Hepatitis C Virus (HCV) Genotyping, Reverse Transcription PCR
Test Mnemonic
HEPGEN
CPT Codes
- 87902 - QTY (1)
Aliases
- Hepatitis C Viral RNA, Genotype, LiPA
- HCV genotype
- Hep C Genotype
- Hepatitis C Genotype
- Abbott HCV Genotype II
Performing Laboratory
Cleveland Clinic Laboratories
FDA Category
In Vitro Diagnostic
Specimen Requirements
| Volume | Type | Container | Collect Temperature | Transport Temperature | Special Instructions |
|---|---|---|---|---|---|
| 2 mL | Plasma | EDTA PPT (White) | Refrigerated | Separate plasma from whole blood within 6 hours of collection by centrifugation at 800-1600 x g for 20 minutes at room temperature. Transport using cold packs. |
Alternate Specimen Requirements
| Volume | Type | Container | Collect Temperature | Transport Temperature | Special Instructions |
|---|---|---|---|---|---|
| 2 mL | Plasma | EDTA (Lavender) | Refrigerated | Separate plasma from whole blood within 6 hours of collection by centrifugation at 800-1600 x g for 20 minutes at room temperature. Transfer plasma to a sterile polypropylene screw-cap vial. Transport using cold packs. | |
| 2 mL | Serum | SST (Gold) | Refrigerated | Separate serum from whole blood within 6 hours of collection by centrifugation at 800-1600 x g for 20 minutes at room temperature. Transport using cold packs. | |
| 2 mL | Serum | No additive (Red) | Refrigerated | Separate serum from whole blood within 6 hours of collection by centrifugation at 800-1600 x g for 20 minutes at room temperature. Transfer serum to a sterile polypropylene screw-cap vial. Transport using cold packs. |
Minimum Specimen Requirements
| Volume | Type | Container | Collect Temperature | Transport Temperature | Special Instructions |
|---|---|---|---|---|---|
| 0.6 mL | Separate plasma/serum from whole blood within 6 hours of collection by centrifugation at 800-1600 x g for 20 minutes at room temperature. If there is no gel separator in the tube, transfer plasma/serum to a sterile polypropylene screw-cap vial. Transport using cold packs. |
Stability
| Environmental Condition | Description |
|---|---|
| Refrigerated | 3 days |
| Frozen | 60 days |
| Ambient | 24 hours |
Days Performed
2 days per week
Turnaround Time
3 - 6 days
Methodology
| Name | Description |
|---|---|
| Reverse Transcription/Polymerase Chain Reaction (RT/PCR) |
Reference Range
Special Info
This Hepatitis C virus (HCV) genotyping assay should only be ordered on patients with a diagnosis of HCV infection with detectable viral load. Genotyping may be unsuccessful in specimens with viral load <500 IU/mL. A negative result does not exclude HCV infection. If a genotype is unable to be determined using this assay and the viral load is >500 IU/mL, the specimen may be sent out to a reference laboratory for genotyping by an alternative method (ARUP Hepatitis C Virus Genotype by Sequencing: https://ltd.aruplab.com/Tests/Pub/0055593).
Clinical Info
The Hepatitis C virus (HCV), a significant cause of blood-borne hepatitis, is an enveloped virus containing a single-stranded positive sense RNA genome of approximately 9,500 nucleotides. It has been identified as the major etiological agent for post-transfusion non-A and non-B hepatitis worldwide. Based on genetic similarity, HCV has been classified into six major genotypes (1-6) and numerous subtypes (1a, 1b, etc.). Genotypes 1a, 1b, 2, and 3 are the most common HCV genotypes in the United States. HCV genotype testing may be considered for those in whom it may alter treatment recommendations. With the advent of pangenotypic HCV treatment regimens, HCV genotyping is no longer required prior to treatment initiation for all individuals. In those with evidence of cirrhosis and/or past unsuccessful HCV treatment, treatment regimens may differ by genotype and thus pretreatment genotyping is recommended. For noncirrhotic treatment-naive patients, although genotyping may impact the preferred treatment approach, it is not required if a pangenotypic regimen is used. HCV genotyping may also be ordered to obtain insurance pre-authorization for medications. The Abbott RealTime HCV Genotype II is an FDA-cleared in vitro reverse transcription-polymerase chain reaction (RT-PCR) assay used for the qualitative identification of hepatitis C virus (HCV) genotypes 1, 1a, 1b, and 2-5 in plasma or serum from individuals chronically infected with HCV. The Abbott RealTime HCV Genotype II is intended for use as an aid in the management of HCV-infected individuals and in guiding the selection of therapeutic treatment indicated for the above listed genotypes. The assay is intended for use on patients who are chronically infected with HCV, are being considered for antiviral treatment, and are positive for HCV RNA. The Abbott RealTime HCV Genotype II assay is not for screening blood, plasma, serum or tissue donors for HCV.
Clinical Limitation
1. Multiple genotype assay results may be caused by a mixed genotype infection, recombination of HCV genotypes, or assay probe cross-reactivity. 2. The Abbott RealTime HCV Genotype II assay is capable of detecting both genotypes in a genotype mixture when the concentrations of both genotypes are near equal; however, the assay may not detect the lower concentration genotype. 3. Performance has not been established with the Abbott RealTime HCV Genotype II assay for HCV genotype 6 specimens. HCV genotype 6 specimens may generate a HCV genotype 1 result with the Abbott RealTime HCV Genotype II assay based on probe cross-reactivity of the HCV genotype 1 probe. 4. A specimen with a result of “HCV not detected” cannot be presumed to be negative for HCV RNA. A specimen with an interpretation of “No Genotype Result” can not be presumed to be negative for the tested genotypes.
Clinical Reference
1. AASLD-IDSA. HCV testing and linkage to care. Recommendations for testing, managing, and treating hepatitis C. http://www.hcvguidelines.org/full-report/hcv-testing-and-linkage-care. [Last Accessed: 4/28/2023]. 2. US Food and Drug Administration. Abbott RealTime HCV Genotype II: Summary of Safety and Effectiveness Data. Approved June 20, 2013. https://www.accessdata.fda.gov/cdrh_docs/pdf12/P120012b.pdf. [Last Accessed: 4/28/2023].