Hepatitis C Virus (HCV) Genotype with Reflex to HCV High-Resolution Genotype by Sequencing
2009255
Ordering Recommendation
•Reflex genotyping panel to use for prognosis and treatment selection when a higher level of subtype resolution is required (ie, 1a vs.1b; 1a or 1b vs. Type 6).
•Do not order prior to molecular confirmation of positive HCV screen.
Mnemonic
HCV REFLEX
Methodology
Polymerase Chain Reaction/Sequencing
Performed
Sun-Sat
Reported
8-10 days  
New York DOH Approval Status
This test is New York DOH approved.
Submit With Order
Specimen Required
Patient Preparation
  
Collect
Lavender (EDTA), pink (K2EDTA), plasma preparation tube or serum separator tube.  
Specimen Preparation
Separate serum or plasma from cells within 6 hours. Transfer 2 mL serum or plasma to an ARUP Standard Transport Tube. (Min: 1 mL)  
Storage/Transport Temperature
Frozen.  
Unacceptable Conditions
Heparinized specimens.  
Remarks
Please submit most recent viral load and test date, if available.  
Stability
On cells: Ambient: 6 hours. After separation from cells: 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' un-translated 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.

See Compliance Statement B: www.aruplab.com/CS
Statement B: 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 HCV RNA viral load is less than log 3.6 or 4000 IU/mL. If subtype 1a or 1b is detected, then Hepatitis C High Resolution Genotyping will be added. Additional charges apply.
CPT Code(s)
87902; if reflexed add 87902
Components
Component Test Code*Component Chart NameLOINC
0055593HCV Genotype by Sequencing32286-7
* 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, Subtype (Hepatitis C Virus Genotyping)