Table I.
Mock Serum Samples with ADA, NGF, and Fulranumab
| Samples | Melon™ gel confirmation | “Double” confirmation | ADA (+/−) |
|---|---|---|---|
| 20 ng/mL ADA1 + 200 ng/mL NGF | − | + | + |
| 200 ng/mL NGF | − | − | − |
| 20 ng/mL ADA1 (monkey ADA) | + | + | + |
| 20 ng/mL ADA1 + 5 ug/mL fulranumab | + | + | + |
| 20 ng/mL ADA1 + 3 ng/mL NGF | + | + | + |
| 3 ng/mL NGF | − | − | − |
| 5 μg/mL fulranumab + 200 ng/mL NGF | + | − | − |
| 5 μg/mL fulranumab + 3 ng/mL NGF | + | − | − |
| 500 ng/mL ADA1 | + | + | + |
| 500 ng/mL ADA2 (mouse ADA) | − | + | + |
| 2 ng/mL ADA1 | + | + | + |
| No. classified correctly | 7/11 | 11/11 |
Mock serum samples containing different levels of ADA, NGF, and fulranumab were treated with anti-NGF MAbs-coated beads and followed with competitive inhibition of fulranumab in two-step confirmatory assay. Using Melon™ Gel treatment as the confirmatory method, the ADA status for 7 out of 11 mock samples were classified correctly, whereas 11 out of 11 mock samples were classified correctly using the two-step confirmatory method