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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