Table 2.
Overall sensitivity and specificity of the Genedrive® HCV ID Kit compared with the sensitivity and specificity of the Abbott RealTime HCV Viral Load Assay at different detection thresholds.
| Abbott: 12–30 IU/mL Threshold |
Total | Diagnostic Accuracy (95% CI) | |||
|---|---|---|---|---|---|
| Target Detected |
Target Undetected |
||||
| Genedrive® HCV ID assay | Positive | 205 | 1 | 206 |
Sensitivity: 96.2% (92.7–98.4) Specificity: 99.5% (97.4–100) |
| Negative | 8 | 212 | 220 | ||
| Total | 213 | 213 | 426 | ||
| Abbott: 1000 IU/mL threshold | Total | ||||
| Target detected | Target undetected | ||||
| Genedrive® HCV ID assay | Positive | 205 | 1 | 206 |
Sensitivity: 100% (98.2–100) Specificity: 99.5% (97.5–100) |
| Negative | 0 | 220 | 220 | ||
| Total | 205 | 221 | 426 | ||
| Abbott: 2362 IU/mL threshold | Total | ||||
| Target detected | Target undetected | ||||
| Genedrive® HCV ID assay | Positive | 203 | 3 | 206 |
Sensitivity: 100% (98.2–100) Specificity: 98.7 (96.1–99.7) |
| Negative | 0 | 220 | 220 | ||
| Total | 203 | 223 | 426 | ||
Abbreviations: IU: International Units; CI: Confidence interval.