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HelpTest Name HCVQN Hepatitis C Quantitative
Specimen Requirements
Preparation of Patient:
None
Container Type:
Gold Top SST Gel & Clot Activator Tube
Specimen Type:
Serum
Specimen Volume:
2.5 mL of Serum minimum 1.0 mL of Serum
Specimen Handling/Transport:
Separate serum from cells within 2 hours of collection.
Transport refrigerated 2-8°C.
Specimen Stability/Storage:
4 days ambient room temperature
5 days refrigerated 2-8°C
Performing Laboratory
Munson Medical Center Laboratories
Priority, Frequency, & Turnaround
Priority:
Non-Emergent
Frequency:
Monday through Thursday
Turnaround:
0-4 Days
Methodology
RT-PCR
Reporting
Reference Range:
Negative
Critical Decision:
None
Result Interpretation:
|
Result |
Analytical Interpretation |
Clinical Interpretation |
|
Target Not Detected |
HCV RNA not detected. Report results as “HCV not detected.” |
No current HCV infection For HCV Diagnosis: No further testing indicated.* For Viral Load Assessment: Routine clinical follow-up according to national HCV guidelines. |
|
< Titer Min |
HCV RNA detected but not quantified. Calculated titer is below the Lower Limit of Quantitation (LLoQ) of the assay. Report results as “HCV detected, less than (Titer Min)” Titer min = 15 IU/mL |
Low-level HCV viremia, may indicate previous spontaneous or treatment-related resolution of HCV infection. For HCV Diagnosis: Results must be interpreted within the context of all relevant clinical and laboratory findings.* For Viral Load Assessment: Routine clinical follow-up according to national HCV guidelines. |
|
15 IU/mL≤ Titer < 25 IU/mL |
HCV RNA detected and quantified. Calculated titer is within the Linear Range of the assay – greater than or equal to 15 IU/mL and less than 25 IU/mL. Report results as “(Titer) of HCV detected” |
Low-level HCV viremia, may indicate previous spontaneous or treatment-related resolution of HCV infection.* For HCV Diagnosis and Viral Load Assessment: Provide patient with appropriate counseling and link to care and treatment according to current national HCV treatment guidelines. |
|
25 IU/mL≤ Titer ≤ Titer Max |
HCV RNA detected and quantified Calculated titer is within the Linear Range of the assay – greater than or equal to 25 IU/mL and less than or equal to Titer Max. Report results as “(Titer) of HCV detected”. |
Current HCV Infection. For HCV Diagnosis and Viral Load Assessment: Provide patient with appropriate counseling and link to care and treatment according to current national HCV treatment guidelines. |
|
> Titer Max |
Calculated titer is above the Upper Limit of Quantitation (ULoQ) of the assay. Report results as “HCV detected, greater than (Titer Max).” Titer max = 1.00E+08 IU/mL |
Current HCV Infection. For HCV Diagnosis and Viral Load Assessment: Provide patient with appropriate counseling and link to care and treatment according to current national HCV treatment guidelines. |
CPT Code(s)
87522
Clinical Significance
HCV is considered to be the principal etiologic agent responsible for 90% to 95% of the cases of post-transfusion hepatitis. HCV is a single-stranded, positive sense RNA virus with a genome of approximately 9,500 nucleotides coding for 3,000 amino acids. As a blood-borne virus, HCV can be transmitted by blood and blood products. Widespread adoption of HCV blood screening measures has markedly lowered the risk of transfusion-associated hepatitis. The incidence of HCV infection is highest in association with intravenous drug abuse and to a lesser extent with other percutaneous exposures.
Detection of antibodies to HCV (anti-HCV) indicates prior exposure to hepatitis C but does not distinguish between cleared or active infection (i.e. where the virus is still replicating). 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.
Quantitation of HCV RNA for measuring baseline viral loads and for on-treatment viral loads have been well established in demonstrating the efficacy of antiviral response to pegylated interferon plus ribavirin (pegIFN/RBV) combination therapy.
An HCV RNA level below 25 IU/mL, 12 weeks after the end of treatment, is the goal of treatment and indicates that a sustained virologic response (SVR) has been achieved.