TABLE 4.
Clinical performance of AMPLICOR HCV Test v2.0
| Site(s) | Specimen type | Total no. of specimens | No. of specimens with indicated resulta
|
% Prevalence | Versus HCV serology
|
||||
|---|---|---|---|---|---|---|---|---|---|
| TP | TN | FP | FN | % Sensitivity (95% CI)b | % Specificity (95% CI) | ||||
| EU | Serum | 136 | 113 | 13 | 0 | 10 | 83.1 | 91.9 (85.6–96.0) | 100 (73.5–100) |
| VCU | Serum | 343 | 212 | 117 | 3 | 11 | 61.8 | 95.1 (91.3–97.5) | 97.5 (92.9–99.5) |
| UM | Serum | 266 | 173 | 77 | 3 | 13 | 65.0 | 93.0 (88.3–96.2) | 97.5 (89.4–99.2) |
| UM | Plasma | 35 | 25 | 8 | 0 | 2 | 71.4 | 92.6 (75.7–99.1) | 100 (63.1–100) |
| UW | Serum | 156 | 124 | 19 | 1 | 12 | 79.5 | 91.2 (85.1–95.4) | 95.0 (75.1–99.9) |
| UW | Plasma | 153 | 119 | 19 | 2 | 13 | 77.8 | 90.2 (83.7–94.7) | 95.2 (69.6–98.8) |
| All | Serum | 901 | 622 | 226 | 7 | 46 | 69.4 | 93.1 (90.9–94.9) | 97.0 (93.9–98.8) |
| Plasma | 188 | 144 | 27 | 2 | 15 | 76.6 | 90.6 (84.9–94.6) | 93.1 (77.2–99.2) | |
a
TP, true positive; TN, true negative; FP, false positive; FN, false negative in comparison with HCV serology results as defined in Table 3.
b
CI, confidence interval.