Hepatitis C Viral RNA, Genotype, LiPA
Also known as: HCV Viral RNA Genotype, LiPA, HCV RNA Genotype, LIPA
Use
Determination of hepatitis C genotype is required to select the most appropriate direct‑acting antiviral agents and guide treatment duration and regimen; genotyping assists in therapeutic decision‑making particularly for genotype‑specific treatment protocols. A concurrent hepatitis C viral load of ≥2,000 IU/mL is generally required for successful genotype detection; failure to genotype may result from low viral load (<2,000 IU/mL), mutations at PCR primer sites, or other factors.
Special Instructions
Performing laboratory: Quest Diagnostics Nichols Institute (San Juan Capistrano/Chantilly). This assay is performed by nucleic acid extraction, reverse transcription, PCR amplification, and Sanger sequencing; patients require adequate viral load. Reflex patterns: if quantitative HCV RNA ≥300 or ≥2,000 IU/mL depending on assay, genotype, LiPA will be performed at additional charge (CPT 87902). Reflexes are part of ordered test workflows (e.g., test codes 11348, 94345 have reflex to this genotype, LiPA).
Limitations
Genotyping may fail if viral load is below threshold (varies by genotype, range ~500–5,000 IU/mL). Mutations in viral genome at PCR priming regions or other unknown factors may impair assay performance.
Methodology
PCR-based (PCR)
Biomarkers
Result Turnaround Time
3-7 days
Related Documents
For more information, please review the documents below
Specimen
Plasma
Volume
2.0 mL (optimum)
Minimum Volume
0.6 mL
Container
Lavender (EDTA) tube; also acceptable: PPT (potassium EDTA), serum separator tube or red‑top (no gel) tube
Collection Instructions
Collect blood in lavender (EDTA) tube; centrifuge and separate plasma within 24 hours. Alternate: serum collected in serum separator or red‑top tube. Transfer aliquot to transport tube and refrigerate or freeze.
Storage Instructions
Refrigerated; transport cold packs
Causes for Rejection
Gross hemolysis; gross lipemia; unspun PPT tube; unspun serum separator tube; unspun red‑top tube; heparin anticoagulant; received at room temperature
Stability Requirements
| Temperature | Period |
|---|---|
| Room Temperature | 72 hours |
| Refrigerated | 14 days |
| Frozen | 30–42 days |