HCV Genotype

Expected Turnaround Time

24 Hours

Turnaround time is defined as the usual number of days from the date of pickup of a specimen for testing to when the result is released to the ordering provider. In some cases, additional time should be allowed for additional confirmatory or additional reflex tests. Testing schedules may vary.

Specimen Requirements

Specimen

Serum

Container

SST (Serum)

Storage Instructions

Room Temp., Refrigerated (2-8 C)

Stability Requirements

Room temp. 72hrs, Refrigerated 7 days

Test Details

Methodology

Molecular Pathology

Additional Information

A genotype is a way to put the hepatitis C virus (HCV) into categories based on similar genes. It’s important to know and understand HCV genotypes because different genotypes respond differently to medicines that treat and cure HCV. 

HCV has six genotypes, labeled 1 through 6. There are also subtypes labeled with letters, for example, genotypes 1a and 1b. Most people are infected by a single, dominant genotype, but it is possible to have more than one at the same time (called a mixed infection). 

A person is more likely to have a mixed infection if they: 

  • Got blood products like platelets, plasma, red cells, or whole blood many years ago 
  • Received blood products in a place that doesn’t check blood for hep C 
  • Are on kidney dialysis 
  • Inject drugs with shared or unsterilized needles 

All HCV genotypes cause the same amount of liver damage. However, people infected with genotype 1, particularly subtype 1b, may have a greater chance of developing cirrhosis, or severe liver scarring, than other genotypes. Genotypes 1b and 3 may increase the risk of liver cancer. 

In the era of interferon-based treatment and early direct-acting antiviral (DAA) therapy, genotype testing was an important part of hepatitis C care. Genotype 1—especially subtype 1b—is more difficult to treat. Early interferon-free DAA regimens worked against specific genotypes, so testing was important to guide treatment. But widely used modern DAAs are “pangenotypic,” meaning they work against all genotypes. People who will be treated with a pangenotypic regimen may not need genotype testing. 

Footnotes

  1. Scott JD, Gretch DR. Molecular diagnostics of hepatitis C virus infection: A systematic review. JAMA. 2007;297:724–32. [PubMed] [Google Scholar] 
  2. Smith DB, Bukh J, Kuiken C, Muerhoff AS, Rice CM, Stapleton JT, Simmonds P (2014). “Expanded classification of hepatitis C virus into 7 genotypes and 67 subtypes: updated criteria and genotype assignment web resource”. Hepatology. 59 (1): 318–27. doi:10.1002/hep.26744. PMC 4063340. PMID 24115039. 

Statement on Medical Necessity
All ordered tests should be medically necessary for the diagnosis or detection of disease, illness, impairment, symptom, syndrome, or disorder and the results should be used in the medical management and treatment decisions for the patient. Solaris requires ICD-10 codes with each order for lab testing and both the tests ordered and the diagnosis should be documented in the provider’s medical record for the patient. The United States Department of Health and Human Services, Office of Inspector General, takes the position that a provider who orders medically unnecessary tests may be subject to civil penalties.

Panels and Profiles
Solaris offers Providers the convenience of ordering test combinations in a group at times with the flexibility to choose appropriate test(s) for individual patients. Providers should only order those tests that he or she believes are medically necessary for each patient, and a lesser inclusive profile or individual tests should be ordered if not all tests in the test combination/profile are medically necessary. All tests offered in a test combination/profile may be ordered separately as individual tests. Solaris encourages clients to contact their Solaris representative if the testing configurations shown do not meet individual needs for any reason, or if some other combination of procedures is needed.

CPT Codes
CPT Codes listed are in accordance with Current Procedural Terminology, a publication of the American Medical Association. CPT codes are the responsibility of the billing party and are listed here for informational purposes. Correct coding may vary from one carrier to another. Solaris may bill specific carriers using codes other than what is shown.

Questions?

For questions or inquiries related to testing please reach out to
customerservice@solarisdx.com or contact us by phone at (844) 550-0308.