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HCV RNA Quantitation by PCR

Hepatitis C RNA quantitation, HCV viral load, HCV Quantitative, HCV Quantitation, Hep C, Hepatitis C Virus, Quantitative by PCR

Test Codes

EPIC: LAB6403, Beaker: IQHCG

Department

Molecular Pathology

Instructions

This test is not intended for use as a screening test for the presence of HCV in blood or blood products.

Specimen Collection Criteria

Collect: Serum OR Plasma.

• Plasma: One Lavender-top EDTA tube.
• Serum: One Gold-top SST or plain Red-top tube.
• Preferred: 2mL; Minimum: 0.650 mL
• Separate specimens must be submitted when multiple tests are ordered.

Physician Office/Draw Specimen Preparation

Centrifuge to separate serum or plasma from cells within 24 hours of collection.

Collect enough whole blood to allow for a minimum of 1 mL of serum or plasma. Whole blood collected in SST or EDTA tubes are stable for up to 24 hours at room temperature (20-26°C or 68-78.8°F) or refrigerated (2-8°C or 36-46°F) prior to centrifugation.

After centrifugation, transfer all available plasma/serum to a sterile plastic transport tube and refrigerate (2-8°C or 36-46°F). Plasma or serum samples may be stored refrigerated (2-8°C or 36-46°F) for up to 6 days.

Preparation for Courier Transport

Transport:

• Uncentrifuged whole blood can be transported at room temperature (20-26°C or 68-78.8°F) or refrigerated (2-8°C or 36-46°F) if processed within 24 hours of collection.
• Centrifuged/processed plasma or serum can be transported refrigerated (2-8°C or 36-46°F).

Rejection Criteria

• Specimens not centrifuged within 24 hours of collection.
• Specimens collected in Green-top heparin tubes or White-top PPT tubes.
• Specimens not maintained refrigerated or frozen following separation.
• Specimens exposed to repeated freeze/thaw cycles.
• Specimens with less than 0.650 mL plasma/serum.
• Unlabeled tubes.

In-Lab Processing

Specimens must be centrifuged with plasma or serum separated from cells within 24 hours of collection. After centrifugation, please ensure that all available plasma or serum is transferred to a sterile plastic transport 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): 6 days – Centrifuged plasma or serum only
Frozen (-20°C/-4°F or below): 12 weeks – Centrifuged plasma or serum only

Specimen Storage in Department Prior to Disposal:

Frozen (-20°C/-4°F or below): 4 weeks

Laboratory

Royal Oak Molecular Pathology Laboratory

Performed

At least once per week.
Results available within 7 days.

Reference Range

HCV RNA not detected. The analytical sensitivity is 12.0 IU/mL (plasma) and 13.7 IU/mL (serum).

Reportable range is 15 - 100,000,000 IU/mL. Results exceeding 100,000,000 will not be diluted and will be reported as greater than 100,000,000 IU/mL.

Test Methodology

Quantitative real-time polymerase chain reaction (qPCR)-Roche COBAS^® 6800 HCV Test (FDA Approved).

Interpretation

This test determines the presence or absence of HCV RNA. When HCV RNA is detected, the corresponding HCV RNA viral load will be reported.

Clinical Utility

• This test is used as an aid in the diagnosis and management of HCV infection. This test can be used to confirm the diagnosis of HCV infection in patients with a positive or equivocal HCV antibody test (seropositive patients) and determine if the patient has active viremia. This test can also be used to monitor the HCV RNA viral load in patients undergoing antiviral therapy.
• The lower limit of reporting in this assay is less than 15 IU/mL. A result reported as “detected” less than 15 IU/mL indicates the presence of HCV RNA concentrations below the level of quantitation of the assay.
• This test is not intended for use as a screening test for the presence of HCV in blood or blood products.

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 liver enzyme profiles. 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.

Epidemiology

The Centers for Disease Control and Prevention (CDC) estimates that in the United States 3,621 to 50,300 persons become infected with HCV each year. Over 65% of acute hepatitis C cases reported to CDC during 2018 occurred among persons aged 20–39 years. A total of 850 patients with acute hepatitis C were hospitalized with 3.72 deaths per 100,000 population in 2018.

Studies have shown that between 0.2 and 0.6 percent of volunteer blood donors in the U.S. are infected with HCV. Much higher prevalence rates have been found in high-risk populations.

Incubation Period

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. This leads us to believe that there may be another means of transmission that has not been identified.

CPT Codes

87522

Contacts

Last Updated

10/7/2023