Accuracy

The accuracy of the Abbott RealTime HCV Genotype II assay was evaluated by testing 266 HCV genotype 1 (144 of genotype 1a, 122 of genotype 1b), 116 HCV genotype 2, 87 HCV genotype 3, 79 HCV genotype 4, and 27 HCV genotype 5 specimens. Nucleotide sequencing was used to determine the reference genotype of each specimen tested in this study.

The percent correctly identified (Accuracy) rate for the Abbott RealTime HCV Genotype II assay while

excluding “No Result” determinations was 99.6% (265/266) for HCV genotype 1, 99.1% (110/111) for HCV genotype 2, 100.0% (86/86) for HCV genotype 3, 98.7% (76/77) for HCV genotype 4, and 100.0% (24/24) for HCV genotype 5, and 99.3% (139/140) for subtype 1a and 99.1% (114/115) for subtype 1b.

The percent correctly identified (Accuracy) rate for the Abbott RealTime HCV Genotype II assay while excluding “No Result” determinations was 99.5% (561/564) overall for genotypes 1 – 5.

The results, representative of the Abbott RealTime HCV Genotype II assay, are summarized in Tables 4 and 5.

Table 4. Abbott RealTime HCV Genotype II– Accuracy Analysis for HCV Genotypes 1 Through 5 HCV

Genotype

By

Sequencing Total Number of Number of Eligible ResultsEligible Excluding aResults "No Result"b Number of RealTime Results in Agreement with Sequencing Percent Correctly Identified (Accuracy) c LL UL

1d 266 266 265 99.6 (265/266) 97.9 99.9 2e 116 111 110 99.1 (110/111) 95.1 99.8

86 86 100 (86/86) 95.7 100 3f 87

77 76 98.7 (76/77) 93.0 99.8 4g 79

24 24 100 (24/24) 86.2 100 5h 27

Overall

a 1 through 5 i575 564 561 99.5(561/564) 98.4 99.8 This number includes all valid Abbott RealTime HCV Genotype II assay and Sequencing results and excludes

11 mixed infection results by the Abbott RealTime HCV Genotype II assay. b 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 Includes HCV genotype 1 and all subtypes of 1 (1a, 1b) results. e Four out of 116 HCV genotype 2 samples were identified as “HCV Detected, No Genotype Result” and one sample was

identified as “HCV not detected.” f One out of 87 HCV genotype 3 samples was identified as “HCV Detected, No Genotype Result.” g Two out of 79 HCV genotype 4 samples were identified as “HCV Detected, No Genotype Result.” h Two out of 27 HCV genotype 5 samples were identified as “HCV Detected, No Genotype Result” and one sample was

identified as “HCV not detected.” I Denotes analysis based on results from HCV genotypes 1 through 5 combined.