Sample | Dilution | Result | Average Result |
Spike | Average Spike |
Std Dev | %CV | Spike Recovery |
Dilution Corrected Result (pg/10 μL) |
Average Result (pg/10 μL) |
Reported Result (ng/mL) |
Reported Result (ng/mg) |
Ion Exchange (IgG, ~5mg/mL) |
5 | 0.161 | 0.1600 | 24.3 | 24.05 | 0.354 | 1.5% | 96% | 0.8 | 0.817 | 0.082 | 0.0163 |
0.159 | 23.8 | |||||||||||
10 | 0.08 | 0.0810 | 10.93 | 11.08 | 0.212 | 1.9% | 88% | 0.81 | ||||
0.082 | 11.23 | |||||||||||
20 | 0.041 | 0.0420 | 5.63 | 5.65 | 0.028 | 0.5% | 90% | 0.84 | ||||
0.043 | 5.67 | |||||||||||
Protein A Pool (IgG, ~8mg/mL) |
5 | 19.38 | 19.6400 | 47.29 | 47.34 | 0.071 | 0.1% | 111% | 98.2 | 103.417 | 10.342 | 1.2927 |
19.9 | 47.39 | |||||||||||
10 | 10.57 | 10.5250 | 21.19 | 21.21 | 0.028 | 0.1% | 85% | 105.25 | ||||
10.48 | 21.23 | |||||||||||
20 | 5.3 | 5.3400 | 11.17 | 11.275 | 0.148 | 1.3% | 95% | 106.8 | ||||
5.38 | 11.38 | |||||||||||
Drug Substance Y (IgG, ~ 50mg/mL) |
5 | 3.1 | 3.1000 | 28.17 | 27.865 | 0.431 | 1.5% | 99% | 15.5 | 17.917 | 1.792 | 0.0358 |
3.1 | 27.56 | |||||||||||
10 | 1.86 | 1.8100 | 12.91 | 13.035 | 0.177 | 1.4% | 90% | 18.1 | ||||
1.76 | 13.16 | |||||||||||
20 | 1.03 | 1.0075 | 6.61 | 6.67 | 0.085 | 1.3% | 91% | 20.15 | ||||
0.985 | 6.73 |