TABLE 5.

Results of precision testing for C. trachomatis

Panel memberaNo. testedbNo. positiveMean delta cycleSDc
Within-run componentBetween-run componentBetween-lot componentBetween-site componentTotal
115015014.780.3000.1940.0660.1370.388
214914915.150.3850.1390.2850.0000.499
31491493.120.5910.2410.0000.0470.640
41501508.890.3850.1560.1690.1620.477
51480
614814816.880.1670.2070.1490.2150.373
71500
814910.67
91481031.090.6370.0000.1920.0000.665
  • a 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.

  • b Invalid replicates were excluded from the analysis.

  • c 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.