Ordering Recommendation

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. 

Mnemonic
HCV CORE
Methodology

Polymerase Chain Reaction/Sequencing

Performed

Sun-Sat

Reported

5-8 days

New York DOH Approval Status
This test is New York DOH approved.
Specimen Required
Patient Preparation
Collect

Lavender (EDTA), pink (K2EDTA), plasma preparation tube, or serum separator tube (SST).

Specimen Preparation

Separate serum or plasma from cells. Transfer 2 mL serum or plasma to an ARUP Standard Transport Tube. (Min: 0.5 mL)

Storage/Transport Temperature

Frozen.

Unacceptable Conditions

Heparinized specimens.

Remarks

Please submit most recent viral load and test date if available.

Stability

Ambient: Unacceptable; Refrigerated: 72 hours; Frozen: 4 months

Reference Interval

By report

Interpretive Data

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.

Note

This test may be unsuccessful if the HCV RNA viral load is less than log 5.0 or 100,000 IU/mL.

Hotline History
N/A
CPT Codes

87902

Components
Component Test Code* Component Chart Name LOINC
2006899 Hepatitis C High-Res Genotype by Seq 32286-7
* Component test codes cannot be used to order tests. The information provided here is not sufficient for interface builds; for a complete test mix, please click the sidebar link to access the Interface Map.
Aliases
  • 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)
Hepatitis C Virus High-Resolution Genotype by Sequencing