TABLE 4.

Clinical performance of the CIC-HCV RT-PCR assay

SampleViral load (IU/ml)b,cGenotypeCIC-HCV RT-PCR assay result (sample OD value/cutoff value)a
HCVrQβ
169>850,000b2a/2cP (2.580/0.280)P (0.880/0.100)
181>850,000b1P (2.490/0.280)P (0.700/0.100)
700702,000c1aP (2.960/0.280)P (0.620/0.100)
701>2,000,000c1bP (2.010/0.280)P (0.330/0.100)
716819,000c1aP (2.900/0.280)P (0.510/0.100)
171>850,000b1bP (1.620/0.160)P (0.560/0.160)
173>850,000b1bP (1.010/0.160)P (0.850/0.160)
331NDb2a/2cN (0.030/0.160)N (0.150/0.160)
332NDb1N (0.080/0.160)P (0.800/0.160)
71039c3aP (0.460/0.160)P (0.660/0.160)
174>850,000b3aP (0.860/0.100)P (0.770/0.080)
179>850,000b2aP (0.200/0.100)P (0.800/0.080)
336NDb3aN (0.060/0.100)P (0.860/0.080)
697NDc1bN (0.080/0.100)P (0.660/0.080)
176>850,000b1bP (2.230/0.280)P (2.770/0.260)
229600b1bP (0.790/0.280)P (2.680/0.260)
  • a Results of the CIC-HCV RT-PCR assay are expressed as being positive (P) or negative (N).

  • b Viral load determined by Amplicor HCV Monitor 2.0 (Roche) (dynamic range, 600 to 850,000 IU/ml).

  • c Viral load determined by quantitative RT-PCR (NGI) (dynamic range, 39 to 2,000,000 IU/ml).