Hepatitis C Virus (HCV) RNA, Quantitative PCR, Plasma/Serum
Test Mnemonic
HCQPCR
CPT Codes
- 87522 - QTY (1)
LOINC ®
20416-4
Aliases
- HCQPCR
- hep c
- SQHCQPCR
- HCV RNA
- HCVRNA
- viral load
Includes
- HCV RNA
- HCV RNA (IU/mL)
- HCV RNA (log IU/mL)
Performing Laboratory
Cleveland Clinic Laboratories
Specimen Requirements
| Volume | Type | Container | Collect Temperature | Transport Temperature | Special Instructions |
|---|---|---|---|---|---|
| 2 mL | Plasma | EDTA PPT (White) | Centrifuge and refrigerate. | Collect EDTA plasma according to standard protocol. Separate plasma by centrifugation (at 1,100 RCF for a minimum of 10 minutes) within 24 hours of collection. Plasma must be aliquoted first if sample is to be frozen. Sample can only be shared with AHCV1B, CMVQNT, HCQPCR, HIVRNA, HBVDNU, EBVQNT, or BKQUAN. |
Alternate Specimen Requirements
| Volume | Type | Container | Collect Temperature | Transport Temperature | Special Instructions |
|---|---|---|---|---|---|
| 2 mL | Plasma | EDTA (Lavender) | Centrifuge, aliquot and refrigerate ASAP. | Collect EDTA plasma according to standard protocol. Centrifuge (at >1300 RCF for a minimum of 10 minutes) and aliquot into a sterile secondary tube within 24 hours of collection. Plasma must be aliquoted first if sample is to be frozen. Sample cannot be shared with a test performed outside of Molecular Microbiology. Sample can only be shared with AHCV1B, CMVQNT, HCQPCR, HIVRNA, HBVDNU, EBVQNT, or BKQUAN. | |
| 2 mL | Serum | SST (Gold) | Centrifuge and refrigerate. | Collect serum according to standard protocol. Separate serum by centrifugation (at 1,100 RCF for a minimum of 10 minutes) within 24 hours of collection. Serum must be aliquoted first if sample is to be frozen. Sample cannot be shared with a test performed outside of Molecular Microbiology. Sample can only be shared with AHCV1B or HBVDNU. | |
| 2 mL | Serum | SST (Speckled or Tiger Top) | Centrifuge, aliquot and refrigerate ASAP. | Collect serum according to standard protocol. Centrifuge (at 1,100 RCF for a minimum of 10 minutes) and aliquot into a sterile secondary tube within 24 hours of collection. Serum must be aliquoted first if sample is to be frozen. Sample cannot be shared with a test performed outside of Molecular Microbiology. Sample can only be shared with AHCV1B or HBVDNU. | |
| 2 mL | Plasma | Pink KEDTA | Centrifuge and refrigerate. | Collect EDTA plasma according to standard protocol. Centrifuge (at >1300 RCF for a minimum of 10 minutes) and aliquot into a sterile secondary tube within 24 hours of collection. Plasma must be aliquoted first if sample is to be frozen. Sample cannot be shared with a test performed outside of Molecular Microbiology. Sample can only be shared with CMVQNT, HCQPCR, HIVRNA, HBVDNU, EBVQNT, or BKQUAN. |
Minimum Specimen Requirements
| Volume | Type | Container | Collect Temperature | Transport Temperature | Special Instructions |
|---|---|---|---|---|---|
| 1 mL | Minimum volume for testing is 1.0 mL of plasma/serum. Aliquots must be made from specimen prior to testing in any lab outside of Molecular Microbiology, and must be placed in a sterile aliquot tube. |
Stability
| Environmental Condition | Description |
|---|---|
| Ambient | 24 hours for plasma/serum or for whole blood unspun/unseparated |
| Refrigerated | 6 days for plasma/serum separated from whole blood within 24 hours; 24 hours for whole blood unspun/unseparated |
| Frozen | 12 weeks for plasma/serum if separated from whole blood and aliquoted into a secondary tube within 24 hours (plasma/serum cannot be frozen in PPT/SST tubes) |
Days Performed
7 days a week
Turnaround Time
1 - 3 days
Methodology
| Name | Description |
|---|---|
| Polymerase Chain Reaction (PCR), Quant |
Reference Range
| HCV RNA | |||||
|---|---|---|---|---|---|
