Table 4. ITCcmEPO duplex assay testing of WBC samples from NHP transduced IM in vivo with rAAV1 or rAAV8.
| Serotype/Time Point | Mean* cmEPO Ct (s.e.) | Mean ITCcmEPO Ct** (s.e.) | Positive/Negative | Actual Copy Number*** |
| rAAV1/Pre-injection. | 40.00# (0) | 37.00 (0.29) | Negative (P-value<0.0001) | 0 |
| rAAV1/3 Days p.i. | 32.81 (0.10) | 37.21 (0.15) | Positive (P-value<0.0001) | 188 |
| rAAV1/7 Days p.i. | 35.92 (0.27) | 37.48 (0.29) | Positive (P-value = 0.0019) | 13 |
| rAAV1/14 Days p.i. | 36.94 (0.51) | 37.46 (0.40) | Positive (P-value = 0.4350) | 8 |
| rAAV1/10 Weeks p.i. | 38.49 (0.49) | 37.67 (0.13) | Positive (P-value = 0.1066) | 2 |
| rAAV1/16 Weeks p.i. | 38.32 (0.72) | 37.16 (0.73) | Positive (P-value = 0.2913) | 3 |
| rAAV1/23 Weeks p.i. | 39.91 (0.09) | 37.18 (0.23) | Negative (P-value<0.0010) | 0 |
| rAAV8/Pre-injection. | 40.00# (0) | 37.43 (0.24) | Negative (P-value<0.0001) | 0 |
| rAAV8/3 Days p.i. | 35.70 (0.49) | 36.67 (0.12) | Positive (P-value<0.0875) | 10 |
| rAAV8/7 Days p.i. | 36.68 (0.35) | 36.99 (0.44) | Positive (P-value = 0.5923) | 7 |
| rAAV8/14 Days p.i. | 37.44 (0.43) | 37.43 (0.14) | Positive (P-value = 0.9795) | 8 |
| rAAV8/10 Weeks p.i. | 40.00 (0) | 36.82 (0.33) | Negative (P-value<0.0001) | 0 |
| rAAV8/16 Weeks p.i. | 38.02 (0.68) | 36.83 (0.68) | Positive (P-value = 0.2528) | 2 |
| rAAV8/23 Weeks p.i. | 38.17 (0.54) | 37.30 (0.19) | Positive (P-value = 0.1432) | 3 |
*
From five replicates of each 500 ng in vivo sample. s.e. = standard error, s.e., (in parenthesis).
**
From an input of five copies of ITCcmEPO template.
***
The actual copy number is from our previous study [32].
#
The number of cycles of the real-time PCR program was set to 40.