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Beaumont Laboratory

HCV RNA Quantitation By PCR

Hepatitis C RNA quantitation, HCV viral load, HCV Quantitative, HCV Quantitation, Hep C, Hepatitis C Virus, Quantitative by PCR, EPIC: LAB6403, SOFT: IQHCG

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.

  • Serum: One Gold-top SST or plain Red-top tube.
  • Plasma: One Lavender-top EDTA tube.
  • Minimum volume and pediatric minimum (single test with no repeat): 650 mcL (0.650 mL) serum or plasma.
  • Separate specimens must be submitted when multiple tests are ordered.

Physician Office/Drawsite 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). (Min: 1.1 mL)

Rejection Criteria

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

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): 72 hours
Frozen (-20°C/-4°F or below): 6 weeks

Specimen Storage in Department Prior to Disposal:

Refrigerated (2-8°C or 36-46°F): 7 days

Laboratory

Royal Oak Clinical Molecular Pathology Laboratory.

Performed

Once a week.
Results available within 7 days.

Reference Range

HCV RNA not detected. The limit of detection is 15 IU/mL.

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® Ampliprep/COBAS® TaqMan® HCV Test, v2.0 (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 primarily used to monitor the HCV RNA viral load in patients undergoing antiviral therapy. This test can also be used to confirm the diagnosis of HCV infection in seropositive patients and determine if the patient has active viremia. 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

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 Code

87522.

Test Codes

EPIC: LAB6403, SOFT: IQHCG

Last Updated

06/20/2017

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UroVysion® is a registered trademark of Abbott Laboratories. ThinPrep® is a registered trademark of Hologic, Incorporated.

This directory currently reflects information only for specimens collected and/or processed at the Farmington Hills, Grosse Pointe, Royal Oak, and Troy campuses.