Hepatitis C Virus RNA Quantitative, Real-Time PCR
0098268
Ordering Recommendation
Preferred test to confirm active hepatitis C virus (HCV) infection. Following positive HCV positive. Order only after positive HCV screen. Use to monitor therapy.
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Mnemonic
HEPCQNT
Methodology
Quantitative Real-Time Polymerase Chain Reaction
Performed
Sun-Sat
Reported
1-3 days
New York DOH Approval Status
This test is New York DOH approved.
Specimen Required
Patient Preparation
 
Collect
Lavender (EDTA), pink (K2EDTA), plasma preparation tube (PPT), or serum separator tube.  
Specimen Preparation
Separate serum or plasma from cells within 6 hours. Transfer 3.5 mL serum or plasma to an ARUP Standard Transport Tube. (Min: 1.5 mL)  
Storage/Transport Temperature
Frozen.  
Unacceptable Conditions
Heparinized specimens.  
Remarks
 
Stability
On Cells: Ambient: 6 hours; After separation from cells: Refrigerated: 72 hours; Frozen: 6 weeks  
Reference Interval
Not Detected
Interpretive Data
The quantitative range of this assay is 1.6 - 7.8 log IU/mL (43- 69,000,000 IU/mL).

Limit of detection (LOD):
All genotypes - 18 IU/mL (1.2 log IU/mL). Genotype 1 - 7.1 IU/mL (0.85 log IU/mL).
LOD values do not apply to diluted specimens.

An interpretation of "Not Detected" does not rule out the presence of PCR inhibitors in the patient specimen or hepatitis C virus RNA concentrations below the level of detection of the test. Care should be taken when interpreting any single viral load determination.

This test should not be used for blood donor screening, associated re-entry protocols, or for screening Human Cell, Tissues and Cellular Tissue-Based Products (HCT/P).
Note
The limit of quantification for this RNA assay is 1.6 log IU/mL (43 IU/mL). If the assay DID NOT DETECT the virus, the test result will be reported as "<1.6 log IU/mL (<43 IU/mL)." If the assay DETECTED the presence of the virus but was not able to accurately quantify the number of copies, the test result will be reported as "Not Quantified."

Specimens received with less than minimum volume for testing will automatically be run with a dilution according to the guidelines below:
-Specimens with 500-1000 µL will be diluted resulting in a modification of the quantitative range of the assay to 1.9-8.1 log IU/mL (88-140,000,000 IU/mL).
-Specimens with 200-500 µL will be diluted resulting in a modification of the quantitative range of the assay to 2.3-8.5 log IU/mL (219-350,000,000 IU/mL).

This test is intended for use in conjunction with clinical presentation and other laboratory markers as an indicator of disease prognosis. This test is also used in assessing viral response to antiretroviral treatment as measured by changes in HCV RNA levels.
CPT Code(s)
87522
Components
Component Test Code*Component Chart Name
0051819HCV RNA Qnt Real-Time PCR Interp
0099030HCV RNA Qnt Real-Time PCR
2002324HCV RNA Qnt Real-Time PCR
2005724EER Hepatitis C Virus RNA Quant RT-PCR
* Component test codes cannot be used to order tests. The information provided here is not sufficient for interface builds; for a complete test mix, please click the sidebar link to access the Interface Map.
Cross References
  • HCV monitoring
  • HCV quantitative
  • HCV Screen confirmation
  • HCV Viral Load
  • Nucleic Acid Amplification Test (NAAT)
  • Viral load monitoring