Laboratory Test Directory

Laboratory Test Directory

Share

Hepatitis C Virus Genotype

776


Methodology: Polymerase Chain Reaction
Performed: Varies
Reported: 4 days
Specimen Required: Collect: Lavender (EDTA) OR Serum Separator Tube (SST) - 0.5 ml plasma or serum. 

Specimen Preparation: Separate serum or plasma from cells within 6 hours. Transfer 2 mL serum or plasma to a Standard Transport Tube. 
Storage/Transport Temperature: Frozen. 
Unacceptable Conditions: Heparinized specimens. 
Stability: On cells: Ambient: 6 hours. After separation from cells: Refrigerated: 72 hours; Frozen: 1 month. 

NOTE: * This test is not available for New York patients, please refer to test code A776 for specimen requirements.* 

Performing Lab
Accu Reference Medical Laboratory

CPT Code(s): 87902
Test Panel Components Genotype 1a, Genotype 1b, Genotype 2a/c, Genotype 2b, Genotype 3, Genotype 4, Genotype 5, Genotype 6, Dual infections 1-4

Description

The hepatitis C virus (HCV) is a RNA virus that undergoes constant mutation, making it an infection that is a major, widespread public health problem.1 Globally, more than one million new cases are reported annually and currently, HCV is responsible for an estimated 8,000-to-10,000 deaths in the United States each year.2,3 HCV infection is also one of the main causes of cirrhosis to the liver, and hepatocellular carcinoma and HCV-related end stage liver disease is the leading reason for liver transplantation in the United States, as well.1,4 

Upon infection, individuals may note fatigue, loss of appetite, muscle aches, or even fever.5 Among most individuals, the immune system is unable to clear the infection successfully, leading to chronic HCV infection that progresses over decades.5 Individuals who develop cirrhosis of the liver may continue to advanced cirrhosis, which can lead to death.5 As a result, HCV infections are the leading indication for liver transplants and account for up to 50% of hepatocellular carcinoma cases.5

Six total HCV genotypes with several distinct subtypes have been identified, it cover the vast majority of disease presence seen in the US and the world. Each genotype has distinct consequences and differs in their responsiveness to combination therapy.1 Typically, patients are only infected with one genotype, but since each genotype is actually a combination of quasi-species, these quasi-species mutate quickly. This results in patients becoming immune to treatments and makes it difficult to treat HCV. Genotype 1 is the most common HCV genotype in the United States, and is the most difficult genotype to treat.1,4

Indications For Use

Determining the HCV genotype is a useful clinical tool for making therapeutic recommendations.1,6 Individuals with HCV genotypes 2 and 3 are about 3x more likely than individuals with genotype 1 to respond to therapy (both mono- and combination therapy). When using combination therapy, recommended treatment duration also depends on the genotype, adding to the clinical value of HCV genotype testing.1

Testing Frequency

Patients with chronic HCV should be examined every 1-to-4 weeks while on therapy. Evaluation should continue for at least 6 months after stopping therapy to assess whether the response to therapy has been sustained.1

HCV Test components

The GenMark Dx eSensor HCV genotyping test is designed to genotype for the most common HCV types and subtypes, listed below:

    • Genotype 1a

    • Genotype 1b

    • Genotype 2a/c

    • Genotype 2b

    • Genotype 3

    • Genotype 4

    • Genotype 5

    • Genotype 6

    • Dual infections 1-4

      Testing Overview

        • Multiplex Reverse-Transcription Polymerase Chain Reaction (RT-PCR) using the GenMark Dx eSensor Technology to amplify specific regions of the HCV genome

          o    Analysis distinguishes among the major genotypes and the most common HCV subtypes within the serum- or plasma-extracted nucleic acids, inclusive of the 5’ UTR and core regions

          • An HCV positive control is included in each assay
          • The test also covers co-infection capabilities for 1a+1b, 1+2, 1+3, and 1+4 HCV types and subtypes
          • Testing results are automatically generated on a single page for ease of understanding, and do not require any data interpretation

          Individuals Suitable For Testing

          • Patients suitable for testing are those with detectable hepatitis C viral RNA (estimated at >300 IU/mL) and those which are being evaluated for treatment1,3

          Test Limitations

          • This RT-PCR test may not be successful if the HCV RNA viral load is less than 50 IU/mL, and results should be correlated with additional methods (eg, routine serologic and molecular-based testing) in addition to clinical presentation1
          • Cross-reactivity between assay probes and various HCV genotypes may limit the ability of this assay to identify multiple HCV genotypes present in a given specimen5

