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Hcv Rna Quantitation Viral load
MessageFor additional information regarding CDC guidelines for appropriate testing, please see: http://www.cdc.gov/hepatitis/hcv/labtesting.htm.
Test Code
CPT Codes
87522
Preferred Specimen
SERUM
Minimum Volume
Instructions
COLLECT 3 STERILE SERUM GEL TUBES. SEPARATE WITHIN 6 HOURS BY CENTRIFUGATION 800-1600 XG FOR 20 MINUTES. TRANSFER TO STERILE POLYPROPYLENE TUBE.
Transport Container
SST/3
Transport Temperature
Specimen Stability
Reject Criteria (Eg, hemolysis? Lipemia? Thaw/Other?)
Methodology
Real-Time Polymerase Chain Reaction (RT-PCR)
Setup Schedule
ONCE WEEKLY- WEDNESDAY A.M.
Report Available
Reference Range
NOT DETECTED
Clinical Significance
Hepatitis C virus is considered to be the principal etiologic agent responsible for 90% to 95% of the cases of post-transfusion hepatitis. As a blood-borne virus, HCV is transmitted by blood and blood products. Widespread adoption of HCV blood screening measures has markedly lowered the risk of transfusion-associated hepatitis. The incidence of HCV infection is highest in association with intravenous drug abuse and to a lesser extent with other percutaneous exposures. Following exposure, 75% to85% of HCVinfected individuals develop chronic hepatitis, with up to 20% of these chronic cases progressing to cirrhosis. In cirrhotic patients, hepatocellular carcinoma is observed in 1% to4% of the population every year. Quantitation of HCV RNA for measuring baseline viral loads and for on-treatment monitoring has been well established in demonstrating the efficacy of antiviral response to pegylated interferon plus ribavirin combination therapy.
Current guidelines for the management and treatment of HCV recommend quantitative testing for HCV RNA before the start of antiviral therapy, during therapy (response guided therapy), and generally 12 to 24 weeks following the end of treatment. Absence of detectable HCV RNA by a sensitive test, 24 weeks after the end of treatment, is the goal of treatment and 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 a SVR and has been incorporated in futility (stopping) rules for pegylated interferon plus ribavirin therapies. A rapid viral response (RVR), undetectable levels of HCV RNA after 4 weeks of therapy, has a high positive predictive value for SVR. HCV RNA can be detected in either plasma or serum using nucleic acid extraction and amplification technologies.