Hepatitis C Virus Genotype by Sequencing

0055593
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Example Reports
1a or 1b
Indeterminate

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

HEPCGENO

Methodology

Polymerase Chain Reaction/Sequencing

Performed

Sun-Sat

Reported

3-5 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 (PPT) or Serum Separator Tube (SST).

Specimen Preparation

Separate from cells within 6 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

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.

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

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Components

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