Hepatitis C Virus Genotype by Sequencing

0055593
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Example Reports
1a or 1b
Indeterminate

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Additional Technical Information
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.

Compliance Statement B: For laboratory developed tests not using a RUO kit, and for FDA approved, cleared or 510(k) exempt assays with alterations. This test was developed and its performance characteristics determined by ARUP Laboratories. The U. S. Food and Drug Administration has not approved or cleared this test; however, FDA clearance or approval is not currently required for clinical use. The results are not intended to be used as the sole means for clinical diagnosis or patient management decisions.

Note

This test may be unsuccessful if the HCV RNA viral load is less than log 3.6 or 4000 IU/mL.

Hotline History

View Hotline History

 

Hotline History

Date of Change
Test Name Change
Methodology
Performance/Reported Schedule
Specimen Requirements
Reference Interval
Interpretive Data
Note
CPT Code
Component Change
Other Interface Change
New Test
Inactive
08/20/2018
X
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