sample lot A，and four replicate experiments for sample lot B.The standard deviation and the percentage coefficient of variation for the minimum quantifiable peak area values are included.The assay sensitivity for both samples tested was estimated as one pIL-2 plasmid copy per genome.

Table 5　Sensitivity of plasmid copy number assay