Table 10 Performance Summary of the Aptima, Roche and Abbott Assays
Assay | 95% Limit of Detection WHO standarda (IU/mL) | Lower limit of Quantitation (IU/mL) | Linear Range (IU/mL) | Precision (log SD) |
|---|---|---|---|---|
Aptima HCV Quant Dx | plasma 4.3 serum 3.9 | 10 | 10-100,000,000 | 0.14 at 2.06 log IU/mL (115 IU/mL) |
Abbott RealTime | plasma 10.5 serum 7.2 | 12 | 10-100,000,000 | 0.10 at 1.96 log IU/mL (91 IU/mL) |
Roche Ampliprep/ COBAS Taqman HCV test v2.0 | plasma 11 serum 12 | 15 | 10-100,000,000 | </= 0.09 at 2.48 log IU/mL (300 IU/mL) |