TABLE 1.
Reproducibility | Sample testeda | No. of replicates | Expected HCV virus load (log10 IU/ml) | Observed mean HCV virus load ± SD (log10 IU/ml) | Coefficient of variation (%) |
---|---|---|---|---|---|
Intra-assay | Calibrator A | 5 | 3.00 | 3.03 ± 0.06 | 1.83 |
Standard | 5 | 4.70 | 4.77 ± 0.02 | 0.23 | |
Calibrator B | 5 | 7.03 | 7.01 ± 0.02 | 0.35 | |
Interassay | Calibrator A | 15 | 3.00 | 3.01 ± 0.05 | 1.66 |
Standard | 15 | 4.70 | 4.64 ± 0.10 | 2.06 | |
Calibrator B | 15 | 7.03 | 6.96 ± 0.04 | 0.59 |
The calibrators were supplied by Abbott Molecular: calibrator A, 1,000 IU/ml; calibrator B, 1.07 × 107 IU/ml. The standard represents the dilution of the HCV RNA high-positive control with a virus load of 5.0 ×104 IU/ml.