Table 3: Maximum incubation time (3 days) between blood collection in EDTA tubes and initial processing prior to loss of common T and B cell surface markers.
For baseline analysis (left side), a range of −20% to +20% of the Day 1 (D1) value for all samples and populations was used for quantitative analysis. Subsequent timepoint population values were examined and flagged if out of range. The out-of-range rate was calculated at each timepoint by the number of flagged populations out of the 20 total parameters examined per timepoint (5 populations for each of the 4 samples per timepoint). Total number of flags and out of D1 range rates are shown on the left. For inter-assay precision analysis (right side), the %CV for each population at each timepoint in comparison to the D1 value was determined. Values were flagged if out of range. Total number of flags and out of inter-assay range rates are shown on the right.
Parameters Out of D1 Baseline Range | Parameters Out of D1 Inter-Assay Precision Range | |||||||
---|---|---|---|---|---|---|---|---|
Post-Collection Timepoint | D2 | D3 | D4 | D7 | D2 | D3 | D4 | D7 |
CD3+ | 0 | 0 | 1 | 2 | 0 | 0 | 1 | 2 |
CD4+ | 0 | 0 | 0 | 1 | 0 | 0 | 2 | 2 |
CD8+ | 0 | 1 | 2 | 1 | 0 | 2 | 2 | 2 |
CD3− | 1 | 0 | 3 | 4 | 0 | 0 | 1 | 3 |
CD19+CD22+ | 2 | 2 | 3 | 3 | 2 | 2 | 3 | 3 |
Total Number of Flags | 3 | 3 | 9 | 14 | 2 | 4 | 9 | 12 |
Out-of-Range Rate (%) | 15 | 15 | 45 | 55 | 10 | 20 | 45 | 60 |