TABLE 8.
Performance of the COBAS AMPLICOR HCV Test v2.0 compared to serological, biochemical, and histological findings in the previously treated patient group
| Histological findingsa | Serology results | No. of PCR- positive cases | No. of PCR- negative cases | % Proportion agreeing with EIA result (95% CI)b |
|---|---|---|---|---|
| Elevated ALT and hepatitis | EIA+/RIBA+ | 85 | 2 | 97.7 (91.9–99.7) |
| EIA+/RIBA IND | 4 | 0 | 100.0 (2.5–100.0) | |
| EIA+/RIBA− | 0 | 0 | ||
| EIA− | 0 | 0 | ||
| Normal ALT and hepatitis | EIA+/RIBA+ | 22 | 5 | 81.5 (61.9–93.7) |
| EIA+/RIBA IND | 0 | 1 | 0.0 (0.0–97.5) | |
| EIA+/RIBA− | 0 | 0 | ||
| EIA− | 0 | 0 | ||
| Elevated ALT and no hepatitis | EIA+/RIBA+ | 0 | 1 | 0.0 (0.0–97.5) |
| EIA+/RIBA IND | 0 | 0 | ||
| EIA+/RIBA− | 0 | 0 | ||
| EIA− | 0 | 0 |
a
There were no cases showing normal ALT levels and no hepatitis in this patient group.
b
CI, confidence interval.