TABLE 4.
Target viral load of specimens
| Viral load (log10 IU or copies per mL) (N per site) |
|||
|---|---|---|---|
| Study | HBV | HCV | HIV-1 |
| Method comparison | Negative (30) | Negative (30) | Negative (30) |
| 1.0–3.7 (50)a | 1.2–3.5 (50) | 1.3–3.3 (50) | |
| 3.7–6.3 (50) | 3.5–5.7 (50) | 3.3–5.0 (50) | |
| 6.3–9.0 (50) | 5.7–8.0 (50) | 5.0–7.0 (50) | |
| Reproducibility | 1.0 (LLOQ) (30) | 1.2 (LLOQ) (30) | 1.3 (LLOQ) (30) |
| 1.7 (30) | 1.4 (30) | 1.7 (30)c | |
| 3.0 (30) | 2.0 (30) | 2.3 (30) | |
| 3.3 (30) | 4.0 (30) | 3.0 (30) | |
| 4.3 (30) | 5.9 (30) | 5.0 (30) | |
| 5.3 (30) | 6.8 (30) | 5.7 (30) | |
| 9.0 (ULOQ) (30)b,d | 8.0 (ULOQ) (30) | 7.0 (ULOQ) (30) | |
a
Number of specimens for method comparison in each VL range counted based on cobas 6800 result at site 3.
b
Nine pairs of results were excluded from analysis because one result of each pair was outside the linear range (over the ULOQ).
c
One pair of results was excluded from analysis because one result was outside the linear range (below the ULOQ).
d
LLOQ, lower limit of quantitation; ULOQ, upper limit of quantitation.