Mayo Test Catalog, (Sorted By Test Name) - Mayo Medical ...

HCVQU
83142
0.58 – 0.72 = Stage F3 – Bridging fibrosis with many septa
0.72 – 0.74 = Stage F3 – F4
>0.74 = Stage F4 – Cirrhosis
Macroinflamm Activity Scoring:
0.62 = Grade A3 – Severe activity
Limitations:
The negative predictive value of a Fibrotest score 0.48 (F2, 3, 4) was 61% in that same patient
cohort. HCV FibroSURE is not recommended in patients with
Gilbert Disease, acute hemolysis (e.g. HCV ribavirin therapy
mediated hemolysis), acute hepatitis of the liver, extra-hepatic
cholestasis, transplant patients, and/or renal insufficiency patients.
Any of these clinical situations may lead to inaccurate quantitative
predictions of fibrosis and necroinflammatory activity in the liver.
Comment:
The performance characteristics of this test have been
determined by LabCorp. This test has not been cleared or
approved by the U.S. Food and Drug Administration (FDA).
The FDA has determined that such clearance or approval is not
currently required. LabCorp is regulated under the Clinical
Laboratory Improvement Amendments of 1988 (CLIA) and is
certified to perform high complexity testing.
Results and Interpretation Provided By:
Lab-Corp RTP
1912 Alexander Drive
Research Triangle Park, NC 27709
Test Performed By: Lab-Corp Burlington
1447 York Court
Burlington, NC 27215-2230
Hepatitis C Virus (HCV) RNA Detection and Quantification by
Real-Time Reverse Transcription-PCR (RT-PCR), Serum
Clinical Information: Immunocompetent individuals infected with hepatitis C virus (HCV) will
have anti-HCV antibodies detectable in their serum. In general, 70% to 80% of these individuals will
develop chronic infection with ongoing viral replication in the liver and detectable HCV RNA in serum,
eventually causing fibrosis and cirrhosis. The other 20% to 30% of infected individuals recover from the
infection without evidence of viral replication or the presence of detectable HCV RNA. In patients with
chronic HCV infection, the response to combined interferon-alpha and ribavirin therapy is correlated
with pretreatment serum HCV RNA levels (viral load) and HCV genotype. Similarly, the optimal
duration of combined interferon and ribavirin therapy can be determined from the patient's pretreatment
viral load and HCV genotype. Clinical studies also indicate that a decrease in HCV RNA levels of more
than 2 log IU/mL at 4 weeks and/or 12 weeks of therapy is predictive of an increased chance of
achieving a sustained virologic response (undetectable HCV RNA levels in serum 6 months after
completing antiviral therapy). Despite typically undergoing a longer duration of treatment (48 weeks
Current as of January 3, 2013 2:22 pm CST 800-533-1710 or 507-266-5700 or MayoMedicalLaboratories.com Page 907