The Abbott RealTime HCV Genotype II assay consists of 2 reagent kits: 

• Abbott RealTime HCV Genotype II Amplification Reagent Kit
• Abbott mSample Preparation 

Covers All Major US Genotypes

The Abbott RealTime HCV Genotype II assay detects genotypes 1, 2, 3, 4, and 5 and subtypes 1a and 1b.

Accurate Genotype Detection

Accuracy of the Abbott RealTime HCV Genotype II assay was determined in comparison to a validated nucleotide sequencing reference method.

The Abbott RealTime HCV GT II assay demonstrated less hands-on time and processing time than the LiPA v.2.0 RUO assay.

Indications and Limitations of Use

Intended Use

The Abbott RealTime HCV Genotype II is an in vitro reverse transcription-polymerase chain reaction (RT-PCR) assay for use with the Abbott mSample Preparation System reagents and with the Abbott m2000sp and m2000rt instruments for the qualitative identification of hepatitis C virus (HCV) genotypes 1, 1a, 1b, and 2 -5 in plasma or serum from individuals chronically infected with HCV. The Abbott RealTime HCV Genotype II is intended for use as an aid in the management of HCV-infected individuals and in guiding the selection of therapeutic treatment indicated for the above listed genotypes. The assay is intended for use on patients who are chronically infected with HCV, are being considered for antiviral treatment, and are positive for HCV RNA. The Abbott RealTime HCV Genotype II assay is not for screening blood, plasma, serum or tissue donors for HCV.

Limitations of the Procedure

• Human serum or plasma (ACD-A, CPD, potassium EDTA, or sodium EDTA) specimens may be used with the Abbott RealTime HCV Genotype II assay. The use of other anticoagulants has not been validated with the Abbott RealTime HCV Genotype II assay.
• 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.
• A specimen with an interpretation of “No Genotype Result” cannot 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.
• 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.

Warnings and Precautions

The Abbott RealTime HCV Genotype II assay is not for screening blood, plasma, serum or tissue donors for HCV. 

CAUTION:

United States Federal law restricts this device to sale and distribution to or on the order of a physician or to a clinical laboratory; and use is restricted to, by, or on the order of a physician.