Hepatitis C Viral RNA Genotype, LiPA with Reflex to HCV NS5A Drug-resistance
Use
Determines HCV viral genotype (genotypes 1–6, including subtypes 1a and 1b) via LiPA; when genotype 1, 1a, or 1a/1b is identified, reflex testing for NS5A drug‑resistance‑associated variants is performed, enabling clinicians to guide direct acting antiviral (DAA) therapy selection, particularly NS5A inhibitors such as elbasvir/grazoprevir, ledipasvir/sofosbuvir, or sofosbuvir/velpatasvir.
Special Instructions
Reflex testing is automatic: if genotype result is “GENOTYPE 1”, “1a”, or “1a or 1b”, additional NS5A drug‑resistance testing (test code 92447) is performed at additional charge.
Limitations
Genotyping requires sufficient HCV RNA viral load (typically ≥2,000 IU/mL) for reliable result; low viral loads may fail typing. NS5A resistance testing limited to genotype 1 cases. Reflex increases cost and may not execute if genotype is not 1 or subtyping is ambiguous.
Methodology
PCR‑based (PCR)
Biomarkers
Result Turnaround Time
2-4 days
Related Documents
For more information, please review the documents below
Specimen
Plasma
Volume
Not provided
Minimum Volume
Not provided
Container
PPT tube (unspun)
Collection Instructions
Unspun PPT tube
Causes for Rejection
Unspun PPT tube