Table 5. Abbott RealTime HCV Genotype II– Accuracy Analysis for HCV Genotypes 1a and 1b Number of Number of HCV Total

Genotype Number of Eligible ResultsRealTime Results

Excluding in Agreement By Eligible abSequencingResults "No Result" with Sequencing

1a

1b

a Percent Correctly Identified (Accuracy) LL UL cd144 140 122 115 139 99.3 (139/140) 96.1 99.9 114 99.1 (114/115) 95.2 99.8 eThis number includes all valid Abbott RealTime HCV Genotype II assay and Sequencing results and excludes

4 mixed infection results by the Abbott RealTime HCV Genotype II assay. b For HCV subtypes 1a and 1b, Abbott RealTime HCV Genotype II Assay results “HCV Detected, No Genotype Result,”

“HCV not detected,”or HCV genotype “1” without being subtyped are considered “No Result.” c 95% Lower and Upper Confidence Interval limits. d Four out of 144 HCV genotype 1a samples were identified as genotype 1 only but not as subtype 1a. e Seven out of 122 HCV genotype 1b samples were identified as genotype 1 but not as subtype 1b.

The overall Abbott RealTime HCV Genotype II “No Result” rate for all HCV genotypes combined was 1.9% (11/575). Overall, HCV genotype 1 samples were not subtyped in 4.1% (11/266) of specimens: 2.8% (4/144) for subtype 1a and 5.7% (7/122) for subtype 1b.

Analytical Specificity

Potentially Interfering Substance

The susceptibility of the Abbott RealTime HCV Genotype II assay to interference by elevated levels of potentially interfering substances was evaluated in two studies.

In the first study, HCV negative plasma samples and plasma samples containing 10,000 IU/mL of HCV genotype 2 armored RNA were spiked with high levels of hemoglobin (500 mg/dL), bilirubin (20 mg/dL), protein (9 g/dL), or triglycerides (3000 mg/dL) and tested. In the second study, HCV negative plasma samples and plasma samples containing 1000 IU/mL of HCV genotype 1 virus were spiked with high levels of hemoglobin (2 g/L), bilirubin (342 uM), protein (120 g/L), or triglycerides (37.34 mM) and tested.

No interference in the performance of the Abbott RealTime HCV Genotype II assay was observed in the presence of the endogenous substances for all HCV positive and negative samples tested.

Two studies were conducted to assess the susceptibility of the assay to potential interference from high levels of drugs commonly prescribed for the treatment of hepatitis C virus (HCV) and other related diseases. Antivirals and antibiotics at concentrations in excess of peak plasma or serum levels were tested. The drugs listed below were tested in five pools in which each drug was present in excess of reported peak plasma or serum levels.

Each drug pool was spiked into an HCV serologically negative plasma aliquot and HCV positive plasma aliquot (HCV genotype 2 armored RNA at 10,000 IU/mL in Study 1 and HCV genotype 1 virion at 1000 IU/mL in Study 2) for testing. Non-spiked aliquots were used as controls. No interference in the performance of the Abbott RealTime HCV Genotype II assay was observed in the presence of the following drugs for all HCV positive and negative samples tested: