雅培RealTime HCV Genotype⒒(18)

Table 1. Abbott RealTime HCV Genotype II Reproducibility Study

Overall Analyses by HCV Genotype for all Sites and Lots Combined

Total Number of Number Percent Correct Detection Rate bb HCV Number of Correctly “No Result” 95% CI c Genotype Eligible Identified Determinations Percent Detected

Resultsa (T) Results (D) Panel NR (NR%) % [D/(T – NR)] LL UL

1a

1b

2

3

4

5

Overalld

a

b180 179 178 179 178 178 1072 180 179 178 179 177 177 1070 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0) 1 (0.6) 1 (0.6) 2 (0.2) 100 (180/180) 100 (179/179) 100 (178/178) 100 (179/179) 100 (177/177) 100 (177/177) 100 (1070/1070) 97.9 97.9 97.9 97.9 97.9 97.9 99.6 100 100 100 100 100 100 100 This number includes all Abbott RealTime HCV Genotype II valid assay results. For HCV genotypes 1 through 5, Abbott RealTime HCV Genotype II assay results “HCV Detected,

No Genotype Result” or “HCV not detected” are considered “No Result.” c 95% Lower and Upper Confidence Interval limits. d Denotes analysis based on assay results from all genotyped panels 1a, 1b, 2, 3, 4, and 5 combined.

Table 2. Abbott RealTime HCV Genotype II Precision Study – Overall Analysis all Sites and Lots Combined

HCV Panel Within-Run Between-Run Between-Lot Between-Site Genotype Concentration Mean Component Component Component Component Totald Panel Level n CN a SD %CV SD %CV SD %CV SD %CV SD %CV 1a High 60 22.95 0.24 1.1 0.14 0.6 0.08 0.3 0.14 0.6 0.32 1.4 1b High 59b 21.65 0.18 0.9 0.01 0.1 0.13 0.6 0.09 0.4 0.25 1.1

b2 High 58 21.81 0.25 1.2 0.00 0.0 0.16 0.7 0.12 0.5 0.32 1.5

3 High 60 20.87 0.47 2.2 0.00 0.0 0.34 1.6 0.00 0.0 0.58 2.8

b4 High 59 22.76 0.57 2.5 0.11 0.5 0.09 0.4 0.17 0.7 0.61 2.7

5 High 58b 21.40 0.41 1.9 0.00 0.0 0.43 2.0 0.71 3.3 0.92 4.3 1a Medium 60 25.29 0.27 1.1 0.00 0.0 0.11 0.4 0.11 0.4 0.31 1.2 1b Medium 60 24.45 0.15 0.6 0.00 0.0 0.10 0.4 0.17 0.7 0.25 1.0 2 Medium 60 23.77 0.26 1.1 0.00 0.0 0.18 0.8 0.16 0.7 0.36 1.5 3 Medium 60 24.15 0.39 1.6 0.00 0.0 0.30 1.3 0.00 0.0 0.49 2.0

b,c0.25 1.0 0.00 0.0 0.27 1.1 0.36 1.5 0.52 2.1 4 Medium 58 24.51

5 Medium 60 25.84 0.63 2.4 0.00 0.0 0.56 2.2 0.00 0.0 0.84 3.3 1a Low 60 29.11 0.27 0.9 0.12 0.4 0.13 0.4 0.08 0.3 0.33 1.1 1b Low 60 27.59 0.27 1.0 0.00 0.0 0.15 0.5 0.21 0.7 0.37 1.3 2 Low 60 25.94 1.37 5.3 0.00 0.0 0.73 2.8 0.00 0.0 1.55 6.0

b3 Low 59 27.67 1.00 3.6 0.00 0.0 0.00 0.0 0.36 1.3 1.06 3.8

4 Low 60 28.30 0.39 1.4 0.00 0.0 0.17 0.6 0.42 1.5 0.60 2.1

c5 Low 59 28.76 0.83 2.9 0.00 0.0 0.45 1.6 0.15 0.5 0.96 3.3

a

b HCV genotype probe specific cycle number. Invalid replicates (8 total) were not included in the analysis.

c Replicates without a HCV genotype identification (2 total) were not included in the analysis. d The total variability contains Within-Run, Between-Run, Between-Lot and Between-Site variability.