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HelpTEST ID HCVQG Hepatitis C Virus (HCV) RNA Quantification with Reflex to HCV Genotype, Serum
Reporting Name
HCV RNA Detect/Quant Reflex Geno, SSpecimen Type
Serum SSTOrdering Guidance
For detection and quantification of hepatitis C (HCV) RNA and genotype in serum before initiating antiviral therapy for chronic hepatitis C.
Do not order this test to monitor response and progress during 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° C (up to 42 days) until shipment on dry ice.
Specimen Required
Supplies: Sarstedt Aliquot Tube, 5 mL (T914)
Collection Container/Tube: Serum gel
Submission Container/Tube: Plastic vial
Specimen Volume: 3.5 mL Serum
Collection Instructions: Within 2 hours of collection, centrifuge and aliquot serum into a plastic vial.
Specimen Minimum Volume
Serum: 1.6 mL
Specimen Stability Information
| Specimen Type | Temperature | Time |
|---|---|---|
| Serum SST | Frozen (preferred) | 42 days |
| Refrigerated | 72 hours |
Special Instructions
Testing Algorithm
Specimens with hepatitis C virus (HCV) RNA levels greater than or equal to 500 IU/mL will be tested for HCV genotype at an additional charge.
Specimens either generating indeterminate genotype results or results with multiple or mixed HCV genotypes (eg, 1, 5; 1a, 2; or 3, 5) containing genotype 1 but no subtype will be automatically evaluated with by genotype resolution at an additional charge.
For more information see:
-Chronic Hepatitis C Treatment and Monitoring Algorithm: Direct Antiviral Antigen (DAA) Combination
Method Name
HCVQG: Real-Time Reverse Transcription-Polymerase Chain Reaction (RT-PCR)
HCVG, HCVGR: RT-PCR followed by Hybridization with Sequence-Specific, Fluorescent-Labeled Oligonucleotide Probes
Reject Due To
| Gross hemolysis | Reject |
| Gross lipemia | OK |
| Gross icterus | OK |
Reference Values
Undetected
Day(s) Performed
Monday through Saturday
Reflex Tests
| Test ID | Reporting Name | Available Separately | Always Performed |
|---|---|---|---|
| HCVG | HCV Genotype, S | Yes | No |
| HCVGR | HCV Genotype Resolution, S | No | No |
Report Available
1 to 8 daysSpecimen Retention Time
60 daysPerforming Laboratory
Mayo Clinic Laboratories in Rochester
CPT Code Information
87522
87902 (if appropriate)
87902 (if appropriate)
Forms
If not ordering electronically, complete, print, and send 1 of the following forms with the specimen:
-Microbiology Test Request (T244)
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 and determining HCV genotype (1 to 5) to guide antiviral therapy in patients with chronic hepatitis C
Quantification of HCV RNA in serum of patients with chronic HCV infection (HCV antibody-positive) before initiating antiviral therapy
Determining cure and detection of relapse of HCV infection 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 and viral genotype before initiating 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.
Clinical Information
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 the 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.
Unique nucleotide sequences of certain regions (eg, 5'-noncoding, core, NS5b) of the HCV genome allow classification of HCV into 6 major genotypes or clades (1-6), based on the most recently proposed HCV genotype nomenclature. In the United States, the most commonly encountered HCV genotypes are 1a and 1b, followed by genotypes 2 and 3. Worldwide geographic distribution, disease outcome, and response to antiviral therapy differ among the genotypes. HCV genotype determination is important for proper selection of antiviral therapy and optimal patient management.
Therapeutic response rates for chronic HCV infection have improved significantly (cure rates of >90%) over the past 5 years when oral DAA agents are used in lieu of interferon-based combination therapy. However, antiviral resistance can emerge during such combination therapy, and occurrence of such resistance is more frequent with HCV subtype 1a than 1b for simeprevir-treated patients.
The American Association for the Study of Liver Diseases and Infectious Disease Society of America recommendations for testing, managing, and treating hepatitis C are available at www.hcvguidelines.org/contents.