Table 2a. Reproducibility Assessment for AAVX Titer Capsid ELISA Kit -
Multiple Serotypes
Batch No. |
Repeats |
Average Measured Conc. (Capsids/mL) |
% CV |
Theoretical Conc. (Capsids/mL) |
Recovery Rate |
#1 |
10 |
4.03E+08 |
4% |
4.00E+08 |
101% |
10 |
1.24E+09 |
3% |
1.20E+09 |
103% |
10 |
4.70E+09 |
2% |
5.00E+09 |
94% |
#2 |
10 |
4.32E+08 |
4% |
4.00E+08 |
108% |
10 |
1.28E+09 |
6% |
1.20E+09 |
107% |
10 |
4.58E+09 |
6% |
5.00E+09 |
92% |
#3 |
10 |
3.94E+08 |
6% |
4.00E+08 |
99% |
10 |
1.24E+09 |
8% |
1.20E+09 |
103% |
10 |
4.50E+09 |
6% |
5.00E+09 |
90% |
Table 2b. Reproducibility Assessment for AAV2 Titer Capsid ELISA
Kit
Batch No. |
Repeats |
Average Measured Conc. (Capsids/mL) |
% CV |
Theoretical Conc. (Capsids/mL) |
Recovery Rate |
#1 |
10 |
1.92E+08 |
6% |
1.80E+08 |
107% |
10 |
4.98E+08 |
7% |
5.00E+08 |
100% |
10 |
1.95E+09 |
2% |
2.00E+09 |
98% |
#2 |
10 |
1.83E+08 |
5% |
1.80E+08 |
102% |
10 |
4.85E+08 |
4% |
5.00E+08 |
97% |
10 |
1.95E+09 |
6% |
2.00E+09 |
98% |
#3 |
10 |
1.79E+08 |
6% |
1.80E+08 |
99% |
10 |
4.69E+08 |
5% |
5.00E+08 |
94% |
10 |
1.94E+09 |
6% |
2.00E+09 |
97% |
Table 3a. Inter-Batch Variability Assessment for AAVX Titer
Capsid ELISA Kit - Multiple Serotypes
Batch Amount |
Repeats |
Average Measured Conc. (Capsids/mL) |
% CV |
Theoretical Conc. (Capsids/mL) |
Recovery Rate |
3 |
3×10 |
4.09E+08 |
6% |
4.00E+08 |
102% |
3×10 |
1.26E+09 |
6% |
1.20E+09 |
105% |
3×10 |
4.59E+09 |
5% |
5.00E+09 |
92% |
Table 3b. Inter-Batch Variability Assessment for AAV2 Titer
Capsid ELISA Kit
Batch Amount |
Repeats |
Average Measured Conc. (Capsids/mL) |
% CV |
Theoretical Conc. (Capsids/mL) |
Recovery Rate |
3 |
3×10 |
1.47E+08 |
9% |
1.80E+08 |
82% |
3×10 |
4.83E+08 |
5% |
5.00E+08 |
97% |
3×10 |
1.88E+09 |
6% |
2.00E+09 |
94% |
Three different batches of the kits were used to test samples at
three concentration levels, with each sample being tested in triplicate. This assessment
aimed to evaluate both within-batch and inter-batch precision for the AAVX Titer Capsid
ELISA Kit - Multiple Serotypes (GenScript, L01035) and the AAV2 Titer Capsid ELISA Kit
(GenScript, L00942). The results indicated that the precision for both kits was less than
10% CV.