TABLE 5.
Panel membera | No. testedb | No. positive | Mean delta cycle | SDc |
||||
---|---|---|---|---|---|---|---|---|
Within-run component | Between-run component | Between-lot component | Between-site component | Total | ||||
1 | 150 | 150 | 14.78 | 0.300 | 0.194 | 0.066 | 0.137 | 0.388 |
2 | 149 | 149 | 15.15 | 0.385 | 0.139 | 0.285 | 0.000 | 0.499 |
3 | 149 | 149 | 3.12 | 0.591 | 0.241 | 0.000 | 0.047 | 0.640 |
4 | 150 | 150 | 8.89 | 0.385 | 0.156 | 0.169 | 0.162 | 0.477 |
5 | 148 | 0 | ||||||
6 | 148 | 148 | 16.88 | 0.167 | 0.207 | 0.149 | 0.215 | 0.373 |
7 | 150 | 0 | ||||||
8 | 149 | 1 | 0.67 | |||||
9 | 148 | 103 | 1.09 | 0.637 | 0.000 | 0.192 | 0.000 | 0.665 |
C. trachomatis concentrations were targeted approximately to 4,500 IFU/assay in members 1, 2, and 6 and to 45 IFU/assay in member 4. The concentration for member 3 was targeted approximately to 0.75 IFU/assay and that for member 9 to 0.2 IFU/assay, both below the claimed assay limit of detection. Members 5, 7, and 8 did not contain any C. trachomatis organisms.
Invalid replicates were excluded from the analysis.
The SD is based on positive replicates only. For member 9, analysis of all replicates with a cycle number (n = 133), including those beyond the assay cutoff, resulted in a total SD of 0.966. The total variability contains within-run, between-run, between-lot, and between-site variability.