Table 3.
Precision of the CAP/CTM HCV test, v2.0, with an HCV-positive clinical specimen (genotype 1) or armored HCV RNA diluted in an EDTA plasma or serum matrixa
Nominal concn (IU/ml) | Source materialb | Precision as Total SD [log10] IU/ml |
|||||
---|---|---|---|---|---|---|---|
EDTA plasma |
Serum |
||||||
Lot 1 | Lot 2 | Lot 3 | Lot 1 | Lot 2 | Lot 3 | ||
300 | CS | 0.22 | 0.07 | 0.09 | 0.07 | 0.05 | 0.09 |
3,000 | CS | 0.15 | 0.07 | 0.07 | 0.06 | 0.06 | 0.06 |
30,000 | aRNA | 0.06 | 0.05 | 0.07 | 0.05 | 0.07 | 0.08 |
300,000 | CS | 0.08 | 0.07 | 0.08 | 0.05 | 0.05 | 0.04 |
3,000,000 | aRNA | 0.14 | 0.04 | 0.07 | 0.11 | 0.06 | 0.07 |
100,000,000 | aRNA | 0.07 | 0.05 | 0.11 | 0.07 | 0.06 | 0.08 |
The total SD represents the total SD of the log-transformed mean titers for each of the concentrations, matrices, and reagent lots.
CS, clinical specimen; aRNA, armored RNA.