          References

          1. WHO. Hepatitis C. http://www.who.int/csr/disease/hepatitis/whocdscsrlyo2003/en/index2.html Accessed: July 12, 2015. Updated: 2015.
          2. National Institutes of Health Consensus Development Conference Panel. National Institutes of Health Consensus Development Conference Panel statement: Management of Hepatitis C. Hepatology. 1997;26(suppl1):2S-10S.
          3. Zein NN. Clinical Significance of Hepatitis C Virus Genotypes. Clin Microbiol Rev. 2000;13: 223–235.
          4. Ghany MG, Strader DB, Thomas DL, et al; American Association for the Study of Liver Diseases. Diagnosis, management, and treatment of hepatitis C: an update. Hepatology. 2009;49:1335-1374.
          5. O’Brien S. The clinical importance of hepatitis C genotyping in the United States. Medical Laboratory Observer. 2013. http://www.mlo-online.com/articles/201311/the-clinical-importance-of-hepatitis-c-genotyping-in-the-united-states.php Accessed: August 26, 2015. Updated: 2015.
          6. 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.

          Back to Search Results



          Accureference Local US Locations Find Lab Locations in Your State

          Bayonne Patient Service Center #1
          546 Ave C, Bayonne NJ 07002
          Phone: (201) 471-7031
          Hours: 7:30 AM - 5:00 PM
          East Orange Patient Service Center
          108 South Munn Ave, East Orange, NJ 07018
          Phone: (862) 520-5315
          Hours: 10:00 AM-5:00 PM
          Florham Park Patient Service Center
          15 James St, Florham Park, NJ 07932
          Phone: (973) 301-1909
          Hours: 9:00 AM - 5:00 PM
          Glassboro Patient Service Center
          359 N Main Street, Glassboro, NJ, 08028
          Phone: (856) 881-5320
          Hours: 7:30 AM-3:30 PM
          Hoboken Patient Service Center
          450 7th Street, Hoboken, NJ 07030
          Phone: (201) 850-1437
          Hours: 8:00 AM - 4:00 PM
          Irvington Patient Service Center
          40 Union Avenue, Suite 205, Irvington, NJ 07111
          Phone: (862) 231-6223
          Hours: 9:00 AM - 7:00 PM
          Jersey City Patient Service Center
          709 Newark Ave 2nd Floor, Jersey City, NJ 07036
          Phone: (201) 222-0178
          Hours: 9:00 AM - 5:00 PM
          Linden Patient Service Center
          1901 East Linden Avenue, Linden, NJ, 07036
          Phone: (908) 474-1004
          Hours: 7:00 AM - 4:00 PM
          Somerset Patient Service Center
          1553 Rt.27, Somerset, NJ, 08873
          Phone: (908)583-6645
          Hours: 9:00 AM - 6:00 PM
          Woodbridge Patient Service Center
          1030 St.Georges Avenue, Lower Level, Suite V, Avenel, NJ, 07001
          Phone: (732) 326-2966
          Hours: 9:00 AM - 5:00 PM
          Have questions or need assistance? Call (877) 733-4522
          Bridgeport Patient Service Center
          754 Clinton Avenue, Bridgeport, CT, 06108
          Phone: (203) 290-4775
          Hours: 8:00 AM - 4:00 PM
          Stamford Patient Service Center
          111 High Ridge Road, First Floor, Stamford, CT, 06905
          Phone: (908) 583-6607
          Hours: 9:00 AM - 5:00 PM
          Have questions or need assistance? Call (877) 733-4522
          Have questions or need assistance? Call (877) 733-4522
          Accu Reference Florida Office
          2700 N 29th Ave, Suite 301 Hollywood, FL 33020
          Phone: (954) 237-7711
          Hours: 9:00 AM - 5:00 PM
          Manatee Patient Service Center
          2302 60th Street CT W, Bradenton, FL, 34209
          Phone: (941) 792-4993, ext.142
          Hours: 8:00 AM - 4:00 PM
          North Miami Patient Service Center
          1380 NE Miami Gardens Dr, Suite 271, Miami, FL, 33179
          Phone: (954) 237-7711
          Hours: 8:30 AM - 5:00 PM
          Have questions or need assistance? Call (877) 733-4522
          Have questions or need assistance? Call (877) 733-4522
          New Hyde Park Patient Service Center
          1575 Hillside Avenue, New Hyde Park, NY, 11040
          Phone: (516) 500-1047
          Hours: 7:30 AM - 4:00 PM
          Wappinger Falls Patient Service Center
          66 Middlebush Road, Wappinger Falls, NY, 12590
          Phone: (845)632-6262
          Hours: 7:30 AM - 4:00 PM
          Have questions or need assistance? Call (877) 733-4522
          Fayetteville Patient Service Center I
          1905 Skibo Road, Suite 101, Fayetteville, NC, 28314
          Phone: (910) 867-7071
          Hours: 9:00 AM - 6:00 PM
          Walter Reed Patient Service Center
          1220 Walter Reed Road, Suite A, Fayetteville, NC, 28304
          Phone: (910) 491-1956
