TABLE 10.
No. of HCV RNA copies/ml | Correct result | AMPLICOR
|
COBAS AMPLICOR
|
||||
---|---|---|---|---|---|---|---|
No. of specimens tested | % Correct result | 95% CIb | No. of specimens tested | % Correct result | 95% CI | ||
0 | Negative | 153 | 99.3 | 96.4–99.9 | 171 | 100 | 97.9–100 |
200 | Positive | 38 | 100 | 90.1–100 | 43 | 100 | 91.8–100 |
300 | Positive | 38 | 100 | 90.8–100 | 42 | 100 | 91.6–100 |
500 | Positive | 38 | 97.4 | 86.2–99.9 | 43 | 97.7 | 87.1–99.9 |
50,000 | Positive | 38 | 100 | 90.8–100 | 43 | 100 | 91.8–100 |
Pooled data from four test sites (EU, UM, UW, and Roche Molecular Systems). Results for five PI panel members were excluded from the data analysis (one in AMPLICOR and four in COBAS AMPLICOR).
CI, confidence interval.