Table 1.
Qualification parameters, methods, FDA guidance, and derived results. Assay performance and characteristics are reported along with summarized FDA guidance for the five HIV bnAbs tested.
| Derived Assay Criteria |
|||||||
|---|---|---|---|---|---|---|---|
| Qualification parameter | Experimental design | FDA Guidance | 10–1074 | 3BNC117 | 3BNC117LS | PGDM1400 | PGT121 |
| Serum dilution factor | Dilutions of anti-id in multiple concentrations of PNHS were used to estimate matrix effects and identify a suitable serum dilution. | < 1:100 | 1:12 | 1:12 | 1:12 | 1:6 | 13:1 |
| Sensitivity | Dilutions of anti-id were run in duplicate. Assay sensitivity (ng/mL of ADA in serum) was determined using the qualification cut point. | < 100 ng/mL | 22.9 | 11.1 | 22.9 | 0.293 | 31.3 |
| Repeatability | QC samples were run by multiple operators over several days. Within plate % CVs were calculated. | < 20% | 4.7% | 3.3% | 5.5% | 6.5% | 7.5% |
| Intermediate precision | QC samples were run by multiple operators over several days. Between plate % CVs were calculated. | < 20% | 2.1–4.9% | 1.9–5.9% | 3.1–4.5% | 6.0–6.5% | 4.8–6.7% |