Hepatitis C Virus Genotype
HCV Genotyping, HCV Typing, Hep C, HCV Mutation Analysis, HCV Genotype
EPIC: LAB6530, IHCVG
This assay should not be used for screening or confirmation of HCV infection. Testing should be performed only on specimens obtained from patients confirmed to have HCV RNA levels in serum of >1,000 IU/mL. If HCV RNA levels are unknown, please order both HCV RNA Quantitation by PCR and Hepatitis C Virus Genotype.
Specimen Collection Criteria
Collect: Serum OR plasma.
Physician Office/Draw Specimen Preparation
Centrifuge to separate serum or plasma from cells within 24 hours of collection. Transfer serum or plasma to a plastic transport tube and refrigerate (2-8°C or 36-46°F). A centrifuged SST tube is also acceptable at refrigeration temperature.
Preparation for Courier Transport
Transport: Serum or plasma, or centrifuged SST tube, refrigerated (2-8°C or 36-46°F).
Samples with recent viral loads <1,000 IU/mL.
Specimens collected in green-top heparin or white-top PPT tubes.
Samples not centrifuged with the serum or plasma separated within 24 hours of collection.
Specimens not maintained refrigerated or frozen following separation.
Samples exposed to repeated freeze/thaw cycles.
Specimens must be centrifuged and serum or plasma separated from cells within 24 hours of collection. Transfer the serum or plasma to a sterile polypropylene tube.
Specimen Stability for Testing:
Room Temperature (20-26°C or 68-78.8°F): 24 hours
Refrigerated (2-8°C or 36-46°F): 5 days
Frozen (-20°C/-4°F or below): 3 months
Specimen Storage in Department Prior to Disposal:
Frozen (-20°C/-4°F or below): 1 month
Royal Oak Clinical Molecular Pathology Laboratory
Results available within 7-10 days.
Reverse Transcription Polymerase Chain Reaction (RT-PCR) of target RNA sequences and Multiplexed Hybridization Detection.
HCV genotype 1, 2, 3, 4, 5, or 6 will be reported. When HCV genotype 1 is detected, the subtype will also be reported as HCV genotype 1a or 1b.
For HCV positive patients, a not detected result typically indicates a low viral load (<1,000 IU/mL).
The HCV genotype is of clinical importance for prognosis and options for therapeutic intervention. HCV genotype should be performed in conjunction with a HCV viral load assay.
Hepatitis C virus (HCV) can cause acute hepatitis. However, HCV infection presents most frequently as a chronic hepatitis diagnosed on the basis of blood liver enzyme studies. Seventy-five to eighty percent (75-80%) of patients with acute HCV develop chronic hepatitis. Chronic hepatitis C is one of the major causes of cirrhosis, and the most common indication for liver transplantation in adults in the U.S. Chronic HCV infections may also be a major cause of hepatocellular carcinoma in the world.
The incubation period is approximately 50 days (range, 15–150 days).
Hepatitis C virus (HCV) causes 70-95% of post-transfusion hepatitis infections making it the most common cause of post-transfusion hepatitis. However, with improved universal donor testing HCV infections are rare after blood transfusions. Parenteral exposure due to illicit drug use and needle sharing constitutes the major means of transmission in the U.S. HCV has also been implicated to be the cause of 65 - 90% of cases of sporadic acute viral hepatitis.
Molecular Pathology Lab – RO
Microtainer® and Vacutainer® are registered trademarks of Becton, Dickinson and Company.
UroVysion® is a registered trademark of Abbott Laboratories. ThinPrep® is a registered trademark of Hologic, Incorporated.