Ordering Recommendation
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.
Mnemonic
Methodology
Polymerase Chain Reaction/Sequencing
Performed
Sun-Sat
Reported
3-5 days
New York DOH Approval Status
Specimen Required
Lavender (EDTA), Pink (K2EDTA), Plasma Preparation Tube (PPT) or Serum Separator Tube (SST).
Separate from cells within 6 hours of collection. Transfer 2 mL serum or plasma to an ARUP Standard Transport Tube. (Min: 0.5 mL)
Frozen.
Heparinized specimens.
Please submit most recent viral load and test date, if available.
After separation from cells: Ambient: Unacceptable; Refrigerated: 72 hours; Frozen: 4 months.
Reference Interval
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.
Laboratory Developed Test (LDT)
Note
This test may be unsuccessful if the HCV RNA viral load is less than log 3.6 or 4000 IU/mL.
Hotline History
CPT Codes
87902
Components
Component Test Code* | Component Chart Name | LOINC |
---|---|---|
0055593 | HCV Genotype by Sequencing | 32286-7 |
Aliases
- HCV 5'UTR Genotype
- HCV 5'UTR Sequencing
- HCV Genotype
- HCV Genotyping
- HCV Sequencing
- HCV, Subtype