Test Catalog

Test Id : HCVQN

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Hepatitis C Virus (HCV) RNA Detection and Quantification by Real-Time Reverse Transcription-PCR, Serum

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Overview

Test Catalog

Useful For
Suggests clinical disorders or settings where the test may be helpful

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

Highlights

A reflex test for serum specimens that are hepatitis C virus (HCV) antibody screen-reactive for diagnosis of chronic hepatitis C.

 

This test is appropriate for diagnosis of acute hepatitis C in high-risk or immunosuppressed individuals who may be negative for HCV antibodies.

 

This test can be used to establish a baseline HCV viral load before initiating antiviral therapy for chronic hepatitis C.

 

This test can be used to monitor response and progress during antiviral therapy for chronic hepatitis C.

 

This test is appropriate for confirming a sustained virologic response and detecting a relapse of hepatitis C after completion of antiviral therapy.

 

Testing Algorithm
Delineates situations when tests are added to the initial order. This includes reflex and additional tests.

Method Name
A short description of the method used to perform the test

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

NY State Available
Indicates the status of NY State approval and if the test is orderable for NY State clients.

Yes

Reporting Name
Lists a shorter or abbreviated version of the Published Name for a test

HCV RNA Detect/Quant, S

Aliases
Lists additional common names for a test, as an aid in searching

HCV (RT-PCR) Quantification

HCV PCR

HCV RNA

HCV Quantification

HCV RNA Quantification

HCV Viral Load

Hepatitis C RNA Quantitation

Hepatitis C Viral Load

Testing Algorithm
Delineates situations when tests are added to the initial order. This includes reflex and additional tests.

Specimen Type
Describes the specimen type validated for testing

Serum SST

Ordering Guidance

For detection and quantification of hepatitis C viral 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 than 24 hours, freeze serum at -20 to -80 degrees C (up to 84 days) until shipment on dry ice.

Specimen Required
Defines the optimal specimen required to perform the test and the preferred volume to complete testing

Supplies: Sarstedt 5 mL Aliquot Tube (T914)

Collection Container/Tube: Serum gel

Submission Container/Tube: Plastic vial

Specimen Volume: 1.5 mL

Collection Instructions:

1. Centrifuge blood collection tube per collection tube manufacturer's instructions (eg, centrifuge and aliquot within 2 hours of collection for BD Vacutainer tubes).

2. Aliquot serum into plastic vial.

Special Instructions
Library of PDFs including pertinent information and forms related to the test

Forms

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

-Gastroenterology and Hepatology Test Request (T728)

-Microbiology Test Request (T732)

-General Test Request (T239)

Specimen Minimum Volume
Defines the amount of sample necessary to provide a clinically relevant result as determined by the Testing Laboratory

0.8 mL

Reject Due To
Identifies specimen types and conditions that may cause the specimen to be rejected

Gross hemolysis OK
Gross lipemia OK
Gross icterus OK

Specimen Stability Information
Provides a description of the temperatures required to transport a specimen to the performing laboratory, alternate acceptable temperatures are also included

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

Useful For
Suggests clinical disorders or settings where the test may be helpful

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

Testing Algorithm
Delineates situations when tests are added to the initial order. This includes reflex and additional tests.

Clinical Information
Discusses physiology, pathophysiology, and general clinical aspects, as they relate to a laboratory test

About 75% of all individuals infected with hepatitis C virus (HCV) 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.

 

Cure rates, as defined by sustained virologic response, of over 90% are observed among patients infected with HCV and treated with interferon-free DAA combinations that are of shorter treatment duration (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 12 weeks after completion of therapy. A HCV RNA level below 25 IU/mL in serum or plasma 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.

 

For more information, see the following:

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

-Hepatitis C: Testing Algorithm for Screening and Diagnosis

Reference Values
Describes reference intervals and additional information for interpretation of test results. May include intervals based on age and sex when appropriate. Intervals are Mayo-derived, unless otherwise designated. If an interpretive report is provided, the reference value field will state this.

Undetected

Interpretation
Provides information to assist in interpretation of the test results

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.

Cautions
Discusses conditions that may cause diagnostic confusion, including improper specimen collection and handling, inappropriate test selection, and interfering substances

Except for immunocompromised patients or patients with suspected acute hepatitis, laboratory evaluation of hepatitis C virus (HCV) infection status should begin with HCV serologic testing, including testing for the presence of HCV antibodies (see Hepatitis C: Testing Algorithm for Screening and Diagnosis). A diagnosis of chronic HCV infection should not be based solely on the presence of detectable or quantifiable HCV RNA in a single serum specimen.

 

An "Undetected" HCV RNA test result with a "Reactive" HCV antibody screen result may be due to:

1. A false-reactive HCV antibody screen result

2. Resolved or past HCV infection

3. Transient low viremia (ie, episodic viral replication) of active HCV infection

To distinguish between the first 2 conditions, another HCV antibody test (eg, HCCAD / Hepatitis C Virus Antibody Screen for Cadaveric or Hemolyzed Specimens, Serum) can be requested. To distinguish between the latter 2 conditions, patients should be retested for HCV RNA in 1 to 2 months, as clinically indicated.

