Background:
Hepatitis C (HCV) infection is the most common chronic blood-borne infection in the United States with an estimated seroprevalence of 1.6%. An estimated 3.2 million Americans suffer from chronic HCV infection and an estimated 85% of those with acute hepatitis C progress to chronic infection, of which 20%-25% will develop complications such as cirrhosis within 2 to 3 decades of onset. In addition to the quantitation of HCV RNA by polymerase chain reaction (PCR) to measure active viremia in antibody-positive chronic HCV infected patients, genotype identification of Hepatitis C is important for physicians tailor dose and duration of pegylated interferon – α and ribavirin combination therapy.
Methodology:
The Abbott RealTime HCV Genotype II RUO has been validated in our laboratory for clinical use. This assay detects the major HCV genotypes 1a, 1b, 2, 3, 4, 5, and 6 through the use of genotype-specific fluorescent-labeled oligonucleotide probes.
Specimen Requirements:
- 5-10 mL of blood in purple (EDTA) tube. Specimen must be centrifuged and separated within 6 hours.
- Freeze plasma for transport to lab.
- Alternatively, serum from a red top or SST tube may be separated, frozen, and submitted for the assay.
- Pediatric Minimum is 200µL of plasma or serum.
A REQUISITION FORM MUST ACCOMPANY ALL SAMPLES. Please include detailed clinical information.
Test Performed (Days):
Weekly
Turn Around Time:
7-10 days
Shipment Sensitivity Requirements:
Package and ship specimen on dry ice. Ship via overnight express, using the FedEx priority overnight label provided. Contact Client Services for shipping kits and instructions at (855) 535-1522.
References:
Abbott RealTime HCV Genotype II RUO © 2010 Abbott Molecular, Inc. Des Plaines, Illinois, USA.
Additional Info:
Clinical Utility:
Guidelines and product information for the current FDA-approved pegylated interferon support the determination of HCV genotypes as an independent predictor of sustained virologic response following pegylated interferon – α and ribavirin combination therapy. This test is intended to aid physicians in the management of HCV-infected individuals undergoing anti-viral therapy.
Sensitivity:
The Hepatitis C viral load of the sample being tested must be above 320 IU/mL.