• Test Code:
    3300
  • Department:
  • Test Synonyms:
    Hepatitis C viral RNAHCV
  • CPT Code(s):
    87522
Background:

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, making it the leading cause of chronic liver disease.  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.  The quantitation of HCV RNA by polymerase chain reaction (PCR) nucleic acid amplification offers a measure of active viremia in antibody-positive chronic HCV infected patients undergoing antiviral therapy. The use of HCV RNA for the on-treatment assessment of HCV antiviral therapy is increasingly important for individualizing treatment and optimizing patient outcomes.

Clinical Utility:
Guidelines and product information for the current FDA-approved peginterferons support the importance of measuring HCV RNA levels at baseline prior to treatment, at intervals during treatment to assess antiviral response, and after treatment is completed to assess the efficacy of the treatment.  Current treatment options of peginterferon plus ribavirin have resulted in a sustained virologic response (SVR) of 40% to 78%, depending on genotype as well as other host and viral factors.  The use of on-treatment HCV-RNA viral load assessment serves to improve these response rates and reduce unnecessary exposure to toxic medications.  This test is intended for use as an aid in the management of HCV-infected individuals undergoing anti-viral therapy.

Methodology:

The Abbott RealTime HCV assay quantitates HCV viral RNA and is standardized against the Second WHO International Standard for Hepatitis C Virus RNA (NIBSC code 96/798).  The titer results are reported in International Units (IU/mL).  Specimens containing HCV genotypes 1 to 6 have been validated for quantitation in the assay.


Reportable Range:
12-100,000,000 IU/mL

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.
  • Spin samples for 20 minutes at 1200g
  • Alternatively, serum from a red top tube may be separated, frozen, and submitted for the assay.
  • Pediatric Minimum is 800µL of plasma or serum.

A REQUISITION FORM MUST ACCOMPANY ALL SAMPLES.  Please include detailed clinical information.

Test Performed (Days):

Tuesday and Friday

Turn Around Time:

2 -5 days

Shipment Sensitivity Requirements:

  • Ship plasma / serum on dry ice. 
  • Ship via overnight express, using the FedEx priority overnight label provided. 
  • Contact Client Services for shipping kit and instructions at (855) 535-1522.

References:

Abbott RealTime HCV package insert 51-608374/R3 (1N30-90).

Additional Info:

The Knight Cancer Institute at Oregon Health & Science University is a pioneer in the field of precision cancer medicine. The institute's director, Brian Druker, M.D., helped prove it was possible to shut down just the cells that enable cancer to grow. This breakthrough has made once-fatal forms of the disease manageable and transformed how cancer is treated. The OHSU Knight Cancer Institute is the only National Cancer Institute-designated Cancer Center between Sacramento and Seattle – an honor earned only by the nation's top cancer centers. It is headquarters for one of the National Cancer Institute's largest research collaboratives, SWOG, in addition to offering the latest treatments and technologies as well as hundreds of research studies and clinical trials.

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