TABLE 1.

COBAS AMP HCV 2.0 analytical sensitivity after AMPLICOR manual standard-volume sample processing

Amt of HCV RNAa (IU/ml)Replicates (n)Negative result (A660 < 0.15)Equivocal result (0.15 ≤ A660 < 1.0)Positive result (A660 ≥ 1.0)
n% (95% CI)n% (95% CI)n% (95% CI)
1002613.9 (0.1-19.6)00 (0-13.2)2596.2 (80.4-99.9)
752613.9 (0.1-19.6)00 (0-13.2)2596.2 (80.4-99.9)
602600 (0-13.2)415.4 (4.4-34.9)2284.6 (65.1-95.6)
02626100 (86.8-100)00 (0-13.2)00 (0-13.2)
  • a Determined with dilutions of the First WHO HCV International Standard for Nucleic Acid Amplification Technology Assays for HCV RNA (standard 96/790).