表2-1. AAVX Titer Capsid ELISA Kit - Multiple Serotypes 重复性评估
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% |
表2-2. AAV2 Titer Capsid ELISA Kit 重复性评估
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% |
表3-1. AAVX Titer Capsid ELISA Kit - Multiple Serotypes
三批次批间差评估
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% |
表3-2. AAV2 Titer Capsid ELISA Kit 三批次批间差评估
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% |
使用三批次试剂盒分别对3个浓度水平的样本进行测试,每个样本各重复检测10次。以此分析AAVX Titer Capsid ELISA Kit -
Multiple Serotypes(GenScript, L01035)和AAV2 Titer Capsid ELISA Kit(GenScript,
L00942)的批内精密度和批间精密度。结果显示,L01035和L00942的精密度CV<10%。< /p>