Order before initiating hepatitis C virus (HCV) therapy to aid in prognosis and therapy selection when a higher level of subtype resolution is required (ie, non 6a/b vs. type 1 and type 1a vs. 1b). Do not order prior to molecular confirmation of positive HCV screen.
Polymerase Chain Reaction/Sequencing
Lavender (EDTA), pink (K2EDTA), plasma preparation tube, or serum separator tube (SST).
Separate serum or plasma from cells. Transfer 2 mL serum or plasma to an ARUP Standard Transport Tube. (Min: 0.5 mL)
Please submit most recent viral load and test date if available.
Ambient: Unacceptable; Refrigerated: 72 hours; Frozen: 4 months
Hepatitis C viral RNA is assayed using reverse transcription polymerase chain reaction (RT-PCR) to amplify specific portions of both the Core and NS5B regions of the viral genome. The amplified nucleic acid is sequenced bi-directionally using dye-terminator chemistry (ABI). Sequencing data is compared to a database of characterized sequences.
Isolates of hepatitis C virus are grouped into six major genotypes (1-6). These genotypes are subtyped according to sequence characteristics. Sequencing both the Core and NS5B regions allows for subtyping of all confirmed and most provisional genotypes, including differentiation of 1a from 1b and typing of genotype 6.
Compliance Statement B: For laboratory developed tests not using a RUO kit, and for FDA approved, cleared or 510(k) exempt assays with alterations. This test was developed and its performance characteristics determined by ARUP Laboratories. The U. S. Food and Drug Administration has not approved or cleared this test; however, FDA clearance or approval is not currently required for clinical use. The results are not intended to be used as the sole means for clinical diagnosis or patient management decisions.
This test may be unsuccessful if the HCV RNA viral load is less than log 5.0 or 100,000 IU/mL.
|Component Test Code*||Component Chart Name||LOINC|
|2006899||Hepatitis C High-Res Genotype by Seq||32286-7|
- HCV Genotyping
- HCV Core and NS5B Sequencing
- HCV Core Sequencing
- HCV Genotype
- HCV NS5B Sequencing
- HCV prognosis
- HCV Sequencing
- HCV, Subtype (Hepatitis C Virus Genotyping)