TABLE 6.

Results of precision testing for N. gonorrhoeae

Panel memberaNo. testedbNo. positiveMean delta cycleSDc
Within-run componentBetween-run componentBetween-lot componentBetween-site componentTotal
115015013.430.3820.1720.0000.1470.444
21491497.890.4300.0640.0970.1660.475
31491498.240.2700.1490.0570.0600.319
41500
51481487.800.2310.1980.0400.1850.358
61470
715015013.590.5390.1910.0000.2050.608
81490
9148560.580.3860.0000.0000.1200.404
  • a N. gonorrhoeae concentrations were targeted approximately to 2,000 CFU/assay in members 1 and 7 and to 20 CFU/assay in members 2, 3, and 5. Member 9 was targeted to 0.1 CFU/assay, below the claimed assay limit of detection. Members 4, 6, and 8 did not contain any N. gonorrhoeae 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 = 148), including those beyond the assay cutoff, resulted in a total SD of 0.978. The total variability contains within-run, between-run, between-lot, and between-site variability.