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.
Polymerase Chain Reaction/Sequencing
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)
Please submit most recent viral load and test date, if available.
After separation from cells: Ambient: Unacceptable; Refrigerated: 72 hours; Frozen: 4 months.
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.
This test may be unsuccessful if the HCV RNA viral load is less than log 3.6 or 4000 IU/mL.
|Component Test Code*||Component Chart Name||LOINC|
|0055593||HCV Genotype by Sequencing||32286-7|
- HCV 5'UTR Genotype
- HCV 5'UTR Sequencing
- HCV Genotype
- HCV Genotyping
- HCV Sequencing
- HCV, Subtype