          Hours: 7:00 AM - 4:00 PM
          Have questions or need assistance? Call (877) 733-4522
          Have questions or need assistance? Call (877) 733-4522
          Bangor Patient Service Center
          225 Erdman Avenue, Bangor, PA, 18013
          Phone: (610) 452-9174
          Hours: 7:00 AM- 3:00 PM
          Hazelton Patient Service Center
          101 South Church Street, Hazelton, PA 18704
          Phone: (570) 455-0747
          Hours: 8:00 AM - 4:00 PM
          Kingston Patient Service Center
          517 Pierce Street, Kingston, PA 18704
          Phone: (570) 283-0674
          Hours: 7:00 AM - 3:00 PM
          Nanticoke Patient Service Center
          233 South Prospect Street, Nanticoke, PA, 18634
          Phone: (570) 735-2626
          Hours: 7:00 AM - 1:00 PM
          Have questions or need assistance? Call (877) 733-4522
          Conlin Patient Service Center
          4420 Conlin Street, Ste#100, Metairie, LA, 70006
          Phone: (504) 302-2035
          Hours: 8:00 AM - 5:00 PM
          Saxon Patient Service Center
          4213 Saxon Street, Metairie, LA, 70006
          Phone: (504) 779-8163
          Hours: 7:00 AM - 4:00 PM
          West Bank Patient Service Center
          1799 Stumpf blvd, Gretna, LA 70056
          Phone: (504) 301-1817
          Hours:
          Have questions or need assistance? Call (877) 733-4522
          Have questions or need assistance? Call (877) 733-4522
          Physician & Hospital Lab Services, Montana (MT): Partnership
          Accu Reference Medical Lab
          Phone: (800) 295-0529
          Hours: 24H
          Physician & Hospital Lab Services, Nevada (NV): Partnership
          Accu Reference Medical Lab
          Phone: (800) 295-0529
          Hours: 24H
          Physician & Hospital Lab Services, Ohio (OH): Partnership
          Accu Reference Medical Lab
          Phone: (800) 295-0529
          Hours: 24H
          Physician & Hospital Lab Services, Oklahoma (OK): Partnership
          Accu Reference Medical Lab
          Phone: (800) 295-0529
          Hours: 24H
          Physician & Hospital Lab Services, Oregon (OR): Partnership
          Accu Reference Medical Lab
          Phone: (800) 295-0529
          Hours: 24H
          Physician & Hospital Lab Services, Alabama (AL): Partnership
          Accu Reference Medical Lab
          Phone: (800) 295-0529
          Hours: 24H
          Physician & Hospital Lab Services, Alaska (AK): Partnership
          Accu Reference Medical Lab
          Phone: (800) 295-0529
          Hours: 24H
          Physician & Hospital Lab Services, Arizona (AZ): Partnership
          Accu Reference Medical Lab
          Phone: (800) 295-0529
          Hours: 24H
          Physician & Hospital Lab Services, Arkansas (AR): Partnership
          Accu Reference Medical Lab
          Phone: (800) 295-0529
          Hours: 24H
          Physician & Hospital Lab Services, Colorado (CO): Partnership
          Accu Reference Medical Lab
          Phone: (800) 295-0529
          Hours: 24H
          Physician & Hospital Lab Services, Connecticut (CT): Partnership
          Accu Reference Medical Lab
          Phone: (800) 295-0529
          Hours: 24H
          Physician & Hospital Lab Services, Delaware (DA): Partnership
          Accu Reference Medical Lab
          Phone: (800) 295-0529
          Hours: 24H
          Physician & Hospital Lab Services, Florida (FL): Partnership
          2700 N 29th Ave, Suite 301, Hollywood, FL 33020
          Phone: 954-237-7711
          Hours: 24H
          Physician & Hospital Lab Services, Georgia (GA): Partnership
          Accu Reference Medical Lab
          Phone: (800) 295-0529
          Hours: 24H
          Physician & Hospital Lab Services, Hawaii (HI): Partnership
          Accu Reference Medical Lab
          Phone: (800) 295-0529
          Hours: 24H
          Physician & Hospital Lab Services, Idaho (ID): Partnership
          Accu Reference Medical Lab
          Phone: (800) 295-0529
          Hours: 24H
          Physician & Hospital Lab Services, Illinois (IL): Partnership
          Accu Reference Medical Lab
          Phone: (800) 295-0529
          Hours: 24H
          Physician & Hospital Lab Services, Indiana (IN): Partnership
          Accu Reference Medical Lab
          Phone: (800) 295-0529
          Hours: 24H
          Physician & Hospital Lab Services, Iowa (IA): Partnership
          Accu Reference Medical Lab
          Phone: (800) 295-0529
          Hours: 24H
          Physician & Hospital Lab Services, Kansas (KS): Partnership
          Accu Reference Medical Lab
          Phone: (800) 295-0529
          Hours: 24H
