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Test ID: HCVQN Hepatitis C Virus (HCV) RNA Detection and Quantification by Real-Time Reverse Transcription-PCR (RT-PCR), Serum


Advisory Information


For detection and quantification of HCV RNA in serum before, during, and after antiviral therapy for chronic hepatitis C.



Shipping Instructions


1. Freeze serum immediately, and ship specimen frozen on dry ice only.

2. If shipment will be delayed for more 24 hours, freeze serum at -20 to -80° C (up to 84 days) until shipment on dry ice.



Specimen Required


Supplies: Aliquot Tube, 5 mL (T465)

Collection Container/Tube: Serum gel

Submission Container/Tube: Polypropylene vial (T465)

Specimen Volume: 1.5 mL

Collection Instructions:

1. Centrifuge blood collection tube per collection tube manufacturer's instructions.

2. Pour off serum into aliquot tube.


Useful For

Detection of acute hepatitis C virus (HCV) infection before the appearance of HCV antibodies in serum (ie, <2 months from exposure)

 

Detection and confirmation of chronic HCV infection

 

Quantification of HCV RNA in serum of patients with chronic HCV infection (HCV antibody-positive)

 

Monitoring disease progression in chronic HCV infection and response to antiviral therapy

 

Determining cure and detection of relapse after completion of antiviral therapy

Method Name

Real-Time Reverse Transcription-Polymerase Chain Reaction (RT-PCR)

Reporting Name

HCV RNA Detect/Quant, S

Specimen Type

Serum SST

Specimen Minimum Volume

0.8 mL

Specimen Stability Information

Specimen Type Temperature Time Special Container
Serum SST Frozen (preferred) 84 days
  Refrigerated  6 days

Clinical Information

Of all individuals infected with hepatitis C virus (HCV), about 75% of them will develop chronic hepatitis C, with ongoing viral replication in the liver and detectable HCV RNA in serum or plasma, eventually resulting in cirrhosis. The remaining 25% of the infected individuals recover from the infection without evidence of viral replication or presence of detectable HCV RNA in serum or plasma. Chronic HCV infection can be cured at variable success rates with either combined interferon-alpha and ribavirin therapy or interferon-free combination of direct-acting antiviral (DAA) agents.

 

The antiviral response rates correlate with pretreatment serum or plasma HCV RNA levels (viral load) and the HCV genotype found in the infected individuals. The optimal duration of combined interferon and ribavirin therapy can be determined from the patient's pretreatment viral load and HCV genotype. Clinical trial studies indicated that a decrease in HCV RNA levels of more than 2 log IU/mL at 4 weeks or 12 weeks of therapy is predictive of an increased chance of achieving a sustained virologic response (defined as undetectable HCV RNA levels in serum 6 months after completing antiviral therapy). Despite receiving longer duration of antiviral therapy (48 weeks versus 24 weeks), patients with chronic infection due to HCV genotypes 1 and 4 generally have less favorable sustained virologic response rates (40%-50%) than those infected with genotypes 2 and 3 (>80%). Due to the necessary prolonged duration (typically 24 to 48 week duration) and low cure rates of such antiviral therapy, interferon-based therapy has been supplanted with potent interferon-free DAA combination therapy now.

 

Cure rates, as defined by sustained virologic response (SVR), of over 90% are observed among HCV-infected patients treated with interferon-free DAA combinations that are of shorter duration of treatment (eg, 8 or 12 weeks) than those of interferon-based therapy. Current guidelines for antiviral therapy of chronic hepatitis C recommend quantitative testing for HCV RNA in serum or plasma before initiating antiviral therapy, at 4 weeks of therapy, and at 12 weeks after completion of therapy. HCV RNA level of below 25 IU/mL in serum or plasma at 12 weeks after ending therapy is the therapeutic goal and indicates an SVR is achieved. Quantitative HCV RNA testing can be considered at the end of therapy and at 24 weeks or later after completion of antiviral therapy.

 

The following algorithms are available in Special Instructions:

-Chronic Hepatitis C Treatment and Monitoring Algorithm: Direct Antiviral Antigen (DAA) Combination

-Hepatitis C: Testing Algorithm for Screening and Diagnosis

Reference Values

Undetected

Interpretation

This assay has a result range of 15 to 100,000,000 IU/mL (1.18 log to 8.00 log IU/mL) for quantification of hepatitis C virus (HCV) RNA in serum.

 

An "Undetected" result indicates that the HCV is absent in the patient's serum specimen.

 

A result of "<15 IU/mL (<1.18 log IU/mL)" indicates that HCV RNA is detected, but the HCV RNA level present cannot be quantified accurately below this lower limit of quantification of this assay. When clinically indicated, follow-up testing with this assay is recommended in 1 to 2 months. To assess response-guided therapy eligibility, an "Undetected" result is required, and a result of "<15 IU/mL mL (<1.18 log IU/mL)" should not be considered equivalent to an "Undetected" result.

 

A quantitative result expressed in IU/mL and log IU/mL indicates the degree of active HCV viral replication in the patient. Monitoring HCV RNA levels over time is important to assess disease progression and/or monitoring a patient's response to anti-HCV therapy.

 

A result of ">100,000,000 IU/mL (>8.00 log IU/mL)" indicates the presence of active HCV viral replication, and the HCV RNA level present cannot be quantified accurately above this upper limit of quantification of this assay.

 

An "Inconclusive" result reported with a comment indicates that testing failed, likely due to presence of inhibitory substances in the submitted serum specimen. A new specimen should be collected for retesting.

Clinical Reference

1. de Leuw P, Sarrazin C, Zeuzem S: How to use virological tools for the optimal management of chronic hepatitis C. Liver Int 2011;31 Suppl 1:3-12

2. Centers for Disease Control and Prevention: Testing for HCV infection: an update of guidance for clinicians and laboratorians. MMWR Morb Mortal Wkly Rep 2013;62(18):362-365

3. American Association for the Study of Liver Diseases and Infectious Diseases Society of America: HCV guidance: Recommendations for testing, managing, and treating hepatitis C. Accessed July 14, 2017 Available at www.hcvguidelines.org/full-report-view

Day(s) and Time(s) Performed

Monday through Saturday; 7 a.m.-4 p.m.

Analytic Time

Monday through Thursday, 1 day; Friday and Saturday, 3 days

Test Classification

This test has been cleared, approved or is exempt by the U.S. Food and Drug Administration and is used per manufacturer's instructions. Performance characteristics were verified by Mayo Clinic in a manner consistent with CLIA requirements.

CPT Code Information

87522

LOINC Code Information

Test ID Test Order Name Order LOINC Value
HCVQN HCV RNA Detect/Quant, S 11011-4

 

Result ID Test Result Name Result LOINC Value
97291 HCV RNA Detect/Quant, S 11011-4

Forms

If not ordering electronically, complete, print, and send 1 of the following forms with the specimen:

-General Request (T239)

-Gastroenterology and Hepatology Client Test Request (T728)

Mayo Clinic Laboratories | Gastroenterology Catalog Additional Information:

mml-gi-liver-hepatitis