Table 5.
Final rAAV2 Reference Standard Material Titer Estimates after Transformation and Modeling
| Titer units (method) | Transformationa | Mean | Lower 95% confidence limit for the mean | Upper 95% confidence limit for the mean | ± 2 SD | ± 3 SD |
|---|---|---|---|---|---|---|
| Particles/ml (ELISA) | Untransformed | 9.18 × 1011 | 7.89 × 1011 | 1.05 × 1012 | 3.73 × 1011–1.45 × 1012 | 1.04 × 1011–1.78 × 1012 |
| Vector genomes/ml (qPCR) | Square root | 3.28 × 1010 | 2.70 × 1010 | 4.75 × 1010 | 9.00 × 108–1.04 × 1011 | 0–1.66 × 1011 |
| Transducing units/ml (green cells) | Square root | 5.09 × 108 | 2.00 × 108 | 9.60 × 108 | 0–2.47 × 109 | 0–4.00 × 109 |
| Infectious units/ml (TCID50) | Log10 | 4.37 × 109 | 2.06 × 109 | 9.26 × 109 | 5.15 × 108–3.71 × 1010 | 1.77 × 108–1.08 × 1011 |
a
Used to better qualify the assumption of normal distribution for the purpose of determining distributional values.