HCV Genotyping Assay (CE-IVD)

HCV Genotyping Assay (CE-IVD)

Virology

Regulatory Status: CE-IVD, AUSTRALIA-IVD, HSA (Singapore)

DESCRIPTION

Hepatitis C Virus (HCV) infects the liver and symptoms include jaundice, stomach pain, loss of appetite, nausea and fatigue. HCV has been classifed into six major genotypes, each containing multiple subtypes. Professional guidelines recommend that HCV genotyping be performed to guide selection of the most appropriate antiviral therapy. Genotyping is based on clinically-relevant genes: NS3, NS5A and NS5B. Genotypes 1 – 6 and RAS calling for subtypes 1a and 1b can be obtained from a single run. The HCV genotyping test offered by ADL is a HSA-registered next generation sequencing-based in vitro diagnostic test intended for viral genotyping in patients diagnosed with Hepatitis C Virus infection from human plasma or serum.
The genotyping information from this test will help in the management of patients with HCV. Results should be used in conjunction with other available laboratory and clinical information and are not intended for use as a stand-alone diagnostic test.

SAMPLE REQUIREMENT

Minimum volume: 2 mL of serum or plasma.  Samples should be collected from patients positive for HCV RNA with a viral load of > 1,000 IU/ML.

TURNAROUND TIME

5 working days

GENOTYPES AND SUBTYPES

Target Genes Number of Amplicons Target Genotypes and Subtypes
NS5B 1 1a, 1b, 2, 3, 4, 5, 6
NS3 1 1a, 1b
NS5A 1 1a, 1b
System Control 1 NA
Total 4

FEATURES AND BENEFITS

Targeting clincially-relevant genes:
  • Genotyping based on NS5B
  • Calling of resistance-associated variance based on NS3, NS5A and NS5B according to target regions of directly acting anti-viral drugs
Performance of the test
  • Limit of Detection: ≥ 1000 HCV IU/mL for genotypes 1a, 1b, 2, 3 and 4; ≥ 2000 HCV IU/mL for genotypes 5 and 6
  • Non-interference: No cross-reactivity with HAV, HBV, HIV, CMV, EBV, BKV, Dengue virus or genomic DNA
  • Sensitivity: 96.9%
  • Specificity: 99.5%
  • Diagnostic Accuracy: 99.11%

 

REFERENCES (Technology Comparisons: NGS vs PCR/Sanger)

  1. G. Dirani, et. al. (2018) A novel next generation sequencing assay as an alternative to currently available methods for hepatitis C virus genotyping, Journal of Virological Methods, 251: 88-91. https://doi.org/10.1016/j.jviromet.2017.10.005
  2. Wales, et. Al.(2017) Hepatitis C Virus Genotyping Using Next-Generation Sequencing: An Efficient Alternative to Sanger Sequencing. Archives of Pathology & Laboratory Medicine: 141(3):323-324. https://doi.org/10.5858/arpa.2016-0338-LE