Preferred single test to confirm hepatitis C virus (HCV) infection following positive HCV screen.
- Patient Preparation
- Lavender (EDTA), pink (K2EDTA), plasma preparation tube (PPT), or serum separator tube.
- Specimen Preparation
- Separate serum or plasma from cells within 24 hours. Transfer 2 mL serum or plasma to an ARUP Standard Transport Tube. (Min: 1 mL)
- Storage/Transport Temperature
- Unacceptable Conditions
- Heparinized specimens.
- Ambient: Unacceptable; Refrigerated: 72 hours; Frozen: 6 weeks
Limit of detection (LOD):
15 IU/mL (1.2 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).
Specimens received with less than minimum volume for testing will automatically be run with a dilution according to the guidelines below:
-Specimens with 325-650 µL will be diluted resulting in a modification of the quantitative range of the assay to 1.5-8.3 log IU/mL (30-200,000,000 IU/mL).
-Specimens with 130-325 µL will be diluted resulting in a modification of the quantitative range of the assay to 1.9-8.7 log IU/mL (75-500,000,000 IU/mL).
This test is intended for use as an aid in the management of HCV-infected patients undergoing anti-viral therapy in conjunction with clinical and laboratory markers of infection. This test is also used in assessing HCV RNA levels at baseline, during treatment, at the end of treatment, and at the end of follow up of treatment to determine sustained or non-sustained viral response.
|Component Test Code*||Component Chart Name||LOINC|
|0051819||HCV Qnt by PCR Interp||11259-9|
|0099030||HCV Qnt by PCR (log IU/mL)||38180-6|
|2002324||HCV Qnt by PCR (IU/mL)||11011-4|
|2005724||EER HCV Qnt by PCR||11526-1|
- HCV monitoring
- HCV quantitative
- HCV Screen confirmation
- HCV Viral Load
- Nucleic Acid Amplification Test (NAAT)
- Viral load monitoring