Clinical Reference
Recommendations for in-depth reading of a clinical nature

1. de Leuw P, Sarrazin C, Zeuzem S: How to use virological tools for the optimal management of chronic hepatitis C. Liver Int. 2011 Jan;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 May 10;62(18):362-365

3. American Association for the Study of Liver Diseases, Infectious Diseases Society of America: HCV guidance: Recommendations for testing, managing, and treating hepatitis C. AASLD, IDSA; Accessed September 8, 2022. Available at www.hcvguidelines.org/contents

Method Description
Describes how the test is performed and provides a method-specific reference

The cobas hepatitis C virus (HCV) assay is a US Food and Drug Administration-approved, in vitro nucleic acid amplification test for the quantification of HCV RNA in human serum using the cobas 6800 System or cobas 8800 System for fully automated viral nucleic acid extraction (generic silica-based capture technique) and automated amplification and detection of the viral nucleic acid sequence. This polymerase chain reaction (PCR) assay amplifies sequences within the highly conserved 5' noncoding region of the HCV genome and generates amplification products that are detected and quantified in real-time with 2 sequence-specific TaqMan probes. A non-HCV armored RNA quantitation standard (RNA QS) is introduced into each specimen during sample preparation to serve as internal control for nucleic acid extraction and PCR amplification/detection processes. Fluorescent reporter dye-labeled TaqMan probes hybridized to the complementary HCV target sequences and RNA QS sequence undergo hydrolysis during PCR amplification step to generate fluorescent signal detected in 2 different dye channels. Concentration of the HCV RNA in a patient's serum sample is determined by a ratio of the intensity of the fluorescent dye from the cleaved HCV target sequence probes and that from the RNA QS target probe detected throughout the PCR process.(Package insert: cobas HCV-Quantitative nucleic acid test for use on the cobas 6800/8800 Systems. Roche Molecular Systems, Inc; Rev. 2.0, 12/2020)

PDF Report
Indicates whether the report includes an additional document with charts, images or other enriched information

No

Day(s) Performed
Outlines the days the test is performed. This field reflects the day that the sample must be in the testing laboratory to begin the testing process and includes any specimen preparation and processing time before the test is performed. Some tests are listed as continuously performed, which means that assays are performed multiple times during the day.

Monday through Saturday

Report Available
The interval of time (receipt of sample at Mayo Clinic Laboratories to results available) taking into account standard setup days and weekends. The first day is the time that it typically takes for a result to be available. The last day is the time it might take, accounting for any necessary repeated testing.

1 to 3 days

Specimen Retention Time
Outlines the length of time after testing that a specimen is kept in the laboratory before it is discarded

2 months

Performing Laboratory Location
Indicates the location of the laboratory that performs the test

Rochester

Fees
Several factors determine the fee charged to perform a test. Contact your U.S. or International Regional Manager for information about establishing a fee schedule or to learn more about resources to optimize test selection.

  • Authorized users can sign in to Test Prices for detailed fee information.
  • Clients without access to Test Prices can contact Customer Service 24 hours a day, seven days a week.
  • Prospective clients should contact their account representative. For assistance, contact Customer Service.

Test Classification
Provides information regarding the medical device classification for laboratory test kits and reagents. Tests may be classified as cleared or approved by the US Food and Drug Administration (FDA) and used per manufacturer instructions, or as products that do not undergo full FDA review and approval, and are then labeled as an Analyte Specific Reagent (ASR) product.

This test has been cleared, approved, or is exempt by the US 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
Provides guidance in determining the appropriate Current Procedural Terminology (CPT) code(s) information for each test or profile. The listed CPT codes reflect Mayo Clinic Laboratories interpretation of CPT coding requirements. It is the responsibility of each laboratory to determine correct CPT codes to use for billing.

CPT codes are provided by the performing laboratory.

87522

LOINC® Information
Provides guidance in determining the Logical Observation Identifiers Names and Codes (LOINC) values for the order and results codes of this test. LOINC values are provided by the performing laboratory.

Test Id Test Order Name Order LOINC Value
HCVQN HCV RNA Detect/Quant, S 11011-4
Result Id Test Result Name Result LOINC Value
Applies only to results expressed in units of measure originally reported by the performing laboratory. These values do not apply to results that are converted to other units of measure.
97291 HCV RNA Detect/Quant, S 11011-4

Test Setup Resources

Setup Files
Test setup information contains test file definition details to support order and result interfacing between Mayo Clinic Laboratories and your Laboratory Information System.

Excel | PHP Pdf | CMS Pdf

Sample Reports
Normal and Abnormal sample reports are provided as references for report appearance.

Normal Reports | Abnormal Reports

SI Sample Reports
International System (SI) of Unit reports are provided for a limited number of tests. These reports are intended for international account use and are only available through MayoLINK accounts that have been defined to receive them.

SI Normal Reports | SI Abnormal Reports