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Hepatitis C Virus Genotype

HCV Genotyping, HCV Typing, Hep C, HCV Mutation Analysis, HCV Genotype

Test Codes

EPIC: LAB6530, Beaker: IHCVG

Department

Molecular Pathology

Instructions

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.

• Serum: One Gold-top SST or plain Red-top tube.
• Plasma: One Lavender-top EDTA tube.
• Minimum volume and pediatric minimum 1.5 mL serum or plasma.
• Separate specimens must be submitted when multiple tests are ordered.

• HCV viral load >1,000 IU/mL required for testing. 

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).

Rejection Criteria

• 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.

In-Lab Processing

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.

Storage

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

Laboratory

Royal Oak Clinical Molecular Pathology Laboratory

Performed

Results available within 7-10 days.

Reference Range

Not Applicable.

Test Methodology

Reverse Transcription Polymerase Chain Reaction (RT-PCR) of target RNA sequences and Multiplexed Hybridization Detection.

Interpretation

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).

Clinical Utility

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. 

Clinical Disease

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.

Incubation Period

The incubation period is approximately 50 days (range, 15–150 days).

Transmission

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.

CPT Codes

87902

Contacts

Last Updated

10/7/2023