Which hepatitis C genotype tests are available?

Updated: Oct 07, 2019
  • Author: Vinod K Dhawan, MD, FACP, FRCPC, FIDSA; Chief Editor: BS Anand, MD  more...
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Answer

In June 2013, the FDA approved the Abbott RealTime HCV Genotype II test, which, by analyzing a sample of an infected patient’s blood plasma or serum, can differentiate HCV genotypes 1, 1a, 1b, 2, 3, 4, and 5. This test is approved for use in adult, non-immunocompromised patients with known chronic HCV infection but has not been approved for diagnostic use or as a screening test for HCV genetic material. FDA approval was based partly on a comparison of the test's accuracy with that of a validated gene-sequencing method. [63, 64]

Other genotype tests are available, including the following, although none have been approved by the FDA [65] :

  • Trugene HCV 5'NC Genotyping Kit: Based on direct sequencing followed by comparison with a reference sequence database
  • Line Probe Assay (Inno LiPA HCV II): Based on reverse hybridization of PCR amplicons on a nitrocellulose strip coated with genotype-specific oligonucleotide probes
  • Versant HCV Genotyping Assay (INNO-LiPA) 2.0: Next-generation line-probe assay

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