Table VI.
IgG4 Cutpoint Determination in the Assays Using the Biotin Mouse Anti-human IgG4 Detector
| Anti-CHO-HCP negative samples | lgG4 (OD) | |
|---|---|---|
| 1:10 | 1:25 | |
| HS-6 | 0.181 | 0.140 |
| HS-23 | 0.077 | 0.074 |
| HS-B14 | 0.086 | 0.078 |
| HS-63 | 0.163 | 0.119 |
| HS-B13 | 0.249 | 0.094 |
| HS-B20 | 0.131 | 0.094 |
| HS-B12 | 0.120 | 0.107 |
| HS-B16 | 0.094 | 0.084 |
| Mean NS OD | 0.137 | 0.099 |
| SD | 0.058 | 0.022 |
| cutpoint OD | 0.274 | 0.198 |
The cutpoint OD was calculated by multiplying the mean of the anti-CHO-HCP negative sample (NS) ODs obtained in the IgG4 assay by a multiplication factor of 2. Samples were tested at dilutions of 1:10 and 1:25
NS negative sample