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Laboratory Testing for Hepatitis C

Patient Case

Slide 16

April 2008

The final series of tests  to present are the genotyping tests for Hepatitis C. They’re important to determine and guide the duration of anti-HCV treatment because HCV genotypes 1 and 4 requires prolonged treatment duration, namely 48 weeks, versus a shorter duration necessary to achieve desirable responses for those infected with genotypes 2, 3, 5, and 6. These assays are important to provide a genotype that will predict virologic response to anti HCV treatment.

Commercially there are three assays that are available in the US. They differ in the assay method and limit of detection. A method of reverse hybridization of the line probe assay (LiPA) from Siemens Healthcare Diagnostics, which market this assay manufactured by Innogenetics, the lower limit of detection is around 3,700 IU/mL.

Another assay from Siemens Diagnostics which utilizes gene sequencing assay known as to TRUGENE HCV 5’NC, has a lower limit of detection of 5,000 IU/mL.

Finally, an analyte specific reagent assay from third wave technologies, using a proprietary cleavase enzyme, with an oligonucleotide probe assay, known as the Invader HCV Genotyping Assay has a lower limit of detection at 1,000 IU/mL.

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