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Epic Code LAB848 Hepatitis C Virus Genotype by Sequencing

Important Note

Order as Reference Miscellaneous #LAB848; indicate complete test name when ordering.

Additional Codes

ARUP code: 0055593

Test Name Alias

HEPCGENO | Hepatitis C Genotype | HCV | HCV 5'UTR Genotype | HCV 5'UTR Sequencing | HCV Genotype | HCV Sequencing | HCV, Subtype

 

Clinical Information

Assay does not differentiate between type 1a and 1b, or between rare type 6 and type 1. Do not order prior to molecular confirmation of positive hepatitis C (HCV) screen.

Viral Hepatitis Screening and Diagnosis Algorithm

Specimen Requirements

Specimen Collection: Blood

 

Container(s): Lavender (EDTA), Pink (K2EDTA), Plasma Preparation Tube (PPT) or Serum Separator Tube (SST).

Preferred Volume to Collect: 4 mL

Minimum Volume to Collect: 2 mL

 

Collection Instructions:

  • Separate from cells within 6 hours of collection.
  • LAB: Transfer 2 mL serum or plasma to an ARUP Standard TransportTube. (Min: 0.5 mL)
  • Please submit most recent viral load and test date, if available.

 

Specimen Transport Temperature

Frozen

Rejection Criteria

Heparinized specimens.

Specimen Stability

After separation from cells:

Ambient: Unacceptable

Refrigerated: 72 hours

Frozen: 4 months

Test Frequency

Send Out to ARUP Laboratory

Turn-Around Time: 7 days

Reference Range

By report

Interpretive Data:

Hepatitis C viral RNA is tested using reverse-transcription polymerase chain reaction (RT-PCR) to amplify a specific portion of the 5' untranslated region (5' UTR) 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. Due to high conservation of the 5' untranslated region of the HCV genome, this test has limitations in differentiating subtype 1a from 1b. Therefore, these subtypes will be reported as "1a or 1b." In rare instances, Type 6 virus may be misclassified as Type 1.

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.

Performing Department

Send out to ARUP Ref. Lab

Performing Department Laboratory Location

REFERRAL SEND OUTS

Methodology

Polymerase Chain Reaction/Sequencing

CPT

87902

CDM Code

N/A

Epic Test ID

N/A

Reviewed Date

1/23/2024