TABLE 1.
Results of HCV Ag/Ab assay for the 12 HCV RNA-positive, anti-HCV Ab-negative blood donor samples included in panel 1
| Case no. | Clinical contexta | Genotype | HCV RNA level (IU/ml)b | HCV core Ag result by blood screening assay (S/CO)c | trak-C assay result (Ag level [pg/ml]) | Monolisa HCV Ag/Ab ULTRA result (S/CO)c |
|---|---|---|---|---|---|---|
| 1 | WP | 1a | 1.6 × 107 | + (20.6) | + (183.5) | + (5.95) |
| 2 | IS | 1b | 8 × 105 | + (2.14) | + (48.8) | − (0.65) |
| 3 | WP | 2a/2c | 8 × 106 | + (20.1) | + (>217) | Gray zone (0.90) |
| 4 | WP | 1b | 6.5 × 105 | + (3.05) | + (51.7) | − (0.40) |
| 5 | WP | 3 | 3.6 × 104 | − (0.27) | + (2.8) | − (0.10) |
| 6 | WP | 1 | 8 × 107 | + (>53.8) | + (>217) | + (>6.64) |
| 7 | WP | 1a | 4.7 × 107 | + (49) | + (>217) | Gray zone (0.93) |
| 8 | IS | 1a | 1.7 × 107 | NAd | + (>217) | + (1.20) |
| 9 | WP | 3a | 1.2 × 105 | − (0.45) | + (15.2) | − (0.10) |
| 10 | IS | 4a | >5 × 105 | + (9.1) | + (>278) | + (2.58) |
| 11 | ? | 3a | 7 × 106 | + (1.3) | + (105) | − (0.13) |
| 12 | WP | 1b | 1.8 × 107 | + (38) | + (>240) | − (0.50) |
a
WP, window period; IS, immunosilent chronic carrier.
b
Amplicor HCV Monitor Roche v 2.0.
c
S/CO, OD for the sample/cutoff OD; S/CO ≥ 1 = positive; 0.9 ≤ S/CO < 1 = gray zone.
d
NA, not available.