Test Catalog

Test ID: HCVG    
Hepatitis C Virus Genotype, Serum

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

Determining hepatitis C virus (HCV) genotype (1 to 5) to guide antiviral therapy in patients with chronic hepatitis C


Differentiating between HCV subtypes 1a and 1b


This assay should not be used as a screening test for HCV infection. It should be performed only on specimens obtained from patients confirmed to have HCV RNA levels in serum of 500 IU/mL or higher.

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

Unique nucleotide sequences of certain regions (eg, 5'-noncoding, core, NS5b) of the hepatitis C virus (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. Therefore, reliable methods for genotype determination are important for proper selection of antiviral therapy and optimal patient management. Infections with HCV genotypes 2 and 3 have better therapeutic response rates (80%-90%) than genotypes 1 and 4 (40%-50%) to previous standard combination therapy (ribavirin plus pegylated interferon alpha-2a or alpha-2b). Duration of such combination therapy is 24 weeks for chronic HCV genotype 2 and 3 infections in patients who show early virologic response (>2 log or 100-fold decrease in HCV RNA or no detectable HCV RNA at week 12 of therapy), while patients with chronic HCV genotype 1 and 4 infections receive a minimum of 48 weeks of such combination therapy if early virologic response is achieved (undetectable HCV RNA at week 4 of therapy).


Therapeutic response rates for HCV genotype 1 infection are improved significantly (80%-90%) when oral direct acting antiviral agents (eg, daclatasvir, sofosbuvir, ledispasvir + sofosbuvir, velpatasvir + sofosbuvir, glecaprevir + pibrentasvir, elbasvir + grazoprevir, velpatasvir + voxilaprevir + sofosbuvir) are added or used in lieu of interferon-based combination therapy.


The American Association for the Study of Liver Diseases (AASLD) and Infectious Disease Society of America (IDSA) recommendations for testing, managing, and treating hepatitis C are available at www.hcvguidelines.org/full-report-view


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 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.


Interpretation Provides information to assist in interpretation of the test results

An "Undetected" result indicates the absence of detectable hepatitis C virus (HCV) RNA in the specimen.


An "Indeterminate" result may be due to 1 or more of the following causes: 1) low HCV RNA level (ie,<500 IU/mL), 2) HCV genotype 6, 3) probe reactivity with multiple HCV genotypes, or 4) variation in patient's HCV target sequences with mismatches to PCR primers and/or probes. Specimens generating indeterminate results with this assay will be automatically evaluated with the subsequent test HCVGR / Hepatitis C Virus Genotype Resolution, Serum.


An HCV genotype result of "1" without a subtype result may be due to 1 or more of the following causes: 1) low HCV RNA level (ie, <500 IU/mL), 2) probe reactivity with multiple genotype 1 subtypes, 3) variation in HCV genotype 1 target sequence, or 4) misclassification of some true genotype 6 strains.


This assay is able to differentiate between HCV subtypes 1a and 1b. However, subtypes are not reported for HCV genotypes 2 to 5 due to limitations of the current genotyping assay in accurately differentiating the various subtypes of these genotypes.


Results with multiple or mixed HCV genotypes (eg, 1, 5; 1a, 2; or 3, 5) may be due to mixed genotype infection or assay probe cross-reactivity. Only those specimens with multiple or mixed genotype results containing genotype 1 but no subtype will be automatically evaluated with the subsequent test HCVGR / Hepatitis C Virus Genotype Resolution, Serum.

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

An "Undetected" or "Indeterminate" hepatitis C virus (HCV) genotype result does not rule-out active HCV infection. Test results should be correlated with routine serologic and molecular-based testing, as well as clinical presentation. Specimens with indeterminate results will be automatically evaluated with the subsequent test HCVGR / Hepatitis C Virus Genotype Resolution, Serum.


Known cross-reactivity between the assay probes and various HCV genotypes limits the ability of this assay to identify multiple HCV genotypes present in a given specimen. Such cross-reactivity or the actual presence of multiple HCV genotypes in the same specimen may result in an "Indeterminate" or multiple/mixed genotype result.

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

1. Germer JJ, Mandrekar JN, Bendel JL, et al: Hepatitis C virus genotypes in clinical specimens tested at a national reference testing laboratory in the United States. J Clin Microbiol 2011;49:3040-3043

2. American Association for the Study of Liver Diseases and the Infectious Diseases Society of America. Recommendations for testing, managing, and treating hepatitis C. Accessed August, 2015. Available at www.hcvguidelines.org/full-report-view

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