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Table 2 Traceability of Sansure HCV assay assessed by mean log10 HCV RNA viral load using the WHO standard (HCV Genotype 1a) - within assay rangesa

From: Traceability, reproducibility and clinical evaluation of Sansure Realtime HCV RNA assay

Expected HCV RNA (IU/ml) Expected HCV RNA (log10 IU/ml) Observed Mean HCV RNA (log10 IU/ml) Difference of Observed and Expected HCV RNA (log10 IU/ml) Standard Deviation of the mean HCV RNA (log10 IU/ml)
25 1.398 1.596 0.198 0.032
50 1.699 1.812 0.113 0.081
100 2 2.173 0.173 0.050
1000 3 2.969 −0.031 0.043
10000 4 3.945 −0.055 0.143
  1. Each test had 27 results with panel members within the range of the assay
  2. a The limit of detection (LOD) of Sansure Realtime HCV assay is 25 IU/ml and its linear range is defined as from 5.0E + 01 IU/ml to 1.0E + 08 IU/ml