Evaluation of hepatitis C virus RNA RT/PCR qualitative and quantitative second generation assays

Hepatitis C virus (HCV) RNA qualitative and quantitative second generation assays (Amplicor HCV v2.0 and Amplicor HCV Monitor v2.0, respectively) were evaluated by testing serum samples from 132 blood donors anti-HCV positive HCV RNA negative by first generation qualitative assay and 326 viremic pat ients. An HCV RNA transcript was synthesized and ten-fold dilutions were us ed to assess sensitivity. Second generation assays were one log more sensit ive than their respective first generation tests (10(2) copies per mi vs. 1 0(3) for the qualitative tests; 103 copies per mi vs. 10(4) for the quantit ative tests). From the 132 anti-HCV positive RNA negative subjects, 6 (5%) were positive by Amplicor v2.0. Quantification figures by Monitor v2.0 were similar in genotypes 1, 2 and 3, whereas Monitor 1.0 values were higher in genotype 1 than in genotype 2 or 3. In 114 patients, branched-DNA v2.0 obt ained higher values than Monitor v2.0 and Monitor v1.0 (6.6 +/- 0.6 log RNA copies per mi, 6.4 +/- 0.6, and 5.3 +/- 0.7, respectively, P < 0.001). HCV RNA qualitative and quantitative second generation assays are more sensiti ve and genotype independent than first generation assays. (C) 2001 Elsevier Science B.V. All rights reserved.