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 |