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. 

New York DOH Approval Status

This test is New York state 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

Methodology

Polymerase Chain Reaction/Sequencing

Performed

Sun-Sat

Reported

5-8 days

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.

This test was developed and its performance characteristics determined by ARUP Laboratories. It has not been cleared or approved by the US Food and Drug Administration. This test was performed in a CLIA certified laboratory and is intended for clinical purposes.

Compliance Category

Laboratory Developed Test (LDT)

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