- Acceptable specimens include whole blood, serum or plasma. Blood should be collected in sterile lavender-top tubes, using EDTA as the anticoagulant, or in serum-separation tubes.
- Samples must be collected aseptically to minimize hemolysis and bacterial contamination.
- Whole blood must be centrifuged within 6 hours of collection for 20 minutes at 800 - 1600xg. Plasma or serum may be transported frozen at -80 °C.
- Transportation of whole blood or plasma must comply with country, federal, state and local regulations for the transport of etiologic agents.
- The minimum required sample volume is 650 μL of plasma or serum
Sample Rejection Reasons
- Clotted or frozen specimens
- Volume less than 650 μL
- Whole blood more than one day old that has not been spun
Serum or plasma specimens may be stored at 4 °C for up to 72 hours or at -80 °C for up to 6 weeks. It is recommended that specimens be stored in 800 - 900 μL aliquots in microtubes (such as Sarstedt tubes).
Serum and plasma specimens may be frozen and thawed up to five times without loss of HCV RNA.
This test is intended for use as an aid in the management of patients with chronic HCV infection, undergoing antiviral therapy. Current guidelines for the management and treatment of HCV recommend quantitative testing for HCV RNA before the start of antiviral therapy, during therapy and approximately two months following the end of treatment. Absence of detectable HCV RNA six months after the end of treatment indicates that a sustained virologic response (SVR) has been achieved. During antiviral therapy an early virologic response (EVR), defined as a two-log or greater decrease in HCV RNA or undetectable HCV RNA after 12 weeks of therapy, is commonly observed. Failure to achieve EVR has a high negative predictive value for achieving SVR and has been incorporated in futility (stopping) rules for pegylated interferon plus ribavirin therapies. A rapid viral response, undetectable levels of HCV RNA after 4 weeks of therapy, has a high positive predictive value for SVR.
5 - 8 business days
Reference Interval: HCV RNA not detected
The quantitative range of this assay is 15 – 1 x108 IU/mL
Low limit of detection (LoD) = Limit of Quantitation (LoQ) = 15 IU/mL