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.

New York DOH Approval Status

This test is New York state approved.

Specimen Required

Patient Preparation
Collect

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

Specimen Preparation

Separate from cells ASAP or within 24 hours of collection. 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 (PCR)/Sequencing

Performed

Sun-Sat

Reported

3-5 days

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 bidirectionally 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.

Compliance Category

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

N/A

CPT Codes

87902

Components

Component Test Code* Component Chart Name LOINC
0055593 HCV Genotype by Sequencing 92731-9
* 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 5'UTR Genotype
  • HCV 5'UTR Sequencing
  • HCV Genotype
  • HCV Genotyping
  • HCV Sequencing
  • HCV, Subtype
Hepatitis C Virus Genotype by Sequencing