Hepatitis C Viral RNA, Quantitative Real‑Time PCR with Reflexes
Use
This test quantitatively measures Hepatitis C virus RNA in patient specimens using real‑time PCR and reflexes to genotype, and NS5A drug-resistance testing under specific conditions. It aids in diagnosis, quantification of HCV viral load, guiding treatment decisions, and monitoring therapy effectiveness, particularly where genotype influences therapeutic regimens. If the viral load is ≥2,000 IU/mL, the specimen reflexes to genotyping; and if genotype is 1a, reflexes further to NS5A drug-resistance testing. Such tiered reflex testing enables sequential, cost-effective clinical decision-making based on viral load and genotype results.
Special Instructions
Reflex testing: if HCV RNA is ≥2,000 IU/mL, the test reflexes to hepatitis C viral genotype at additional charge; if genotype is 1a, the test reflexes to NS5A drug‑resistance testing at additional charge. This is a true reflex workflow, automating subsequent testing dependent on quantitative thresholds and genotype. Performing laboratory: Quest Diagnostics Infectious Disease, Inc. Effective date: 11/22/2021.
Limitations
Genotyping may not be successful when viral load is below approximately 2,000 IU/mL due to assay sensitivity; certain genotypes may fail due to low RNA or mutations at PCR priming sites. The NS5A drug‑resistance component (for genotype 1a) targets codons 28, 30, 31, 58, and 93; resistance-associated variants may be missed if outside these codons or if sequencing quality is insufficient. Limits of quantitation and detection of the PCR assay may affect reportable range, and detection below 15 IU/mL may be reported as “Detected but not quantifiable.”
Methodology
PCR-based (PCR)
Biomarkers
Result Turnaround Time
Not provided.
Related Documents
For more information, please review the documents below
Not provided.