TABLE 2.
Limit of detection for the COBAS AMPLICOR and AMPLICOR HCV MONITOR version 2.0 testsa
| Actual input (IU/ml) | % Positive (no. positive/total no. of tests)
|
|
|---|---|---|
| COBAS AMPLICOR format | AMPLICOR format | |
| 1,100 | 100 (48/48) | 100 (48/48) |
| 900 | 95 (91/96) | 99 (94/95)b |
| 700 | 99 (95/96) | 100 (96/96) |
| 600 | 95 (74/78) | 96 (75/78) |
| 500 | 90 (92/102) | 98 (106/108) |
| 400 | 97 (29/30) | 89 (32/36) |
| 300 | 57 (17/30) | 75 (27/36) |
a
Limit of detection was determined with dilutions of the secondary standard that was calibrated against the WHO international standard for HCV (96/790) as described in Results.
b
One reaction was excluded from the calculation because it gave a negative IC result.