Regulatory Status: CE-IVD, AUSTRALIA-IVD, HSA (Singapore)
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.
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.
5 working days
|Target Genes||Number of Amplicons||Target Genotypes and Subtypes|
|NS5B||1||1a, 1b, 2, 3, 4, 5, 6|