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Evaluation of HCV NAT Positive/Anti-HCV Antibody Negative Samples - samples identified by MP-NAT in blood donors from U.S.

10E1 0.01 0.1 1 10 100 1000 10E0 10E2 10E3 10E4 10E5 10E6 10E7 10E8 10E9

Cutoff HCV RNA (Copies/ml) S/CO

HCV Combo Assay #1– 47 of 55 (85.5%) HCV Combo Assay #2 19 of 55 (35%)

8 nonreactive samples 100-70,000 copies/mL; 1st reactive sample = 110,000

14

Research HCV Combo Assay

Correlation with HCV RNA titer

R2 = 0.9279

CO = 44,000 RNA copies/mL 95% CI = 8300 - 229,000 copies/mL

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log RNA copies/mL Ag log S/CO .

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