          Physician & Hospital Lab Services, Kentucky (KY): Partnership
          Accu Reference Medical Lab
          Phone: (800) 295-0529
          Hours: 24H
          Physician & Hospital Lab Services, Louisiana (LA): Partnership
          Accu Reference Medical Lab
          Phone: (800) 295-0529
          Hours: 24H
          Physician & Hospital Lab Services, Maine (ME): Partnership
          Accu Reference Medical Lab
          Phone: (800) 295-0529
          Hours: 24H
          Physician & Hospital Lab Services, Maryland (MD): Partnership
          Accu Reference Medical Lab
          Phone: (800) 295-0529
          Hours: 24H
          Physician & Hospital Lab Services, Massachusetts (MA): Partnership
          Accu Reference Medical Lab
          Phone: (800) 295-0529
          Hours: 24H
          Physician & Hospital Lab Services, Michigan (MI): Partnership
          Accu Reference Medical Lab
          Phone: (800) 295-0529
          Hours: 24H
          Physician & Hospital Lab Services, Minnesota (MN): Partnership
          Accu Reference Medical Lab
          Phone: (800) 295-0529
          Hours: 24H
          Physician & Hospital Lab Services, Missouri (MO): Partnership
          Accu Reference Medical Lab
          Phone: (800) 295-0529
          Hours: 24H
          Physician & Hospital Lab Services, Nebraska (NE): Partnership
          Accu Reference Medical Lab
          Phone: (800) 295-0529
          Hours: 24H
          Physician & Hospital Lab Services, New Hampshire (NH): Partnership
          Accu Reference Medical Lab, New Hampshire, NH
          Phone: (800) 295-0529
          Hours: 24H
          Physician & Hospital Lab Services, New Jersey (NJ): Partnership
          Accu Reference Medical Lab
          Phone: (800) 295-0529
          Hours: 24H
          Physician & Hospital Lab Services, New Mexico (NM): Partnership
          Accu Reference Medical Lab
          Phone: (800) 295-0529
          Hours: 24H
          Physician & Hospital Lab Services, New York (NY): Partnership
          Accu Reference Medical Lab, New York NY
          Phone: (800) 295-0529
          Hours: 24H
          Physician & Hospital Lab Services, North Carolina (NC): Partnership
          Accu Reference Medical Lab
          Phone: (800) 295-0529
          Hours: 24H
          Physician & Hospital Lab Services, North Dakota (ND): Partnership
          Accu Reference Medical Lab
          Phone: (800) 295-0529
          Hours: 24H
          Physician & Hospital Lab Services, Pennsylvania (PA): Partnership
          Accu Reference Medical Lab
          Phone: (800) 295-0529
          Hours: 24H
          Physician & Hospital Lab Services, Rhode Island (RI): Partnership
          Accu Reference Medical Lab
          Phone: (800) 295-0529
          Hours: 24H
          Physician & Hospital Lab Services, South Carolina (SC): Partnership
          Accu Reference Medical Lab
          Phone: (800) 295-0529
          Hours: 24H
          Physician & Hospital Lab Services, South Dakota (SD): Partnership
          Accu Reference Medical Lab
          Phone: (800) 295-0529
          Hours: 24H
          Physician & Hospital Lab Services, Tennessee (TN): Partrnership
          Accu Reference Medical Lab
          Phone: (800) 295-0529
          Hours: 24H
          Physician & Hospital Lab Services, Texas (TX): Partnership
          Accu Reference Medical Lab
          Phone: (800) 295-0529
          Hours: 24H
          Physician & Hospital Lab Services, Utah (UT): Partnership
          Accu Reference Medical Lab
          Phone: (800) 295-0529
          Hours: 24H
          Physician & Hospital Lab Services, Vermont (VT): Partnership
          Accu Reference Medical Lab
          Phone: (800) 295-0529
          Hours: 24H
          Physician & Hospital Lab Services, Virginia (VA): Partnership
          Accu Reference Medical Lab
          Phone: (800) 295-0529
          Hours: 24H
          Physician & Hospital Lab Services, Washington (WA): Partnership
          Accu Reference Medical Lab
          Phone: (800) 295-0529
          Hours: 24H
          Physician & Hospital Lab Services, West Virginia (WV): Partnership
          Accu Reference Medical Lab
          Phone: (800) 295-0529
          Hours: 24H
          Physician & Hospital Lab Services, Wisconsin (WI): Partnership
          Accu Reference Medical Lab, Wisconsin, WI
          Phone: (800) 295-0529
          Hours: 24H
          Physician & Hospital Lab Services, Wyoming (WY): Partnership
          Accu Reference Medical Lab
          Phone: (800) 295-0529
          Hours: 24H
          Have questions or need assistance? Call (877) 733-4522