Table 7.
Qualification precision results. Assay precision was assessed via the coefficient of variation (CV) for samples with net mean responses ≥0.1%. Values are averaged over animal and peptide pool. All 4 CVs were evaluated, but only day and vial were used for qualification pass/fail. Pass if: for samples with mean response %<0.2, CV must be≤70%; for all other samples, CV≤35%.
| Measurement | Mean response (% of CD4 or CD8 T cells) |
Avg CV% day |
Avg CV% vial |
Avg CV% operator |
Avg CV% residual error |
Avg CV% total |
|---|---|---|---|---|---|---|
| CD4 IFNγ | 0.27 | 7.7 | 0 | 6.4 | 21.7 | 26.1 |
| CD4 IL-2 | 0.29 | 10.3 | 0 | 7.8 | 19.5 | 25.6 |
| CD4 TNF | 0.60 | 7.0 | 0.5 | 5.2 | 16.3 | 20.0 |
| CD8 IFNγ | 0.71 | 13.2 | 2.0 | 14.3 | 28.2 | 39.7 |
| CD8 IL-2 | 0.26 | 17.4 | 0 | 21.7 | 24.9 | 44.1 |
| CD8 TNF | 0.58 | 11.2 | 0.9 | 15.6 | 18.3 | 30.1 |