A specimen with an interpretation of “No Genotype Result” can not be presumed to be negative for the tested genotypes.

Multiple genotype assay results may be caused by a mixed genotype infection, recombination of HCV genotypes, or assay probe cross-reactivity.17

The Abbott RealTime HCV Genotype II assay is capable of detecting both genotypes in a genotype mixture when the concentrations of both genotypes are near equal; however, the assay may not detect the lower concentration genotype.

Performance has not been established with the Abbott RealTime HCV Genotype II assay for HCV genotype 6 specimens.

HCV genotype 6 specimens may generate a HCV genotype 1 result with the Abbott RealTime HCV Genotype II assay based on probe cross-reactivity of the HCV genotype 1 probe.

As with any diagnostic test, results from the Abbott RealTime HCV Genotype II assay should be

interpreted in conjunction with other clinical and laboratory findings. A specimen with a result of “HCV not detected” cannot be presumed to be negative for HCV RNA.

Contamination from HCV positive controls and clinical specimens can be avoided only by good

laboratory practices and careful adherence to the procedures specified in this package insert.

SPECIFIC PERFORMANCE CHARACTERISTICS

REPRODUCIBILITY / PRECISION

The Reproducibility / Precision of Abbott RealTime HCV Genotype II was evaluated by testing a 36-member panel (2 vials of 18 unique members) representing HCV genotypes 1a, 1b, 2, 3, 4, and 5, each at three

concentration levels (500 to 1000, 5000 to 10000, > 50000 IU/mL). All panel members were composed of HCV positive donor units diluted in defibrinated human plasma.

A total of 3 Abbott RealTime HCV Genotype II Amplification reagent lots were used. Each of the 3 clinical sites tested 2 of the 3 Amplification reagent lots for 5 nonconsecutive days each, resulting in a total of 10 runs at each site.

The percent correctly identified rate for the Abbott RealTime HCV Genotype II assay was 99.8% (1070/1072) overall for genotypes 1 – 5. The overall No Result (“HCV detected, No Genotype Result” or “HCV not detected”) rate was 0.2% (2/1072) for genotypes 1 – 5.

Within-run, between-run, between-lot, between-site, and total standard deviations and %CV for cycle number (CN) were determined. The total SD ranged from 0.25 to 1.55, the within-run component SD ranged from 0.15 to 1.37, the between-run component SD ranged from 0.00 to 0.14, the between-lot component SD ranged from 0.00 to 0.73, and the between-site component SD ranged from 0.00 to 0.71.

The results, representative of the reproducibility / precision of the Abbott RealTime HCV Genotype II assay, are summarized in Tables 1 and 2.