| Sex | Age From | Age To | Type | Range | Range Unit |
| Normal | Not detected |
Clinical Info
HCV is a single stranded, positive sense RNA virus, which can be transmitted by blood and blood products. Detection of antibodies to HCV (anti-HCV) indicates prior exposure to hepatitis C but does not distinguish between cleared or active infection. Detection of HCV RNA with the detection of anti-HCV identifies an active hepatitis C infection. The results of HCV RNA testing together with other biochemical and clinical information, may be used to confirm an active HCV infection, measure the level of virus in the blood and assist in HCV prevention counseling medical care and treatment decision making. cobas HCV is an FDA-approved in vitro nucleic acid amplification test for both the detection and quantitation of hepatitis C virus (HCV) RNA, in human EDTA plasma or serum, of HCV antibody positive or HCV infected individuals. Specimens containing HCV genotypes 1 to 6 are validated for detection and quantitation in the assay. cobas HCV is intended for use as an aid in the diagnosis of HCV infection in the following populations: individuals with antibody evidence of HCV with evidence of liver disease, individuals suspected to be actively infected with HCV antibody evidence, and individuals at risk for HCV infection with antibodies to HCV. Detection of HCV RNA indicates that the virus is replicating and therefore is evidence of active infection. cobas HCV is intended for use as an aid in the management of HCV infected patients undergoing anti viral therapy. The assay can be used to measure HCV RNA levels at baseline during treatment, at the end of and at the end of follow up of treatment to determine sustained or non sustained viral response. The results must be interpreted within the context of all relevant clinical and laboratory findings. cobas HCV has not been approved for use as a screening test for the presence of HCV in blood or blood products. The assay is a quantitative PCR that targets highly-conserved regions of HCV and is reported out in international units (IU/mL). The linear range of the assay is 15 to 100,000,000 IU/mL (1.18 - 8.00 log IU/mL). The lower limit of detection of the assay is 15 IU/mL.
Clinical Limitation
For full limitations, refer to the assay instructions for use available on the manufacturer's website. The most important limitations are summarized as follows. Though rare, mutations within the highly conserved regions of a viral genome covered by cobas HCV may affect primer and/or probe binding resulting in the under quantitation of virus or failure to detect the presence of virus. Our laboratory accepts remnant specimens previously tested for anti-HCV from select other laboratories, in accordance with reflex testing algorithms recommended by the Centers for Disease Control (https://www.cdc.gov/mmwr/volumes/72/wr/mm7228a2.htm). This is associated with a small risk of carryover contamination, which may lead to rare cases of false positive results. In this setting, if results are discordant with clinical history/presentation or other lab findings, it is recommended to submit a dedicated specimen for repeat HCV RNA testing.
Clinical Reference
1. AASLD-IDSA. Recommendations for testing, managing, and treating hepatitis C. Accessed July 5, 2024. http://www.hcvguidelines.org. 2. Cartwright EJ, Patel P, Kamili S, Wester C. Updated Operational Guidance for Implementing CDC’s Recommendations on Testing for Hepatitis C Virus Infection. MMWR Morb Mortal Wkly Rep 2023;72:766–768. DOI: http://dx.doi.org/10.15585/mmwr.mm7228a2. 3. U.S. Food and Drug Administration (FDA). Premarket Approval Summary of Safety and Effectiveness Data P150015. Accessed July 5, 2024. https://www.accessdata.fda.gov/cdrh_docs/pdf15/P150015B.pdf.