Hepatitis C (HCV) virus infection is often chronic and can lead to the development of liver cirrhosis and hepatocellular carcinoma. Therapies for HCV are limited and at present no effective vaccine is available. Serological diagnostic assays are available, but in some (especially immunocompromised) patients, there is a long seronegative window immediately after infection, preventing a reliable diagnosis. At least 6 major genotypes have been recognized, each with a number of subtypes. The likelihood of a response to antiviral therapy is clearly associated with the HCV genotype, and genotyping is clinically important in choosing the appropriate duration of HCV therapy.
Detection and quantification
- Detection of HCV RNA (all known genotypes)
- Based on the nested, reverse transcriptase polymerase chain reaction (RT-PCR)
- Targeting the 5' untranslated region (UTR) of the viral genome
- Quantitation of HCV RNA (viral load testing)
Genotyping
- Simultaneous identification of genotypes 1, 2, 3, 4, 5, and 6 and over 25 subtypes
- Based on RT-PCR followed by a reverse hybridization line probe assay (LiPA)
- Targeting the 5' UTR and core region
Screening for mutations associated with resistance to antiviral therapy
- Based on RT-PCR followed by sequence analysis of the relevant region of the genome (e.g., the NS5b region encoding the RNA-dependent, RNA polymerase or the NS3 region encoding the viral protease/helicase)
- NS3, NS4A, NS4B, NS5A and NS5B regions can be analysed
- Monitoring of mutations during antiviral therapy by pair-wise or group-wise sequence comparisons
- Tailor-made reporting (including FDA compatible) formats available
Phylogenetic analysis
- Determination of relatedness between different strains
- For outbreak management and epidemiologic studies
- Based on RT PCR followed by DNA sequencing analysis
- Targeting the NS5B region (preferred target)
Samples
Serum or EDTA plasma. Heparinized blood can not be used. Minimal volume 1 ml. Ship on dry ice and store at -20°C.
