Table 1. Conversion factor for each cycle and comparison of values pre and post-conversion as 2-, 3- and 5-fold difference from reference laboratory.
Testing cycle/parameter | Calculated conversion factor (manufacturer's values) | 2-fold raw (%) | 2-fold post-conversion (%) | 3-fold raw (%) | 3-fold post-conversion (%) | 5-fold raw (%) | 5-fold post-conversion (%) |
Baseline conversion factor determination (n = 21) | 0.43 (NA) | 7 (33) | 14 (67) | 11 (52) | 17 (81) | 81 (86) | 18 (86) |
1st revalidation cycle (n = 25) | 0.43 (NA) | 13 (52) | 15 (60) | 17 (68) | 20 (80) | 21 (84) | 23 (92) |
2nd revalidation cycle (n = 22) | 0.47 (NA) | 15 (68) | 13 (59) | 18 (82) | 19 (86) | 22 (100) | 21 (95) |
3rd revalidation cycle (n = 12) | 0.47 (0.47) | 3 (25) | 11 (92) | 8 (67) | 11 (92) | 12 (100) | 11 (92) |
4threvalidation cycle (n = 29) | 0.47 (0.47) | 6 (21) | 24 (83) | 15 (52) | 26 (90) | 26 (90) | 28 (97) |
The manufacturer also provided a lot specific efficiency value for cycles 3 and 4 which was incorporated into the instrument software after July 2012. The conversion factor determined by the manufacturer is provided in brackets for cycles 3 and 4. The % is calculation of the percentage of the reference laboratory's results.