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Table 3 Total precision (variance, standard deviation and CV %) of PCR assays for HCV genotypes 2b, 1a, 3a and 6a (mean log10 HCV RNA viral load) at different key concentrations - within assay ranges

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

HCV genotype

Expected HCV RNA (IU/ml)

Expected HCV RNA (log10 IU/ml)

No. tests performed

Observed mean HCV RNA (log10 IU/ml)

Difference of observed and expected HCV RNA (log10 IU/ml)

Total precision variance (SD) of log10 HCV RNA

Lognormal CV%

WWHV303-02 (1b)

25

1.398

9

1.372

−0.026

0.019 (0.137)

10.01

 

50

1.699

9

1.665

−0.034

0.004 (0.067)

4.023

 

100

2

9

1.951

−0.049

0.008 (0.088)

4.486

 

1000

3

9

2.959

−0.041

0.022 (0.150)

5.055

 

10000

4

9

4.015

0.015

0.003 (0.057)

1.410

 

100000

5

9

5.049

0.049

0.002 (0.050)

0.989

WWHV303-04 (2a)

25

1.398

9

1.411

0.013

0.012 (0.109)

7.755

 

50

1.699

9

1.710

0.011

0.009 (0.093)

5.453

 

100

2

9

2.022

0.022

0.016 (0.126)

6.231

 

1000

3

9

2.886

−0.114

0.017 (0.130)

4.513

WWHV303-11 (3a)

25

1.398

9

1.379

−0.019

0.013 (0.113)

8.181

 

50

1.699

9

1.737

0.038

0.007 (0.080)

4.664

 

100

2

9

2.044

0.044

0.019 (0.139)

6.798

 

1000

3

9

2.893

−0.107

0.023 (0.150)

5.185

WWHV303-19 (6a)

25

1.398

9

1.413

0.015

0.013 (0.112)

7.958

 

50

1.699

9

1.712

0.013

0.008 (0.087)

5.100

 

100

2

9

1.980

−0.02

0.026 (0.162)

8.170

 

1000

3

9

2.915

−0.085

0.017 (0.130)

4.478

  1. Abbreviations: SD standard deviation